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

John B. Kostis; Brent Shelton; Gilbert Gosselin; Claude Goulet; William B. Hood; Robert M. Kohn; Spencer H. Kubo; Eleanor Schron; Melvin B. Weiss; Park W. Willis; James B. Young; Jeffrey Probstfield

doi:10.1016/S0002-8703(96)90365-8

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

John B. Kostis, Brent Shelton, Gilbert Gosselin, Claude Goulet, William B. Hood, Robert M. Kohn, Spencer H. Kubo, Eleanor Schron, Melvin B. Weiss, Park W. Willis, James B. Young, Jeffrey Probstfield

Internal Medicine

Research output: Contribution to journal › Article › peer-review

149 Scopus citations

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 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.

Original language	English
Pages (from-to)	350-355
Number of pages	6
Journal	American Heart Journal
Volume	131
Issue number	2
DOIs	https://doi.org/10.1016/S0002-8703(96)90365-8
State	Published - 1996

Bibliographical note

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.

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/S0002-8703(96)90365-8

Cite this

@article{011334a783a347e09837ee40de2e7670,

title = "Adverse effects of enalapril in the Studies of Left Ventricular Dysfunction (SOLVD)",

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 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.",

author = "Kostis, {John B.} and Brent Shelton and Gilbert Gosselin and Claude Goulet and Hood, {William B.} and Kohn, {Robert M.} and Kubo, {Spencer H.} and Eleanor Schron and Weiss, {Melvin B.} and Willis, {Park W.} and Young, {James B.} and Jeffrey Probstfield",

note = "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.",

year = "1996",

doi = "10.1016/S0002-8703(96)90365-8",

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pages = "350--355",

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

Abstract

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