Tegaserod safely improves core symptoms of IBS with constipation in women below 65 years

Tegaserod is popularly known for its role as a serotonergic agonist and a gastrointestinal drug. This is the first FDA approved drug for irritable bowel syndrome with constipation (IBS-C) in women.

Dr Eric D. Shah, MD, MBA and team have found in a new study that Tegaserod 6 mg when used twice a day reduced IBS-C symptoms in women aged less than 65 years without history of any cardiac ischemic events.

These findings are published in The American Journal of Gastroenterology.

The objective of the study was to evaluate its efficacy of the drug as the clinical trials were performed almost 20 years ago, an integrated analysis on patient-reported outcomes relevant to current practice including previously unpublished data was performed.

The study was based on data collected from 4 to 12-week, randomized, placebo-controlled trials evaluating tegaserod 6 mg b.i.d. in patients with IBS-C were pooled. 2 groups were analyzed: all women (overall population) and women younger than 65 years without a history of cardiovascular ischemic events (indicated population). The primary end point was subjective global assessment of IBS-C symptom relief. Responders 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.

The results of the study were

• A total of 2,939 (tegaserod [n = 1,478]; placebo [n = 1,461]) and 2,752 (tegaserod [n = 1,386]; placebo [n = 1,366]) participants, from the overall and indicated populations were included respectively.

• The pooled odds ratios (95% confidence interval) for clinical response during the last 4 weeks in the overall and indicated populations with tegaserod were 1.37 (1.18, 1.59; P < 0.001) and 1.38 (1.18, 1.61; P < 0.001).

• In the overall and indicated populations, clinical response rates for tegaserod during the last 4 weeks were 43.3% and 44.1% versus 35.9% and 36.5% with placebo (P < 0.001).

• Adverse events were similar between groups. No significant cardiovascular events related to tegaserod were observed in patients with ≤1 cardiac risk factor.

Dr Shah, and team conveyed that this study was effective in evaluating the efficacy of Tegaserod revealing 6 mg Tegaserod b.i.d. reduced IBS-C symptoms in overall and US Food and Drug Administration indicated populations i.e women aged <65 years with no history of cardiovascular ischemic events.

Reference: doi: 10.14309/ajg.0000000000001313