Highlights of the 66th annual scientific meeting of the american college of gastroenterology

Highlights of the 66th Annual Scientific Meeting
of the American College of Gastroenterology
by Lawrence M. Prescott, PhD
Las Vegas, Nevada was the venue for nearly 3,000 recent studies included new therapeutic approaches and gastroenterologists, research scientists, nurses, and other novel agents for the treatment of gastroesophageal reflux healthcare professionals attending the 66th Annual Scien- disease (GERD), with or without erosive esophagitis, pre- tific Meeting of the American College of Gastroenterolo- vention of upper GI bleeding in ICU patients, steroid gy from October 22 to 24, 2001. Participants met to sparing in autoimmune hepatitis, relief of irritable bowel hear the latest advances in the detection, treatment, and syndrome (IBS), and the treatment of Crohn’s disease.
prevention of gastrointestinal (GI) diseases. The most Below are highlights of these presentations.
Novel Proton Pump Inhibitor for GERD with EE
(UGI) bleeding, resulting in the elimination of UGI bleeding Speaker: Donald O. Castell, MD, Professor of Medicine, Medical
events or related symptoms during a recent study.
University of South Carolina, Charleston, South Carolina The multicenter study randomized 86 ICU patients at risk for UGI bleeding to one of four dosing regimens of IV pantoprazole Esomeprazole (Nexium, AstraZeneca), the S-isomer of omeprazole, (P)—P 40 mg once daily, P 40 mg twice daily, P 80 mg twice daily, when taken in doses of 40 mg daily, is more effective in rapidly P 80 mg three times daily—or the standard approved regimen of achieving sustained resolution of daily and nocturnal heartburn in continuous infusion cimetidine (Tagamet, GlaxoSmithKline), to patients with gastroesophageal reflux disease (GERD) with erosive evaluate the potential ability of an IV PPI to rapidly raise intragas- esophagitis (EE) than lansoprazole (Prevacid, TAP) 30 mg daily.
tric pH in ICU patients. Patients were treated with the study drug This conclusion was based on a large-scale, U.S., multicenter, for at least 48 hours and up to seven days. Gastric aspirations were randomized, double-blind trial including 5,241 adult GERD taken every two hours for the determination of gastric pH and the patients with endoscopically confirmed EE to assess the efficacy of esomeprazole compared with lansoprazole for treating daily Preliminary results suggested that all IV pantoprazole groups and nocturnal heartburn in these patients. Patients were random- could achieve and maintain gastric pH over 4 within 2.9 to 3.2 ly assigned to once-daily esomeprazole 40 mg or lansoprazole 30 hours of the initiation of therapy, with a progressive increase in pH by day 2. Cimetidine reached a pH over 4 in approximately Baseline severity of heartburn was balanced between treat- the same time frame (2.5 hours) on day 1, but was unable to ment groups. Time to sustained resolution of heartburn, recorded maintain control of the percentage of time with pH over 4 by day by patient diary data, was achieved significantly faster with 2, presumably because of tolerance. The percentage of time that esomeprazole (seven days) than with lansoprazole (eight days).
pH was greater than 4 on days 1 and 2, respectively, was 45% and In addition, faster sustained nocturnal heartburn resolution was 55% for P 40 mg every 24 hours; 55% and 69% for P 40 mg every 12 recorded with esomeprazole (one day) than with lansoprazole hrs; 71% and 82% for P 80 mg every 12 hours; 73% and 83% for (two days). Finally, more patients treated with esomprazole had P 80 mg every eight hours; and 81% and 73% for cimetidine.
complete resolution of investigator-recorded heartburn at the endof week 4 than did those on lansoprazole (62.9% vs. 60.2%). Over- Steroid-Sparing Agent for Autoimmune Hepatitis
all, both esomeprazole and lansoprazole were well-tolerated.
Speaker: Abdullah Rashdan, MD, Senior Fellow, Division of
Gastroenterology and Hepatology, St. Louis University School
Intravenous PPI for ICU Patients
Speaker: Robert Aris, MD, Associate Professor of Medicine,
University of North Carolina at Chapel Hill, Chapel Hill,
Mycophenolate mofetil (MMF) (Cellcept, Roche Laboratories, Inc.), a drug indicated for the prophylaxis of organ rejection inpatients receiving allogenic renal, cardiac, or hepatic transplants, Intermittent dosing with intravenous (IV) pantoprazole (Protonix appears to be a safe and effective steroid-sparing alternative to the IV, Wyeth-Ayerst) a proton pump inhibitor (PPI), rapidly achieves standard treatment with azathioprine (Imuran, Faro) for the treat- and maintains pH equal to or greater than 4 in critically ill inten- sive-care unit (ICU) patients at risk for upper gastrointestinal Five patients with AIH who were intolerant of or resistant to standard therapy were identified prospectively and treated withMMF. Azathioprine was discontinued in all patients. The initial Dr. Prescott is a medical, health, and science writer based in San Diego dose of MMF was 500 mg daily and this was gradually and a former medical micrbiologist and clinical pathologist for the WorldHealth Organization. increased in 500-mg daily increments to 2 gm daily or to the 42 P&T® • January 2002 • Vol. 27 No. 1
highest tolerated dose. Prednisone was subsequently tapered to 5 5-acetylsalicylic acid product mesalamine or placebo for inducing remission in patients with mild to moderate active Crohn’s disease All patients achieved and maintained a biochemical remission and can be used as first-line treatment. Also, while equivalent in over an average follow-up period of 18 months. Two patients had action with conventional corticosteroids, budesonide MRC is resolution of potentially serious azathioprine-related complica- markedly less likely to cause corticosteroid-associated adverse tions (cervical dysplasia and skin cancer) when switched to events than conventional steroids like prednisolone.
MMF. While on MMF, two patients were able to completely The meta-analysis was carried out on approximately 1,000 discontinue prednisone; two patients had prednisone doses patients with mild to moderate active Crohn’s disease of the ileum tapered to 5 mg daily; and one patient had prednisone tapered and/or ascending colon enrolled in five randomized control trials to 3 mg daily. None of the patients had any adverse effects from comparing either the safety and efficacy of mesalamine (one MMF. Based on these findings, further larger controlled trials, study), placebo (two studies), or prednisolone (two studies). The using histologic endpoint and longer-term follow-up, are strong- trials reported on the effectiveness of treatment, defined as ly suggested to confirm these observations.
decreasing or maintaining Crohn’s Disease Activity Index (CDAI)scores of 150 points or less, and on adverse event data.
CCK Receptor Antagonist for Constipation-Dominant IBS
The main results showed that budesonide MRC was more Speaker: Massimo D’Amato, MD, Senior Investigator, Clinical
likely to induce remission of mild to moderately active Crohn’s Pharmacology, Rotta Research Laboratories, Monza, Italy disease than placebo (relative risk [RR]=1.82) or mesalamine(RR=1.73), with no significant difference in inducing remission The cholecystokinin (CCK) receptor antagonist dexloxiglu- between budesonide MRC and prednisolone. Budesonide, how- mide (Rotta Research Laboratories/Forest Laboratories) might ever, was less likely to cause corticosteroid-related adverse be a novel therapeutic agent for the treatment of constipation- predominant irritable bowel syndrome (C-IBS) in female patients,having demonstrated its effectiveness in relieving IBS symptoms, Monoclonal Antibody for Crohn’s Disease
Speaker: Gary R. Lichtenstein, MD, Associate Professor of
Because CCK might play a role in the pathogenesis of IBS, as a Medicine and Director of the Center for Inflammatory Bowel Dis- result of its involvement in the modulation of GI visceral sensory ease, Hospital of the University of Pennsylvania and University of and motor responses, a study was designed to assess the safety Pennsylvania School of Medicine, Philadelphia, Pennsylvania and efficacy of the selective CCK receptor antagonist dexloxiglu-mide. A total of 405 patients (328 females, 77 males) with IBS were Data from the ACCENT I (A Chronic Clinical Trial Evaluating randomized to receive either dexloxiglumide 200 mg three times Infliximab in a New Long-Term Treatment Regimen demonstrat- daily (202 patients) or placebo (203 patients) for 12 weeks, in a ran- ed that infliximab (Remicade, Centecor) maintenance therapy in domized, double-blind, parallel-group clinical trial. Prior to random- corticosteroid-dependent Crohn’s disease (CD) patients makes it ization, patients were stratified to IBS subgroups according to their possible for these individuals to reduce or discontinue corticos- bowel habit predominance: alternating–134 patients; diarrhea–113 teroid use, while maintaining disease remission.
patients; constipation–126 patients. At the end of the treatment peri- Although the ACCENT I study was designed to determine od or at early termination, patients rate their response as much bet- whether maintenance dosing with infliximab could prolong dis- ter to better (improved), no change, or much worse (not ease progression, after six weeks in the trial, patients who were improved). Responders, according to a validated Global Improve- on corticosteroids at baseline and had a clinical response at ment Assessment (GIA), were those patients who judged them- week 2 were allowed to taper their corticosteroid doses by 5 mg selves improved and had a decrease in mean abdominal pain per week if their baseline doses were 20 mg daily or more of during the last two weeks of treatment compared to baseline.
prednisolone or equivalent, or 2.5 mg per week if their baseline The proportion of responders with dexloxiglumide was high- er than with placebo in the patient population as a whole (39% Initially, 573 CD patients were enrolled in the trial and 335 per- vs. 34%). This improvement reached statistical significance in sons were included in the efficacy analysis to be carried out at 30 the subgroup of female patients with C-IBS (dexloxiglumide, and 54 weeks. Some 52.2% of week-2 responders were receiving 40% vs. placebo, 22%). In addition, actively treated female C-IBS corticosteroids at baseline, with a median dose of 20 mg daily. At patients reported significantly reduced abdominal pain or dis- week 30, the period of these reported data, the median dose of cor- comfort; improved straining, incomplete evacuations, and global ticosteroids was 10 mg daily in the placebo maintenance group and well-being; and they had more pain-free and bloating-free days.
0 mg daily in the two infliximab maintenance groups (5 mg dailyand 10 mg daily). In addition, approximately three times as many Locally Active Corticosteroid for Crohn’s Disease
patients in the infliximab maintenance groups were able to discon- Speaker: Sunanda Kane, MD, Assistant Professor of Medicine,
tinue corticosteroids while maintaining clinical remission as com- University of Chicago Medical Center, Chicago, Illinois pared to those who received a single dose of infliximab 5 mg forinduction, followed by placebo maintenance. This included 10.7% of A systematic review and meta-analysis of selected clinical trials placebo maintenance patients, 31% of 5-mg daily maintenance reveals that budesonide modified release capsules (MRC) (Ento- patients, and 36.8% of 10-mg daily maintenance patients. This bene- cort, EC), a synthetic locally active glucocorticosteroid, at a 9-mg fit was seen whether patients had been on corticosteroids for less dose, has been shown to be more active than the commonly used than a year or more than a year before entering the study. ■ Vol. 27 No. 1 • January 2002 • P&T® 43

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