Enalapril increased reported side effects compared to placebo (28.1% vs 16.0%, p<0.0001) and led to higher therapy discontinuation (15.2% vs 8.6%, p<0.0001) in patients with LVD.
RCT (n=6,797)
Double-blind
Absolute Event Rate: 28.1% vs 16%
p-value: p=< 0.0001
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.
Kostis et al. (Thu,) conducted a rct in Left Ventricular Dysfunction (n=6,797). Enalapril vs. Placebo was evaluated on Reported side effects (p=< 0.0001). Enalapril increased reported side effects compared to placebo (28.1% vs 16.0%, p<0.0001) and led to higher therapy discontinuation (15.2% vs 8.6%, p<0.0001) in patients with LVD.