TY - JOUR
T1 - Adverse effects of enalapril in the Studies of Left Ventricular Dysfunction (SOLVD)
AU - Kostis, John B.
AU - Shelton, Brent
AU - Gosselin, Gilbert
AU - Goulet, Claude
AU - Hood, William B.
AU - Kohn, Robert M.
AU - Kubo, Spencer H.
AU - Schron, Eleanor
AU - Weiss, Melvin B.
AU - Willis, Park W.
AU - Young, James B.
AU - Probstfield, Jeffrey
N1 - Funding Information:
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.
PY - 1996
Y1 - 1996
N2 - 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 analapril 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.
AB - 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 analapril 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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U2 - 10.1016/S0002-8703(96)90365-8
DO - 10.1016/S0002-8703(96)90365-8
M3 - Article
C2 - 8579032
AN - SCOPUS:9044222486
SN - 0002-8703
VL - 131
SP - 350
EP - 355
JO - American Heart Journal
JF - American Heart Journal
IS - 2
ER -