Renal & Urology News August 2013 Issue

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Volume 12, issue Number 8

CAD in Dialysis Patients Rising

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CAD Prevalence Up in Dialysis Patients A large longitudinal study reveals that coronary artery disease (CAD) grew in prevalence among dialysis patients in the U.S. from 1995 to 2004. Shown here are the proportions of patients with CAD at the time of dialysis initiation. n 1995 n 2004

Death rates are declining, however

in this issue 8 Urine test may predict transplant rejection 10 Systolic BP rises observed in living kidney donors 11 Prostate cancer ADT raises acute kidney injury risk

12 New algorithm predicts dialysis patient transfusion risk

17 Immunosuppresive drug costs decline, but still high

Mediterranean diet shows long-term cardiac and mortality benefits PAGE 16

dialysis patients from 1995-2004 in the U.S. The overall annual prevalence of CAD at dialysis initiation increased significantly from 23.7% in 1995 to 27.6% in 2004. Increases in the overall burden of clinical CAD were observed among men and women and across almost all race groups, according to Dr. Stack.

The prevalence increased significantly from 25.2% to 29.7% among men (peaking at 30.1 in 2001) and from 22.1% to 25.1% among women (peaking at 25.3 in 2001). These findings are consistent with the increasing accep-

Discharge eGFR Can Be Misleading

by ROSEMARY FREI, MSc HONG KONG—Estimated glomerular filtration rate (eGFR) may be an inaccurate measure of kidney function at discharge among patients hospitalized for acute kidney injury (AKI), a new study suggests.

A British team found that eGFR overestimates renal function by 1.23fold in patients being discharged after an episode of AKI. They believe the overestimation is due to the calculations for eGFR not taking into account the significant loss of muscle mass in critically ill patients. “When a patient who had AKI leaves hoscontinued on page 6

23.7%

27.6%

Overall

25.2%

29.7%

Men

tance of older patients with a higher burden of overall comorbid disease.

Racial, gender differences What is interesting about the study, noted Consultant Nephrologist and senior author Liam Casserly, MD, “is that not only does it highlight the tre-

22.1%

25.1%

Women

© thinkstock

BY JODY A. CHARNOW U.S. dialysis patients are experiencing a rising burden of coronary artery disease (CAD), but their death rates are declining, perhaps due in part to better cardiovascular care in the general population prior to dialysis, researchers speculate.

Austin G. Stack, MD, Professor and Chairman of Medicine at the University of Limerick Graduate Entry Medical School in Ireland, and colleagues evaluated changes in the patterns of CAD prevalence and associated mortality in 823,753 incident

mendous burden of coronary disease in a very vulnerable population, but it also shows that substantial differences exist in prevalence and longitudinal trends over time among sex and race groups in the U.S.” Dr. Casserly pointed out that black continued on page 6

IgA Nephropathy Ups Mortality Mortality among patients with IgA nephropathy (IgAN) is twice the expected rate, but the rate is not significantly elevated prior to the start of renal replacement therapy (RRT), Norwegian researchers reported online in the American Journal of Kidney Diseases. Moreover, the risk of end-stage renal disease (ESRD) among IgAN patients is substantially greater than the risk of death.

During a mean follow-up of 11.8 years in a cohort of 633 patients diagnosed with IgAN during 1988-2004, the number of observed deaths was 80 and the number of expected deaths was 42, resulting in an age- and gender-

adjusted standardized mortality ratio (SMR) of 1.9.

The SMR, which is calculated by dividing the number of observed deaths in a study population by the number of expected deaths, for the IgAN patients varied according to their estimated glomerular filtration rate (eGFR) at the time of kidney biopsy. The researchers, led by Rune Bjørneklett, MD, PhD, of Haukeland University Hospital in Bergen, found no increase in mortality among patients with an eGFR of 60 mL/min/1.73 m2 or higher (low-risk patients), but the SMR was 1.9 for those with an eGFR of continued on page 6

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FDG-PET May Aid PCa Management

BY ROSEMARY FREI, MSc N I AGA R A FA LLS, O nt.— Positron emission tomography using 18F-fluorodeoxyglucose (FDG-PET) findings can help identify prostate cancer (PCa) patients who have high-risk disease prior to radical prostatectomy and are at elevated risk for treatment failure, researchers reported at the Canadian Urological Association’s 68th annual meeting.

Lead investigator Frederic Pouliot, MD, PhD, a urologic oncologist at Laval University in Quebec, and his team found that increased FDG uptake

in this issue 8 Azoospermia associated ith increased cancer risk 8 Many men with ED are aged 40 years or younger 11 High intake of omega-3 fatty acids may hike PCa risk

11 ADT found to increase likelihood of acute kidney injury

17 Obese prostate cancer patients have worse RP outcomes

Mediterranean diet shows long-term cardiac and mortality benefits PAGE 16

by the prostate is highly correlated with factors indicative of a poor prognosis such as advanced clinical stage, a pathological Gleason score of 8 or higher, and percentage of intraprostatic cancer.

They also found it strongly parallels patients’ likelihood of five-year progression-free survival based on two of the most highly regarded PCa nomograms, the pre-treatment nomogram from Memorial Sloan-Kettering Cancer Center (MSKCC) in New York and the Cancer of the Prostate Risk Assessment (CAPRA) – S (CAPRA-S) post-radicalprostatectomy nomogram from the

Nomogram Helps Predict SWL Success

BY ROSEMARY FREI, MSc NIAGARA FALLS, Ont.—Canadian researchers have validated a nomogram they say accurately predicts the success of treatment for renal or ureteral stones with shockwave lithotripsy (SWL).

Andrea Lantz, MD, a kidney stone and endourology fellow at the University of Toronto, described the nomogram at the Canadian Urological Association’s 68th Annual Meeting.

The nomogram was developed based on a study of patients who underwent treatment with an electromagnetic lithotripter. Dr. Lantz conducted the study with lead investigator Kenneth Pace, continued on page 6

Image courtesy of frederic pouliot, md

It identified men with Gleason 8 or higher disease

FDG-PET images may indicate which patients have high-grade prostate cancer.

University of California San Francisco.

“You could use FDG-PET before you operate on patients to help determine their management,” Dr. Pouliot said.

“Since there is a high failure rate with prostatectomy, the presence or absence of FDG uptake can help you decide

whether to still do a radical prostatectomy in a morbid patient or just reorient the patient to radiation therapy or androgen deprivation therapy.”

The researchers analyzed data from 54 patients with Gleason 8 or higher continued on page 6

Testosterone Takes off Pounds

BY ROSEMARY FREI, MSc Hypogonadal men receiving testosterone therapy may experience significant and sustained weight loss, a new study suggests.

In the study, men lost an average of 10.5% of their baseline body weight after five years of treatment. Over the same period, their mean body mass index (BMI) fell from 31.6 to 29.4 kg/m2.

The study involved 261 men with a mean age of 59.5 years who presented to a single urologist complaining of erectile dysfunction. They also had a range of common comorbidities, including benign prostatic hyperplasia/lower urinary tract symptoms

(57%), hypertension (45%), dyslipidemia (33%), and type 2 diabetes (31%).

All subjects received parenteral testosterone undecanoate 1,000 mg at baseline, again six weeks later, and then every 12 weeks for up to five years.

The two investigators, Aksam Yassin, MD, of the Segeberger Kliniken, Norderstedt, Germany, and Gheorghe Doros, PhD, of the Boston University School of Public Health, found that the men’s average testosterone levels rose from 7.72 nmol/L at baseline to 16.2 nmol/L within the first year of therapy, and plateaued at 18-19 nmol/L At the start of treatment, 162 men continued on page 6

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Renal & Urology News 3

From the Editor Editorial Advisory Board

Another Nutritional Warning: Omega-3s

O

nce again, a study offers evidence that one of the keys to good nutrition is avoiding excess. Theodore M. Brasky, PhD, of the Ohio State University Comprehensive Cancer Center in Columbus, and colleagues recently reported in the Journal of the National Cancer Institute that men who had the highest intake of omega-3 fatty acids had a 44% and 71% increased risk of low- and high-grade prostate cancer (PCa), respectively, compared with men who had the lowest intake (see article on page 11). Intake of omega-3 fatty acids, either by eating fish rich in these fatty acids (such as salmon or mackerel) or by taking fish oil supplements, have been widely advocated as a way to lower the risk of cardiovascular disease and cancer. But the new study underscores that the human body needs nutrients in the right amounts for proper functioning, and exceeding these amounts either offers no additional health benefit or could even be harmful.

Vitamins are a good (but hardly the only) example. The study by Dr. Brasky’s group looked at men who participated in SELECT (Selenium and Vitamin E Cancer Prevention Trial), which previously had shown that men who took vitamin E supplements had an elevated PCa risk compared with those who took placebo after seven years of follow-up. Earlier investigations had suggested that vitamin E had a protective effect.

And consider niacin, a water-soluble vitamin needed for proper metabolic functioning. It is used to lower levels of low-density lipoprotein and raise levels of high-density lipoprotein, and has been shown to decrease cardiovascular event risk. Within a certain dose range, niacin keeps the body healthy. But too much niacin can cause liver damage and other adverse effects.

Then there is magnesium, a mineral vital to a number of bodily functions. Excessive intake of magnesium supplements can cause an irregular heartbeat and low blood pressure.

In the U.S., there seems to be a widespread perception that, with respect to nutrition, if something is good for you, then more of it is even better or at least will not do any harm. In light of these recent studies, clinicians who counsel patients about embracing a healthy lifestyle may want to issue a caution about excessive intake of any food or supplement, even those high on the list of healthy items.

Sincerely, Jody A. Charnow Editor

Medical Director, Urology

Medical Director, Nephrology

Robert G. Uzzo, MD, FACS G. Willing “Wing” Pepper Chair in Cancer Research Professor and Chairman Department of Surgery Fox Chase Cancer Center Temple University School of Medicine Philadelphia

Kamyar Kalantar-Zadeh, MD, MPH, PhD Medical Director, Nephrology Professor & Chief Division of Nephrology & Hypertension University of California, Irvine School of Medicine Orange, Calif.

Nephrologists

Urologists Christopher S. Cooper, MD Director, Pediatric Urology Children’s Hospital of Iowa Iowa City R. John Honey, MD Head, Division of Urology, Endourology/Kidney Stone Diseases St. Michael’s Hospital University of Toronto Stanton Honig, MD Associate Clinical Professor of Surgery/Urology University of Connecticut School of Medicine, Urology Center New Haven J. Stephen Jones, MD, FACS, MBA Chief of Surgical Operations Fairview Hospital, a Cleveland Clinic hospital Professor of Surgery (Urology) Cleveland Clinic Lerner College of Medicine at Case Western Reserve University Leonard Horvitz and Samuel Miller Distinguished Chair in Urological Oncology Research Jaime Landman, MD Professor of Urology and Radiology Chairman, Department of Urology University of California, Irvine James M. McKiernan, MD Assistant Professor of Urology Columbia University College of Physicians and Surgeons New York City Kenneth Pace, MD, MSc, FRCSC Assistant Professor Division of Urology St. Michael’s Hospital University of Toronto Ryan F. Paterson, MD, FRCSC Assistant Professor Division of Urologic Sciences University of British Columbia Vancouver, Canada

Anthony J. Bleyer, MD, MS Professor of Internal Medicine/Nephrology Wake Forest University School of Medicine Winston-Salem, N.C. Suphamai Bunnapradist, MD Director of Research Department of Nephrology Kidney Transplant Research Center The David Geffen School of Medicine at UCLA R. Michael Hofmann, MD Associate Professor and Medical Director, Living Kidney Donor Program University of Wisconsin School of Medicine and Public Health, Madison Csaba P. Kovesdy, MD Associate Professor of Clinical Medicine University of Virginia, Charlottesville Chief of Nephrology Salem VA Medical Center Salem, Va. Edgar V. Lerma, MD, FACP, FASN, FAHA Clinical Associate Professor of Medicine Section of Nephrology Department of Medicine University of Illinois at Chicago College of Medicine, Chicago Allen Nissenson, MD Emeritus Professor of Medicine The David Geffen School of Medicine at UCLA, Chief Medical Officer, DaVita Inc. Rulan Parekh, MD, MS Associate Professor of Pediatrics and Medicine University of Toronto Robert Provenzano, MD Chief, Section of Nephrology St. John Hospital and Medical Center, Detroit Robert S. Rigolosi, MD Director, Regional Hemodialysis Center Holy Name Hospital, Teaneck, N.J. Lynda Anne Szczech, MD, MSCE Medical Director, Pharmacovigilence and Global Product Development, PPD, Inc. Morrisville, N.C.

Renal & Urology News Staff

Editor

Executive editor Senior editor

Web editor

Editorial coordinator Art director Group art director, Haymarket Medical VP, audience development and operations

Production manager

Production director

Product manager, digital products

Circulation manager

National accounts manager

Editorial director

Publisher VP medical magazines and digital products

CEO, Haymarket Media Inc.

Jody A. Charnow Marina Galanakis Delicia Honen Yard Stephan Cho Candy Iemma Andrew Bass Jennifer Dvoretz John Crewe Brian Wask Kathleen Millea Chris Bubeck Paul Silver William Canning Jeff Forster Dominic Barone Jim Burke Lee Maniscalco

Renal & Urology News welcomes letters to the editor.

Send to: Jody A. Charnow, 114 West 26th Street, 4th Floor, New York, NY 10001 or e-mail jody.charnow@haymarketmedia.com

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Renal & Urology News (ISSN 1550-9478) Volume 12, Number 8. Published monthly by Haymarket Media, Inc., 114 West 26th Street, 4th Floor, New York, NY 10001. Periodicals postage paid at New York, NY, and an additional mailing office. The subscription rates for one year are, in the U.S., $75.00; in Canada, $85.00; all other foreign countries, $110.00. Single issues, $20.00. www.renalandurologynews.com. Postmaster: Send address changes to Renal & Urology News, c/o DMD Data Inc., 2340 River Road, Des Plaines, IL 60018. For reprints, contact Wright’s Reprints at 1.877.652.5295. Copyright: All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of Haymarket Media, Inc. Copyright © 2013.

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Contents

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Nephrology 6

Dialysis Patient Mortality Lower with Sevelamer Hemodialysis patients using sevelamer rather than calcium carbonate experienced significantly reduced risks of cardiovascular and all-cause mortality.

ONLINE

10

Living Kidney Donors May Experience BP Rises Even blood pressure not considered ­hypertensive may reflect latent risk for adverse outcomes.

Expert Q&A

13

THC Locks May Offer Catheter Salvage Edge Taurolidine-heparin-citrate line locks appear to be better than heparin line locks for ­preventing the recurrence of catheter-related bacteremia in hemodialysis patients.

17

Immunosuppressive Drug Costs Decline The annual per-patient cost for kidney transplant patients has been in decline since 2007, but was twice as high in 2011 as in 1993.

this month at renalandurologynews.com Paul L. Crispen, MD, Assistant Professor of Urology at the University of Florida in Gainesville, discusses active surveillance for renal masses.

Clinical Quiz

Take our latest quiz at renalandurologynews.com /clinical-quiz/. Answer correctly and you will be entered to win a $50 American Express gift card.

Congratulations to our June winner: David Buchwald, MD

Urology 7

No Finasteride, Fatal PCa Link Finasteride use decreases the risk of prostate cancer without significantly increasing the risk of either high-grade or lethal prostate cancer.

11

Omega-3 Fatty Acids May Up PCa Risk The highest versus the lowest intake was associated with a 44% and 71% increased likelihood of low- and high-grade disease, respectively.

The Medical Minute

Visit renalandurologynews.com /the-medical-minute/ to hear podcast reports on new studies.

Our latest include: • Breath Test for Diabetes Shows Promise • Obese Found to Benefit from Robotic Kidney Transplants • Many Nephrologists Avoid Giving HD Patients Bad News

R&U University NEW

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11

17

ADT May Increase AKI Risk Compared with never-use, current use of ADT was significantly associated with a 2.5 times increased odds of AKI. Obese Men Have Worse RP Outcomes Abdominal obesity is associated with an increased likelihood of surgical complications and worse functional outcomes in men undergoing radical prostatectomy for prostate cancer.

This [algorithm] is not an answer unto itself,

but we hope that it is a small step in a positive direction for patient care.

See our story on page 12

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Upcoming Conference Coverage Visit our website for coverage of the following meetings: ··International Continence Society annual meeting Barcelona, Spain, August 26-30 ··ASTRO annual meeting, Atlanta, September 22-25 ·· World Congress of Endourology, New Orleans, October 22-26

14

Departments 3

From the Editor Omega-3s and prostate cancer risk

8

News in Brief Azoospermia linked to higher cancer risk

14

Legal Issues in Medicine Forgotten chart note leads to a lawsuit

16

Renal Nutrition Update The benefits of a Mediterranean diet

18

Practice Management A move toward pay-for-performance?

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Contents

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Urology

ONLINE

this month at renalandurologynews.com Expert Q&A

Paul L. Crispen, MD, Assistant Professor of Urology at the University of Florida in Gainesville, discusses active surveillance for renal masses.

Clinical Quiz

Take our latest quiz at renalandurologynews.com /clinical-quiz/. Answer correctly and you will be entered to win a $50 American Express gift card.

Congratulations to our June winner: David Buchwald, MD

The Medical Minute

Visit renalandurologynews.com /the-medical-minute/ to hear podcast reports on new studies.

Our latest include: • Testosterone Helps Improve Pain Perception, Quality of Life • IMRT After RP Not More Effective than Cheaper Radiotherapies • Vegetable Fats May Improve Survival in Prostate Cancer

7

No Finasteride, Fatal PCa Link Finasteride use decreases the risk of prostate cancer without significantly increasing the risk of either high-grade or lethal prostate cancer.

11

Omega-3 Fatty Acids May Up PCa Risk The highest versus the lowest intake was associated with a 44% and 71% increased likelihood of low- and high-grade disease, respectively.

11

ADT May Increase AKI Risk Compared with never-use, current use of ADT was significantly associated with a 2.5 times increased odds of AKI.

17

Obese Men Have Worse RP Outcomes Abdominal obesity is associated with an increased likelihood of surgical complications and worse functional outcomes in men undergoing radical prostatectomy for prostate cancer.

Nephrology 6

Dialysis Patient Mortality Lower with Sevelamer Hemodialysis patients using sevelamer rather than calcium carbonate experienced significantly reduced risks of cardiovascular and all-cause mortality.

10

Living Kidney Donors May Experience BP Rises Even blood pressure not considered ­hypertensive may reflect latent risk for adverse outcomes.

13

THC Locks May Offer Catheter Salvage Edge Taurolidine-heparin-citrate line locks appear to be better than heparin line locks for ­preventing the recurrence of catheter-related bacteremia in hemodialysis patients.

17

Immunosuppressive Drug Costs Decline The annual per-patient cost for kidney transplant patients has been in decline since 2007, but was twice as high in 2011 as in 1993.

R&U University NEW

Earn points and badges for your time spent on the Renal & Urology News website. Enroll at RenalandUrologyNews.com/R&U

We’re not preventing bone metastases

with this group of patients…Rather, we’re improving quality of life.

See our story on page 7

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Upcoming Conference Coverage Visit our website for coverage of the following meetings: ··International Continence Society annual meeting Barcelona, Spain, August 26-30 ··ASTRO annual meeting, Atlanta, September 22-25 ·· World Congress of Endourology, New Orleans, October 22-26

14

Departments 3

From the Editor Omega-3s and prostate cancer risk

8

News in Brief Azoospermia linked to higher cancer risk

14

Legal Issues in Medicine Forgotten chart note leads to a lawsuit

16

Renal Nutrition Update The benefits of a Mediterranean diet

18

Practice Management A move toward pay-for-performance?

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august 2013 www.renalandurologynews.com

CAD/dialysis

Mortality “Despite the high burden of CAD at dialysis initiation, adjusted mortality rates have fallen over time, albeit modestly, and this is a very welcome development,” said Dr. Stack, a Consultant Nephrologist at University Hospital Limerick.

Death rates (per 1,000 person-years) among men rose from 352 in 1995 to 379 in 1997 and then decreased to 248 in 2004. The rates among women rose increased from 366 in 1995 to 396 in 1999 and then declined to 357 in 2004.

The researchers found significant

reductions in mortality with advancing calendar year among white, Asian, and Native American men and white and Native American women, but no significant changes in mortality for black men and women. Their study, published in the American Journal of Nephrology (2013;38:66-74), is the first longitudinal assessment of trends in prevalence and mortality of coronary disease in the U.S. dialysis population.

“Most deaths that occur following dialysis initiation are cardiovascular in origin, and so it is essential that we evaluate time trends in mortality to assess the efficacy of conventional treatment practices,” Dr. Stack said. “The current study does show that very modest improvements have occurred in survival in this high-risk population with CAD despite advancing age and worsening comorbidity profiles.”

However, he noted that the study also shows clearly that substantial differences exist across race groups, which require detailed further exploration.

Dr. Stack said he and his colleagues can only speculate as to what would explain falling mortality rates despite increasing

Discharge eGFR

IgA nephropathy

continued from page 1

continued from page 1

30-60 (moderate-risk patients) and 3.6 among subjects with an eGFR below 30 (high-risk patients).

The age- and gender-adjusted SMR was not increased significantly in the pre-RRT period, but after RRT initiation, patients died at nearly five times the expected rate. Cardiovascular disease was the most common cause of death, accounting for 45% of all deaths.

The study also showed that ESRD occurred 3.2 times more frequently than pre-ESRD deaths, which is different from the findings of many other studies of chronic kidney disease (CKD), according to the researchers.

Dr. Bjørneklett’s group stated that their findings, particularly the observation that SMR is not increased among low-risk patients, indicate that pre-ESRD deaths and ESRD perhaps should be studied as separate endpoints in prognostic models of IgAN. Additionally, the researchers noted that low-risk IgAN patients have been denied access to life insurance, “probably due to their general status as CKD patients. Our results demonstrate that this is not appropriate and that patients with IgAN should be assessed on an individual basis from an insurance perspective.” n

pital with the same creatinine levels they entered hospital with, we might be falsely reassured they had complete recovery of renal function,” lead investigator John Prowle, MD, MSc, of the Royal London Hospital in the U.K. told Renal & Urology News. `However, when you factor in the expected fall in creatinine due to loss of muscle mass, we can see that some patients in fact had developed or progressed to CKD [chronic kidney disease] after their AKI and critical illness.”

Dr. Prowle and his co-investigators presented the results in poster form at the 2013 World Congress of Nephrology. They analyzed informa-

continued from page 1

men and women had the lowest CAD prevalence, whereas white men and women had the highest prevalence, although in each of these racial groups a rising burden of disease was observed over time.

From 1995 to 2004, the prevalence increased significantly from 28.7% to 32.4% among whites and from 14.3% to 17.5% among blacks.

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CAD burden. In their report, they cited the possible positive effect of “improved effectiveness of cardiovascular surveillance and treatments in the general population prior to dialysis as well as advancements in clinical care delivery after initiation.”

patients with advanced kidney disease in order to achieve better outcomes.

“While we all welcome these findings,” Dr. Stack cautioned, “we should not get too complacent and take our foot off the pedal. The mortality rates for patients with CAD who reach endstage kidney disease remain unacceptably high and much work needs to be done.”

He also stated that the implementation and quality assurance of evidence-based cardiovascular guidelines remains an important goal for all health professionals who care for

‘A long way to go’ “The most significant lesson to be learned from these data is that we have a long way to go to improve the outcomes of our patients on ­dialysis,” commented Beth Marie Piraino, MD, President of the National Kidney Foundation and Professor of Medicine at the University of Pittsburgh, who did not participate in the study. “Those who have a history of CAD at the start of dialysis are clearly at very high risk of dying and require special attention to electrolytes, fluid management, control of hypertension, and anemia. It remains to be seen what effect bundling and the trends for lower dosing of erythropoietin and hemoglobin levels have on mortality in this high risk group of patients.”

The authors speculate why mortality may have improved for some groups and not others, but the answer to the variation in outcome based on gender and race is not known. “In truth, all of the groups with CAD at the start of dialysis had very high two-year mortality.” n

tion from a database of all patients who were admitted to the Royal London Hospital’s intensive care unit (ICU) for five or more days in 2011 and survived to discharge. They excluded anyone who had a current or new diagnosis of end stage renal disease or who had received a kidney transplant.

For baseline creatinine level, researchers used the last available result from between one year and seven days before hospital admission or, if neither of these was available, they used creatinine level at hospital admission.

The 282 patients in their study had a median age of 51 years and 68% were male. Of them, 180 had AKI in the ICU, and 56 received dialysis. The median discharge creatinine level was 57 µmol/L (range 16-654 µmol/L).

The median creatinine level of

patients without AKI decreased from 84 µmol/L at admission to 54 µmol/L at discharge. Their discharge eGFRs were significantly higher than the predicted normal eGFR for patients of the same age (median 115 vs.

95 mL/min/1.73 m2). Among patients without AKI, this was 110 vs. 98 mL/ min/1.73 m2.

The investigators calculated that 44% more patients (36 vs. 25) should have been diagnosed with CKD at discharge, including three more patients who should have been diagnosed with CKD stage 3a, four more with stage 3b, and four more with stage 4.

“The message is that clinicians should be careful in judging renal recovery on the basis of hospital-discharge creatinine or an eGFR calculated from it,” Dr. Prowle said. n

Blacks had the lowest prevalence of CAD, whites had the highest.

Dialysis Patient Mortality Lower with Sevelamer Phosphate control in hemodialysis (HD) patients using

the risk of death from cardiac arrhythmias compared with

sevelamer rather than calcium carbonate is associated with

calcium carbonate treatment, Biagio Di Iorio, MD, of A.

a significant reduced risk of cardiovascular (CV) and all-cause

Landolfi Hospital, Solofra, Avellino, Italy, and colleagues

mortality, data from a 24-month open-label study of 466 HD

reported online ahead of print in the American Journal

patients suggest. In the study, subjects were randomized to

of Kidney Diseases. Compared with calcium carbonate,

receive either sevelamer (232 patients) or calcium carbonate

sevelamer was associated with a significant 10-fold decreased

(234 patients). In adjusted analyses, sevelamer treatment was

risk of any CV-related death and a significant 77% decreased

significantly associated with a greater than 10-fold reduction in

risk of death from any cause. n

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FDG-PET

Testosterone

continued from page 1

continued from page 1

10 kg or more, and 80% lost 5 kg or more. Four percent gained weight.

PCa who underwent FDG-PET. Forty-one also had radical prostatectomy and extended pelvic lymph node dissection and the remaining 13 underwent non-operative management with androgen deprivation therapy and/or radiotherapy, or both.

The team compared the findings from FDG-PET to those at surgery.

Increased FDG uptake occurred in 44%, 13% and 6% of patients’ prostates, lymph nodes, and bones, respectively. It had a 27% sensitivity for detecting lymph node metastases, but a specificity and positive predictive value of 100%.

(62%) had a BMI of 30 kg/m 2 or higher and 88 (34%) had a BMI of 25-25.9 kg/m2. In addition, 179 (69%) had a waist circumference (WC) greater than 102 cm and 74 (28%) had a WC of 94-101.9 cm.

The men experienced a mean weight loss of 11.1 kg or 10.5% of their initial weight, and the loss occurred linearly over five years, the researchers reported online in Clinical Obesity. Results showed that 14% of patients lost 20 kg more, 31% lost 15 kg or more, 51% lost

Waist circumference declines Concomitantly, WC declined in 97.5% of men. The mean reduction was 9.4 cm and occurred in a linear fashion during the study period. In addition, 84% had a WC decrease of 5 cm or more, 48% had at least a 10 cm drop, and 15% had at least a 15 cm reduction. WC increased in 2% of the men.

Furthermore, subjects’ mean BMI dropped from 31.7 kg/m 2 at baseline to 30.6 kg/m 2 after one year, 29.9 kg/m 2 at two years, 29.5 kg/m 2

at three years, and 29.4 kg/m2 at both four and five years.

The men who were obese at the start of the study period experienced the greatest reductions in body weight, waist circumference and BMI. “We may have found at least a partial solution for obese hypogonadal men,” said Farid Saad, MD, of Global Medical Affairs-Andrology at Bayer Pharma, Berlin, which funded the study. “While one would usually prefer a controlled study, here we have very robust data in an unselected group of patients who did not even have the intention to lose weight.” n

electromagnetic lithotripter in a more recent patient population. They reviewed data from patients treated at their lithotripsy unit from June 2010 to June 2013 using a Modulith SLX-F2 lithotripter (Storz). Their analysis included 147 patients with renal stones and 139 with ureteral stones. All had a solitary treated radio-opaque stone not more than 2 cm in diameter and had a computed tomography (CT) scan taken within four weeks of the SWL treatment.

Using the CT images, the investigators determined the skin-to-stone distance and the mean stone density.

The procedure began with fluoroscopic localization of the stone, followed by SWL with dose escalation up to a power setting of six for renal and upper ureteral stones and nine for stones in the mid- and distal ureter, all at a rate of 120 shocks per minute. The treatment was stopped when either good fragmentation had taken

place or the patient had received 3,000 shocks, whichever came first. A threemonth follow-up radiograph was used to determine whether patients with renal stones were stone free or had only insignificant stone fragments and those with ureteral stones were stone free.

The single-treatment success rates for renal and ureteral stones were 74.8% and 59.7%, respectively. For renal stones, significant predictors of successful SWL were stone area, stone density, and SSD; for ureteral stones, significant predictors were BMI, stone area, stone density, and SSD. The study population had more men than women. The average patient age was 53 years and the average stone area was 65.9 mm2 for renal stones and 51.5 mm 2 for ureteral stones. The stone length averages were 9.0 and 8.6 mm, respectively, the mean stone densities were 921.8 and 1000.8 Hounsfield units, and the mean SSDs were 105.8 and 134.3 mm. n

SWL nomogram continued from page 1

Gleason 8 or higher predicted Increased FDG uptake provided statistically significant correlations with a range of negative prognostic factors, including clinical stage and Gleason

FDG-PET may help determine which local treatment men should undergo. score. Furthermore, it predicted pathologic Gleason score: 81.8% of patients with increased FDG uptake had a pathologic Gleason score of 8 or higher at radical prostatectomy and none were downstaged to Gleason 6 or 7.

In addition, none of the patients with increased FDG uptake had a postprostatectomy Gleason pattern of 3 + 3, 3 + 4, or 3 + 5. Most had a pattern of 4 + 3, 4 + 4 and 4 + 5, and one had a 5 + 4 pattern.

“So without operating on your patients you can know whether it’s a real Gleason 8 or whether they will be downstaged to less than 8 on prostatectomy,” Dr. Pouliot explained.

Progression-free survival When the investigators entered the patients’ disease characteristics into nomograms, they found a 70.2% probability of five-year progression-free survival with CAPRA-S among patients without increased FDG uptake and a 91.5% probability with the MSKCC nomogram. The respective probabilities among patients with increased FDG uptake were 26.9% and 72.0%.

They concluded that FDG-PET may identify patients with a higher risk of local-treatment biochemical failure. n

RUN0813_Cvr.Uro.indd 2

MD, and R. John Honey, MD, both of the University of Toronto.

Drs. Pace and Honey, together with other collaborators, had created a nomogram to predict the success of a single treatment with SWL (J Urol 2011;186:556-562). It was based on patients treated with the Lithotron (Philips), an electrohydraulic lithotripter, from 2004 to 2009. The nomogram was based on patient- and stonerelated factors. For renal stones, it incorporated three variables for predicting the single-treatment success: age, skin-to-stone distance (SSD), and stone area. For ureteral stones, the nomogram used two factors for predicting treatment success: body mass index (BMI) and stone area.

Dr. Pace’s team wanted to determine whether the nomogram is valid and generalizable to SWL with an

Small BP Declines Post-HD Predict Better Survival Modest declines in blood pressure (BP) after hemodialysis

between -30 and 0 mm Hg were associated with improved

(HD) are associated with the greatest survival, whereas any

survival. The investigators observed the greatest survival

rise or large decline in BP is associated with worse survival.

among patients who had a 14 mm Hg decrease in systolic BP,

“BP change between pre- and post-HD could be highlighted

which was associated with an 8% decreased risk of mortality

as a therapeutic target for further improving patients’ out-

in adjusted analyses, the researchers reported online in Kidney

comes,” concluded a team led by Kamyar Kalantar-Zadeh,

International. Large decreases in systolic BP (greater than 30

MD, MPH, PhD, of the University of California Irvine School of

mm Hg), however, were associated with increased mortality.

Medicine in Orange.

Dr. Kalantar-Zadeh and his colleagues analyzed data from

Better survival was observed among patients whose change in diastolic BP was between -15 and 5 mm Hg. The great-

113,255 HD patients to evaluate an association between

est survival was observed among subjects with a diastolic

change in BP during HD and mortality. They defined change

BP decrease of 6 mm Hg, which was associated with a 7%

in BP as post-HD minus pre-HD BP. They used the mean of BP

decreased risk of death. The subjects had a mean age of 61

change values during the HD session as a mortality predictor.

years. The racial composition of the study population was

Over a median follow-up of 2.2 years, 53,461 subjects

43% Caucasian, 32.4% African American, 14.5% Hispanic, and

(47.2%) died from any cause and 21,548 (25.7%) died from

3% Asian. Hypertension and diabetes were comorbidities in

cardiovascular causes. Post-HD declines in systolic BP

80% and 57.5% of patients, respectively. n

7/23/13 4:44 PM

www.renalandurologynews.com august 2013

■ CUA 2013

Renal & Urology News 7

Reports from the Canadian Urological Association 2013 annual meeting, Niagara Falls, Ont. Rosemary Frei, MSc, provided news coverage.

No Finasteride, High-Grade PCa Link The finding is based on an analysis of data from the Health Professionals Follow-up Study Finasteride use decreases the risk of prostate cancer (PCa) without significantly increasing the risk of either high-grade or lethal PCa, according to an analysis of data from the Health Professionals Follow-up Study (HPFS).

Lead investigator Mark Preston, MD, a urologist at Massachusetts General Hospital in Boston, and his colleagues conducted the study after the FDA issued a notice to healthcare professionals in June 2011 stating they believed men being treated with 5-alpha reductase inhibitors (5-ARIs) for benign prostatic hyperplasia (BPH) were at increased risk of developing high-grade PCa. The FDA based its conclusions on the results of two large, randomized, controlled trials. The Prostate Cancer Prevention Trial (PCPT) compared finasteride 5 mg per day to placebo

Denosumab Delays Bone Metastases Denosumab significantly delays the time to bone metastases in men who have non-metastatic castrateresistant prostate cancer (CRPC) and a PSA doubling time (PSADT) of six months or less.

In a poster presentation, Blair Egerdie, MD, and his colleagues showed that the median time to the development of bone metastases was 25.9 months for patients treated with denosumab compared with 18.7 months for placebo recipients, for a significant 23% risk reduction.

In addition, the median time to multiple or symptomatic bone metastases was 44.6 months for denosumabtreated patients compared with 30.6 months for placebo recipients, for a significant 30% risk reduction.

“We’re not preventing bone metastases with this group of patients, who are the riskiest of the risky in terms of bone metastases. Rather, we’re improving quality of life,” said Dr. Egerdie, a urologist at Urology Associates/Urology

RUN0813_CUA.indd 7

for seven years in BPH patients. The Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial compared dutasteride 0.5 mg per day to placebo for four years. The FDA determined there was a reduction in overall PCa risk in patients on active treatment in the two trials. However, they found that this was largely due to a reduced incidence of lower-risk forms of PCa and there was an increased incidence of high-grade PCa with 5-ARI treatment.

The HPFS has been following male health professionals since 1986. The subjects were 40 to 75 years of age at the start of the study. The investigators focused on the information collected from 38,430 cancer-free men every two years starting in 1996 and ending in 2010. They were all cancer-free in 1996.

PCa developed in 3,710 men. Of these,

Medical Research in Kitchener, Ontario.

Denosumab is a human monoclonal antibody that inhibits osteoclastmediated bone destruction. The new study confirms the findings of a previous study published in the Lancet (2012;379:39-46) showing that the medication delays time to bone metastases in patients with non-metastatic CRPC. Dr. Egerdie’s group recruited and randomized men with non-metastatic CRPC who had a PSA level of 8.0 ng/mL or higher and PSADT of 10 months or less. Patients received either subcutaneous denosumab 120 mg or placebo once every four weeks Of the 716 patients who were randomized to each arm, 427 in the denosumab arm and 419 in the placebo arm had a PSADT of six months or less.

The researchers focused their analysis on these patients.

The men in the two groups had the same median age (73 years) and were generally similar with respect to other baseline characteristics, including median time from diagnosis to randomization (5.5 years for denosumab patients and 5.6 years for placebo patients), median PSA (12.3 and 12.5 ng/mL, respectively), and median PSADT (3.2 and 3.1 months, respectively). n

Mark Preston, MD

293 were lethal cases, 578 were advanced cases, and 463 were high-grade cases.

The remaining 72% of the patients had localized PCa. After adjusting for

confounders, men who had ever used finasteride had a 23% reduced risk of any PCa and a 34% decreased risk of Gleason 7 disease compared with men who never used the drug.

Commenting on the new findings, J. Curtis Nickel, MD, Professor of Urology at Queen’s University in Kingston, Ont., said the apparent higher rate of highgrade PCa detected in the PCPT and the REDUCE trial was due to a number of biases, such as change in PSA, reduction in prostate volume, and suppression of low-grade cancers.

Finasteride and dutasteride, said Dr. Nickel, who was not involved in the new study, appear to suppress both BPH and low-grade, low-risk cancer, “and like the scum that rises out of the muck, we more easily detect the higher-grade, higher-risk PCa—the potentially lethal cancer that we want to find.” n

Metabolic Abnormalities May Raise Prostate Cancer Risk New research findings suggest that

for its relationship with PCa, it does

having more components of the meta-

appear to be greater than the sum of

bolic syndrome is associated with a

its parts.”

higher risk for developing any prostate cancer (PCa).

In a study, Bimal Bhindi, MD, and

Dr. Bhindi’s group evaluated the association between five components of the metabolic syndrome and PCa

colleagues at the University of Toronto

in men whose biopsy samples are

found that men with three or more

included in the GenitoUrinary BioBank

components of the metabolic syn-

at the Princess Margaret Hospital in

drome had 38% higher odds of being

Toronto. These components included

diagnosed with PCa than men with no

elevated fasting glucose concentration

risk factors, and they had 52% and

or diabetes, obesity, elevated levels

43% higher odds of being diagnosed

of triglycerides, low concentration of

with clinically significant PCa (cancers

high-density-lipoprotein cholesterol,

fulfilling grade and/or volume criteria

and hypertension.

making the cancer less suitable for sur-

“Obesity is associated with a hemo-

veillance) or high-grade PCa (Gleason 7

dilution of PSA, therefore decreasing

or higher), respectively.

the risk of referral for biopsy,” he said.

Individual components of metabolic

“In our study, everyone had a biopsy,

syndrome were not associated with

therefore circumventing this potential

PCa. “In the cardiovascular litera-

source of bias,” he said. All of the

ture, many argue whether metabolic

2,144 patients who were included in

syndrome is greater than the sum of

the analysis underwent a biopsy for

its parts,” said Dr. Bhindi, a urologic

suspected cancer. None were on active

surgery resident. “In our study, at least

surveillance.

n

7/23/13 4:46 PM

8 Renal & Urology News

august 2013 www.renalandurologynews.com

News in Brief

Please visit us at www.renalandurologynews.com for the latest news updates from the fields of urology and nephrology

Short Takes Many ED Patients Are 40 or Younger

New England Journal of Medicine that

An exploratory analysis revealed that

encode immune-system proteins impli-

one in four men seeking first medical

cated in transplant rejection, along with

help for new-onset erectile dysfunction

one noncoding RNA molecule involved

(ED) was no older than age 40 years.

in protein production, could be used to

Of 439 consecutive patients, new-

detect transplant rejection as well as

onset ED as the primary disorder was

predict future rejection.

two messenger RNA molecules that

found in 114 men (26%) aged 40 and Sexual Medicine study (2013;10:1833-

Alcohol Use Down After Stopping Finasteride

1841). ED was severe in nearly half of

Men who stopped using the 5-alpha-

the young men (48.8%), comparable

reductase inhibitor finasteride noted a

with the rate of 40% for the older

reduction in their alcohol consumption,

patients. The younger men had a

as described in a study in Alcoholism:

higher mean circulating total testoster-

Clinical and Experimental Research.

one level and were more likely to have

Of 63 otherwise healthy men who

younger, according to The Journal of

premature ejaculation, but less likely to

had developed persistent sexual

have Peyronie’s disease.

side effects associated with use of finasteride and who had consumed at

Urine Test May Predict Transplant Rejection

least one alcoholic beverage per week

Three urinary biomarkers have been

noted a decrease in their alcohol

found to form a diagnostic signature

consumption after stopping treatment,

that could distinguish kidney recipients

investigator Michael S. Irwig, MD, of

with biopsy-confirmed rejection from

the George Washington University

those whose biopsies showed no signs

School of Medicine in Washington, DC,

of rejection or who did not undergo

found. The mean number of alcoholic

biopsy. Manikkam Suthanthiran, MD,

beverages consumed per week fell

of Weill Cornell Medical College in New

from 5.2 before finasteride use to 2.0

York, and colleagues reported in The

afterward.

before starting the drug, 41 (65%)

The Treated ESRD Population As of December 31, 2010, the total population of individuals treated for end-stage renal disease (ESRD) in the U.S. was 593,086, a 4% increase from 2009, according to the U.S. Renal Data System. This is the smallest increase in 30 years. Here is a population breakdown by ESRD treatment:

Hemodialysis Peritoneal dialysis Functioning kidney transplant

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

Source: U.S. Renal Data System, USRDS 2012 Annual Data Report: Atlas of End-Stage Renal Disease in the United States.

RUN0813_NewsInBrief.indd 8

Proteinuria Decline Predicts Lupus Nephritis Outcomes A

50% or greater reduction in proteinuria after six months of treatment for severe lupus nephritis (SLN) predicts favorable outcomes, investigators reported online in Nephrology Dialysis Transplantation.

Stephen M. Korbet, MD, of Rush University Medical Center in Chicago, and collaborators studied 61 patients who originally participated in a prospective, controlled trial comparing standard therapy with plasmapheresis for SLN. Of these, 34 patients attained a 50% or greater reduction in proteinuria at six months and 27 did not. The two groups had a similar mean follow-up period: 133 and 136 months, respectively.

At follow-up, a complete remission (CR)—defined as a serum creatinine level of 1.4 mg/dL or less and proteinuria of 0.33 g/day or less—was attained in 56% of patients who had a 50% or greater reduction in proteinuria at six months compared with 22% of the patients who did not. The 15-year renal survival was 71% and 25%, respectively, and patient survival without end-stage renal disease was 66% and 18%, respectively. All the differences between the groups were statistically significant.

Smaller, Regular Iron Doses Reduce Dialysis Infections M

aintenance iron supplementation may result in fewer infections than does bolus dosing in patients on hemodialysis (HD), particularly those with a catheter, according to study findings published in the Journal of the American Society of Nephrology (2013;24:1151-1158). Multivariable additive risk models based on clinical data from 117,050 U.S. HD patients indicated that patients receiving large amounts of iron over a short period of time on an as-needed basis were at increased risk of infection-related hospitalization over a three-month follow-up compared with patients receiving smaller amounts on a regular schedule to maintain iron repletion. They experienced 25 additional events per 1,000 patient-years.

Risks were largest among patients with a catheter. Bolus dosing also was associated with infection-related mortality.

Men with Azoospermia May Be At Increased Cancer Risk A

zoospermia is associated with an elevated risk of cancer, according to new findings published online in Fertility and Sterility. A team led by Michael L. Eisenberg, MD, Director of Male Reproductive Medicine and Surgery at Stanford University School of Medicine in Palo Alto, Calif., analyzed data from 2,238 infertile Texas men seen in a clinic at the Baylor College of Medicine in Houston. Of these, 451 had azoospermia and 1,787 did not. Cancer was diagnosed in 29 of the 2,238 subjects over a 5.8-year average period from their semen analysis to the cancer diagnosis. Men with azoospermia were nearly three times as likely to receive a cancer diagnosis as men in the general Texas population. The researchers concluded that additional follow-up of azoospermic men after reproductive efforts end may be warranted.

7/23/13 4:45 PM

10 Renal & Urology News

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Denervation Works for Resistant HTN Data show sustained blood pressure and pulse pressure reductions two years after the procedure

BY JOHN SCHIESZER SAN FRANCISCO—Renal denervation may provide safe and sustained reductions in blood pressure (BP) and pulse pressure for two years in patients with treatment-resistant hypertension, according to new data presented at the 28th Annual Scientific Meeting of the American Society of Hypertension.

“The use of renal denervation is an extremely promising approach to the treatment of patients with uncontrolled resistant hypertension,” said investigator John Flack, MD, Associate Chairman for Clinical Research at Wayne State University Health Center in Detroit.

Pooled two-year data from the Symplicity HTN-1 and Symplicity HTN-2 trials show impressive reductions in office systolic BP (SBP) with a single renal denervation treatment to both renal arteries using radiofrequency ablation, Dr. Flack said.

The Symplicity HTN-1 and Symplicity HTN-2 trials involved the use of a percutaneous catheter-based approach to deliver low-power radiofrequency energy to the renal nerves, thus interrupting the renal efferent and afferent sympathetic pathways. In this analysis, 239 patients had treatment-

resistant hypertension. At baseline, they had a mean SBP of 160 mm Hg and a mean estimated glomerular filtration rate of 45 mL/min/1.73m2. During the studies, all of the patients remained on their antihypertensive regimen; however, changes in their regimens were allowed as clinically indicated. The mean age of patients who received renal denervation was 57 years and mean body mass index was 32 kg/m2.

For these trials, treatment-resistant hypertension was defined as uncontrolled BP despite use of three or more antihypertensive medications including a diuretic.

At one month after renal denervation, BP had decreased by a mean 19/8 mm Hg. In 149 patients followed out to two years, BP had decreased by a mean of 29/13 mm Hg. In addition, 38.9% of 12 patients who had an SBP of 140159 mm Hg at baseline had an SBP below 140 mm Hg at two years after treatment.

“Research into renal denervation is very important and timely,” Dr. Flack told Renal & Urology News. “First, this approach allows for very impressive reductions in both systolic and diastolic BP in patients who manifest persistently high blood pressures

despite intensive antihypertensive drug therapy. The reductions in blood pressure do not appear to be dependent on the type of antihypertensive drug therapy prescribed. Second, the bloodpressure lowering effect is durable out to beyond two years with a single treatment. Third, there are other clinically

At one month after renal denervation, BP had decreased by a mean 19/8 mm Hg. relevant benefits of renal denervation other than simply BP lowering.”

Small studies have shown that sleep apnea and glycemic control is improved in patients who have undergone this procedure, he noted.

The adverse events observed in the two trials were similar to those commonly observed with percutaneous access and catheter manipulation within the arteries. “There was no change in kidney function as determined by estimated glomerular filtration rate,” Dr. Flack said. “Adverse events related to the procedure have

been very modest and mostly related to post-procedure hypotension.”

Patients older than 65 tended to have a lower baseline diastolic blood pressure (DBP) and higher baseline pulse pressure than younger patients.

Both groups, however, had similar significant drops in pulse pressure at 24 months: (-16.4 and -15.7 mm Hg for those younger and older than 65, respectively).

Significant reductions in pulse pressure were driven by reductions in SBP, which lowers myocardial wall stress and subsequent oxygen requirements, Dr. Flack explained. Lowering SBP even when DBP is in the normal range has been shown consistently to reduce cardiovascular risk in older patients with wide pulse pressure hypertension.

“Two-year follow-up data, though impressive, is not enough to determine the long-term efficacy and safety of the renal denervation procedure,” Dr. Flack said. “Nevertheless, there is ongoing long-term follow-up of patients beyond two years, and ongoing larger and more tightly controlled trial (Symplicity HTN-3) that will enroll 530 patients with severe uncontrolled resistant hypertension, and planned future studies in less severe hypertension.” n

Living Kidney Donors May Experience BP Rises

BY JOHN SCHIESZER SAN FRANCISCO—Living kidney donors may experience an increase in systolic blood pressure (SBP) and may need closer monitoring for renal and cardiovascular (CV) abnormalities, researchers reported at the 28th Annual Scientific Meeting of the American Society of Hypertension.

“Elevations in blood pressure that are still ‘non-hypertensive’ but in the currently defined pre-hypertension stage could be reflective of a latent risk for adverse cardio-metabolic outcomes in living kidney donors,” said investigator George Thomas, MD, a staff physician at Cleveland Clinic.

Dr. Thomas pointed out that living kidney donors make up a population that undergoes extensive evaluation prior to possible donation and is presumably healthy with no clinical diagnosis of hypertension, cardiovascular disease (CVD), or chronic kidney dis-

RUN0813_ASH1.indd 1

ease. He and his colleagues studied 606 consecutive living kidney donors who underwent nephrectomy from April 1997 to November 2010. Of these, 88% were Caucasian and 59% were women. The mean age of the cohort was 41.3 years. Donors with an SBP of

Increased blood pressure may signal a need for closer monitoring.

115-139 mm Hg or greater had a significantly greater number of potentially adverse cardiovascular (CV) and renal risk factors compared with the donors who had lower SBP, the researchers reported.

The study excluded donors if they had clinical hypertension (140/90 mm

Hg), kidney disease, diabetes, CVD, obesity, and proteinuria. The investigators looked at age, gender, race, body mass index (BMI), office BP, fasting blood glucose, glucose tolerance, uric acid, lipid profile, and iothalamate glomerular filtration rates (iGFR).

The study population was stratified into SBP below 115 mm Hg and 115-139 mm Hg because clinical trials suggest an increased risk for CV events beginning with an SBP of 115 mm Hg. Compared with donors with an SBP below 115 mm Hg, those with a SBP of 115-139 mm Hg had higher total cholesterol levels (201.8 vs. 192.6 mg/ dL), higher LDL cholesterol levels (122.4 vs. 113.1 mg/dL), lower HDL cholesterol levels (54.2 vs. 57.1 mg/ dL), higher triglyceride levels (123.1 vs. 106.3 mg/dL), and higher fasting blood glucose levels (89.6 vs. 85.9).

The study also showed that uric acid

(even within the normal range) was independently associated with elevated SBP. “This study indicates early derangement and clustering of cardiovascular risk factors in living kidney donors, who are presumably healthy, with mild to modest increases in systolic blood pressure, even within what is considered per current definition to be within the non-hypertensive range,” Dr. Thomas said. Further studies are needed to see if instituting early interventions would improve their risk profile and prevent cardiovascular events, he said. A previous study presented at Kidney Week 2011 showed that African Americans who were living kidney donors had a significant 2.4-fold increased risk of hypertension compared with African Americans who were suitable candidates for living kidney donation but did not donate because of nonmedical reasons. n

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www.renalandurologynews.com august 2013

Renal & Urology News 11

Omega-3 Fatty Acids May Up PCa Risk Increased intake of omega-3 fatty acids, which is widely promoted as a way to prevent cardiovascular disease and cancer, may increase the risk of prostate cancer (PCa), especially aggressive disease, according to a study that confirms the findings of previous investigations.

Theodore M. Brasky, PhD, of the Ohio State University Comprehensive Cancer Center in Columbus, and colleagues studied 2,198 men enrolled in the SELECT (Selenium and Vitamin E Cancer Prevention Trial). Of these, 834 were diagnosed with PCa (156 with high-grade disease) and 1,364 were not.

Compared with men in the lowest quartile of total long-chain omega-3 fatty acids, those in the highest quartile had a 44% and 71% increased risk of lowand high-grade disease, respectively, and a 43% increased risk of any PCa, Dr. Brasky’s team reported online in the

ADT May Increase AKI Risk Prostate cancer patients on androgen deprivation therapy (ADT) are at increased risk of acute kidney injury (AKI), according to a new study published in the Journal of the American Medical Association.

The study, by Francesco Lapi, PharmD, PhD, of Jewish General Hospital in Montreal, and colleagues included 10,250 patients with newly diagnosed nonmetastatic prostate cancer from January 1997

Journal of the National Cancer Institute.

The researchers calculated the total long-chain omega-3 fatty acid level as the sum of eicosapentaenoic (EPA), dodosapentaenoic (DPA), and docosahexaenoic acids (DHA), which are derived from oily fish and fish oil supplements. High levels of each of these fatty acids were associated with an increased PCa risk. High levels of EPA were associated with an increased risk of low-grade PCa. High levels of DPA and DHA were associated with an increased risk of low-grade and total PCa. The new findings corroborate those of a study published in the American Journal of Epidemiology by Dr. Brasky and colleagues in 2011. That study examined data from men enrolled in the Prostate Cancer Prevention Trial. Compared with men in the lowest quartile of serum DHA, those in

© thinkstock

Highest versus lowest intake was associated with a 71% increased risk of high-grade disease

Too much fish oil may be harmful.

the highest quartile had a 2.5 times increased risk of high-grade PCa. The study also found that high serum levels of trans-fatty acids were associated with

a decreased risk of high-grade disease.

The researchers said it is unclear from the present study why high levels of long-chain omega-3 fatty acids would increase PCa, but the replication of this finding in two large studies indicates the need for further research into possible mechanisms. One potentially harmful effect of omega-3 fatty acids is their conversion into compounds that can cause damage to cells and DNA, and their role in immunosuppression.

The SELECT trial enrolled 35,533 men who were randomly assigned to take vitamin E alone, selenium alone, and vitamin E and selenium. Results showed that men who took vitamin E alone had a significant 17% increased risk of PCa compared with placebo recipients after a total follow-up of seven years. Men who took both vitamin E and selenium did not have an increased risk. n

NSS Cuts Renal Dysfunction Risk Nephron-sparing surgery (NSS) for small renal masses substantially decreases the incidence of moderate renal dysfunction compared with radical nephrectomy (RN), according to the results of the prospective European Organization for Research and Treatment of Cancer (EORTC) randomized trial.

The beneficial impact of NSS on renal function, as assessed by estimated glomerular filtration rate (eGFR), did not result in improved survival, however.

In the study, investigators random-

ized 273 patients to undergo RN and 268 to undergo NSS for renal masses 5 cm or less in size. After a median follow-up of 6.7 years, moderate renal dysfunction (eGFR below 60 mL/ min/1.73 m2) developed in 85.7% of the RN patients compared with 64.7% of the NSS patients. The incidence of advanced kidney disease (eGFR below 30) was similar in the two treatment arms (10% and 6.3%); the incidence of kidney failure (eGFR below 15) was nearly identical (1.5% and 1.6%), Emil Scosyrev, PhD, and colleagues at the University of Rochester Medical

Center in Rochester, N.Y., reported online ahead of print in European Urology.

The researchers acknowledged that lack of longer follow-up for eGFR was a study limitation.

The EORTC trial previously had demonstrated that NSS was associated with a significant 50% increased overall mortality risk compared with RN over a median follow-up of 9.3 years. When the analyses were limited to patients with renal cell carcinoma, researchers found no significant difference in overall survival. n

TO-TVT Approaches Offer Similar Outcomes

to December 2008. Patients were followed up until December 2009.

During follow-up, the investigators identified 232 cases with a first-ever AKI admission. These cases were compared with controls matched for age, calendar year of PCa diagnosis, and duration of follow-up. Compared with never-use, current use of ADT was significantly associated with a 2.5 times increased odds of AKI. n

RUN0813_Omega3.indd 1

The outside-in and inside-out approaches to transobturator tensionfree vaginal tape (TO-TVT) surgery are associated with similar five-year outcomes, according to researchers.

Rachel Yau Kar Cheung, MB, and colleagues at The Chinese University of Hong Kong, prospectively studied 213 women who underwent TO-TVT surgery for stress urinary incontinence.

Surgeons used the outside-in approach (TOT) in 124 cases and the inside-out

approach (TVT-O) in 89 cases.

After a mean follow-up of 59.2 months, the TOT and TVT-O groups had an objective cure rate of 82.6% and 82.5%, respectively, and a subjective cure rate of 81.7% and 84.1%, respectively, the investigators reported online in the International Journal of Urology.

The TOT and TVT-O arms also were similar with respect to the development of de novo overactive bladder syndrome (10.6% and 14.6%) and de novo detru-

Five year cure rate did not differ for outside-in and inside-out methods. sor overactivity (5.8% and 15%). In addition, complications at the fifth year were low and did not differ significantly between the groups. n

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12 Renal & Urology News

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Radiologic PD Catheter Insertion Okay Interventional radiologists placed Tenckhoff catheters percutaneously under local anesthesia

BY JILL STEIN ISTANBUL—Radiologic insertion of Tenckhoff catheters for peritoneal dialysis (PD) offers multiple advantages over the conventional laparoscopic method, Australian researchers reported at the 50th Congress of the European Renal Association-European Dialysis and Transplant Association.

Their series included 30 patients in whom swan-neck Tenckhoff catheters were inserted percutaneously by interventional radiologists under local anesthesia and sedation over a recent 12-month period. Results showed that the procedure had a good technical success rate even in patients who had prior abdominal surgery and could be performed safely on an outpatient basis.

“Establishing Tenckhoff catheters using this method may potentially improve the uptake and initiation of peritoneal dialysis, which is an important home-based dialysis modality for patients with end-stage kidney disease,” said Trung Quach, MD, a consultant nephrologist at Alfred Hospital in Melbourne. However, the initiation of PD requires the timely

insertion of a reliable Tenckhoff catheter, he explained. Before the introduction of radiologic insertion at his institution in 2011, Tenckhoff catheters were always inserted laparoscopically by vascular surgeons under general anesthesia, which was time-consuming and resource-intensive. “Patients needed to be referred to see a surgeon in the clinic, they also had to seen by an anesthesiologist, and then they needed to be put on a surgical elective waiting list, which was often full with long waiting times,” he related.

The multi-step process frequently hindered the timeliness of catheter insertion, he added. “You want to be able to insert the Tenckhoff catheter at least two weeks before patients need to start dialysis in order to give the insertion site time to heal with a goal of reducing the incidence of leakage and infections.

And, in fact, International Society of Peritoneal Dialysis guidelines recommend waiting at least two weeks after insertion before starting dialysis.”

If patients wait too long for insertion of a Tenckhoff catheter for PD, “they may miss the boat and end up getting temporary catheters inserted for hemo-

Key Points ■■ Tenckhoff catheters were

inserted successfully in all 30 patients in a series.

■■ The procedures were per-

formed under local anesthesia on an outpatient basis.

■■ No patient experienced

peritonitis or exit site infections.

■■ The most common

complications were minor and temporary pain and bleeding around the exit site.

dialysis,” he said. “This is a shame because hemodialysis may not be their preference for dialysis and may also increase their risk of infection.”

Dr. Quach reported that all catheters in his series were inserted successfully. No patient experienced peritonitis or exit site infections, which are likely due to strict adherence to sterile techniques, he said. No catheter leakages occurred.

Catheter migration occurred in four (13.3%) patients, but only one patient needed surgical intervention. The catheter was successfully repositioned without further complications. The most common complications were pain and bleeding around the exit site, both of which were minor and temporary.

Patients were initially selected for radiologic insertion of their Tenckhoff catheter if they did not have any significant cardiorespiratory disease, were within a normal weight range, and were not on intense anticoagulation, Dr. Quach pointed out. Notably, since his institution switched to radiologic insertion as the preferred approach, the number of incident PD patients has increased by about 67%.

He also emphasized that with additional experience with radiologic insertion, patients who were initially deemed not suitable will likely be considered eligible. “For example, we initially included only normal weight patients, and now we are performing this procedure in patients in the obese category as well at those with previous abdominal surgery,” he said. n

Algorithm Predicts Dialysis Pt Transfusion Risk

BY JILL STEIN ISTANBUL—Investigators have developed an algorithm using routinely available patient data that accurately predicts subsequent transfusion risk in dialysis patients.

Preliminary results, released at the 50th Congress of the European Renal Association-European Dialysis and Transplant Association, show that the algorithm can accurately identify the need for transfusion in 73% of patients.

The algorithm combines demographic, biochemical, clinical, and transfusion data from the DaVita Clinical Data Warehouse. Thirty-two variables were identified and included in the final model.

“We have never had a quantifiable method of predicting which dialysis patients were likely to require a transfusion,” said Steven Brunelli, MD, Senior Director of DaVita Clinical Research in Minneapolis, Minn. “In general, we felt that patients with low hemoglobin

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were at increased risk. But there’s a bell curve of hemoglobin level, and the question is, where do you draw the line on the bell curve? We want to be able to rigorously quantify risk and say, for example, that for a particular patient, the risk of transfusion is ‘X’ or the risk of transfusion is ‘Y.’”

Routinely available patient data are used to identify at-risk patients.

The team tested the algorithm in 103,350 patients, 1,756 of whom had a transfusion during the first three months of 2011. Transfusion data were drawn from hospital medical records by independent data services.

Patients with chronic kidney disease who undergo dialysis are at risk of persistent anemia, Dr. Brunelli explained.

Transfusion is an option of last resort for anemia management, and it may decrease survival, patient well-being, and the likelihood of transplant candidacy.

The algorithm uses data commonly available in electronic health records, he said, but he could not cite specific variables that are included in the model “because of its proprietary and confidential nature.”

Following recent changes in the regulatory environment (changes in the FDA Black Box warning) and reimbursement (the introduction of Medicare’s prospective payment system for dialysis care), anemia management practices changed substantively throughout the U.S, he noted.

“Specifically, the amount of erythropoiesis-stimulating agents that patients were getting went down, the amount of iron that patients were getting went up, and hemoglobin levels decreased,” Dr. Brunelli said. “And the big fear was that transfusion rates were going

to go up, which could lead to bad outcomes for patients, for example, loss of transplant candidacy.”

In response, DaVita initiated a registry that tracks transfusion rates in its in-center hemodialysis patients.

Because of the large volume of data compiled by the registry, Dr. Brunelli and colleagues believed they had an invaluable opportunity to develop a predictive model that could accurately and reproducibly risk-stratify patients on the basis of future transfusion risk.

Finally, Dr. Brunelli pointed out that the algorithm has broad potential applications. It could enable real-time clinical assessment of patient risk, identify opportunities for prevention efforts, and identify high-risk patients in whom prophylactic interventions can be tested.

“This is not an answer unto itself,” he said, “but we hope that it is a small step in a positive direction for patient care.” n

7/23/13 4:51 PM

www.renalandurologynews.com august 2013

Renal & Urology News 13

Dietary Phosphorus Restriction Tough

Consumption of phosphorus-containing additives in beverages and fast foods may add to the challenge Difficulty following advice HD patients were reported as being most likely to have difficulty restricting phosphorus. Thirty two (40%) respondents reported that most of their HD patients found it difficult to follow advice on phosphorus restriction.

When asked about the relative importance of restricting phosphorus and maintaining protein intake in HD, 42 (50%) respondents considered them equally important and 30 (36%) favored maintaining protein intake even if maintaining protein intake worsened phosphorus control.

Patients on dialysis typically require a combination of dietary modification and phosphate binder therapy (to reduce intestinal absorption of phosphorus) to manage hyperphosphatemia, she added. Maintaining optimal serum phosphorus levels may be difficult for patients, however. In fact, in the prospective Dialysis Outcomes and Practice Patterns Study (DOPPS), less than half of hemodialysis (HD) patients maintained their serum phosphorus level below the upper limit of the target range of 5.5 mg/dL over the

Phosphorus-containing additives are often added to processed foods to prolong their shelf life and enhance their color or flavor.

© thinkstock

BY JILL STEIN ISTANBUL—Despite increased awareness of the phosphorus content of food, many patients on dialysis do a poor job of restricting dietary phosphorus intake, according to the results of a survey described at the 50th Congress of the European Renal AssociationEuropean Dialysis and Transplant Association (ERA-EDTA).

Elizabeth Lindley, PhD, a clinical scientist in renal care, at Leeds Teaching Hospitals NHS Trust in Leeds, U.K., and co-workers analyzed responses to an online questionnaire that examined dietary trends among dialysis patients and the problems associated with phosphorus control.

Forty-eight dietitians, 35 nurses, and one physician responded to the questionnaires. They represented clinics with more than 15,000 dialysis patients. Respondents were from the Netherlands, Spain, Sweden, and the U.K. The survey was organized by the European Dialysis and Transplant Nurses Association/European Renal Care Association, which is the ERAEDTA’s multidisciplinary sister organization.

Soda and fast food intake may add to the difficulty of phosphorus control.

five-year study period.

Dietary counseling has been shown to help patients with chronic kidney disease (CKD) achieve the required reduction in phosphorus burden, she observed. At the same time, consumption of beverages and fast foods that have a high amount of phosphoruscontaining additives makes it more difficult for patients to achieve their target serum phosphorus levels.

Better labeling urged Dr. Lindley urged the “renal community” to lobby for accurate labeling of food and beverages that cites the use of phosphorus additives and specifies phosphorus content per portion. “Thorough and honest labeling would enable patients to avoid or limit their intake of unnecessary phosphorus from additives and help maintain adequate protein intake within the restriction imposed by dialysis and an acceptable phosphate binder regimen,” she said.

Survey results showed that since entering practice a mean of 15 years ago, 47 (56%) respondents had observed an increase in fast food consumption, and 40 (48%) respondents had noticed an increase in consumption of foods rich in phosphorus-containing additives/preservatives. Fifty survey participants, or 60%, believed that there has been a trend of increasing awareness of the phosphorus content of fresh food in CKD patients. n

THC Locks May Offer Catheter Salvage Advantage

BY JILL STEIN ISTANBUL—New findings presented at the 50th Congress of the European Renal Association-European Dialysis and Transplant Association suggest that taurolidine-heparin-citrate (THC) locks are better than heparin line locks for preventing recurrence of catheterrelated bacteremia (CRB) in hemodialysis (HD) patients.

Richard Corbett, MD, a nephrologist at Imperial College Renal and Transplant Centre, London, U.K., and co-workers randomized patients within two weeks of the onset of bacteremia to receive either THC (containing heparin 500 units/mL) or heparin (5,000 units/mL) line locks following each dialysis for six months, in addition to standard antibiotic therapy.

The study included 27 patients with evidence of a CRB who were eligible for catheter salvage therapy, had been on HD for more than 90 days, and were currently using a heparin line lock. The pre-specified primary out-

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come measure was the duration of bacteremia-free catheter survival at 180 days.

CRB is a cause of significant morbidity in patients maintained on long-term tunneled HD catheters for vascular access, Dr. Corbett noted.

Catheter salvage involving antibiotic

Bacteremia-free catheter survival better than with heparin-only locks. treatment without removal of the catheter is recommended for individuals without signs of systemic sepsis and who have a good initial response to antibiotics.

Taurolidine, which was developed in the 1970s as a broad-spectrum antibiotic, requires high concentrations for efficacy and is thus not suitable as a

parenteral antibiotic. To date, there have been no reports of taurolidineresistant organisms.

Taurolidine line locks have been shown to be effective in preventing catheter-related bloodstream infections in patients on home parenteral nutrition and in pediatric cancer patients. When used without heparin, however, taurolidine line locks have led to unacceptably high levels of catheter dysfunction in dialysis patients, according to researchers.

The two treatment groups in the U.K. study were similar with respect to baseline demographic and clinical characteristics.

The analysis showed significant improvement in bacteremia-free catheter survival in the cohort that had catheter salvage with the THC lock.

The researchers observed no cases of recurrent CRB in the 14-patient THC group, whereas six of 13 catheters were removed in the heparin group during the six-month study.

Dr. Corbett said that the trial was too small to reliably interpret predefined secondary outcome measures that included hospital admissions for catheter-related problems such as catheter removal, erythropoietin resistance, and HD adequacy. He and his colleagues observed an increase in systemic thrombolytic use in the THC arm, but subsequent analysis out to 600 days from trial recruitment does not suggest that the reduction in bacteremia observed is at the expense of delayed catheter dysfunction, he added. He also emphasized that the study was conducted at a single center.

“For now, THC line locks should be used as an adjunctive therapy in the setting of catheter salvage,” Dr. Corbett said. “Their role as a standard line lock still needs to be clarified considering that the marked reduction in bacteremia may be offset by increased levels of catheter dysfunction given the use of a lower concentration of heparin than is conventionally used.” n

7/25/13 2:35 PM

14 Renal & Urology News

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Legal Issues in Medicine A doctor forgot about his own note in a patient’s chart that the patient should be screened for liver cancer. By ANN W. LATNER, JD

Large liver mass found Unfortunately, the test came back abnormal, and an abdominal ultrasound revealed a large mass on the right lobe of the liver. Magnetic resonance imaging confirmed the result.

Given the size and extent of the tumor

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at the time of diagnosis, Mr. C was denied listing on the transplant list. In desperation, he returned to his native China where the condition is more prevalent. He was treated with resection, chemotherapy, and eventually had a liver transplant. Despite continued treatment, he succumbed to the disease within a few years, leaving behind a widow and two teenage children.

Mr. C’s widow sought out a plaintiff’s attorney and explained the situation, including the fact that her husband had been seeing Dr. L for close to three years before he ordered the screening.

“Perhaps if that doctor had ordered the test earlier, as he should have, my husband would still be alive,” she said. The attorney agreed, and took on the case.

When Dr. L received notification that he was being sued, he went to see the defense attorney appointed by his malpractice insurance. After hearing the whole story, the attorney asked Dr. L why he had not ordered the screenings earlier.

“I intended to,” the physician replied.

“That’s why I noted it in the file. But by the time I saw him next, months later, I didn’t remember and didn’t see the note in my chart.”

The attorney nodded. Once his client left, he sent the patient file to a few physician experts to get their opinion. “In your opinion,” he asked the experts, “did the physician breach the standard of care?” All of the experts agreed that he had. The attorney recommended to Dr. L that he settle the case out of court, which he did for $2.7 million.

owed to a patient); 3) that the breach caused an injury; and 4) that the injury damaged the patient. A failure by a healthcare provider to conform to the standard of care expected of someone in his/her position is an essential element of medical malpractice. In this case, Dr. L’s attorney realized that this would be a particularly difficult case to defend once he polled several expert physicians about what the standard of care expected of Dr. L was. Dr. L owed a duty to Mr. C. He breached that duty by not ordering the screening tests.

Mr. C was injured by Dr. L’s failure to order the tests, and this injury (the delayed diagnosis of cancer) resulted in damage.

Healthcare practitioners these days are often busy and overworked, sometimes seeing dozens of patients in a day. Yet this can never be an excuse for failing to pay attention to a necessary health screening or being familiar with a patient’s health issues and concerns.

Even if your time with your patients is limited, taking a moment or two to look over a patient’s file before walking into that examination room can mean the difference between being knowledgeable about your patient’s health needs or simply reacting to what the patient is telling you. Had Dr. L looked at his own note in the patient’s file, Mr. C might have had a better outcome. n

Legal background For a plaintiff to succeed in a medical malpractice case, four elements must be proven: 1) that a duty was owed (which is always the case in a doctor/ patient relationship); 2) that the duty was breached (by the provider failing to conform to the standard of care

Protecting yourself Dr. L was aware that his patient needed to be screened for liver cancer. He even noted this in the patient’s file. Yet somehow, despite seeing the patient on multiple occasions, it didn’t occur to him to order the test until the patient specifically asked for it.

Ms. Latner, a former criminal defense attorney, is a freelance medical writer in Port Washington, N.Y.

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D

r. L, 55, was a sole practitioner in a suburban area highly populated by people of Asian descent. Dr. L himself was Chinese and fluent in the language, and because of this, he attracted many Chinese patients. His practice was booming.

Where once he had advertised, now he felt that he was almost handling as many patients as he could manage.

Despite this, he never turned away a new patient.

One new patient was Mr. C, 42, a successful businessman originally from China. The patient had his medical records transferred to Dr. L from his previous general practitioner. Mr. C had a past medical history of hepatitis B infection, and was aware that Asian men older than 40 years who have a history of chronic hepatitis B infection are at an increased risk of developing liver cancer. Mr. C had been diligently seeing his previous physician on an annual basis and had been regularly screened for liver cancer over the past decade. All of the screening tests had been negative. Dr. L noted in the patient’s file that screening studies should be obtained in the future.

Over the course of the next two and a half years, Mr. C saw Dr. L on multiple occasions for simple complaints or annual exams. Dr. L, however, forgot what he had written in the patient’s file about the screenings, and did not order any tests until Mr. C came in for a routine exam and specifically asked for the liver screening. This was almost three years after Mr. C became a patient of Dr. L.

A doctor might have avoided a lawsuit if he had carefully reviewed a patient’s file.

Cases presented are based on actual occurrences. Names of participants and details have been changed. Cases are informational only; no specific legal advice is intended.

What do you think? Did the jury make the right decision in this case? We want to know your thoughts. Leave us a comment at the end of this article—or any article—at www.renalandurologynews.com/legal.

7/23/13 4:50 PM

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7/24/13 1:01 PM

16 Renal & Urology News

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Renal Nutrition Update The Mediterranean diet emphasizes an overarching style of eating that can improve the health of CKD patients By GRISSIM CLARK CONNERY, MS, RD, LD

Calorie restriction in CKD Overall caloric restriction, though, may be a confounding factor. For example, recent studies have indicated similar improvement in estimated glomerular filtration rate (eGFR) in chronic kidney disease (CKD) patients instructed to follow either low fat, low carbohydrate, or a Mediterranean diet (Diabetes Care 2013; published online ahead of

with nuts induced a higher potential renal acid load and net endogenous acid production compared with the Mediterranean diet supplemented with olive oil (J Am Geriatr Soc 2009;57:17891798). The nut-supplemented group experienced significantly higher parathyroid hormone levels.

Clinical observations More recently, investigators have assessed Mediterranean diet adherence on a graded scale and the effect of adherence on metabolic parameters.

In one study, (J Ren Nutr 2010;20:176184), investigators assessed adherence using a validated diet score based on a method developed in the ATTICA study, which enrolled 3,042 men and women. Intake of various food groups and wine is assigned a numerical value of 0-5 depending on the frequency with which they are consumed. These values are added to arrive at a score.

The maximum score using this system is 55, which would indicate complete adherence. A score of 0 would indicate non-adherence. Each 10-point increase in Mediterranean diet adherence was associated with a 3.7-unit increase in creatinine clearance in women and

In a study of 1,110 elderly Swedish men, the risk of chronic kidney disease decreased as adherence to a Mediterranean diet increased. print). Similar results also occurred in the PREDIMED study, in which no significant improvements were found when a Mediterranean diet supplemented with either nuts or olive oil were compared with a control low fat diet (Am J Kidney Dis 2012;60:380-389).

Of note, further analysis has found that the Mediterranean diet supplemented

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10.1-unit increase in men. Fruit and moderate alcohol intake had the most positive intake on creatinine clearance, whereas red meat, potato, and poultry intake had the most negative impact.

Diet adherence and CKD risk In a separate study, Huang et al. assessed the associations between

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T

he Mediterranean diet is getting more attention because of its long-term benefits in terms of overall mortality and cardiovascular disease (CVD) risk. The diet improves a wide range of metabolic parameters— including blood lipids, blood pressure, and insulin sensitivity—so it may be a good model diet to teach patients with renal disease.

Studies have shown that adherence to a Mediterranean diet significantly improves creatinine clearance (QJM 2010;103:413-422). Other potential benefits of the Mediterranean diet may include the higher intakes of phytates which, due to their ability to bind calcium, may reduce endothelium calcifications typically found in dialysis populations (Eur J Nutr 2010;49:321-326).

The Mediterranean diet improves a wide range of metabolic parameters.

Mediterranean diet adherence and mortality risk in CKD patients (Clin J Am Soc Nephrol 2013; published online ahead of print). The cohort consisted of 1,110 Swedish men enrolled in a prospective trial. Adherence to the Mediterranean diet was quantified on an 8-point scale. Eight different dietary components of the Mediterranean diet were assessed. Each individual was categorically designated as adherent or nonadherent with a particular dietary component. If adherent, the participant was given a point for that component. A diet score of 2 points or less was considered low adherence; a score of 3-5 points and 6 points or more were considered medium and high adherence, respectively. Each 2-point increment in diet score was associated with a 12% decrease in CKD risk. More specifically, those with the highest score had a 42% reduction in CKD risk compared with who had the lowest score. Interestingly, no typical metabolic parameters were found to be significantly different between groups.

Instead, most notable differences between groups existed in oral intakes of sodium, phosphate, and net endogenous acid production (NEAP). Of note, phosphate and net endogenous acid production were significantly lower in the high compliance group. After a 10-year follow-up, researchers found that each 2-point increment in diet score was associated with a 34% reduction in all-cause mortality. The highest compliance group had a 58% reduction in all-cause mortality compared with the lowest compliance group.

Summary From a clinical perspective, teaching patients the Mediterranean diet model can be advantageous because it emphasizes an overarching style of eating rather than focusing on individual nutrients. Because people often eat mixed meals comprising several food groups and various macro and micro nutrients, single nutrient focus is often difficult for those not well-educated on the subject. n

We’ve got more on our website highlighting effective diets for delaying CKD progression and ­helping patients manage sodium and phosphorus intake. See us at www.renalandurologynews.com/nutrition.

7/23/13 5:02 PM

www.renalandurologynews.com august 2013

Immunosuppressive Drug Costs Decline Prices remain high and may discourage patients from adhering to therapy

BY JODY A. CHARNOW SEATTLE—Annual per-patient costs of maintenance immunosuppressive medications for kidney transplant recipients have declined since 2007, but the cost was twice as high in 2011 as it was in 1993, according to a new analysis.

Adjusted for inflation and expressed in 2012 dollars, the annual per-patient cost rose from $9,280 in 1993 to a high of $33,040 in 2007 and then declined to $18,746 in 2011, Roger W. Evans, PhD, of the United Network for the Recruitment of Transplantation Professionals in Rochester, Minn., reported at the 2013 American Transplant Congress.

The costs for other solid organ transplant (SOT) patients followed a similar pattern. For liver transplant patients, the annual per-patient cost rose from $9,280 in 1993 to $34,832 in 2007 and then dropped to $23,999 in 2011. For heart transplant recipients, the annual perpatient cost rose from $9,280 in 1993 to $32,928 in 2007 and $31,209 in 2011.

Although the per-patient costs in general have declined, Dr. Evan’s analysis shows that they now are increasing.

Since 1993, insurance actuaries have published estimates of the costs associated with maintenance immunosuppressive medications, . These reports are the basis for Dr. Evans’ analysis.

Annual Drug Costs for Kidney Tx Patients

Renal & Urology News 17

Obese Men Have Worse RP Outcomes Abdominal obesity is associ-

After adjusting for inflation, the annual cost of immunosuppressive drugs for each kidney transplant patient peaked in 2007, but then declined perhaps as a result of the debut of generic versions.

35,000

ated with an increased likelihood of surgical complications and worse functional outcomes in men undergoing radical prostatectomy (RP) for

30,000 25,000

prostate cancer (PCa), according to

20,000

new findings.

15,000

Mauro Gacci, MD, of the University

10,000

of Florence in Italy, and colleagues

5,000 0

$9,280 1993

$33,040 2007

$18,746 2011

Source: Evans RW. Data presented at the 2013 American Transplant Congress in Seattle. Abstract A796.

studied 470 men, of whom 131 (27.8%) had abdominal obesity, defined as a waist circumference (WC) of 102 cm or more. After adjusting for potential confounding factors,

The decline in costs from 2007 probably is due to the availability of generic versions of some immunosuppressive drugs, such as cyclosporine, tacrolimus, and mycophenolate mofetil. Dr. Evans pointed out, however, that concerns about the bioequivalency of some generics could dissuade doctors from prescribing them, leading to cost increases.

The high cost of immunosuppressive drugs contributes to treatment nonadherence. About 8.3% of kidney transplant patients have no insurance coverage and either pay out of pocket or transplant centers write off the cost of the drugs.

Another 23.5% of kidney transplant

recipients rely on industry-sponsored pharmacy assistance programs.

In a previous survey of 254 U.S. kidney transplant centers (Clin J Am Soc Nephrol 2010;5:2323-2328), Dr. Evans and colleagues found that more than 70% of these centers reported that their patients have a problem paying for their medications. About 47% of the centers indicated that more than 40% of their patients are having difficulty paying for their immunosuppressive medications. Additionally, 68% of the programs report deaths and graft losses attributable to cost-related immunosuppressive medication nonadherence. n

these men had a threefold greater risk of intraoperative complications and need for blood transfusions compared with men who had a WC below 102 cm, investigators reported online in the Scandinavian Journal of Urology. The study also revealed a significant positive correlation between abdominal obesity and the severity of postoperative urinary incontinence. Additionally, compared with men who had a WC below 102 cm, those with a greater WC had a twofold increased likelihood of having positive surgical margins.

Bone Metastases Signal Worse RCC Outcomes

BY JOHN SCHIESZER CHICAGO—Bone metastases (BM) predict shorter progression-free survival (PFS) and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC) treated with molecularly targeted agents, according to new findings presented at the 2013 American Society of Clinical Oncology annual meeting.

The findings are based on a pooled analysis of data from 2,749 patients with mRCC treated from 2003-2011. “We did this study because the treatment paradigm for metastatic renal cell carcinoma has changed significantly over the past decade and prognostic factors need to reflect changes in systemic therapy,” said investigator Rana McKay, MD, of the Dana-Farber Cancer Institute in Boston.

This is the largest study to date to analyzed BM in mRCC patients treated with molecularly targeted agents, Dr. McKay

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said. The investigators identified 1,059 treated with sunitinib, 335 treated with sorafenib, 359 treated with axitinib, 208 treated with temsirolimus, 208 treated with temsirolimus plus interferon-alfa, and 560 treated with interferon-alfa alone. Most patients were male (71%) and had a baseline ECOG performance status of 0 (47%) or 1 (51%). Of 2,749 patients, 91% had clear cell histology and 84% had undergone prior nephrectomy.

A total of 285 patients (10.4%) received bisphosphonate therapy. Of these, 233 received zoledronic acid; no patient received denosumab. Among patients with BM, the SRE rate was 20.7% in patients receiving bisphosphonate therapy compared to 79.3% in patients not receiving bisphosphonate therapy, but the difference was not statistically significant.

Bisphosphonate therapy was associated with an increased rate of osteonecrosis of the jaw, with six cases (2.1%) occurring

in bisphosphonate recipients compared with only one case (less than 0.1%) in those not treated with a bisphosphonate.

Bisphosphonate therapy was also associated with hypocalcemia (7.4% vs. 3.0%) and renal insufficiency (4.9% vs. 2.5%).

The presence of baseline BM (compared with its absence) was associated with a statistically significant shorter PFS (5.1 vs. 6.7 months) and shorter OS (13.2 vs. 20.2 months). Dr. McKay said the use of bisphosphonate therapy was not associated with improved PFS or OS compared with patients not receiving bisphosphonate therapy.

Data regarding site of metastases may have therapeutic implications and inform the use of newer agents currently under investigation in mRCC. Larger prospective studies are needed to better define the efficacy and toxicity of concomitant bisphosphonates and molecularly targeted therapy in mRCC. n

Dr. Gacci’s team found that the mean preoperative International Index of Erectile Function score was significantly higher in the non-obese than the obese men: 18.8 vs. 16.0.

The investigators explained that increased adiposity is associated with PCa aggressiveness, specifically an increased risk of incident high-grade PCa and postoperative biochemical recurrence. In addition, among patients with localized PCa, obesity is associated with an increased risk of prostate enlargement and greater PCa volume at surgery. Thus, in obese patients, the larger prostate volume means a larger cancer volume. A surgeon’s discomfort performing RP in such patients may be associated with a difficult procedure and a higher rate of intraoperative complications, the authors commented. n

7/23/13 4:54 PM

18 Renal & Urology News

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Practice Management U

nderstanding how healthcare will function in the next five to 10 years is much like trying to work a puzzle. But the puzzle is missing some integral pieces—one of which is how you are going to get paid.

The only problem is, absent the use of a crystal ball, no one can really predict the answer to that question. Physicians can be reimbursed or compensated in numerous ways, including salary, feefor-service, bundled payments, and capitation. A couple of these will likely float to the top, however.

“There is institutionalized resistance to changing what we are comfortable with even though we know it doesn’t work and the system is broken,” said Jeffrey Kaufman, MD, Chair, Health Policy, Western Section, American Urological Association, and Chair of Urology at Western Medical Center in Santa Ana, Calif. “I think there is going to be some sort of gradual transition under the ACA [Accountable Care Act] to…a smorgasbord of practice and payment styles and I don’t think any single one style is the answer.”

Likely models There seems to be a consensus that fee-for-service will be a mainstay and the building block upon which other payment methods will revolve.

Michael Brown, president of Health Care Economics, a consulting firm in Fishers, Indiana, said the insurers he talks with plan to use fee-for-service and move toward pay-for-performance.

Moving from volume-based to performance-based pay has not been an easy shift, though.

Pay-for-performance, which essentially reimburses physicians based on patient outcomes, presents some challenges. The first challenge is

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determining what to measure. “You have to define performance and when you start getting into an outcome discussion, you have all kinds of measurement problems,” Brown said.

Various types of measurements include quality, utilization, and safety, but they will vary depending upon the practice. For example, primary care doctors might try to lower blood glucose levels for diabetic patients, while urologists might reduce the number of complications after prostate surgery.

A second challenge is how to attribute payments. Dr. Kaufman provides the example of a patient with prostate cancer. He may see a patient initially and then send him to one hospital for surgery and another for chemotherapy. Who would receive payments for the procedure?

“Attribution is tricky and there are several proposals out there,” he said.

“Right now, PCPs are going in one direction, and others are not sure where to go.”

Amy Lischko, a healthcare policy specialist and associate professor at Tufts University School of Medicine in Boston, said specialists might also be moving toward bundled payments.

Lischko said some specialties–like obstetrics–have been using this method for a long time. She thinks it will be a more gradual transition for others.

“Providers will need to look at data and figure out what is reasonable reimbursement for episodic and chronic diseases,” she said.

For instance, a urinary tract infection may take one visit, a test, and a course of antibiotics. Chronic conditions like kidney disease, she said, may have more variability. These would be more difficult to pinpoint cost.

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Changing payment paradigms suggest a move to pay-for-performance, but fee-for-service will be a reimbursement mainstay By Tammy Worth

Deciding how to attribute payment could be a reimbursement challenge.

Preparing for change No one really knows if, or how, physician reimbursement will change. But there are a handful of things physicians can do to prepare for what is to come.

“Specialists can join a large group and hope that size helps them negotiate contracts,” Dr. Kaufman said. “You can join a hospital and hope it pays you well … or you can practice fee-for-service and just retire in a few years.”

If retirement is not in your near future, you may have to alter the way you run your practice. Though many doctors do not like to think about the business side of the practice, Brown said it is imperative.

“They have to understand their cash, revenue, expenses, and volume,” he said. “You can’t look at pay-for-performance or any other type of formula unless they know how to bid on it.”

Specialists need to understand what their per-patient cost is, Brown said.

A general way to figure this is by looking at the number of patients you treat each year, divide it by expenses and divide that by 12. This will give a very broad idea of how much it costs to treat your patients each month, which is sometimes how payments are allocated.

If this is something you don’t want to do, Brown said you need a consultant or accountant who knows these numbers. If you are going to blend fee-forservice with pay-for-performance or move toward bundled care, you have to know what payments you need to cover your costs.

Another tip is to be proactive. Brown said 90% of doctors do not know what contracts they have with insurers, when they are renewable, and what they pay. n Tammy Worth is a freelance medical ­journalist based out of Blue Springs, MO.

Want to improve your practice? Look for our tips on how to handle equipment issues, adjust to EHRs, ­comply with HIPAA, and more at www.renalandurologynews.com/practice.

7/23/13 5:01 PM

www.renalandurologynews.com august 2013

Renal & Urology News 19

Trinity Health is seeking a BC/BE Urologist Based in Minot, the trade center for Northern and Western North Dakota, Trinity Health offers the opportunity to work within a dramatically growing community that offers more than just a high quality of life.

Comprised of a network of nearly 200 physicians in hospitals, clinics and nursing homes, Trinity Health’s Urology department offers: • da Vinci® Si™ HD Robotic Surgical System • Mobile Lithotripsy • State-of-the-Art Cancer Center • Supported Call Schedule Trinity Health is an award winning system with stroke accreditation, Blue Distinction® for cardiac care and knee and hip replacement, Most Wired and one of America’s top 50 heart hospitals.

Physicians are offered a generous guaranteed base salary. Benefits also include a health and dental plan, life and disability insurance, 401(k), 401(a), paid vacation, continuing medical education allowance and relocation assistance.

www.trinityhealth.org

For immediate confidential consideration, or to learn more, please contact

Shar Grigsby Health Center - East 20 Burdick Expressway Minot ND 58702 Ph: (800) 598-1205, Ext 7860 Pager #0318 Email: shar.grigsby@trinityhealth.org

As a physician you have options.

As a healthcare leader We have opportunities.

We are one of the nation’s leading operators of general, acute-care hospitals. Our affiliates operate 135 hospitals in 29 states and these locations could provide ideal environments for your professional success.

Compensation packages may include: • Flexible and generous start-up incentives • Medical education debt assistance • Various practice types

For more information visit: www.chsmedcareers.com Email: docjobs@chs.net or Call: 800-367-6813

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7/23/13 5:14 PM