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Adverse effects of enalapril in the Studies of Left Ventricular Dysfunction (SOLVD). SOLVD Investigators
J B Kostis1, B Shelton, G Gosselin
1University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA.
Insights
Enalapril, used for left ventricular dysfunction (LVD), caused more side effects like hypotension and cough than placebo. While generally tolerated, these adverse events led to treatment discontinuation in a notable number of patients.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Left Ventricular Dysfunction (LVD) is a critical condition affecting heart function.
- Enalapril is a commonly prescribed medication for cardiovascular conditions.
Purpose of the Study:
- To evaluate the side effect profile of enalapril in patients with LVD.
- To compare the incidence of adverse events between enalapril and placebo groups.
Main Methods:
- A double-blind, placebo-controlled study involving 6797 participants with LVD (ejection fraction ≤ 0.35).
- Participants were randomized to receive either enalapril or a placebo.
- Follow-up averaged 40 months to record side effects and treatment discontinuations.
Main Results:
- Enalapril group reported significantly higher side effects (28.1%) compared to placebo (16.0%).
- Specific side effects included hypotension, azotemia, cough, fatigue, hyperkalemia, and angioedema, all more frequent with enalapril.
- Treatment discontinuation due to side effects was higher in the enalapril group (15.2%) versus placebo (8.6%).
Conclusions:
- Enalapril is generally well-tolerated in LVD patients.
- However, a significant minority of patients discontinue enalapril due to adverse effects like hypotension and azotemia.
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 < or = 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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