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gastroendonews.com
The Independent Monthly Newspaper for Gastroenterologists
ASCO GI
IBS AWARENESS MONTH
Surveillance in Barrett’s Lacking
Physicians, Patients Becoming More Aware of Effects of Diet in IBS
BY CAROLINE HELWICK BY MONICA J. SMITH
see Barrett’s Surveillance, page 23
Blood Test for Pancreatic Cancer BY CAROLINE HELWICK SAN FRANCISCO— —The presence of even one circulating tumor cell (CTC) appears to be diagnostic of pancreatic ductal adenocarcinoma, according to research conducted at the University of California, Los Angeles (UCLA), and presented at the see Pancreatic Cancer, page 34
SAN DIEGO—Nearly all patients with gastrointestinal (GI) distress wonder if their problems stem from what they eat or don’t eat, and if they might feel better on the right diet. This is especially true in patients with irritable bowel syndrome (IBS), two-thirds of whom report symptomatic responses to food. With the rising popularity of specialized diets and heavy marketing of the notion that wellbeing depends on eating specific foods, it’s no surprise that many people view their plate as a potential friend or foe. An average of three tons of food is consumed over a lifetime. A small proportion of this amount gives rise to food poisoning, food allergies and food sensitivities, with the latter two being reported with increasing frequency. In a presentation at the 2013 American College of Gastroenterology (ACG) Annual Scientific
Endoluminal Devices For GERD The Struggle To Arrive and Thrive BY MAUREEN SULLIVAN It is about 14 years since the CSM Stretta System (Mederi Therapeutics) was launched as the first endoluminal treatment for patients with gastroesophageal reflux disease (GERD). Its introduction
Meeting entitled “Food Intolerances and IBS: Coexistent or Separate Entities?” Sheila Crowe, MD, professor of medicine and director of research at the University of California, San Diego, in La Jolla, discussed the influence of diet on symptoms of IBS. see IBS, page 14
I N S I D E FROM THE BENCH TO THE BEDSIDE see pages 8-9
Maximizing Bowel Preparation for Colonoscopy: The Patient Component Lawrence B. Cohen, MD
Pancreatic Exocrine Insufficiency FDA Regulations on Pancreatic Enzyme Products Questioned .................... page 36
CORPORATE SPOTLIGHT
CLINICAL REVIEW
see pages 16-17
see insert after page 70
Medivators Inc.
Pancreatic Exocrine Insufficiency Part 1 of 2: Treatment Approaches
Your best practice is our promise.
By Vivek Kadiyala, MD, Shadeah Laila Suleiman and Darin L. Conwell, MD, MS
see GERD, page 20 PROCEDURAL BREAKTHROUGH
FROM THE BENCH TO THE BEDSIDE
see pages 24-25
see pages 38-39
Use of FibroScan for Noninvasive Assessments of Liver Disease
Switching From 5-ASA to Mesalamine Granules in Patients With Ulcerative Colitis in Remission
David Bernstein, MD
Gary R. Lichtenstein, MD
Switching From 5-ASA to Mesalamine Granules in Patients With Ulcerative Colitis in Remission Faculty Gary R. Lichtenstein, MD Professor of Medicine Director, Center for Inflammatory Bowel Disease Department of Medicine Division of Gastroenterology Raymond and Ruth Perelman School of Medicine University of Pennsylvania Philadelphia, Pennsylvania
Indication for APRISO APRISO® (mesalamine) is a locally acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. The use of APRISO for treating ulcerative colitis beyond 6 months has not been evaluated in controlled clinical trials.
Important Safety Information About APRISO APRISO extended-release capsules are contraindicated in patients with hypersensitivity to salicylates or aminosalicylates (sulfasalazine) or to any of the components of APRISO capsules. It is recommended that patients have an evaluation of renal function prior to initiation of APRISO therapy and periodically while on therapy. Exercise caution when using APRISO in patients with known renal dysfunction or a history of renal disease. Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, promptly discontinue treatment with APRISO. There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering APRISO to patients with liver disease. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Caution should be taken to closely monitor blood cell counts during mesalamine therapy in patients ages 65 and older. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 2.24 mg of phenylalanine per day.
The most common treatment-related adverse events occurring in at least 3% of adult patients taking APRISO and at a rate greater than placebo in clinical trials were headache (11%), diarrhea (8%), upper abdominal pain (5%), nausea (4%), nasopharyngitis (4%), influenza and influenzalike illness (4%), and sinusitis (3%).
Introduction Primary goals in the treatment of ulcerative colitis (UC) include maintenance of remission.1 Reduction in the need for corticosteroids also is important to avoid the long-term adverse effects otherwise associated with such therapy.1 Although mesalamine (5-aminosalicylic acid, 5-ASA) is an effective nonsteroid for maintenance of remission in patients with UC, one popular mesalamine formulation (ASACOL 400 mg) was recently discontinued thus requiring physicians to choose another mesalamine formulation for their patients who were formerly receiving this medication.1,2 This clinical scenario requires a review of the available data to help guide the transition of patients in remission from one formulation to another, including an investigation of whether flare-ups may occur while transitioning to the new regimen. This article will discuss available data regarding the efficacy and safety of a switch from one mesalamine formulation to another mesalamine formulation with once-daily dosing (mesalamine extendedrelease [ER] granules [APRISO]) for maintenance of remission.
Mesalamine Extended-Release Granules Mesalamine ER granules (APRISO, Salix Pharmaceuticals) are a once-daily 5-ASA preparation approved by the FDA in October 2008 for maintenance of remission of UC in patients aged 18 years and older.3 Mesalamine ER capsules possess Intellicor® technology that allows both delayed-release and ER delivery of mesalamine to areas of the gastrointestinal tract affected in patients with UC.3,4 Once ingested, the gelatin capsules dissolve, releasing thousands of granules that provide a large surface area from which mesalamine is released. Each granule has a delayed-release, gastric acid–resistant coating that allows it to travel intact until a pH of 6.0 is reached. Intestinal fluids dissolve the coating to initiate ER delivery. Each granule’s polymer matrix core then swells as intestinal fluid is
absorbed, forming channels through which mesalamine is delivered in an extended release, providing once-daily protection throughout the colon.3 Clinical investigation also revealed that 32%±11% (mean ± SD) of the administered dose was systemically absorbed under fasting conditions and that a high-fat meal did not affect peak concentration for 5-ASA, indicating that APRISO can be taken without regard to food.3
Clinical Studies of Mesalamine Granules Double-blind, placebo-controlled trials have described the efficacy of mesalamine granules for the maintenance of remission of UC.5 In the 2010 study, patients with UC were randomized to receive either mesalamine granules (1.5 g once daily; n=209) or placebo (n=96) for up to 6 months. The percentage of relapse-free patients at the end of the treatment period was significantly higher for the group receiving mesalamine granules than for those receiving placebo (78.9% vs 58.3%; P<0.001). Furthermore, patients receiving mesalamine granules had positive outcomes in terms of secondary end points, including improvement in rectal bleeding, stool frequency, physician’s disease activity rating, and the Sutherland Disease Activity Index.
Probability of remaining relapse-free
SAN FRANCISCO—Surveillance of patients with Barrett’s esophagus (BE) requires a more systematic approach that incorporates risk stratification, and although that paradigm is still a work in progress there are ways that endoscopists can make the
Headaches (11%), diarrhea (9%), abdominal pain (7%), nasopharyngitis (5%), upper abdominal pain (4%), abnormal feces (3%), back pain (3%), and nausea (3%) were the most frequently reported adverse events in patients receiving mesalamine granules.5 A subanalysis of patients with UC from the 2010 study as well as patients from another randomized, double-blind, placebo-controlled 6-month study of identical design (N=487) was performed.6 The specific patients examined were those who had switched to mesalamine granules (1.5 g once daily) or to placebo from other 5-ASA formulations. The results were remarkably similar to those seen in the larger group of patients in the 2010 study; the relapse-free rate after 6 months was significantly higher for those who had switched from other 5-ASA formulations to mesalamine granules compared with those who switched from other 5-ASA formulations to placebo (78.3% vs 58.8%; P<0.001) (Figure).6 Furthermore, rectal bleeding, stool frequency, and the physician’s rating of disease activity remained unchanged after 6 months in a higher percentage of patients who switched to mesalamine granules compared with those who had switched to placebo (P<0.004 for each end point). Of note, withdrawal due to UC flare-ups in the group receiving mesalamine
1.0 MG 1.5 g qd (N=322)
0.80 0.60
Placebo (N=165)
0.40 0.20
MG vs placebo 55% reduction in risk of relapse (P<0.001)
0 0
50
N at risk, MG: N at risk, placebo:
100 150 200 Relapse-free duration, d Month 1 322 165
Month 3 299 135
250
Month 6 267 114
Figure. Kaplan–Meier estimates of time to relapse during the treatment period in patients who switched from other 5-ASA formulations to either APRISO 1.5 g daily or placebo. Based on Lichtenstein G, et al. Aliment Pharmacol Ther. 2012;36(2):126-134, with permission. 5-ASA, 5-aminosalicylic acid; MG, mesalmine granules; qd, daily
300