Reevaluation of the Cardiovascular Safety Profile of Tegaserod: A Review of the Clinical Data.

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Tegaserod is a 5-HT4 receptor agonist approved for irritable bowel syndrome with constipation in females <65 years without a history of cardiovascular ischemic events.Safety data are presented from two external adjudications from the 2018 Gastrointestinal Drugs Advisory Committee meeting supporting tegaserod's reintroduction after its voluntary 2007 withdrawal. Withdrawal was based on an internal adjudication using pooled placebo-controlled tegaserod data to identify potential cardiovascular ischemic signals.An independent committee conducted an external adjudication to evaluate 24 possible cardiovascular ischemic events (tegaserod: n=20; placebo: n=4) identified internally. A second independent external adjudication further evaluated these events.A total of 18,645 patients were included (tegaserod n=11,614; placebo n=7,031). The first adjudication identified 14 events (0.075%; tegaserod: n=13 [0.11%]; placebo: n=1 [0.014%]). All patients had ≥1 cardiovascular risk factor, and 11 had ≥2. The second adjudication identified 390 events, 24 (0.13%) were classified as probable new/worsening events (tegaserod: 18 [0.16%]; placebo: 6 [0.09%]). For tegaserod, seven (0.06%) were coronary/cerebrovascular ischemic events compared with one (0.01%) for placebo (odds ratio [95% confidence interval]: 4.24 [0.52-34.74]; p=0.273). All tegaserod patients reporting cardiovascular events had ≥1 risk, including cardiovascular disease, hyperlipidemia, age ≥55 years, hypertension, diabetes, obesity, and smoking. Females <65 years without a history of cardiovascular ischemic events and ≤1 cardiovascular risk factor receiving tegaserod experienced no major adverse cardiovascular events.Two independent, external adjudications suggest tegaserod is safe for women <65 years with irritable bowel syndrome with constipation, no history of cardiovascular ischemic events, and ≤1 cardiovascular risk factor.

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Authors: Brian E Lacy, Darren M Brenner, William D Chey


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