title: Safety and tolerability of tegaserod in patients with chronic constipation: pooled data from two phase III studies.
abstract: OBJECTIVE
  Studies show that tegaserod effectively relieves the symptoms of chronic constipation/idiopathic constipation (CC). This pooled analysis assessed the safety and tolerability of tegaserod in a large dataset of CC patients.
  
  
  METHODS
  Adverse event (AE) data were pooled from 2 double-blind, placebo-controlled phase III trials of 12 weeks' duration. Post hoc analysis was conducted for the most frequent AEs (incidence, >or=3%).
  
  
  RESULTS
  Eight hundred eighty-one, 861, and 861 patients received tegaserod 6 mg twice a day, 2 mg twice a day, or placebo, respectively. Most AEs were mild/moderately severe. AE incidence was similar for the tegaserod 6 mg and 2 mg twice a day (57.1% and 56.3%, respectively) and placebo groups (59.6%) and most frequent in the gastrointestinal system (tegaserod 6 mg twice a day, 25.8%; 2 mg twice a day, 22.5%; placebo, 24.6%). Headache, the most common AE, was slightly more frequent in the placebo group (tegaserod 6 mg twice a day, 11.0%; 2 mg twice a day, 10.1%; placebo, 13.2%). Diarrhea (generally transient and resolved with continued treatment) was the only AE with a statistically significant difference between groups (tegaserod 6 mg twice a day 6.6% vs placebo 3.0%, P=.0005). Serious AE incidence (1.4% overall) was comparable across treatment groups, although abdominal surgery was less common in the combined tegaserod (0.5%) than the placebo group (1.0%). Discontinuation as a result of AEs was slightly higher in tegaserod 6 mg twice a day patients (5.7%; 2 mg twice a day, 3.3%; placebo, 3.7%), mainly because of diarrhea. Laboratory and electrocardiogram parameters were comparable across groups.
  
  
  CONCLUSIONS
  Tegaserod is well tolerated by patients with CC during 12 weeks of treatment.
authors: Alimentary Pharmabiotic Centre, Department of Medicine, Cork University Hospital, Wilton, Cork, Ireland. e.quigley@ucc.ie
authors: Eamonn M M
authors: EM
authors: Quigley
authors: Arnold
authors: A
authors: Wald
authors: James
authors: J
authors: Fidelholtz
authors: Michel
authors: M
authors: Boivin
authors: Eckhard
authors: E
authors: Pecher
authors: David
authors: D
authors: Earnest