|A randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation|
|Lin, San-Ren1; Ke, Mei-Yun1; Luo, Jin-Yan1; Yuan, Yao-Zong1; Wang, Ji-Yao1; diTommaso, Shelley1; Walter, Verena1; Huang, Jiaqing1|
|关键词||Chronic Constipation Tegaserod China Complete Spontaneous Bowel Movement Placebo-controlled Stool|
|刊名||WORLD JOURNAL OF GASTROENTEROLOGY|
|WOS标题词||Science & Technology|
|类目[WOS]||Gastroenterology & Hepatology|
|研究领域[WOS]||Gastroenterology & Hepatology|
|关键词[WOS]||IRRITABLE-BOWEL-SYNDROME ; MANAGEMENT ; SYMPTOMS ; TRANSIT|
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 treatmentfree 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. (c) 2007 The WJG Press. All rights reserved.
|作者单位||1.Shanghai Zhongshan Hosp, Shanghai, Peoples R China|
2.Novartis Pharma AG, Basel, Switzerland
3.Shanghai Ruijin Hosp, Shanghai, Peoples R China
4.Beijing Med Univ, Hosp 3, Beijing 100083, Peoples R China
5.Xian Jiaotong Univ, Hosp 2, Shanxi, Peoples R China
6.Novartis Pharmaceut Corp, Gastroenterol Urol Therapeut Area, Clin Dev & Med Affairs, E Hanover, NJ 07936 USA
7.Beijing Union Med Coll Hosp, Beijing, Peoples R China
|Lin, San-Ren,Ke, Mei-Yun,Luo, Jin-Yan,et al. A randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation[J]. WORLD JOURNAL OF GASTROENTEROLOGY,2007,13(5):732-739.|
|APA||Lin, San-Ren.,Ke, Mei-Yun.,Luo, Jin-Yan.,Yuan, Yao-Zong.,Wang, Ji-Yao.,...&Huang, Jiaqing.(2007).A randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation.WORLD JOURNAL OF GASTROENTEROLOGY,13(5),732-739.|
|MLA||Lin, San-Ren,et al."A randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation".WORLD JOURNAL OF GASTROENTEROLOGY 13.5(2007):732-739.|