A randomized, double‐blind, placebo‐controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation

• Published in: Alimentary pharmacology & therapeutics Vol. 16; no. 11; pp. 1877 - 1888
• Main Authors: Novick, J., Miner, P., Krause, R., Glebas, K., Bliesath, H., Ligozio, G., Rüegg, P., Lefkowitz, M.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01-11-2002; Blackwell
• Subjects: Adult; Biological and medical sciences; Colonic Diseases, Functional - complications; Colonic Diseases, Functional - drug therapy; Constipation - drug therapy; Constipation - etiology; Digestive system; Double-Blind Method; Female; Gastrointestinal Agents - adverse effects; Gastrointestinal Agents - therapeutic use; Humans; Indoles - adverse effects; Indoles - therapeutic use; Medical sciences; Middle Aged; Patient Satisfaction; Pharmacology. Drug treatments; Prospective Studies; Serotonin Receptor Agonists - adverse effects; Serotonin Receptor Agonists - therapeutic use; Treatment Outcome; Human; Agonist; 5-HT4 Serotonine receptor; Controlled therapeutic trial; Chemotherapy; Randomization; Treatment; Irritable bowel syndrome; Placebo; Double blind study; Digestive diseases; Intestinal disease; Clinical trial; Female; Constipation; Tegaserod
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1046/j.1365-2036.2002.01372.x

Summary
Background : Irritable bowel syndrome is a common functional gastrointestinal disorder which affects up to 20% of the population, with a predominance in females.
Aim : To evaluate the efficacy and safety of tegaserod in female patients with irritable bowel syndrome characterized by symptoms of abdominal pain/discomfort and constipation.
Methods : In a randomized, double‐blind, multicentre study, 1519 women received either tegaserod, 6 mg b.d. (n = 767), or placebo (n = 752) for 12 weeks, preceded by a 4‐week baseline period without treatment and followed by a 4‐week open withdrawal period. The primary efficacy evaluation was the patient's symptomatic response as measured by the Subject's Global Assessment of Relief. Other efficacy variables included abdominal pain/discomfort, bowel habits and bloating.
Results : Tegaserod produced significant (P < 0.05) improvements in the Subject's Global Assessment of Relief and other efficacy variables. These improvements were seen within the first week, and were maintained throughout the treatment period. After withdrawal of treatment, the symptoms rapidly returned. Overall, tegaserod was well tolerated. Diarrhoea was the most frequent adverse event; however, this led to discontinuation in only 1.6% of tegaserod‐treated patients.
Conclusions : Tegaserod, 6 mg b.d., produced rapid and sustained improvement of symptoms in female irritable bowel syndrome patients and was well tolerated.