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Title: Tegaserod Safe, Rapid and Effective Therapy for Women With Constipation-Predominant Irritable Bowel Syndrome: Presented at UEGW

"Tegaserod Safe, Rapid and Effective Therapy for Women With Constipation-Predominant Irritable Bowel Syndrome: Presented at UEGW"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 30, 2004 -- Repeated short-term treatment with tegaserod can provide a safe, rapid, and effective therapy with multisymptom relief for women with constipation-predominant irritable bowel syndrome (IBS-C), according to a study presented here September 29th at the 12th United European Gastroenterology Week. Presenter Jan Tack, MD, professor in internal medicine, Department of Gastroenterology and Hepatology, and Centre for Gastroenterological Research, University of Leuven, Leuven, Belgium, described IBS-C as a chronic, recurrent, dysmotility disorder characterized by abdominal pain, discomfort, bloating, and constipation. Serotonin (5-HT) is thought to play an important role in the motility and pain perception in the intestinal system, he said. Tegaserod, the first of a new class of 5-HT[₄ receptor partial agonists, was developed to treat these multiple symptoms. To determine the efficacy and safety of this agent in relieving the symptoms of IBS-C, Dr. Tack and colleagues conducted a multicentre, randomised, double-blind, placebo-controlled trial.

"The regulatory authority of the European Community [CHMP; European Committee for Medicinal Products for Human Use] has recommended a re-randomization trial design to investigate efficacy and safety of initial and repeated short-term treatment with novel IBS therapies, and moreover, they have also requested two co-primary efficacy variables, overall symptom relief and relief of abdominal pain and discomfort," he said. The study was therefore designed and conducted to meet these recommendations.

The researchers used a 2-week baseline and two 4-week double-blind treatment periods (P1, P2), separated by a treatment-free interval (TFI). Only the P1 patients who had a response partial or better proceeded to the TFI, after which they were randomized into P2. Due to this design, the initial randomization was on a 4:1, tegaserod to placebo ratio (tegaserod, 2135; placebo, 525), and the demographics of these two groups at baseline were very similar.

Patient criteria included women 65 years or older who satisfied the Rome II criteria for IBS-C, which lists common IBS symptoms as well as red flag symptoms that suggest another medical condition. In all, 4689 women were screened, and 2660 were randomized for P1. These women were 82% Caucasian and 63% premenopausal; they had a mean age of 42 years (range, 17 to 66 years) and a mean IBS symptoms duration of 13 years (range, 1 to 59 years).

Patients' assessments of various categories of symptoms were collected via electronic diaries. For the primary efficacy variables of patients' global assessment of relief of IBS-C symptoms and of abdominal discomfort or pain, the assessment was on the basis of a response of 75% or more weeks with satisfactory relief.

On a weekly basis, in P1 and P2, tegaserod 6 mg BID showed significantly greater relief of overall IBS symptoms and abdominal discomfort and pain versus placebo (P1: 33.7%, 24.2%, and 31.3%, 22.1%, respectively; P2: 44.9%, 28.7%, and 42.4%, 27.1%, respectively, P =.0001).

Secondary variables showed further significant differences in both P1 and P2 for tegaserod benefits towards improved abdominal discomfort and pain intensity (P <.05) and reduction of bloating intensity (P <.05) as weekly assessments, with early improvement in bowel movement frequency (P <.05) and stool consistency (P <.05) as daily assessments.

Finally, tegaserod was significantly better than placebo in IBS quality-of-life overall score (P <.05), all aspects of work productivity (P <.005) and treatment satisfaction (P <.001).

With overall adverse events generally matched across the treatment groups, except for increased mild transient diarrhoea with tegaserod and low incidence of serious adverse events, tegaserod provides a safe, rapid, and effective therapy for women with IBS-C, Dr. Tack concluded.

[Presentation title: Tegaserod Provides Rapid and Sustained Relief of Overall IBS Symptoms and Abdominal Discomfort/Pain When Used as Repeated Treatment in Women With IBS-C. Abstract OP-G-327." Abstract 563]

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