Efficacy and safety of perindopril arginine + amlodipine in hypertension

Abstract

To study the efficacy and safety of a new combination of perindopril arginine and amlodipine besylate, 837 subjects were enrolled in a three-arm, prospective, 59-center, randomized clinical trial. For 42 days, subjects (average seated blood pressure [BP], 158 ± 12/101 ± 5 mm Hg; age, 52 ± 10 years; 52% male; 34% black; 20% diabetic) received amlodipine/perindopril arginine (10/14 mg/d), perindopril erbumine (16 mg/d), or amlodipine (10 mg/d). Goal BP was <140/90 or <130/80 mm Hg in diabetics, per JNC 7 guidelines. The combination showed the largest change in seated BP (-23.7/-15.7 vs. -13.7/-9.5 vs. -19.3/-13.2 mm Hg, respectively; P < .0001), the highest proportion at goal BP (51% vs. 26% vs. 37%; P < .0001), and a lower incidence of pedal edema and adverse events compared with amlodipine. No deaths or significant differences across groups in early discontinuation, serum potassium, or rates of total or serious adverse events or glomerular filtration, were observed.

Keywords: Besylate; erbumine; pedal edema.