Renal & Urology News September 2015 Issue

SEP T EMBER 2015

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V O L U M E 14, I S S U E N U M B E R 7

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Study: mRCC Patient Survival Improving

BY JODY A. CHARNOW RESEARCHERS WHO studied a population-based cohort of patients with metastatic renal cell carcinoma (mRCC) found a trend toward improved survival with the shift from the cytokine to the targeted therapy era.

The degree of improvement, however, was slightly less than that observed in clinical trials of targeted therapies.

For non-clear-cell mRCC, the limited therapeutic options translated into modest survival gains in the targeted therapy era, according to the investigators.

IN THIS ISSUE 7

Researchers identify predictors of recurrent acute kidney injury

11

Some hypogonadism guidelines may need updating

15

ADT for localized prostate cancer increases cardiac risks

16

Heparin plus alkalinized lidocaine may improve IC symptoms

18

Tamsulosin aids passage of large distal ureteral stones Adding heparin to alkalinized lidocaine improves interstitial cystitis symptoms.

PAGE 16

“These data permit accurate counseling of a heterogeneous, ‘real world’ population of mRCC patients seeking care, especially in the setting of late presentation and unclear histology,” a research team led by Liam C. Macleod, MD, of the University of Washington in Seattle, concluded. “We are hopeful this work may serve as an impetus to systematically improve implementation of histologically guided care for mRCC.” Using the Surveillance, Epidemiology, and End Results (SEER) database, Dr. Macleod’s group identified 14,521 patients diagnosed with mRCC from

Close Surgical Margins Hike Risk of BCR CLOSE SURGICAL margins in radical prostatectomy specimens are associated with biochemical recurrence (BCR) rates similar to those of positive surgical margins, according to a new study.

In study of 609 patients who underwent radical prostatectomy for prostate cancer, patients who had close and positive surgical margins on final pathology had 3-year BCR-free survival rates of 70.4% and 74.5%, respectively, a non-significant difference between the groups, Michael J. Whalen, MD, of the Icahn School of Medicine at Mount Sinai Hospital in New York, and colleagues reported. By comparison, patients with negative margins continued on page 9

© PDSN / PHOTOTAKE

Trend mirrors move to targeted therapy era

THIS CT SCAN SHOWS multiple lung metastases in a patient with renal cell carcinoma.

1990 to 2009. They analyzed survival by treatment era (cytokine era, 1990–2005; targeted therapy era, 2006–2009). Prior to the mid-2000s, the authors noted, mRCC treatments included the cytokines interferon alfa and interleukin-2. As a result of stud-

ies elucidating the molecular biology of kidney cancer, researchers developed agents targeting the vascular endothelial growth factor pathway (such as sunitinib, sorafenib, and bevacizumab) and the mammalian target of continued on page 9

ECD Kidney Loss Linked to DSA CIRCULATING donor-specific antiHLA antibody (DSA) and longer cold ischemia time independently predict worse long-term transplantation outcomes among recipients of expanded criteria donor (ECD) kidneys, according to French investigators.

In a large, prospective study, a team led by Alexandre Loupy, MD, PhD, of the Paris Translational Research Centre for Organ Transplantation, Paris Descartes University, in collaboration with physicians from the DIVAT network, found that, compared with ECD kidney recipients who did not have circulating DSA on the day of transplantation (ECD/DSA−),

recipients who did (ECD/DSA+) had significantly lower graft survival rates at 7 years (44% vs. 85%). Antibody mediated rejection was the main cause of graft loss in the ECD kidney recipients with circulating DSA, the researchers reported online in the British Medical Journal.

ECD/DSA+ recipients had a significant 4.4-fold increased risk of graft loss compared with ECD/DSA− recipients and a 5.6-fold increased risk of graft loss compared with all other transplant therapies.

ECD/DSA− recipients experienced a 41% improvement in graft survival continued on page 9

DIALYSIS TIMING DIFFERS

Patients initiating dialysis in the VA health system do so at a lower eGFR. PAGE 11

www.renalandurologynews.com SEPTEMBER 2015

Renal & Urology News 5

FROM THE EDITOR EDITORIAL ADVISORY BOARD 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

Anthony J. Bleyer, MD, MS Professor of Internal Medicine/Nephrology Wake Forest University School of Medicine Winston-Salem, N.C.

Christopher S. Cooper, MD Director, Pediatric Urology Children’s Hospital of Iowa Iowa City

Suphamai Bunnapradist, MD Director of Research Department of Nephrology Kidney Transplant Research Center The David Geffen School of Medicine at UCLA

R. John Honey, MD Head, Division of Urology, Endourology/Kidney Stone Diseases St. Michael’s Hospital University of Toronto Stanton Honig, MD Department of Urology Yale University School of Medicine New Haven, CT J. Stephen Jones, MD, FACS Vice President Regional Medical Operations Professor & Horvitz/Miller Distinguished Chair in Urological Oncology Cleveland Clinic Regional Hospitals Jaime Landman, MD Professor of Urology and Radiology Chairman, Department of Urology University of California Irvine

Csaba P. Kovesdy, MD Chief of Nephrology Memphis VA Medical Center Fred Hatch Professor of Medicine University of Tennessee Health Science Center, Memphis 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.

James M. McKiernan, MD Assistant Professor of Urology Columbia University College of Physicians and Surgeons New York City

Rulan Parekh, MD, MS Associate Professor of Pediatrics and Medicine University of Toronto

Kenneth Pace, MD, MSc, FRCSC Assistant Professor Division of Urology St. Michael’s Hospital 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.

Ryan F. Paterson, MD, FRCSC Assistant Professor Division of Urologic Sciences University of British Columbia Vancouver, Canada

Lynda Anne Szczech, MD, MSCE Medical Director, Pharmacovigilence and Global Product Development, PPD, Inc. Morrisville, N.C.

Renal & Urology News Staff Editor Jody A. Charnow Web editor

Natasha Persaud

Production editor Kim Daigneau Group art director, Haymarket Medical Jennifer Dvoretz Production manager Krassi Varbanov Production director Kathleen Millea Grinder Circulation manager Paul Silver National accounts manager William Canning Publisher Dominic Barone Editorial director Senior VP, medical journals & digital products Senior VP, clinical communications group CEO, Haymarket Media Inc.

Kathleen Walsh Tulley Jim Burke, RPh John Pal Lee Maniscalco

Renal & Urology News (ISSN 1550-9478) Volume 14, Number 7. Published monthly, except for the combined January/February, June/July and November/ December issues, 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. 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 © 2015.

Thoughts on the Biggest PCa Advance in 10 Years

I

nspired by Prostate Cancer Awareness Month (September), I wondered what would be considered the most noteworthy advance in prostate cancer (PCa) management in the past 10 years. The possibilities are many, but certainly scientific and therapeutic advances in metastatic castration-resistant PCa that have extended survival by 4–5 months on average must figure large in my analysis, given that PCa causes an estimated 27,540 deaths annually. The therapeutics include sipuleucel-T (a therapeutic vaccine) and radium-223, a first-in-class drug that targets bone metastases with alpha particles, as well as abiraterone acetate, enzalutamide, and cabazitaxel. Clinicians now have available an array of therapeutic choices with which to manage a clinically challenging group of patients.

Although using therapeutics to prolong life is a major goal of medicine, I cannot ignore advances in the screening and management of low-risk PCa that address the formidable challenge of decreasing PCa overtreatment. Multiple randomized trials have shown that the vast majority of prostate tumors have an indolent course, seldom metastasizing and causing death. It became clear that many men with low-risk PCa could safely avoid radical treatment without shortening their lifespan. The result was the emergence of active surveillance as a reasonable first-line management strategy for selected patients. Today, many institutions have protocols for monitoring patients for disease progression, offering active treatment when appropriate. Guidelines from the National Comprehensive Cancer Network recommend active surveillance as the sole initial treatment for men with low-risk disease and a life expectancy of less than 10 years and men with very-low-risk disease and a life expectancy of less than 20 years. Guidelines from the American Urological Association and European Association of Urology also recommend that active surveillance be considered among the first-line management approaches for clinically localized low-risk PCa. Active surveillance has the potential to spare thousands of patients the complications of radical surgery or radiotherapy (especially erectile dysfunction and urinary incontinence) that can adversely affect quality of life. Although data suggest that active surveillance is underused, this may change as confidence in this management strategy grows. Recent studies may bolster that confidence. For example, some investigations have identified biomarkers that can accurately distinguish between indolent and aggressive tumors, which could assist in risk-stratifying patients. Greater certainty of a tumor’s indolence may translate into more confidence in active surveillance as a management strategy.

New treatments that take patient care in a new and positive direction are a great thing, but so are the medical advances that help patients avoid jumping into treatment unless it is necessary.

Jody A. Charnow Editor

6 Renal & Urology News

SEPTEMBER 2015

www.renalandurologynews.com

Contents

SEPTEMBER 2015 ■ VOLUME 14, ISSUE NUMBER 7

Urology 11

ONLINE

this month at renalandurologynews.com

Answer correctly and you will be entered to win a $50 American Express gift card.

Pelvic Floor Stimulation Found to Improve Overactive Bladder Investigators observe benefit in perimenopausal women with symptoms such as frequency, nocturia, urgency and urge incontinence.

15

ADT for Localized PCa Increases Cardiac Risks Clinicians should weigh risks and benefits in men with prolonged life expectancies.

16

Combo Improves IC Symptom Relief Heparin plus alkalinized lidocaine provides significantly better relief of interstitial cystitis symptoms compared with alkalinized lidocaine alone.

Clinical Quiz Take our latest quiz at renalandurologynews.com /clinical-quiz/.

CALENDAR

18

Congratulations to our August winner: Fedele Lasaponara, MD

Tamsulosin Aids Passage of Large Ureteric Stones Use of the alpha blocker was associated with a significantly improved clearance of 5–10 mm distal calculi.

Nephrology

HIPAA Our latest column discusses the need for having written policies and procedures in place.

Job Board

11

Dialysis Starts Later in the VA System Health system factors may have a role in shaping decisions about dialysis initiation, according to researchers.

15

Low Sodium Raises Risk of Fracture In a study, individuals with chronic hyponatremia had a 4.6-fold increased odds of fragility fracture compared with those who did not have hyponatremia.

17

Post-Cardiac Surgery RRT Need Ups Mortality Requirement for renal replacement therapy is associated with a nearly 13-fold increased risk of 1-year all-cause mortality.

Be sure to check our latest listings for professional openings across the United States.

News Coverage Visit our website for daily updates as well as on-site coverage of major medical meetings.

19

Melanoma Risk Higher in Transplant Recipients Invasive melanoma occurs twice as often among organ transplant recipients compared with the general population.

We badly need a trial of radiotherapy plus hormones

versus surgery in locally advanced disease, but the challenges in doing such a trial are formidable.

See our story on page 10

International Continence Society Montreal October 6–9 American Society for Radiation Oncology (ASTRO) San Antonio, TX October 18–21 American Society of Nephrology Kidney Week San Diego November 3–8 Genitourinary Cancers Symposium San Francisco January 7–9, 2016 Annual Dialysis Conference Seattle February 27–March 1, 2016 National Kidney Foundation Spring Clinical Meetings Boston April 27–May 1, 2016 European Association of Urology 31st Annual Congress Munich, Germany March 11–15, 2016 American Urological Association Annual Meeting San Diego May 6–10, 2016

18

Departments 5

From the Editor Thoughts on the biggest PCa advance in 10 years

8

News in Brief AKI progression linked to increased fluid intake

18

Practice Management Performing a HIPAA risk assessment

www.renalandurologynews.com SEPTEMBER 2015

Renal & Urology News 7

Clinical Predictors of Recurrent AKI Identified RESEARCHERS HAVE identified clinical predictors of recurrent acute kidney injury (AKI), findings they say could aid in risk-stratifying AKI patients, guide appropriate patient referral following AKI, and help develop potential risk reduction strategies, according to a report in the Journal of the American Society of Nephrology (published online ahead of print).

In a study of 11,683 hospitalized patients with AKI, researchers found that the risk of being hospitalized for recurrent AKI was highest among those with longer AKI duration and those hospitalized with a primary diagnosis of congestive heart failure, decompensated advanced liver disease, cancer with or without chemotherapy,

Longer CRRT May Deplete Carnitine LONGER TIME on continuous renal replacement therapy (CRRT) is associated with carnitine deficiency in children, according to a new study.

Kristen Sgambat, MD, and Asha Moudgil, MD, of the Children’s National Health System in Washington, D.C., studied 42 children receiving CRRT for acute kidney injury. At baseline, 30.7% and 35.7% of the patients were deficient in total and free carnitine, respectively, the researchers reported in a paper published online ahead of print in Hemodialysis International.

These proportions rose to 64.5% and 70% within 1 week, 80% and 90% by 2 weeks, and 100% and 100% after receiving CRRT for 3 weeks or more. Total and free carnitine levels negatively correlated with days on CRRT Patients with total and free carnitine deficiency had a 5.9 and 4.9 greater odds of death than those with normal levels, according to the investigators.

“Carnitine is significantly and rapidly depleted with longer time on CRRT, and carnitine deficiency is associated with increased mortality,” the authors concluded. n

acute coronary syndrome, or volume depletion, Edward D. Siew, MD, of Vanderbilt University in Nashville, Tenn., and colleagues reported.

“The risk for recurrent AKI is likely to be due both to intrinsic susceptibility, which may increase after an episode of AKI, as well as the risk conferred by

the residual effects of acute illness or its therapies,” the authors concluded.”

Of the 11,683 patients, 2,954 (25%) were hospitalized with recurrent AKI within 12 months of discharge. The median time to recurrent AKI within 12 months was 64 days. Patients who experienced recurrent AKI were

older than those who did not (71 vs.

67 years). They also had a heavier comorbidity burden. For example, diabetes mellitus and hypertension were, respectively, present in 60% and 88% of patients who had recurrent AKI compared with 52% and 85% of those who did not. n

8 Renal & Urology News

SEPTEMBER 2015 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 Pre-Cystectomy CT Scans May Predict Outcomes

urine output the on the day of AKI I

Computed tomography (CT) scans

liter per day or less (50 vs. 66 mL/

prior to radical cystectomy (RC) for

hour), the researchers reported in

invasive bladder cancer may be useful

Shock. In multivariable analysis,

in predicting patients’ risk of death.

only fluid intake was independently

Sebastian Christoph Schmid, MD, of the Technische Universität München in

compared with those who gained 1

associated with progression to AKI III; reduced urine output was not.

Munich, and colleagues reviewed prewith invasive bladder cancer undergo-

Statins Do Not Lower Risk of Lethal PCa Post-Diagnosis

ing RC. Patients had a median follow-

Statin use following diagnosis of local-

up of 40 months. Results showed that

ized prostate cancer (PCa) does not

increased bladder wall thickness and

lower the risk of dying from the ma-

lymph node size of 6–10 mm and larg-

lignancy, researchers reported online

er than 10 mm correlated significantly

ahead of print in Cancer ­Epidemiology,

with an increased risk of all-cause and

Biomarkers & Prevention.

operative CT images of 206 patients

cancer-specific mortality, the research-

June M. Chan, ScD, of the Univer-

ers reported online ahead of print in

sity of California San Francisco, and

the World Journal of Urology.

colleagues studied 3,949 men in the Health Professionals Follow-up Study

AKI Progression Linked to Increased Fluid Intake

who were diagnosed with localized

Increased fluid intake in early acute

685 were using statins at the time of

kidney injury (AKI) is an independent

PCa diagnosis.

risk factor for progression to AKI III. Investigators studied 210 patients

PCa from 1992 to 2008. Of these,

The researchers observed 242 cases of lethal PCa (metastases or PCa-

with AKI I. Of these, 85 had a subse-

related death). They found no statisti-

quent mean fluid gain of more than 1

cally significant association between

liter per day. AKI I patients who gained

post-diagnosis current use of statins or

more than 1 liter per day had a lower

duration of statin use and lethal PCa.

10-Year PCSM After Radical Prostatectomy A prospective longitudinal study of 1,864 men who underwent radical prostatectomy for clinically localized prostate cancer revealed an overall 10-year prostate cancer-specific mortality (PCSM) rate of 4.6%. The rate varied by pathologic stage and post-operative Gleason score, as shown here.

11.5%

12

9.5%

10 8

Pathologic stage

Post-operative Gleason score

6 4 2 0

2.6% 0.7% pT2

pT3a

pT3b

0.8%

1.0%

4–6

7

8–10

Source: Mendhiratta N, et al. 10-year mortality after radical prostatectomy for localized prostate cancer in the prostate specific antigen screening era. Urology 2015; published online ahead of print.

BPH in Bladder Stone Patients May Be Managed Conservatively C onservative management of benign prostatic hyperplasia (BPH) can be an appropriate option for men with bladder stones, a small study suggests.

Takashi Yoshida, MD, and colleagues at Kansai Medical University in Japan studied 34 men who underwent endoscopic bladder stone removal with subsequent conservative management of mild-to-moderate BPH, including watchful waiting and pharmacologic treatment. Of these, 26 (76.5%) experienced no BPHrelated complications during a mean follow-up of 52.6 months. The cumulative BPH-related complication-free survival rate was 97.0%, 81.8%, and 70.5% at 1, 3, and 5 years, respectively, according to findings published online ahead of print in Urology. The mean International Prostate Symptom Score fell significantly from 13.5 before treatment to 9.7 after treatment.

Proteinuric Remission in LN Predicts Better Outcomes R

emission of proteinuria in patients with diffuse proliferative lupus nephritis (LN) is associated with a good prognosis, South Korean researchers reported online ahead of print in Lupus.

A team led by Ho Jun Chin, MD, of Seoul National University Bundang Hospital studied 26 men and 167 women with biopsy-confirmed diffuse proliferative LN. Patients had a mean age of 31.2 years at renal biopsy. During follow-up, 82 (42.5%) patients experienced proteinuric remission and 111 did not.

Results showed that patients who achieved proteinuric remission had a decreased risk of death, incidence end-stage renal disease (ESRD), and a composite outcome compared with those who did not have remission. During a mean follow-up of 157.9 months, among patients who achieved proteinuric remission, 1 (1.2%) died, 1 (1.2%) progressed to ESRD, and 2 (2.4%) had composite outcomes. Among patients without remission, 9 (8.1%) died, 24 (21.6%) progressed to ESRD, and 30 (27%) had composite outcomes.

Alfuzosin Safe, Effective for Ureteral Stone Expulsion A

lfuzosin is safe and effective for use as medical expulsive therapy for ureteral stones less than 10 mm in diameter, according to the findings of a systematic review and meta-analysis published online in PLoS One. Chenli Liu, MD, and colleagues at The First Affiliated Hospital of Guangzhou Medical University in Guangdong, China, analyzed data from 9 studies that met the study’s selection criteria. These studies included 291 patients who received alfuzosin 10 mg, 134 who received tamsulosin 0.4 mg, and 280 who received conservative therapy (controls). Compared with controls, alfuzosin-treated patients had a significant 85% increased likelihood of becoming stone-free and a significant 4 day shorter expulsion time. Stone-free rate and expulsion time did not differ significantly between alfuzosin and tamsulosin. Both drugs had similar complication rates. Pooled analysis showed a significantly lower frequency of retrograde ejaculation in the alfuzosin group than the tamsulosin group.

www.renalandurologynews.com SEPTEMBER 2015

mRCC survival continued from page 1

r­ apamycin pathway (such as temsirolimus and everolimus).

Results showed that median survival among the 4,149 patients with clearcell mRCC improved significantly from 11 to 14 months before and after the debut of targeted therapy, the researchers reported online ahead of print in Urology. Median survival improved significantly from 7 to 9 months among the 904 patients with non-clear-cell mRCC. Median survival did not change significantly among the 608 patients who had mRCC with sarcomatoid features and the 8,860 patients with RCC not otherwise specified.

Factors influencing survival On multivariate analysis, treatment in the targeted era was associated with a 13% decreased risk of death compared with treatment in the cytokine era. Clear-cell histology was associated with a 24% decreased risk of death compared with other histologic subtypes. Patients who underwent cytoreductive nephrectomy had a 57% decreased risk of death compared with those who did not.

The researchers acknowledged some study limitations. For example, they

ECD, kidney loss link continued from page 1

at 7 years compared with ECD/DSA+ recipients, according to the investigators.

When the researchers performed a Cox analysis in the ECD kidney group, they found that a cold ischemia time of 12–24 hours and 24 hours or longer were associated with a significant 2.49 and 3.77-fold increased risk of graft loss, respectively, compared with a cold ischemia time of less than 12 hours.

The researchers concluded that circulating DSA and cold ischemia time are the main independent determinants of outcome from ECD kidney transplantation.

“Although circulating DSA is known to impair allograft outcomes, its specific impact, the amplitude of its effect, and its independence from other relevant predictors have not been addressed in the ECD population,” Dr. Loupy told Renal & Urology News. “Our data suggest that ECD kidneys may be particularly vulnerable to the effect of DSA injury and cold ischemia time.”

The study’s principal cohort included 2,763 kidney recipients; of these, 916 received ECD kidneys and

did not have available granular information, which portends mRCC prognosis. “Therefore, we cannot account for performance status, key laboratory values, or sites and burden of metastatic disease volume.”

In addition, as a result of increased use of imaging during the targeted therapy era, patients treated in this era may have been diagnosed earlier in the course of their disease than those treated in the cytokine era.

The researchers said the difference in overall survival between their study and trial data may relate to the more stringent selection criteria for inclusion in clinical trials compared with population-based SEER data.

“SEER captures a heterogeneous health care delivery system and patients with disparate access to new agents and decision making,” they wrote. “Many cases may be treated without histologic information, predisposing patients to care with less beneficial agents.”

Eric A. Singer, MD, MA, assistant professor of surgery and director of the Kidney Cancer Program at the Rutgers Cancer Institute of New Jersey in New Brunswick, who was not involved in the new study, commented that that investigation by Dr. Macleod’s group is important but has some weaknesses, such as the exclusion of the 2 most

1,847 received kidneys from standard criteria donors (SCD). The median follow-up time after transplantation for the overall cohort was 5.54 years, but was shorter for ECD kidney recipients than SCD kidney recipients (5.24 vs. 5.72 years).

ECD allograft survival at 7 years improved significantly with screening and transplantation in the absence of circulated DSA and with cold ischemia times of less than 12 hours.

“Our results support the implementation of active ECD specific allocation policies for avoiding DSA, decreasing cold ischaemia time, and performing adequate recipient matching,” the authors concluded. “In the present study, exclusive allocation of ECD kidneys to patients without circulating DSA would have translated to a 544.6 allograft life years saved during the nine years of study inclusion time.”

As a result of study findings, Dr. Loupy said his practice plans to allocate ECD kidneys exclusively to recipients without circulating anti-HLA DSA and expand the indications for using machine perfusion for ECD kidneys due to the deleterious effect of prolonged cold ischemia time. n

recently approved drugs for treating mRCC (pazopanib in 2009 and axitinib in 2012). “It illustrates that this study is limited by the time period it is examining,” Dr. Singer said, adding that pazopanib often is used as first-line therapy.

“However, I suspect even with the inclusion of pazopanib and axitinib in the study, if we could examine data through 2015, we would still see shorter survival

Improvement in survival was slightly less than that reported in clinical trials. compared to the published clinical trials.” This most likely would be due to differences between the study populations and the general population.

Off protocol patients differ “Off protocol, oncologists are able to treat many more patients,” Dr. Singer told Renal & Urology News. “However, many of these patients may be sicker or have non-clear-cell histologies that were not included in the original pivotal trials.” All of the targeted therapies approved by the FDA have been tested predominantly in patients with

BCR risk continued from page 1

had a 3-year BCR-free survival rate of 90%, which was significantly higher than the rates for patients with close and positive margins. On multivariable analysis, patients with close margins had a 2.7-fold increased risk of BCR compared with those who had negative margins.

“These results suggest that the finding of a close margin on final pathology cannot simply be interpreted as negative,” the authors wrote in a paper published online ahead of print in Urologic Oncology.

“Rather, this finding may have similar outcomes to patients with positive margins and should alert the treating physician of the higher risk for recurrence.”

The investigators concluded that a close margin should be noted routinely in pathologic reports and men with close margins should have more frequent post-operative follow-up to monitor for disease recurrence.

Of the 609 patients, 126 (20.7%) had positive margins, 453 (74.4%) had negative margins, and 30 (4.9%) had close margins. Dr. Whalen’s group defined a close margin as the presence of prostate tumor cells less than 1 mm from the

Renal & Urology News 9

clear-cell mRCC, he said, adding that approximately 25% of mRCC patients have non-clear-cell histology.

“We must continue to study nonclear-cell tumors … if we are going to be able to make significant progress against mRCC,” he said.

Dr. Singer was part of a research team that recently published study findings showing that high-dose interleukin-2 therapy is now used infrequently for mRCC in the United States and that its use has decreased with the uptake of targeted therapy. The study evaluated trends in high-dose interleukin-2 therapy use from 2004 to 2012. The use decreased from 444 patients in 2004 to 135 in 2008, than increased to 230 in 2012, the researchers reported online ahead of print in Urologic Oncology: Seminars and Original Investigations.

The findings of this study are in line with those reported recently by another research team in Urology (2015;85:1399-1403). In a study of 25,186 mRCC patients, Elizabeth K. Ferry, MD, of University Hospitals Case Medical Center in Cleveland, and colleagues found that the use of immunotherapy decreased from 30.3% of patients in 1998 to 3.8% in 2011, whereas the use of chemotherapy increased from 16.2% to 54% during the same period. n

inked surface of the surgical specimen.

During a median follow-up of 20.5 months, the proportion of patients in the close, positive, and negative margin groups was 16.7%, 24.6%, and 8.2%, respectively.

The authors observed that although positive margins “are universally defined as the presence of tumor cells at the inked margin, controversy exists with respect to how to characterize tumor cells that approach, but do not touch, the inked surface.” They noted that early studies have concluded that close margins at the time of radical prostatectomy are similar to negative margins, prompting many institutions to categorize all of these cases of negative margins. More recent studies, however, suggest that close margins more closely resemble positive margins and are an independent predictor of BCR. Dr. Whalen and his colleagues acknowledged that the retrospective nature of their study and the relatively small number of patients with close surgical margins relative to the overall cohort were study limitations. In addition, they noted that the length of follow-up may not have been sufficient to detect a true difference in BCR rates between close and positive margins. n

10 Renal & Urology News

SEPTEMBER 2015 www.renalandurologynews.com

ADT-RT Combo Offers Better Outcomes This approach is, or should be, the standard of care for locally advanced PCa, some researchers say

BY JODY A. CHARNOW RECENTLY PUBLISHED studies provide additional evidence supporting the use of combination treatment with androgen deprivation and radiation in patients with locally advanced prostate cancer (PCa).

The studies demonstrate that androgen deprivation therapy (ADT) plus radiation therapy (RT) is associated with superior cancer-specific and overall survival compared with ADT alone, prompting researchers to conclude that ADT plus RT is a reasonable option for treating locally advanced PCa. “For patients [with locally advanced PCa] who are treated by radiation, the standard of care should be ADT plus RT. Period,” said Justin E. Bekelman, MD, Associate Professor of Radiation Oncology at the University of Pennsylvania in Philadelphia. “The challenge is, there’s never been a trial that has compared surgery to ADT plus RT for locally advanced prostate cancer. That trial is crucial. That would fill the evidence gap.”

At his institution, RT plus long-term ADT is the standard recommendation for patients with locally advanced PCa who opt for RT, he said.

Manageable side effects “I think that the important thing to note is that the combination of radiation with hormone therapy not only improves lives, but is tolerable, Dr. Bekelman said. “With modern radiotherapy techniques, studies have shown that the side effects of radiation with hormone therapy are manageable.”

Dr. Bekelman led a study comparing ADT alone and ADT plus RT in 3 groups of men with locally advanced or high-risk PCa. These groups included a cohort of 4,642 men aged 65–75 years in a randomized controlled trial (RCT); an elderly cohort of 8,694 men older than 75 years with locally advanced PCa; and a cohort of 2,017 men aged 65 years and older with screen-detected high-risk PCa. In the RCT cohort, ADT plus RT was associated with a significant 57% decreased risk of cancer-specific mortality and 37% decreased risk of allcause mortality compared with ADT alone in propensity score-adjusted analyses, Dr. Bekelman’s group reported in the Journal of Clinical

Combination Treatment On the Rise For patients with clinically node-positive prostate cancer, the use of androgen deprivation therapy (ADT) alone decreased while the use of ADT plus radiotherapy (RT) increased from 2004 to 2011, according to a new study.

n 2004 n 2011

60 50 40 30 20 10 0

36.6%

32.2%

ADT alone

45.2%

54.1%

ADT + RT

Source: Lin CC et al. Androgen deprivation with or without radiation therapy for clinically node-positive prostate cancer.

J Natl Cancer Inst. 2015;107:djv119.

Oncology (2015;33:716-722). In the elderly cohort, ADT plus RT was associated with a significant 49% and 37% decreased risk of cancer-specific and all-cause mortality, respectively.

In the screen-detected cohort, ADT plus RT was associated with a significant 75% and 50% decreased risk of cancer-specific and all-cause mortality, respectively.

In a separate study, which was published in the Journal of Clinical Oncolog y (2015;33:2143-2150), Malcolm D. Mason, MD, of Cardiff University School of Medicine in Cardiff, UK, and colleagues reported on a study showing that men with locally advanced PCa treated with ADT plus RT had a significant 30% decreased risk of all-cause mortality and 54% decreased risk of PCa mortality compared with those who received ADT alone. The study included 1,205 men with locally advanced PCa who, from 1995 to 2005, were randomly assigned to receive ADT alone (602 men) or ADT plus RT (603 men). After a median follow-up time of 8 years, 465 patients had died, 199 from PCa. The researchers noted that patients in the combination arm experienced a higher frequency of adverse events related to bowel toxicity, but only 2 of 589 patients had grade 3 or higher diarrhea at 24 months after RT. Additionally, based on a recent systematic review and meta-analysis, researchers concluded that longer duration of ADT combined with radiotherapy is associated with better overall, disease-free, and disease-specific survival in patients

with intermediate- and high-risk non-metastatic PCa. The researchers, who published their findings in the International Brazilian Journal of Urology (2015;41:425-434), analyzed pooled data from 6 randomized trials comparing different durations of hormone blockade.

‘Sometimes a contentious area’ In an interview, Dr. Mason said he believes ADT plus RT is the standard of care for locally advanced PCa. “This is sometimes a contentious area in that the results of surgery in properly selected men treated in expert centers are undoubtedly excellent, too, though there is no level 1 evidence to support this,” he said.

Dr. Mason added, “We badly need a trial of radiotherapy plus hormones versus surgery in locally advanced d ­ isease,

Justin E. Bekelman, MD

but the challenges in doing such a trial are formidable. Our trial and others are sometimes interpreted as indicating that curative local therapy is effective in men with locally advanced disease, whatever form of curative therapy is employed. Now, this may be true, but it is an assumption, and it is not the only possible explanation for our study results.”

In a study of men with clinically node-positive (cN+) prostate cancer (PCa), researchers led by Jason A. Efstathiou, MD, DPhil, of the Department of Radiation Oncology at Massachusetts General Hospital in Boston, found that ADT plus RT was associated with a significant 50% decreased risk of 5-year all-cause mortality compared with ADT alone in propensity score-adjusted analyses.

This study, which was published in the Journal of the National Cancer Institute (2015;107:djv119), included 3,540 men with cN+ PCa identified using the National Cancer Data Base.

Of these, 1,818 (51.4%) received ADT plus RT, 1,141 (32.2%) received ADT alone, 220 (6.2%) received RT alone, and 361 (10.2%) received neither ADT nor RT. The propensity score-adjusted analysis, which was performed to balance baseline characteristics, included 318 ADT-only recipients matched to 318 ADT plus RT recipients.

Important clinical implications “As aggressive local management of cN+ prostate cancer may lead to durable disease control and even cure,” the authors concluded, “these data have important implications for clinical practice guidelines and staging systems.”

Prior to propensity score matching, 47.1% of patients who received ADT alone and 25% of those treated with ADT plus RT died within the 5-year follow-up period. The crude 5-year overall survival rate was significantly lower in the ADT-only group compared with the ADT plus RT group (49.4% vs. 72.4%).

The men had a median age of 66 years. The median follow-up time was 5.2 years for patients diagnosed from 2004 to 2006 and 2.7 years for those diagnosed from 2004 to 2011, the researchers reported.

Data showed that the use of ADT alone decreased from 36.6% in 2004 to 32.2% in 2011, whereas use of ADT plus RT increased from 45.2% to 54.1%. n

www.renalandurologynews.com SEPTEMBER 2015

Renal & Urology News 11

Dialysis Starts Later in the VA System Health system factors may have a role in shaping decisions about dialysis initiation, researchers say but those initiating dialysis within the VA system were significantly less likely than the other groups to start dialysis at an eGFR of 10 mL/min/1.73 m2 or higher, Dr. Yu and her colleagues reported online ahead of print in the Clinical Journal of the American Society of Nephrology.

The adjusted probability of initiating dialysis at an eGFR of 10 mL/min/1.73 m2 or higher was 31% for veterans starting dialysis within the VA compared with 36%, 40%, and 39% for veterans whose dialysis was started outside the VA but paid for by the VA, those whose dialysis was not paid for by the VA, and non-veterans, respectively, the investigators reported.

“The finding of an upward trend in eGFR at initiation among veterans who started dialysis within the VA, where physicians are salaried and cannot bill insurance for dialysis services, seems to suggest that temporal trends in eGFR at initiation are unlikely to be explained

Pelvic Floor Stimulation Found to Improve Overactive Bladder IN PERIMENOPAUSAL women with over-

Starting 1 week into treatment, all

active bladder (OAB), pelvic floor electri-

3 groups showed significant improve-

cal stimulation (PFS) in combination

ment in their OAB symptoms, accord-

with local vaginal estrogen effectively

ing to results published in Urology.

reduces symptoms, a new study finds.

Except for detrusor overactivity, PFS

A research team led by Ahmed

monotherapy produced better symp-

Abdelbary, MD, of Bani Swaif University

tom relief overall than estrogen alone.

in Cairo, Egypt recruited 315 perimeno-

Patients receiving a combination of

pausal women suffering with symptoms

PFS and local estrogen fared the best,

such as frequency, nocturia, urgency,

however, experiencing reductions in

and urge incontinence. Investigators

both urgency and incontinence.

randomly assigned women to 1 of 3

Estrogen appears to enhance the

treatments for 6 weeks: PFS alone, local

effect of PFS and can delay the recur-

estrogen alone (2 grams daily of 0.625

rence of urge incontinence. “The sus-

mg/g estrogen cream), or a combination

tained effect may be due to the improve-

of PFS and estrogen. Clinicians adminis-

ment in tissue quality which may lead to

tered PFS treatment (pulses of 20 Hertz

better conductivity that can augment the

for 320 milliseconds to the vaginal area)

results of PFS and make improvement

twice a week for 30 minutes. Using

more stable,” the investigators explained.

patient reports along with laboratory

Symptom relief may be temporary,

and clinical results, the investigators

however. After 6 weeks of active therapy,

recorded the effects of treatment on day

benefits deteriorated over the following 6

and nighttime frequency, incontinence

months in all treatment groups, with the

episodes, urgency, detrusor overactiv-

exception of incontinence episodes in

ity, and functional bladder capacity.

the combination therapy group. n

Patients initiating dialysis within versus outside the VA system do so at a lower eGFR.

entirely by provider-level financial incentives,” the authors wrote.

In addition, the study found that differences in eGFR at initiation within versus outside the VA were most pronounced among older patients and patients with a higher risk of 1-year mortality.

Hypogonadism Guidelines May Need Updating A RECENT systematic review of the safety and efficacy of testosterone replacement therapy (TRT) largely reinforces the 2010 Endocrine Society Clinical Practice Guidelines for male hypogonadism, but also identifies critical areas to update.

Writing in Mayo Clinic Proceedings, published online ahead of print, Allen D. Seftel, MD, of Rowan University in Camden, NJ, and colleagues reviewed Level 1a evidence on TRT published after 2010. The recent research suggests that severe lower urinary tract symptoms (LUTS) and untreated obstructive sleep apnea may not be absolute contraindications to TRT. In several studies including hypogonadal men on TRT, detrimental effects, such as worse sleepiness or voiding, were not observed.

TRT may provide beneficial effects in men with metabolic syndrome. Recent randomized trials indicated improvements in insulin sensitivity and sexual function. The literature also reinforced evidence showing TRT improves physi-

“Collectively these findings suggest that health system factors may play a significant role in shaping decisions about dialysis initiation, especially in medically complex patients and those with limited life expectancy,” they concluded.

In an editorial accompanying the new report, Venkat Ramanathan, MD, and Wolfgang C. Winkelmayer, MD, of the Baylor College of Medicine and the VA Medical Center, both in Houston, observed that the findings of the study by Dr. Yu and her colleagues “support the possibility of provider-induced demand, in that veterans approaching ESRD experienced differential timing of dialysis initiation depending on their providers’ financial incentives, with salaried physicians in the VA system initiating patients relatively later than nephrologists outside the VA who received incrementally higher monthly payments for each additional patient.”n

cal functioning in frail men, such as muscle strength and bone health. How TRT affects the risk of fracture in men with osteoporosis requires further study and might alter the current recommendation for periodic bone density scans.

As in the 2010 guidelines, the reviewers found inconsistent effects of TRT on quality of life, wellbeing, and erectile function (even in men refractory to phosphodiesterase type 5 inhibitors).

Importantly, future studies need to investigate the effect of TRT in men treated for prostate cancer. There also remains a lack of high quality prospective trials examining the effects of TRT on cardiovascular risk.

In March 2015, the FDA issued a safety communication about a possible increased risk of heart attack and stroke with prescription testosterone products. The FDA noted that TRT is indicated only for men with disorders of the testicles, pituitary gland, or brain. The warning, however, was based mostly on retrospective research, according to the reviewers. Some recent study findings challenge the assumption. The FDA has requested clinical trials to clearly address the question.

The current review was based on a total of 17 Level 1 trials published from 2010 to March 2, 2015 and did not include retrospective studies. n

© SHUTTERSTOCK / KEN WOLTER

PATIENTS WITH end-stage renal disease (ESRD) who initiate dialysis within the Veterans Affairs (VA) health system are more likely to do so at lower levels of renal function compared with those who initiate dialysis outside the system, according to new study.

The study, led by Margaret K. Yu, MD, of Veterans Affairs Puget Sound Health Care System in Seattle, compared veterans who initiated dialysis within the VA system (16,761 patients) with 3 groups who initiated dialysis outside the VA: veterans whose dialysis was paid for by the VA (4,013 patients); veterans whose dialysis was not paid for by the VA (99,436 patients); and non-veterans (851,333 patients). For the study, the researchers linked data from the VA, Medicare, and the U.S. Renal Data System.

All 4 groups exhibited a temporal trend toward starting dialysis at higher levels of estimated glomerular filtration rate (eGFR) from 2000 to 2009,

www.renalandurologynews.com SEPTEMBER 2015

ADT for Localized PCa Increases Cardiac Risks Risks and benefits should be weighed in men with prolonged life expectancy ANDROGEN DEPRIVATION therapy (ADT) with gonadotropin-releasing hormone agonists is associated with an increased risk of cardiac events in elderly men with localized prostate cancer (PCa) and a prolonged life expectancy, new findings suggest.

“Clinicians should carefully weigh the risks and benefits of ADT in patients with a prolonged life expectancy,” the authors concluded in a paper published online ahead of print in BJU International. “Routine screening and lifestyle interventions are warranted in atrisk subpopulations treated with ADT.” Guidelines support ADT as an adjunct to radiotherapy for men with high-risk and locally advanced PCa, but do not recommend it as a primary treatment for low-risk PCa, they noted. Various large observational studies have demonstrated associations between ADT and an elevated risk of cardiovascular morbidity.

Using the Surveillance, Epidemiology and End Results (SEER)-Medicare database, Marianne Schmid, MD, of Brigham and Women’s Hospital and Harvard Medical School in Boston, and collaborators identified 50,384 men diagnosed with localized PCa and compared those who received either gonadotropin-releasing hormone (GnRH) agonists or orchiectomy within 2 years and 6 months of PCa diagnosis, respectively, and those who did not. The investigators stratified GnRH use using monthly equivalent doses (less than 8 or 8 or more doses). They stratified patients according to life expectancy: less than 5 years, 5–10 years, and more than 10 years. In addition, the investigators examined the effect of ADT on overall cardiac events, coronary heart disease (CHD), acute myocardial infarction (AMI), and sudden cardiac death (SCD).

Overall, the proportion of patients experiencing cardiac events was significantly greater among those who received GnRH agonists than those who did not (42% vs. 38.6%), the investigators reported. Compared with men not treated with GnRH agonists, those who received fewer than 8 doses and 8 or more doses had a significant 13% and 18% increased risk of any cardiac event, respectively, in adjusted analyses.

GnRH Agonists and Cardiac Risks Primary androgen deprivation therapy with gonadotropin-releasing hormone agonists is associated with an elevated risk of cardiac events in men with localized prostate cancer. The increases in risk (shown below) are higher among those with greater exposure to the drugs.

n Any cardiac event 20 15

n Coronary heart disease 18%

13%

17%

13%

10 5 0

Fewer than 8 doses

8 or more doses

Duration of GnRH agonist treatment Source: Schmid M, et al. Dose-dependent effect of androgen deprivation therapy for localized prostate cancer on adverse cardiac events. BJU Int. 2015; published online ahead of print.

Additionally, men who received fewer than 8 and 8 or more doses of GnRH agonists had a significant 13% and 17% increased risk of CHD. Only patients who had a life expectancy of 5–10 years and received fewer than 8 doses of GnRH agonists had a significantly elevated risk of AMI.

Men with longer life expectancy are most at risk of cardiac morbidity, data show.

Results showed that the effect of prolonged GnRH agonist use on cardiac event risk was sustained across all strata of life expectancy. Researchers, however, observed no effect among patients with a life expectancy of less than 5 years and whose GnRH agonist use was limited to fewer than 8 doses. In addition, men who received 8 or more doses of GnRH agonists and had a life expectancy of 5 or more years had a significantly higher risk of sudden cardiac death.

Orchiectomy was not associated with overall cardiac events, AMI, or SCD, and was protective against cardiacrelated interventions, Dr. Schmid’s group reported.

“Taken together, our findings suggest that patients with longer life expectancy are most at risk of cardiac morbidity after

ADT administration,” the authors wrote.

In consideration of previous reports and their study findings, they noted, “it is worrying and disappointing” that 1 in 3 patients still receives primary ADT as a treatment for localized PCa. In a separate study published online ahead of print in the European Journal of Surgical Oncology, members of the same research team found that ADT use in patients with non-metastatic PCa may increase the risk of mortality from causes other than PCa. The study included 137,524 men, of whom 9.3% had stage III-IV disease and 57.7% received primary ADT. The mean duration of ADT was 22.9 months and mean follow-up was 66.9 months. At 10 years, the overall other-cause mortality rate was 36.5%, but the rate was significantly lower in patients who did not receive ADT (30.6% vs. 40.1%). In multivariable analysis, ADT was associated with an 11% increased risk of other-cause mortality.

In addition, the study found that patients without comorbidities were more subject to harm from ADT than patients with a high comorbidity burden.

Last year in the World Journal of Urology, Arie Carneiro, MD, of ABC Medical School in São Paulo, Brazil, and colleagues reported on a metaanalysis showing that ADT use in PCa patients significantly increases cardiovascular comorbidity associated with (AMI) and with nonfatal cardiovascular events. n

Renal & Urology News 15

Novel Strategies May Help Lower Phosphorus INDIVIDUALIZED coaching and financial incentives may be effective ways to help hemodialysis (HD) patients control phosphorus levels, a small pilot study suggests.

Peter R. Reese, MD, of the University of Pennsylvania in Philadelphia, and colleagues randomly assigned 36 HD patients to 3 groups—coaching, financial incentives, or usual care—for 10 weeks. Baseline serum phosphorus levels ranged from 5.6 to 7.6 mg/dL. Patients’ monthly serum phosphorus levels declined by 0.40, 0.32, and 0.24 mg/dL in the coaching, incentives, and usual care groups, respectively, the researchers reported online ahead of print in the Journal of Renal Nutrition.

“These findings suggest that a future trial might combine education (using a coach or a different delivery method) with financial incentives to give patients the knowledge and motivation to change nutritional and medication adherence habits,” the investigators wrote.

Small pilot study shows the potential of using coaches and financial incentives.

In the coaching group, a renal dietitian worked with individual patients to achieve dietary and medication adherence. The dietitian offered education and practical advice related to shopping, food selection and preparation, and ways to remember to take their phosphate binders.

Patients in the financial incentives group received $1.50 per day when they lowered their phosphorus levels to a reasonable target of 5.5 mg/dL or below or when their serum phosphorus levels declined by at least 0.5 mg/dL from the prior reading. Successful patients also were entered into a lottery to win $50.

The study was not powered to detect clinical differences between groups, but it determined the feasibility of using novel strategies and corroborated findings from similar research on phosphorus education. Other studies have shown that self-management and financial interventions improve medication adherence, smoking cessation, substance abuse, glycemic control, and weight loss. n

16 Renal & Urology News

SEPTEMBER 2015 www.renalandurologynews.com

Combo Improves IC Symptom Relief Heparin added to alkalinized lidocaine provided better reductions in bladder pain and urgency arm reported at least a 50% overall improvement in global assessment response at 1 hour (77% vs. 50%) and 24 hours (57% vs. 23%).

“These data support the rationale for combining the drugs, lidocaine to anesthetize the nerves and heparin to augment the bladder’s defective permeability barrier seen in patients with IC,” the researchers wrote in the Canadian Journal of Urology (2015;22:7739-7744).

“It also appears that the presence of the heparin is important to stabilize lidocaine solubility when it is alkalinized.”

The heparin-lidocaine combination was a 15 mL solution of 50,000 units of heparin and 200 mg of USP lidocaine hydrochloride buffered to pH 7.2.

The researchers separately conducted a second study with a different set of patients to further assess the efficacy of the drug combination. They determined via chromatography that serum lidocaine levels were more than twice

Risk Factors for Chronic Kidney Disease Progression Identified PROTEINURIA, high blood pressure,

According to results published

and anemia are major risk factors for

online in Clinical and Experimental

chronic kidney disease (CKD) progres-

Nephrology, risk factors strongly asso-

sion, a new Japanese study confirms.

ciated with more rapid decline in eGFR

In addition, hyperphosphatemia and

included proteinuria, hyperphosphate-

hyperuricemia—which are other time-

mia, and anemia, suggesting these fac-

dependent factors that change with the

tors could be targets for intervention.

natural course of CKD and treatment—

Older age, lower albumin, and higher

emerged as important potential targets

hemoglobin appeared to be protective.

for clinical intervention.

For the retrospective study, investiga-

The investigators speculated that higher phosphorus levels and subse-

tors led by Shunya Uchida, MD, of Teikyo

quent calcium deposits may contribute

University in Tokyo, calculated the yearly

to arterial sclerosis.

decline in estimated glomerular filtration

The study also found that men with

rate (eGFR) for 770 male and female

CKD experience more rapid decline

patients (mean age 61.9 years) with CKD

in kidney function than women (aver-

stages 3 or 4 and correlated eGFR with

age eGFR decline 2.83 vs. 1.66 mL/

follow-up laboratory results taken every

min/1.73 m2 per year).

1–3 months for an average of 4 years

Limitations of the study included lack

(prior to dialysis initiation). The research-

of information about medication usage

ers looked at a host of blood and urinary

(other than antihypertensive drugs),

parameters, such as hemoglobin, albu-

genetic factors, and parameters

min, nitrogen, creatinine, hematuria, uric

related to CKD mineral bone disease.

acid, sodium, potassium, phosphate,

The researchers calculated eGFR

low-density lipoprotein cholesterol, and

using the Modification of Diet in Renal

C-reactive protein.

Disease study equation. n

Heparin augments the bladder’s defective permeability barrier seen in IC patients.

as high with the heparin-lidocaine combination compared with unalkalinized USP lidocaine, supporting the clinical activity seen in the original study.

In a separate development related to IC treatment, Japanese researchers

Low Sodium Raises Risk of Fracture HYPONATREMIA IS a risk factor for osteoporosis and fracture, a new study confirms.

For the study, researchers matched 30,517 osteoporosis cases to 30,517 controls without osteoporosis and matched 46,256 fragility fracture cases to 46,256 controls without fragility fracture. Compared with individuals without hyponatremia, those with chronic hyponatremia had a 4-fold increased odds of osteoporosis and 4.6fold increased odds of fragility fracture, according to a report published online ahead of print in The Journal of Clinical Endocrinology and Metabolism. Patients with recent hyponatremia had a 3-fold increased odds of both osteoporosis and fragility fracture. Patients with both chronic and recent hyponatremia had a 12- and 11-fold increased odds of osteoporosis and fragility fracture, respectively.

The researchers defined recent hyponatremia as a serum sodium level below 135 mmol/L within 30 days before the end of the encounter window; they

reported that botulinum toxin type A injection could be an alternative treatment option for patients with IC refractory to conventional treatments. A team led by Yuko Homma, MD, PhD, of the Graduate School of Medicine, The University of Tokyo, tested the treatment in 34 patients with refractory IC. The researchers randomly divided patients into 2 groups: those who received immediate injections (group A) or those who had injections delayed 1 month (group B). The response rate was significantly higher in group A than group B (72.2% vs. 25%), and all symptoms measures showed significantly better improvement in group A than group B, the researchers reported online in the International Journal of Urology. When both groups were combined as a single cohort, the response rate was 73.5% at 1 month, 58.8% at 3 months, 38.2% at 6 months, and 20.6% at 12 months. n

defined chronic hyponatremia as at least 2 consecutive serum sodium measurements below 135 mmol/L at least 1 year apart during the encounter window.

Results also showed that lower serum sodium is associated with higher risk.

For example, a median level of 130–134 mmol/L is associated with a 4.4-fold increased odds of osteoporosis and a 4.5-fold increased odds of fragility fracture, whereas a median level below 130 mmol/L is associated with a 6.6-fold and 7.0-fold increased odds of osteoporosis and fragility fracture, respectively.

Women made up 66.3% of the osteoporosis cases and controls and 55.4% of the fragility fracture cases and controls.

“This investigation adds to the accumulating evidence that even mild hyponatremia may have clinical implications for patients risk of osteoporosis and fragility fracture,” the researchers, led by Joseph G. Verbalis, MD, of Georgetown University Medical Center in Washington, D.C., wrote.

Dr. Verbalis’ group noted that their study potentially clarifies and expands the findings of the Rotterdam study, which found that hyponatremia at study entry was associated with a 1.4fold increase in nonvertebral fractures over 7.4 years of follow-up and a 1.8fold increase in prevalent, but not incident, vertebral or hip fractures. n

© SHUTTERSTOCK / SUTTHA BURAWONK

BY NATASHA PERSAUD A COMBINATION OF heparin and alkalinized lidocaine provides significantly better relief of interstitial cystitis (IC) symptoms compared with alkalinized lidocaine alone, a new study found.

For the crossover study, investigators led by C. Lowell Parsons, MD, of the University of California San Diego Health System, treated 14 IC patients with a heparin-alkalinized lidocaine combination or alkalinized lidocaine alone on different days, when they had pain. Patients were blinded to the solutions they received via catheter into the empty bladder. Before and after each treatment, the patients assessed their symptoms via questionnaires.

The heparin-lidocaine group had a significantly greater percentage reduction in bladder pain (38% vs. 13%) and urgency (42% vs. 8%) than the lidocaine-only group. Significantly more patients in the combination

www.renalandurologynews.com SEPTEMBER 2015

TARGETED MILD HYPOTHERMIA in kidney donors prior to organ harvesting after death may be an effective way to improve transplant outcomes, according to a new study.

In a prospective, randomized study, this approach was associated with a significant 38% decreased risk of delayed graft function (DGF) compared with maintaining a normal body temperature, Claus U. Niermann, MD, of the Division of Transplant Surgery at the University of California San Francisco, and colleagues reported in The New England Journal of Medicine (2015;373:405-414).

“This trial showed that a noninvasive temperature-management protocol aimed at achieving a mild level of hypothermia in donors decreased the rate of delayed graft function in recipients,” the investigators concluded. “This decrease was particularly evident in kidney recipients from the highest-risk donors.”

On the recommendation of an independent data and safety monitoring board, the trial was terminated early after an interim analysis showed efficacy of hypothermia. At trial termination, the study had enrolled 370 organ donors, who were randomly assigned to a hypothermia group (180 donors) or a normothermia group (190 donors).

Donors assigned to the hypothermia group were either allowed to spontaneously reach a body temperature of 34° to 35° C (93.2° to 95° F) or were cooled using forced-air systems or passive-cooling devices. Donors assigned to the normothermia group were kept at 36.5° to 37.5° C (97.7° to 99.5°) with the use of the same devices. The primary outcome was DGF, defined as a kidney recipient’s requirement for dialysis during the first week following transplantation. DGF developed in 79 recipients of kidneys from donors in the hypothermia group (28%) and 112 recipients of kidneys from donors in the normothermia group (39%). n

Less Alcohol, More Frequent Exercise Speeds Renal Function Loss in Men Associations persisted regardless of body mass index, a study found

BY NATASHA PERSAUD MEN WHO DRINK small amounts of alcohol or do not exercise may be at increased risk of renal function decline, regardless of body weight, according to a Japanese study.

As part of the Saitama Cardiometabolic Disease and Organ Impairment Study, Eiichiro Kanda, MD, of Tokyo Kyosai Hospital, Meguro, Tokyo, and colleagues examined data from 7,473 healthy men and women (average age 38.8 years) living or working in Saitama, Japan, from 1999 to 2008. They gathered information on participants’ alcohol consumption, exercise frequency, and sleep duration, along with clinical histories and demographic information. The investigators grouped participants according to gender and body mass index (BMI).

Men who consumed a small amount of alcohol each week (20 to 140 grams, roughly equivalent to 1 to 7 glasses of sake) were more likely to experience a greater than 25% decrease in eGFR or to develop CKD within 3 years compared with men who drank more than 140 grams per week, researchers reported online in PLOS One. Their odds were elevated whether they were normal

Alcohol, Exercise, and Renal Function Loss In a Japanese study, men who drank who drank less alcohol or exercised frequently had increased odds of experiencing a greater than 25% decrease in estimated glomerular filtration rate or developing CKD within 3 years, regardless of their weight, as shown here.

100

Increassed odds

Hypothermia In Donors May Cut DGF Risk

Renal & Urology News 17

n Normal weight

n Overweight/obese

80 60 40 20 0

37%

63%

41%

84%

20–140 g vs. >140 g

2 × or more vs. no exercise

Alcohol consumption per week

Exercise frequency per week

Source: Kanda E et al. Alcohol and exercise affect declining kidney function in healthy males regardless of obesity: A prospective cohort study. PLOS One. DOI:10.1371/journal.pone.0134937.

weight (37%) or overweight/obese (63%).

Similarly, men who exercised 2 or more times a week (more than 30-minute sessions with sweating) also had greater odds of kidney function decline compared with men who did not exercise. Men of normal weight and overweight/obesity had 41% and 84% increased odds, respectively.

The investigators found no correlation between alcohol consumption and exercise frequency and loss of kidney function in the female groups.

For each analysis, the researchers adjusted for age, gender, BMI, smoking, eGFR, urinary protein excretion, and histories of diabetes, hypertension, dyslipidemia, and cardiovascular diseases.

The results on male alcohol consumption are in line with previous studies, the investigators noted. Possible mechanisms include the effects of alcohol on preventing hyalinization of renal arterioles, increasing high-density lipoprotein level, and/or reducing inflammation and oxidation. n

Post-Cardiac Surgery RRT Need Ups Mortality PATIENTS WHO REQUIRE renal replacement therapy (RRT) after cardiac surgery are at increased risk of death, independent of other factors, according to a new study.

Charat Thongprayoon, MD, and colleagues at Mayo Clinic in Rochester, Minn., compared with 202 patients who experienced acute kidney injury and required RRT within 30 days after cardiac surgery (cases) with an age- and sex-matched control group of 404 patients who underwent cardiac surgery but did not require RRT post-operatively.

The unadjusted all-cause mortality rate at 1 year was 64% among the cases versus 8% for the matched controls. In multivariate analysis, cases had a 12.6fold increased risk of 1-year all-cause mortality compared with controls, the investigators reported online in Mayo Clinic Proceedings. Renal recovery occurred in 34% of cases by 90 days

and 39% by 1 year. At 1 year, only 4% of the RRT patients were alive and requiring RRT. Among patients who survived, renal recovery occurred in 66% and 86% by 90 days and 1 year after starting RRT, respectively.

“This is the first study, to our knowledge, examining both long-term survival and the likelihood and timeline of renal function recovery among cardiac surgery patients requiring postoperative RRT,” the authors noted.

Among cases, factors independently and significantly associated with 1-year all-cause mortality included increasing age, a history of congestive heart failure (CHF), longer interval between surgery and RRT initiation, need for mechanic ventilation or an intra-aortic balloon pump (IABP) at the time of RRT, and lower preoperative creatinine level.

Each 10-year increase in age was associated with an 18% increased risk of all-cause mortality in multivariate

analysis. A history of CHF was associated with a 51% increased risk. Each 1-day increase in the time from surgery to RRT start was associated with a 3% increased risk. The need for mechanic ventilation or an IABP was associated with a significant 78% and 63% increased risk, respectively. Each 1 mg/ dL increment in preoperative creatinine level was associated with a significant 25% decreased risk.

“Our results may affect care substantially during discussions regarding prognosis,” Dr. Thongprayoon’s team wrote. “Patients and families, who may assume that RRT, once initiated, is permanent, can be told that, although there is a high mortality in the first year, the risk of end-stage kidney disease is unlikely in the case of survival.

Therefore, discussion about goals of care should focus more on mortality than on the implications of end-stage kidney disease.” n

18 Renal & Urology News SEPTEMBER 2015 www.renalandurologynews.com

Tamsulosin Aids Passage of Large Ureteric Stones MEDICAL EXPULSIVE therapy using tamsulosin aids passage of distal ureteric stones 5–10 mm in diameter, according to a randomized trial.

Australian investigators led by Jeremy S. Furyk, MBBS, of Townsville Hospital in Queensland, recruited 403 patients from 5 emergency departments who had distal ureteric stones 10 mm or smaller as shown on computed tomography (CT).

Patients received the alpha blocker tamsulosin (0.4 mg) or identical placebo pills for up to 28 days, the maximum time for spontaneous stone passage. Investigators, treating physicians, and patients were blinded to the pills received.

Each week, researchers contacted patients to ask about pain symptoms and adverse effects, such as dizziness or palpitations. Pain medication was given at the discretion of the treating physician. After 28 days, patients had a limited CT to determine stone passage.

The alpha blocker showed efficacy in clearing 5–10 mm distal calculi.

According to results published in the Annals of Emergency Medicine, stone passage occurred in 87% of tamsulosin patients and 82% of placebo patients overall, a non-significant difference between the groups. Among those with stones 5–10 mm in diameter, however, 83% experienced stone passage with tamsulosin compared with 61% with placebo, a between-group difference that was significant. The researchers calculated that 4.5 patients would need to be treated to observe an effect.

Dr. Furyk’s group observed no significant differences between the treatment arms in the need for urologic interventions, time to stone passage, pain, or analgesia. The groups did not differ significantly with respect to adverse events, which were generally mild.

“For patients with small kidney stones, time seems to be the one sure cure,” Dr. Furyk stated in a release.

“However, when treating patients with large kidney stones, emergency physicians should definitely consider tamsulosin.” Guidelines have suggested “off-label” use of medical expulsive therapies for newly diagnosed stones less than 10 mm in diameter.

Among the study limitations, the investigators noted that 17% of

patients in each group did not have a follow-up CT. The researchers stated that, to their knowledge, the study is the largest clinical trial evaluating tamsulosin versus placebo in distal ureteric calculi.

Commenting on the new findings, Madhu Agrawal, MD, of Global

Rainbow Hospital in Agra, India, who has published research in this area, stated that the results, as would be expected, are by and large in concordance with the results of previous trials.

“The study confirms the usefulness of alpha blockers for medical expulsive therapy in patients with uncom-

plicated presentation of distal ureteral stones sized 0.5–1 cm,” Dr. Agrawal said. “Given its proven efficacy, coupled with low incidence of adverse effects, medical treatment with tamsulosin can now be considered the standard of care for first-line treatment for distal ureteric calculi. n

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Renal & Urology News 19

Melanoma Risk Higher in Transplant Recipients B:15.5” T:15.25” S:14.75”

TRANSPLANT RECIPIENTS have an elevated risk of melanoma and of dying from the cancer, according to a new study.

Investigators led by Hilary A. Robbins, MSPH, a PhD student at Johns Hopkins University in Baltimore, characterized melanoma risk factors and outcomes

among nearly 140,000 Caucasian organ transplant recipients using data from linked transplant and cancer registries.

Invasive melanoma was diagnosed in 519 transplants and in situ skin cancer in 190.

Invasive melanoma occurred twice as often among transplant recipients compared with the general population,

according to results published online in the Journal of Investigative Dermatology.

Patients had a 4-fold risk of regional stage tumors that, along with the risk of distant tumors, peaked within 4 years of transplantation and increased with polyclonal antibody induction therapy.

The rate of localized melanoma was also

elevated and appeared higher with azathioprine maintenance therapy. The risk of dying from melanoma was 3 times higher among transplant recipients.

“Melanoma exhibits increased incidence and aggressive behavior under transplant-related immunosuppression,” the investigators concluded. n

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20 Renal & Urology News SEPTEMBER 2015 www.renalandurologynews.com

Southern-Style Diet Increases Heart Disease Risk

BY NATASHA PERSAUD FREQUENTLY CONSUMING foods typical of a Southern-style diet may increase a person’s risk of a myocardial infarction (MI) or heart-related death, researchers concluded.

James M. Shikany, DrPH, a nutritional epidemiologist at the University

of Alabama at Birmingham, and his research team analyzed food frequency questionnaires from 17,418 Caucasian and African-American participants (other ethnic groups excluded) in the B:7.25” Reasons for Geographic and Racial Differences in Stroke T:7” (REGARDS) S:7” study. The investigators identified and

characterized 5 dietary patterns based on participants’ usual intake of 110 food items: Southern, Plant-based, Sweets, Convenience, and Alcohol-Salad.

The “Southern” diet included a high proportion of fried foods, added fats, eggs, organ and processed meats, and sugar-sweetened beverages (and a low

intake of fruits, vegetables, and fiberrich foods). Men and women with the highest intake of these foods had a 56% greater risk of non-fatal MI or death due to coronary heart disease (CHD) over 5.8 years, compared with people with the lowest consumption, according to results published in Circulation. The participants, aged 45 year and older, had no history of CHD at baseline.

The other dietary patterns showed neither positive nor negative associations with acute CHD, including, interestingly enough, the Plant-based diet consisting of produce, fruit juices, cereals, beans, fish, poultry, and yogurt.

The Sweets eating pattern was loaded with added sugars, desserts, chocolate, candy, and sweetened breakfast foods.

The Convenience diet featured pasta, pizza, Mexican and Chinese foods, as well as mixed dishes. The Alcohol-Salad eating pattern included predominantly beer, wine, liquor, green leafy vegetables, tomatoes, and salad dressing.

The diet is rich in fried foods, added fats, and organ and processed meats.

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The investigators suggest atherosclerosis may link a Southern-style diet with CHD. Previous research on processed meat consumption pointed to its high sodium and nitrate content, as well as its byproducts, which may promote atherosclerosis and vascular dysfunction. Sugar-sweetened beverages likewise may spur atherosclerosis by increasing body mass index (BMI) and glycemic load, which in turn promotes insulin resistance, beta cell dysfunction, and inflammation.

“Regardless of your gender, race, or where you live, if you frequently eat a Southern-style diet you should be aware of your risk of heart disease and try to make some gradual changes to your diet,” Dr. Shikany said in a press release.

Consumers of the Southern diet tended to be male, African American, smokers, residents of the stroke belt, and low income earners. They also were more likely to have a higher BMI, greater waist circumference, hypertension, dyslipidemia, and diabetes. When the researchers accounted for BMI and the above medical conditions, it reduced the risk of acute CHD only somewhat to 37%. n

www.renalandurologynews.com SEPTEMBER 2015

PCa Deaths More Likely in Black Men BLACK MEN LIVING in England have a higher than average lifetime risk of being diagnosed with prostate cancer (PCa) and dying from the disease, a new study finds. The reasons for the elevated risks are still unclear.

Investigators led by Alison Cooper from Prostate Cancer UK combined PCa incidence and mortality data from 2008–2010 from several databases, such as Public Health England and the national census. They examined the data across 3 broad racial categories: Men identifying as black, white, or Asian. Black race included men from Africa, the Caribbean, and other black ancestry. Asian race reflected Indian, Pakistani, Bangladeshi, and other Asian genealogy. White race represented men from Britain, Ireland, and other Caucasian family histories. Men identifying as mixed race were a disparate group that precluded analysis.

According to results published in BMC Medicine, the absolute lifetime risk of a PCa diagnosis was 1 in 4 for black men in England, compared with 1 in 8 for white men. The risk of dying from PCa was also twice as high

Renal & Urology News 21

Cardiovascular Mortality in CKD Patients Possibly Linked to TMAO Trimethylamine-N-oxide levels correlate positively with atherosclerosis burden PRIOR STUDIES in rodents have demonstrated trimethylamine-N-oxide (TMAO) to be a direct promoter of atherosclerosis. Patients with chronic kidney disease (CKD) exhibit accelerated development of atherosclerosis that contributes to the high cardiovascular mortality in this group. According to a new study performed by a research team led by Jason R. Stubbs, MD, of the University of Kansas Medical Center in Kansas City, CKD patients have elevated serum concentrations of TMAO that correlate with increased coronary atherosclerosis burden.

“Based on evidence that TMAO production is dependent on dietary precursors and the intestinal microbiome,” Dr. Stubbs’ group concluded in a report published online ahead of print in the Journal of the American Society of Nephrology, “TMAO may represent a novel modifiable risk factor and therapeutic target for reducing cardiovascular mortality in patients with CKD.” In addition, previous studies have demonstrated an association between elevated TMAO levels and cardiovascular events in humans with preserved kidney function, “providing solid clini-

cal evidence to support a link between TMAO and cardiovascular pathology.”

No studies have examined the relationship between TMAO and atherosclerosis in CKD patients.

Dr. Stubbs and his colleagues measured serum concentrations and urinary excretion of TMAO in a cohort of 104 CKD patients and examined the effect of renal transplantation in 6 of these

TMAO may represent a novel modifiable risk factor and therapeutic target. patients. In addition, the researchers examined the relationship between serum TMAO and coronary atherosclerosis burden, as well as overall mortality, in a separate cohort of 220 CKD patients undergoing coronary angiography.

Study results showed a strong inverse association between serum TMAO and estimated glomerular filtration rate. TMAO concentrations were significantly higher in dialysis-dependent

patients compared with healthy controls (median 94.4 vs. 3.3 µM). In the 6 renal transplant recipients, TMAO concentrations declined significantly from 71.2 µM pre-transplant to 11.4 µM posttransplant, Dr. Stubbs’ group reported.

Furthermore, the researchers observed a statistically significant and independent positive correlation between TMAO concentration and coronary atherosclerosis burden as defined by modified Gensini score. In addition, each 10 µM increment in TMAO concentration was associated with a 26% increase in longterm mortality risk independent of traditional cardiac risk factors.

“The current investigation advances our understanding of cardiovascular disease in CKD by providing a novel mechanistic link to explain the presence of accelerated atherosclerosis in patients with reduced kidney function,” the authors concluded. “As such, our study demonstrates a strong inverse relationship between circulating concentrations of TMAO, a novel atherogenic compound, and residual kidney function in patients with CKD, and defines TMAO as an independent predictor of coronary atherosclerosis in this population.” n

for black versus white men: 1 in 12 compared with 1 in 24.

The odds were most favorable for Asian men. Their lifetime risk of being diagnosed with PCa was 1 in 13 and their chances of dying from the cancer were 1 in 44, roughly half the risk of white men. The researchers found that all PCa patients had a one-third risk of dying of the disease, however, irrespective of ethnicity.

Greater awareness of the higher statistics may prompt black men to see their healthcare provider and discuss whether to have PSA testing, the researchers suggested. Ethnicity, of course, is not the only PCa risk factor. Increasing age, a strong family history, and weight, also play roles, for example.

Future studies need to probe the mechanisms behind the disparities, whether genetic, environmental, and/ or socioeconomic, according to the investigators. n

Metformin Use in Advanced CKD Ups Death Risk METFORMIN USE by patients with stage 5 chronic kidney disease (CKD) may be an independent risk factor for early death, according to the findings of a study conducted in Taiwan.

In the retrospective observational study, investigators led by ChihCheng Hsu, MD, of the National Health Research Institutes, and DerDeng Tarng, MD, of Taipei Veterans General Hospital in Taiwan, compared the mortality risk among 813 metformin users and 2,439 nonusers who had type 2 diabetes and a serum creatinine level greater than 530 µmol/L (which is approximately the equivalent of stage 5 CKD). The researchers obtained 2000–2009 patient data from Taiwan’s national health insurance research database.

Although metformin, a biguanide, has been contraindicated for years in the United States and Europe for patients with advanced CKD, it has been pre-

scribed to patients in Taiwan without renal contraindication until to 2009.

After a median follow up of 2 years, 53% of metformin users and 41% of non-users (controls) died. After adjusting for potential confounders, the researchers discovered that metformin use was associated with a significant 35% increased risk of mortality from all causes, according to findings published online ahead of print in The Lancet. The risk of premature death also increased with metformin dose: Compared with non-users, patients prescribed 501–1,000 mg daily had a 30% increased risk, whereas those taking more than 1,000 mg daily had a 57% increased risk.

“Although the results of an observational study should be interpreted with caution, the dose-dependent association argues strongly in favour of a true association between prescription of metformin and mortality in patients

with advanced chronic kidney disease,” the authors wrote.

Although the study had a number of strengths, such as a large size and national representation, it also had some limitations. For example, the authors acknowledged that potentially important confounders were not available for adjustment, such as the overall intensity of diabetes care or smoking history. In addition, the researchers noted that they did not account for possible changes in treatment regimens after the index date.

In an accompanying editorial, Kamyar Kalantar-Zadeh, MD, MPH, PhD, and Connie M. Rhee, MD, of the University of California Irvine School of Medicine wrote, “Notwithstanding ongoing pressures from the endocrinology and nephrology communities to liberalise use of metformin in patients with CKD, the restrictions should be maintained, bearing in mind the utmost priority of practicing safe and conservative medicine.” n

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Practice Management O

n its website, the Department of Health and Human Services (DHHS) offers steps a practice can take when performing a risk analysis, which is required by the Health Insurance Portability and Accountability (HIPAA). These steps include identifying the scope of the analysis; gathering data; identifying vulnerabilities; assessing security measures; and determining the potential impact of a threat. As with much of the wording of HIPAA— and lists that offer ways to comply with the regulation — there is little that is “actionable, practical, or specific,” said Steve Spearman, CEO of Health Security Solutions.

Organizations that want to perform risk assessments often have no idea where to start or what to do with much of the information meant to help them.

So, where should someone turn to find out how to comply with the risk assessment provision? Experts have some tips on weaving through the mire.

One example is the use of Windows XP. According to Spearman, the operating system is no longer supported by Microsoft, Inc., meaning the developer will no longer provide updates, troubleshooting, or security patches for the system. Because of this, offices that use it after April are technically no longer HIPAA compliant. The rules do not specifically cover this XP point, but a risk analysis would catch this, Spearman said.

Performing a risk analysis not only alerts an organization to this kind of problem, but it is a good way to potentially mitigate punishment after the fact. Imagine two different providers have XP and only one performs a risk analysis. They are both sitting in front of an auditor after a breach and one says, “I didn’t know this was a problem,” whereas the other pulls out its documentation and says, “We knew this was a risk area for us, and to lessen the potential for harm, we repurposed some computers, and took others off of the system.”

Just do it Not performing a risk assessment is akin to doing a home inspection and being surprised to find out a house’s

Steps to take The verbiage of the provision dealing with risk analyses requires providers to perform an accurate and thorough

A risk analysis is the main tool that enables providers to determine where they stand with their protected health information. foundation is settling or there are termites in the rafters. Not only does HIPAA require this step, it is the key provision within the legislation related to meaningful use. A risk analysis is an integral part of HIPAA compliance predominantly because it is the main tool that enables providers to determine where they stand with their protected health information.

On The Web

assessment of the risk and vulnerabilities related to protected health information in their office. Again, the rule leaves much to be desired regarding specifics for providers.

Organizations have to look at both technical and non-technical vulnerabilities related to privacy, confidentiality, and disclosures. Non-technical areas would include things like having

© THINKSTOCK / MICHAELJUNG

To perform a risk analysis under HIPAA, practices have to look at technical and non-technical vulnerabilities BY TAMMY WORTH

Laptop computers are riskier than desktop computers when it comes to data security.

effective policies and procedures, standards and guidelines.

Technical issues related to where there are holes or weakness in an office’s programs or systems. For a technical assessment, Spearman recommends beginning with an IT asset inventory. This will look slightly different for each office, depending upon their electronic usage.

Create a spreadsheet listing each device in the office. Note each computer’s operating system and its purpose. Is it used to store health information or view it?

Encryption If it is storing information, a device should be encrypted, he said. The type of device should also be noted. Laptops are riskier than desktops, for instance, because they are portable. Backup media like tapes and external drives should also be included.

Next, a report or list should be created with the steps taken to ensure the devices are secure. This could include secure storage, encryption, passwords, or special access authorization. Spearman recommends using one of the free online tools that can be used to check computers for

viruses or other bugs and including that in the documentation as well.

Another document that should be created, if it does not already exist, is the security policy. Cindy Winn, deputy director of consulting services for The Fox Group in Upland, Calif., also recommends having “a great backup or disaster recovery plan” should a problem arise.

The last point to note is the frequency of performing assessments. The only guidance HIPAA provides here is that each office follows its own policy. Under meaningful use, an analysis has to be performed annually. Winn also recommends creating a policy for record retention. Actions like checking firewalls to see if they were up or requiring staff to change passwords every 90 days should be documented and retained for at least six years, she said. ■ Tammy Worth is a freelance medical journalist based in Blue Springs, MO. Editor’s note: What to do after the risk assessment will appear in the next issue.

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