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Review article: the safety profile of tegaserod.
Aliment Pharmacol Ther. 2004 Nov; 20 Suppl 7:25-30.AP

Abstract

Gastrointestinal symptoms are the most common side-effects of tegaserod therapy. In data pooled from Phase III randomized controlled trials in patients with irritable bowel syndrome with constipation, diarrhoea was reported by 8.8% of patients treated with tegaserod 6 mg b.d. vs. 3.8% of patients treated with placebo. Similar rates were observed in international post-US marketing randomized controlled trials. In most patients, tegaserod-induced diarrhoea was mild and transient. In randomized controlled trials, it did not elicit fluid or electrolyte disturbances, and fewer than 3% of irritable bowel syndrome patients discontinued tegaserod due to diarrhoea. The incidence of other gastrointestinal symptoms (e.g. abdominal pain, nausea and flatulence) was similar in tegaserod-treated and placebo-treated patients. Pooled analysis of Phase III and post-US marketing randomized controlled trials did not demonstrate significant differences between tegaserod-treated and placebo-treated patients in the incidence of abdominal/pelvic surgery. No episodes of ischaemic colitis were reported in tegaserod-using patients in any Phase III or post-marketing randomized controlled trials, and post-marketing surveillance indicated that the rate of ischaemic colitis in tegaserod-using patients was lower than that in non-tegaserod-using patients. Pooled analysis of Phase III randomized controlled trials demonstrated an increase in the incidence of headaches in tegaserod-treated (6 mg b.d.) vs. placebo-treated patients (15% vs. 12.3%, respectively; P < 0.05), although post-US marketing randomized controlled trials did not demonstrate this increase. Other extra-gastrointestinal adverse events occurred with similar frequency in tegaserod-treated and placebo-treated patients. Tegaserod-treated patients in randomized controlled trials did not demonstrate significant prolongation of the QTc interval or cardiac arrhythmias compared with placebo-treated patients. In summary, tegaserod exhibits a favourable safety and tolerability profile in irritable bowel syndrome patients based on data from clinical trials.

Authors+Show Affiliations

Division of Gastroenterology, University of Michigan School of Medicine, Veterans Affairs Center for Excellence in Health Services Research, Ann Arbor, MI, USA. pschoenf@med.umich.edu

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

15521852

Citation

Schoenfeld, P. "Review Article: the Safety Profile of Tegaserod." Alimentary Pharmacology & Therapeutics, vol. 20 Suppl 7, 2004, pp. 25-30.
Schoenfeld P. Review article: the safety profile of tegaserod. Aliment Pharmacol Ther. 2004;20 Suppl 7:25-30.
Schoenfeld, P. (2004). Review article: the safety profile of tegaserod. Alimentary Pharmacology & Therapeutics, 20 Suppl 7, 25-30.
Schoenfeld P. Review Article: the Safety Profile of Tegaserod. Aliment Pharmacol Ther. 2004;20 Suppl 7:25-30. PubMed PMID: 15521852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Review article: the safety profile of tegaserod. A1 - Schoenfeld,P, PY - 2004/11/4/pubmed PY - 2005/4/13/medline PY - 2004/11/4/entrez SP - 25 EP - 30 JF - Alimentary pharmacology & therapeutics JO - Aliment Pharmacol Ther VL - 20 Suppl 7 N2 - Gastrointestinal symptoms are the most common side-effects of tegaserod therapy. In data pooled from Phase III randomized controlled trials in patients with irritable bowel syndrome with constipation, diarrhoea was reported by 8.8% of patients treated with tegaserod 6 mg b.d. vs. 3.8% of patients treated with placebo. Similar rates were observed in international post-US marketing randomized controlled trials. In most patients, tegaserod-induced diarrhoea was mild and transient. In randomized controlled trials, it did not elicit fluid or electrolyte disturbances, and fewer than 3% of irritable bowel syndrome patients discontinued tegaserod due to diarrhoea. The incidence of other gastrointestinal symptoms (e.g. abdominal pain, nausea and flatulence) was similar in tegaserod-treated and placebo-treated patients. Pooled analysis of Phase III and post-US marketing randomized controlled trials did not demonstrate significant differences between tegaserod-treated and placebo-treated patients in the incidence of abdominal/pelvic surgery. No episodes of ischaemic colitis were reported in tegaserod-using patients in any Phase III or post-marketing randomized controlled trials, and post-marketing surveillance indicated that the rate of ischaemic colitis in tegaserod-using patients was lower than that in non-tegaserod-using patients. Pooled analysis of Phase III randomized controlled trials demonstrated an increase in the incidence of headaches in tegaserod-treated (6 mg b.d.) vs. placebo-treated patients (15% vs. 12.3%, respectively; P < 0.05), although post-US marketing randomized controlled trials did not demonstrate this increase. Other extra-gastrointestinal adverse events occurred with similar frequency in tegaserod-treated and placebo-treated patients. Tegaserod-treated patients in randomized controlled trials did not demonstrate significant prolongation of the QTc interval or cardiac arrhythmias compared with placebo-treated patients. In summary, tegaserod exhibits a favourable safety and tolerability profile in irritable bowel syndrome patients based on data from clinical trials. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/15521852/Review_article:_the_safety_profile_of_tegaserod_ L2 - https://doi.org/10.1111/j.1365-2036.2004.02182.x DB - PRIME DP - Unbound Medicine ER -