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Title: Tegaserod Provides Improved Quality of Life in Patients With Irritable Bowel Syndrome Without Diarrhoea: Presented at UEGW

"Tegaserod Provides Improved Quality of Life in Patients With Irritable Bowel Syndrome Without Diarrhoea: Presented at UEGW"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 30, 2004 -- Tegaserod provides both global relief of multiple symptoms and a sustained improvement in quality of life as a cost-effective treatment option for patients with irritable bowel syndrome without diarrhoea (non-D-IBS), according to data from a multicentre, randomised, double-blind clinical trial presented here September 29th at the 12th United European Gastroenterology Week. Tegaserod, a partial agonist of the selective serotonin receptor type-4 (5-HT4), is the first of its class to be approved for treatment of constipation-predominant IBS, a chronic and episodic disorder characterised by abdominal pain and discomfort, bloating, and altered bowel habits. Study Coordinator Henry Nyhlin, MD, PhD, medical director, Centre of Gastrointestinal Disease, Ersta Hospital, Stockholm, Sweden, said, "Its been shown that it actually has some effect on the sensitivity of the bowel and also the kinetics of the bowel. So it works as a prokinetic, and that combination theoretically would be ideal in patients with IBS with constipation." The agent has also been shown effective for IBS patients whose primary bowel symptom is not diarrhoea (non-D-IBS). This study enrolled a subgroup of 485 patients from the Tegaserod Nordic Trial (TENOR) who met the Rome II criteria for non-D-IBS. Their mean age was 44.4 years, with 86% female. After an initial 2-week baseline period, 247 were randomized to tegaserod 6 mg BID and 238 were randomized to placebo for 12 weeks, followed by a 4-week withdrawal period without medication. No differences between demographic or disease data were observed between the full TENOR study population and the sub-group in this study, nor between the tegaserod and placebo groups in this study. At baseline, after 4 weeks, and again at the end of the treatment period, patients completed the EuroQuol Health State Description (EQ-5D) questionnaire, which evaluates health-related quality of life, related to the effect of their non-D-IBS symptoms, on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In addition, the researchers determined the gain in utility of each patient to estimate their quality-adjusted life years and calculated the incremental cost-effectiveness ratio of tegaserod compared with placebo. After 4 weeks and 12 weeks of treatment, the tegaserod group achieved significant improvement over placebo for both pain/discomfort (odds ratios [OR] 1.74, 1.48, respectively; P <.05) and mobility (OR 1.82, 1.93, respectively; P <.05). The tegaserod group also had a more rapid improvement (P =.036), which was maintained over the full 12-week treatment (P =.023). The change from baseline in quality-adjusted life years at week 4 was significantly higher in the tegaserod group than in the placebo group (0.0694 vs. 0.0327; P =.036). The corresponding changes at week 12 were 0.0655 and 0.0207, respectively (P =.023). When combined with the incremental cost-effectiveness, these data demonstrate that tegaserod is a cost-effective treatment for patients in this population, Dr. Nyhlin said. Thus, these data show that, as well as providing global relief of non-D-IBS symptoms, when compared with placebo, tegaserod significantly improves patient health-related quality of life in a cost-effective manner, he concluded. [Presentation titles: "Tegaserod Improves Quality of Life of Patients With Irritable Bowel Syndrome: Outcomes of the TENOR (TEgaserod in NORdic countries) Study. Abstract TUES-G-287; Tegaserod is Cost-Effective in the Treatment of Patients With IBS: An Economic Analysis of the TENOR (Tegaserod in NORdic countries) Study. Abstract TUES-G-295." Abstract 591]

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