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

Am Heart J. 1996 Feb;131(2):350-5. doi: 10.1016/s0002-8703(96)90365-8.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Angioedema / chemically induced
  • Angiotensin-Converting Enzyme Inhibitors / adverse effects*
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Cough / chemically induced
  • Double-Blind Method
  • Enalapril / adverse effects*
  • Enalapril / therapeutic use
  • Fatigue / chemically induced
  • Female
  • Follow-Up Studies
  • Heart Failure / drug therapy
  • Humans
  • Hyperkalemia / chemically induced
  • Hypotension / chemically induced
  • Male
  • Middle Aged
  • Sex Factors
  • Time Factors
  • Uremia / chemically induced
  • Ventricular Dysfunction, Left / drug therapy*
  • Ventricular Dysfunction, Left / mortality
  • Ventricular Dysfunction, Left / physiopathology

Substances

  • Angiotensin-Converting Enzyme Inhibitors
  • Enalapril