ADVERSE-EFFECTS OF ENALAPRIL IN THE STUDIES OF LEFT-VENTRICULAR DYSFUNCTION (SOLVD)

In the Studies of Left Ventricular Dysfunction (LVD), enalapril or pla cebo was administered in a double-blind fashion to 6797 participants w ith ejection fraction less than or equal to 0.35. During 40 months' av erage follow-up, 28.1% of participants randomized to enalapril reporte d 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 blind ed therapy in 15.2% of the enalapril group compared with 8.6% in the p lacebo group (p < 0.0001). Thus enalapril is well tolerated by patient s with LVD; however, hypotension, azotemia, cough, fatigue, and other side effects result in discontinuation of therapy in a significant min ority of patients.