An integrated analysis on patient-reported outcomes relevant to current practice in the use of Tegaserod in IBS-C was carried out using data from four 12-week, randomized, placebo-controlled trials, evaluating that medication at 6 mg b.i.d. in patients with IBS-C. Two groups were analyzed. All were women younger than 65 years, without a history of cardiovascular ischemic events. The primary end point was subjective global assessment of IBS-C symptom relief. Responders rated themselves “considerably,” or “completely relieved” greater than 50% of the time, or at least “somewhat relieved” 100% of the time over the last 4 weeks.
The population included 2,939 (Tegaserod 1,478; placebo 1,461) and 2,752 (Tegaserod 1,386; placebo 1,366) participants, respectively. The pooled odds ratios for clinical response during the last four weeks of the overall and indicated populations, clinical response rate for Tegaserod during the last four weeks were 43.3% and 44.1% vs. 35.9% and 36.5% with placebo. Adverse events were similar between groups. No significant cardiovascular event related to Tegaserod was observed in patients with one or less than one cardiac risk factor.
It was concluded that Tegaserod 6 mg b.i.d. reduced IBS-C symptoms in overall and US Food and Drug Administration indicated populations, including women aged less than 65 years with no history of cardiovascular ischemic events.
Shah, E., Lacy, B., Chey, W., et al. “Tegaserod for Irritable Bowel Syndrome with Constipation in Women Younger than 65 Years without Cardiovascular Disease: Pooled Analyses of 4 Controlled Trials.” American Journal of Gastroenterology; Vol. 116, August 2021, pp. 1601-1611.