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Zelnorm (Tegaserod) Safe, Effective for Multiple Symptoms of Irritable Bowel Syndrome EAST HANOVER, NJ -- November 1, 2001 -- Zelnorm™ (tegaserod maleate) offers rapid and sustained relief of abdominal pain and constipation associated with irritable bowel syndrome (IBS), according to a new study published this month in Alimentary Pharmacology & Therapeutics. In this study, Zelnorm significantly improved symptoms of abdominal pain and discomfort, the number of bowel movements, and stool consistency in IBS patients with abdominal pain, bloating and constipation. The study also showed a favorable trend for reducing days with significant bloating. Zelnorm currently is under Food and Drug Administration (FDA) review for the treatment of abdominal pain, discomfort and constipation in female patients with constipation-predominant IBS. "This study provides further evidence that Zelnorm is a safe and effective treatment for IBS patients who suffer with abdominal pain, bloating and constipation," said John F. Johanson, MD, Clinical Associate Professor of Medicine, University of Illinois College of Medicine. "We hope that this important new therapy will soon be available to the millions of Americans who suffer with IBS and without effective treatment." This multinational, double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of Zelnorm in patients with IBS. In the study, 881 IBS patients were randomly assigned to receive 4 mg Zelnorm daily, 12 mg Zelnorm daily, or placebo, for 12 weeks. Those treated with 12 mg Zelnorm daily experienced significantly greater relief of their overall IBS symptoms than those on placebo (46.3 percent Zelnorm versus 34.5 percent placebo) as measured by the Subject's Global Assessment (SGA) of Relief, which evaluates overall well-being, abdominal pain and discomfort, and altered bowel habit. The effect on abdominal pain and discomfort (29.9 percent Zelnorm versus 22.6 percent placebo) was sustained throughout the three-month treatment phase. Patients taking Zelnorm also had a reduction of the number of days with significant abdominal bloating compared to patients taking placebo (-11.3 percent Zelnorm vs. +2.1 percent placebo). Improvements were demonstrated as early as the first week and were sustained over the 12-week treatment period. Zelnorm showed a favorable safety profile in this study. The overall incidence of adverse events in the two Zelnorm treatment groups was similar to placebo. The only adverse event reported significantly more often with Zelnorm was diarrhea. The diarrhea typically occurred early during treatment, and quickly resolved without intervention or interruption of therapy. Irritable bowel syndrome is a chronic disorder characterized by abdominal pain, discomfort, and constipation or diarrhea (or an alternating pattern of the two). It is the second leading cause of workplace absenteeism after the common cold, and costs the US healthcare system more than $29 billion in direct and indirect costs each year. SOURCE: Novartis Pharmaceuticals Corporation E-mail this page to a friend or colleague! To print, use this version