Effect of tegaserod in chronic constipation: A randomized, double-blind, controlled trial

详细信息    查看全文

• 作者：John F. Johanson^* ; ¹ ; Arnold Wald^&Dagger ; ; ² ; Gervais Tougas^§ ; ; ^?/sup> ; ³ ; William D. Chey^¶ ; ; ⁴ ; James S. Novick^# ; ⁵ ; Anthony J. Lembo^** ; ⁶ ; Fiona Fordham^?/sup> ; ⁷ ; Mary Guella^&Dagger ; &Dagger ; ; ⁷ ; Brigitte Nault^?/sup> ; ⁷ ; ^{brigitte.nault@pharma.novartis.com}
• 关键词：AEs ; adverse events ; BM ; bowel movement ; CSBM ; complete spontaneous bowel movement ; ECG ; electrocardiogram ; GI ; gastrointestinal ; 5-HT4 ; serotonin subtype 4 receptor ; IBS-C ; IBS with constipation ; ITT ; intent-to-treat ; SAEs ; serious adverse events ; SBM ; s
• 刊名：Clinical Gastroenterology and Hepatology
• 出版年：2004
• 出版时间：September 2004
• 年：2004
• 卷：2
• 期：9
• 页码：796-805
• 全文大小：303 K

文摘

Background & Aims: Chronic constipation is a common gastrointestinal disorder. The aim of this study was to evaluate the efficacy, safety, and tolerability of tegaserod, a serotonin subtype 4 receptor partial agonist in patients with chronic constipation. Methods: This was a randomized, double-blind, placebo-controlled study. After a 2-week baseline, patients received tegaserod 2 mg twice daily (n = 450), tegaserod 6 mg twice daily (n = 451), or placebo (n = 447) for 12 weeks, followed by a 4-week withdrawal period. Responders were those patients having been treated for at least 7 days with an increase of ? complete spontaneous bowel movement/week vs. baseline during weeks 1? (primary variable) and weeks 1?2 (secondary variable). Other secondary variables included patient assessment of constipation symptoms (number of bowel movements, stool form, abdominal bloating/distention, straining, and abdominal pain/discomfort), and global assessment of constipation and bowel habits. Results: Responder rates for complete spontaneous bowel movement during weeks 1? were significantly greater (P < 0.0001) in the tegaserod 2 mg twice daily (41.4 % ) and 6 mg twice daily groups (43.2 % ) vs. placebo (25.1 % ). This effect was maintained over 12 weeks. Statistically significant improvements over placebo were observed across the majority of secondary variables for both tegaserod doses. No rebound effect was observed after treatment withdrawal. Tegaserod was well tolerated; headache and nasopharyngitis, the most frequent adverse events, were more common in the placebo group than in either tegaserod group. Conclusions: Over 12 weeks, tegaserod treatment produced significant improvements in chronic constipation symptoms and was also safe and well tolerated.