Original Contribution
The American Journal of Gastroenterology (2007) 102, 362–370; doi:10.1111/j.1572-0241.2006.00988.x
Efficacy of Tegaserod in Chronic Constipation in Men
Michael Fried MD1, John F Johanson MD2, Kok Ann Gwee MD3, Amy Wagner MD4, Eckhard Pecher MSc4 and Peter Rueegg MD4
- 1University Hospital Zurich, Division of Gastroenterology and Hepatology, Zurich, Switzerland
- 2Rockford Gastroenterology Associates, Ltd., Rockford, Illinois
- 3Gleneagles Hospital Annexe Block, Singapore, Republic of Singapore
- 4Novartis Pharma AG, Basel, Switzerland
Correspondence: Amy Wagner, Novartis Pharma AG, Lichtstrasse 35, CH-4002 Basel, Switzerland
Received 29 March 2006; Accepted 31 August 2006.
Abstract
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.
