Comparison of dilevalol and enalapril administered once daily for mild hypertension.

This was a multicenter, randomized, double-blind, parallel-group study of the efficacy and safety of dilevalol, 200 mg (n = 86), compared with enalapril, 20 mg (n = 92), administered once daily to patients with mild hypertension. Three weeks of placebo washout were followed by 4 weeks of comparative treatment. Beginning with the first week of treatment, both drugs substantially decreased blood pressure from baselines of approximately 160/100 mm Hg. Decreases in systolic pressure were comparable throughout treatment, but dilevalol tended to have a greater effect on diastolic pressure. At the end of double-blind treatment, average decreases in blood pressure with dilevalol and enalapril were 16/13 and 16/11 mm Hg supine and 15/13 and 15/10 mm Hg standing (p = 0.03 for between-group comparisons of standing diastolic pressure). More dilevalol- than enalapril-treated patients achieved a diastolic pressure less than 90 mm Hg; 73 vs 55% (p = 0.02) supine, and 69 vs 43% (p less than 0.01) standing. The safety profiles of the 2 drugs were comparable. The incidence of adverse effects was low, and few patients discontinued treatment. Headache and gastrointestinal discomfort were reported in both groups. Average postural changes in blood pressure were similar to baseline. Electrocardiographic changes were rare and not treatment related. Changes in laboratory test results were minor. Heart rate decreased modestly with dilevalol relative to enalapril (6 vs 2 to 3 beats/min; p less than 0.01), but no bradycardia was observed.

RCT Entities:   Population Interventions Outcomes