Clinical Research
Copyright ©2007 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Feb 7, 2007; 13(5): 732-739
Published online Feb 7, 2007. doi: 10.3748/wjg.v13.i5.732
A randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation
San-Ren Lin, Mei-Yun Ke, Jin-Yan Luo, Yao-Zong Yuan, Ji-Yao Wang, Shelley diTommaso, Verena Walter, Jiaqing Huang
San-Ren Lin, The 3rd Hospital, Beijing Medical University, Beijing, China
Mei-Yun Ke, Peking Union Medical College Hospital, Beijing, China
Jin-Yan Luo, The 2nd Hospital of Xian Jiaotong University, Shanxi, China
Yao-Zong Yuan, Shanghai Ruijin Hospital, Shanghai, China
Ji-Yao Wang, Shanghai Zhongshan Hospital, Shanghai, China
Shelley diTommaso, Verena Walter, Novartis Pharma AG, Basel, Switzerland
Jiaqing Huang, Novartis Pharmaceuticals Corp, East Hanover, New Jersey, United States
Author contributions: All authors contributed equally to the work.
Correspondence to: Jiaqing Huang, MD, PhD, Novartis Pharmaceuticals Corporation, Gastroenterology/Urology Therapeutic Area, Clinical Development and Medical Affairs, One Health Plaza, Building 405/2019, East Hanover, NJ 07936, United States. jiaqing.huang@novartis.com
Telephone: +1-862-7787103 Fax: +1-973-7812390
Received: October 19, 2006
Revised: December 3, 2006
Accepted: December 21, 2006
Published online: February 7, 2007
Abstract

AIM: To evaluate the efficacy and safety of tegaserod, 6 mg twice daily (b.i.d.), in men and women with chronic constipation (CC) from China.

METHODS: This was a multicenter, double-blind, placebo-controlled study. Following a 2-wk treatment-free baseline period, patients were randomized to receive either tegaserod (6 mg b.i.d.) or placebo (b.i.d.) for 4 wk. An analysis of covariance with repeated measures was used to determine the overall effect of treatment for the primary efficacy variable; the change from baseline in the number of complete spontaneous bowel movements (CSBMs) during the 4-wk treatment period. Secondary efficacy endpoints included other measures of response in terms of CSBMs, and patients’ daily and weekly assessment of bowel habits. Safety was also assessed, based on the incidence and severity of adverse events (AEs).

RESULTS: A total of 607 patients were randomized to receive either tegaserod (n = 304) or placebo (n = 303). Tegaserod treatment resulted in a rapid and significant increase from baseline in the adjusted mean number of CSBMs per week over wk 1-4 compared with placebo (1.39 vs 0.91, P = 0.0002). A statistically significant difference in favor of tegaserod was also observed for a mean increase ≥ 1 CSBM/wk over wk 1-4 (47.7% vs 35.0%, tegaserod vs placebo, respectively, P = 0.0018) and for the absolute number of ≥ 3 CSBMs/wk over wk 1-4 (25.0% vs 14.5%, tegaserod vs placebo, respectively, P = 0.0021). Improvements in other symptoms of CC were also seen in the tegaserod group, including improved stool form and reduced straining. In addition, more patients in the tegaserod group reported satisfactory relief from their constipation symptoms. The frequency and severity of AEs was comparable between tegaserod and placebo groups, with the exception of a greater incidence of diarrhea in patients receiving tegaserod (3.6%) compared with placebo (1.7%).

CONCLUSION: Tegaserod treatment improved multiple symptoms of CC and was associated with a favorable safety profile.

Keywords: Chronic constipation; tegaserod; China; Complete spontaneous bowel movement; Placebo-controlled; Stool