Perindopril arginine + amlodipine for the treatment of hypertension in the USA.

BACKGROUND

Controlling blood pressure is a global health priority; single-pill combinations of antihypertensive agents are often prescribed to improve adherence, persistence, and outcomes.

METHODS

A novel preparation of perindopril arginine and amlodipine besylate was approved by the US Food and Drug Administration on 21 Jan 2015, based primarily on a 837-subject, 6-week, randomized, multicenter, prospective, clinical trial. The maximal marketed dose of the combination (14/10 mg daily) lowered both systolic and diastolic blood pressure significantly more than either monotherapy, with a reduction in adverse effects (especially ankle edema), compared to amlodipine alone.

CONCLUSIONS

Substantial clinical trial experience with amlodipine or perindopril suggests that these two agents effectively lower blood pressure, and may reduce the risk of major adverse cardiovascular events. In the Anglo-Scandinavian Cardiac Outcomes Trial, hypertensive subjects randomized to receive these two drugs (in sequence) had a significantly lower incidence of several types of clinical events, compared to those who received atenolol ± bendroflumethiazide. The new formulation of perindopril arginine protects its ethyl ester, without requiring physical separation from amlodipine in a single pill, and is less hydroscopic than perindopril erbumine. These and other attributes may make this combination an attractive addition to the antihypertensive armamentarium.