Elsevier

American Heart Journal

Volume 131, Issue 2, February 1996, Pages 350-355
American Heart Journal

Clinical investigation
Adverse effects of enalapril in the Studies of Left Ventricular Dysfunction (SOLVD)

https://doi.org/10.1016/S0002-8703(96)90365-8Get rights and content
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Abstract

In the Studies of Left Ventricular Dysfunction (LVD), enalapril or placebo was administered in a double-blind fashion to 6797 participants with ejection fraction ≤0.35. During 40 months' average follow-up, 28.1% of participants randomized to enalapril reported side effects compared with 16.0% in the placebo group (p < 0.0001). Enalapril use was associated with a higher rate of symptoms related to hypotension (14.8% vs 7.1%, p < 0.0001), azotemia (3.8% vs 1.6%, p < 0.0001), cough (5.0% vs 2.0%, p < 0.0001), fatigue (5.8% vs 3.5%, p < 0.0001), hyperkalemia (1.2% vs 0.4%, p = 0.0002), and angioedema (0.4% vs 0.1%, p < 0.05). Side effects resulted in discontinuation of blinded therapy in 15.2% of the enalapril group compared with 8.6% in the placebo group (p < 0.0001). Thus enalapril is well tolerated by patients with LVD; however, hypotension, azotemia, cough, fatigue, and other side effects result in discontinuation of therapy in a significant minority of patients.

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Supported under contracts from the National Heart, Lung and Blood Institute and by a gift from Merck Sharp and Dohme, which had no part in the design, conduct, or monitoring of the study or in the analysis, interpretation, or reporting of the results.