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Lack of Association of Tegaserod With Adverse Cardiovascular Outcomes in a Matched Case-Control Study

Cardiology Division University of Utah School of Medicine, Salt Lake City, Utah, jeffrey.anderson{at}imail.org, Cardiovascular Department, Intermountain Medical Center, Murray, Utah

Heidi T. May, PhD, MSPH

Cardiovascular Department, Intermountain Medical Center, Murray, Utah, Cardiology Division University of Utah School of Medicine, Salt Lake City, Utah

Tami L. Bair, BS

Cardiovascular Department, Intermountain Medical Center, Murray, Utah

Joseph B. Muhlestein, MD, FACC

Cardiovascular Department, Intermountain Medical Center, Murray, Utah, Cardiology Division University of Utah School of Medicine, Salt Lake City, Utah

Benjamin D. Horne, PhD, MPH

Cardiovascular Department, Intermountain Medical Center, Murray, Utah, Genetic Epidemiology Division University of Utah School of Medicine, Salt Lake City, Utah

John F. Carlquist, PhD

Cardiovascular Department, Intermountain Medical Center, Murray, Utah, Cardiology Division University of Utah School of Medicine, Salt Lake City, Utah

Tegaserod is a first-in class selective serotonin 4 receptor agonist approved for the treatment of irritable bowel syndrome. In March 2007, the US Food and Drug Administration (FDA) suspended its use citing increased cardiovascular (CV) events in clinical trials. However, there is no known mechanistic basis for an adverse CV effect. To reassess the CV safety of tegaserod, teagaserod-treated patients (pts) in the Intermountain Healthcare database were identified (n = 2603), matched 1:6 with untreated (n = 15,618) patients by age, sex, and date of tegaserod initiation, and followed for an average of 2.5 years. Age averaged 38.6 ± 13.5 years, and 94% were female. Cardiovascular event rates were low and similar in patients treated with tegaserod and matched untreated patients. For the primary composite CV endpoint, 54 (0.35%) untreated and 12 (0.46%) treated pts had an event (treated OR = 1.27, 95% CI: 0.68-2.38, P =.46), with 7 and 0 events, respectively, occurring within 3 months. A total of 12 (0.1%) untreated and 1 (<0.1%) treated pts were hospitalized for a myocardial infarction (MI). 36 (0.2%) untreated and 10 (0.4%) treated pts for a cardiovascular accident, and 1 pt in each group for unstable angina. A total of 6 (<0.1%) untreated and no treated pts died from cardiac causes. Event rates were comparable to expected rates in this population of mostly premenopausal women. This large epidemiologic study failed to confirm a reported large event differential for tegaserod that was noted incidentally in a clinical trials database, suggesting that the prior observation may have been due to chance.

Key Words: tegaserod • adverse events • cardiovascular • epidemiology • irritable bowel syndrome • safety

This version was published on September 1, 2009

Journal of Cardiovascular Pharmacology and Therapeutics, Vol. 14, No. 3, 170-175 (2009)
DOI: 10.1177/1074248409340158


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