Efficacy of tegaserod in chronic constipation in men.
OBJECTIVE
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-HT(4) 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.
Fried
Michael
M
University Hospital Zurich, Division of Gastroenterology and Hepatology, Zurich, Switzerland.
Johanson
John F
JF
Gwee
Kok Ann
KA
Wagner
Amy
A
Pecher
Eckhard
E
Rueegg
Peter
P
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D003248:Constipation / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D003672:Defecation / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D007211:Indoles; D017366:Serotonin Receptor Agonists; C105050:tegaserod