Efficacy of tegaserod in chronic constipation in men

被引:19
作者
Fried, Michael
Johanson, John F.
Gwee, Kok Ann
Wagner, Amy
Pecher, Eckhard
Rueegg, Peter
机构
[1] Novartis Pharma AG, CH-4002 Basel, Switzerland
[2] Univ Zurich Hosp, Div Gastroenterol & Hepatol, CH-8091 Zurich, Switzerland
[3] Rockford Gastroenterol Associates Ltd, Rockford, IL USA
[4] Gleneagles Hosp Annexe Block, Singapore, Singapore
关键词
D O I
10.1111/j.1572-0241.2006.00988.x
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
OBJECTIVES: Chronic constipation/idiopathic constipation is highly prevalent in western countries and traditional treatments are suboptimal. This multicenter study evaluated the efficacy and safety of tegaserod, a selective 5-HT4 agonist and promotility agent, in men with chronic constipation. METHODS: After screening and baseline phases, men with chronic constipation were randomized to receive either tegaserod 6 mg twice daily or placebo in a double-blind manner for 12 wk. Patients recorded symptoms using a diary. Primary efficacy variable was the response rate for an increase in complete spontaneous bowel movements (CSBMs) during the first 4 wk of double-blind treatment. Other efficacy measures included patient assessment of symptoms and satisfaction with symptom relief. Safety and tolerability were also evaluated. RESULTS: In total, 322 patients were randomized to tegaserod (N = 158) or placebo (N = 164). Increases of at least one CSBM per wk during the first 4 wk of treatment observed for tegaserod compared with placebo (40.5% vs 29.3%, P = 0.03) were sustained throughout the 12-wk treatment period. Response rate for CSBM was also superior for tegaserod (P = 0.04 vs placebo) over the treatment period. Benefits for tegaserod over placebo were also observed for some secondary efficacy variables, however, statistical significance was not achieved at all weeks. Frequency of adverse events was similar with tegaserod and placebo. CONCLUSIONS: Tegaserod 6 mg twice daily was effective and well tolerated in the treatment of chronic constipation in men. Tegaserod provided rapid relief of constipation within 1 wk and the effects were sustained for up to 12 wk.
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页码:362 / 370
页数:9
相关论文
共 31 条
  • [1] [Anonymous], 2005, AM J GASTROENTEROL, V100, pS1, DOI [DOI 10.1111/J.1572-0241.2005.50613_1.X, 10.1111/j.1572-0241.2005.50613_1.x]
  • [2] Bradette M, 2004, GASTROENTEROLOGY, V126, pA42
  • [3] Brinker AD, 2004, NEW ENGL J MED, V351, P1361
  • [4] Review article: the role of serotonergic agents in the treatment of patients with primary chronic constipation
    Cash, BD
    Chey, WD
    [J]. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2005, 22 (11-12) : 1047 - 1060
  • [5] Coping strategies, illness perception, anxiety and depression of patients with idiopathic constipation: a population-based study
    Cheng, C
    Chan, AOO
    Hui, WM
    Lam, SK
    [J]. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2003, 18 (03) : 319 - 326
  • [6] CHEY WD, 2005, GASTROENTEROLOGY S2, V128, pT1139
  • [7] Tegaserod, a 5-HT4 receptor partial agonist, decreases sensitivity to rectal distension in healthy subjects
    Coffin, B
    Farmachidi, JP
    Rueegg, P
    Bastie, A
    Bouhassira, D
    [J]. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2003, 17 (04) : 577 - 585
  • [8] Occurrence of colon ischemia in relation to irritable bowel syndrome
    Cole, JA
    Cook, SF
    Sands, BE
    Ajene, AN
    Miller, DP
    Walker, AM
    [J]. AMERICAN JOURNAL OF GASTROENTEROLOGY, 2004, 99 (03) : 486 - 491
  • [9] Effect of tegaserod on gut transit in male and female subjects
    Degen, L
    Petrig, C
    Studer, D
    Schroller, S
    Beglinger, C
    [J]. NEUROGASTROENTEROLOGY AND MOTILITY, 2005, 17 (06) : 821 - 826
  • [10] Tegaserod, a 5-HT4 receptor partial agonist, accelerates gastric emptying and gastrointestinal transit in healthy male subjects
    Degen, L
    Matzinger, D
    Merz, M
    Appel-Dingemanse, S
    Osborne, S
    Lüchinger, S
    Bertold, R
    Maecke, H
    Beglinger, C
    [J]. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2001, 15 (11) : 1745 - 1751