Tegaserod is a safe and effective treatment option for irritable bowel syndrome with constipation (IBS-C) in women aged less than 65 years with no history of cardiovascular ischemic (CVI) events, according to a study published in The American Journal of Gastroenterology.
In 2002, tegaserod was approved by the United States Food and Drug Administration (FDA) for the short-term treatment of women with IBS-C. In 2007, tegaserod was voluntarily withdrawn from the market due to concerns over possible CVI adverse events (AEs) in patients who did not fall within current regulatory guidelines. In 2019, tegaserod was reapproved at a dose of 6 mg twice daily for treating IBS-C in women aged less than 65 years without a history of CVI events (angina, myocardial infarction, transient ischemic attack, or stroke).
Data from 4 separate, 12-week randomized controlled trials (RCTs) assessing tegaserod 6 mg twice daily in patients with IBS-C were pooled (studies 301, 307, 351, and 358). The investigators analyzed 2 groups: all women (overall population) and women aged less than 65 years without a history of CVI events (indicated population).
The primary end point was subjective global assessment of IBS-C symptom relief. The study participants rated themselves as “considerably” or “completely” relieved >50% of the time or at least “somewhat relieved” 100% of the time over the last 4 weeks.
Among all women, the intent-to-treat (ITT) population for the primary and secondary efficacy analyses included 2939 patients randomly assigned to receive tegaserod (n=1478 [study 301, n=244; study 307, n=233; study 351, n=234; study 358, n=767]) or placebo (n=1461 [study 301, n=240; study 307, n=234; study 351, n=235; study 358, n=752]).
The ITT population for the primary efficacy analysis in the indicated population included 2752 patients randomly assigned to receive tegaserod (n=1386 [study 301, n=219; study 307, n=209; study 351, n=220; study 358, n=738]) or placebo (n=1366 [study 301, n=217; study 307, n=212; study 351, n=218; study 358, n=719]).
The pooled odds ratio for clinical response among all women treated with tegaserod was 1.37 (95% CI, 1.18-1.59; P <.001) during the last 4 weeks. The pooled odds ratio for clinical response among the indicated population treated with tegaserod was 1.38 (95% CI, 1.18-1.61; P <.001) during the last 4 weeks.
In all women treated with tegaserod, the clinical response rate during the last 4 weeks was 43.3% compared with 35.9% for placebo (P <.001). In the indicated population treated with tegaserod, the clinical response rate during the last 4 weeks was 44.1% compared with 36.5% for placebo (P <.001).
AEs were noted to be similar between both the tegaserod and the placebo groups. The investigators observed no significant cardiovascular events related to tegaserod in patients with <1 cardiac risk factor.
This study had several potential limitations. The analyses included studies conducted approximately 20 years ago, with diagnostic criteria having since been updated. Additionally, outcomes in men were not analyzed. However, it should be noted that tegaserod is not approved for use in men. Further, the analyses were not capable of identifying the population most likely to benefit from tegaserod. Finally, patients included in the analyses were mostly white (84%), which may preclude these findings from being generalizable to other race/ethnic groups.
The study authors concluded that tegaserod 6 mg twice daily is safe and effective for treating IBS-C in women aged less than 65 years with no history of CVI events.
Disclosure: Some study authors declared affiliations with the industry. Please see the original reference for a full list of authors’ disclosures.
Shah ED, Lacy BE, Chey WD, Chang L, Brenner DM. Tegaserod for irritable bowel syndrome with constipation in women younger than 65 years without cardiovascular disease: pooled analyses of 4 controlled trials. Am J Gastroenterol. 2021;116(8):1601-1611. doi: 10.14309/ajg.0000000000001313
This article originally appeared on Gastroenterology Advisor