Tegaserod for female patients suffering from IBS with mixed bowel habits or constipation: a randomized controlled trial.
OBJECTIVE
Though the greatest proportion of irritable bowel syndrome (IBS) patients report a mixed bowel pattern (IBS-Mixed), no available therapies have been rigorously evaluated in this subgroup. This study aimed to evaluate the efficacy and safety of the 5-HT(4) agonist tegaserod in women with IBS-Mixed and IBS with constipation (IBS-C).


METHODS
This prospective, double-blind, randomized, placebo-controlled, multicenter study was conducted in 100 centers in North America, South America, and Europe. Women with IBS-Mixed or IBS-C received tegaserod 6 mg or placebo twice daily. The primary efficacy variable was the patient's assessment of satisfactory relief over the 4-wk treatment period. The proportion of patients reporting satisfactory relief for >/=3 of 4 treatment weeks (75% rule) and individual IBS symptoms were assessed.


RESULTS
In total, 661 women were randomized (IBS-Mixed 324, IBS-C 337). Baseline symptom assessments identified clear differences between the two cohorts. Tegaserod provided significant improvement in satisfactory relief of IBS symptoms over 4 wk (OR 1.75, 95% CI 1.35-2.25, P < 0.001) in both IBS-Mixed and IBS-C patients. Using the 75% rule, 52.3% of tegaserod-receiving IBS-M patients and 43.3% of IBS-C patients were responders (vs 36.3, OR 1.88, 95% CI 1.16-3.04, P < 0.010; and 28.9, OR 1.90, 95% CI 1.19-3.05, P < 0.008 for placebo, respectively). The most frequent adverse events leading to study discontinuation in tegaserod-treated patients were diarrhea (1.5%) and abdominal pain (0.9%). Overall 7% of IBS-C patients reported diarrhea compared to 12% of IBS-Mixed (placebo 2.4%, 1.8%, respectively).


CONCLUSIONS
Tegaserod is effective in treating overall IBS symptoms in patients with IBS-Mixed and IBS-C.
Chey
William D
WD
University of Michigan Health System, Division of Internal Medicine, Ann Arbor, Michigan, USA.
Paré
Pierre
P
Viegas
Andrea
A
Ligozio
Gregory
G
Shetzline
Michael A
MA
D000328:Adult; D003248:Constipation / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D007211:Indoles; C105050:tegaserod