Perindopril arginine and amlodipine besylate for hypertension: a safety evaluation

Expert Opin Drug Saf. 2018 Feb;17(2):207-216. doi: 10.1080/14740338.2018.1397129. Epub 2017 Oct 31.

Abstract

Controlling blood pressure is a global health priority; single-pill antihypertensive combinations may improve adherence, persistence, and outcomes. Areas covered: A novel combination of perindopril arginine and amlodipine besylate was recently approved. A systematic review of the literature revealed its most common adverse effects as: peripheral edema (depending on the dose of amlodipine, but attenuated by perindopril), cough, dizziness and hypotension. Dose-dependent hyperkalemia, impairment of renal function (especially in renovascular hypertension), angioedema, and teratogenicity were derived from experience with other ACE-inhibitors. Expert opinion: Substantial clinical trial experience with amlodipine or perindopril suggests that these two agents effectively lower blood pressure, and can reduce the risk of major adverse cardiovascular events, as in the Anglo-Scandinavian Cardiac Outcomes Trial. The incidence of adverse effects reported in clinical trials is lower than expected, likely due to exclusion of subjects previously exposed to its components; the nature of open-label, uncontrolled observational studies; and difficulty in recognizing and measuring cough and pedal edema. This new formulation of perindopril arginine protects its ethyl ester, without requiring physical separation from amlodipine in a single tablet, and is less hygroscopic than perindopril erbumine. These and other attributes may make this combination an attractive addition to the antihypertensive armamentarium.

Keywords: Angiotensin converting-enzyme inhibitor; calcium antagonist; clinical trials.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Amlodipine / administration & dosage*
  • Amlodipine / adverse effects
  • Antihypertensive Agents / administration & dosage*
  • Antihypertensive Agents / adverse effects
  • Blood Pressure / drug effects
  • Cough / chemically induced
  • Cough / diagnosis
  • Dose-Response Relationship, Drug
  • Drug Combinations
  • Edema / chemically induced
  • Edema / diagnosis
  • Humans
  • Hypertension / drug therapy*
  • Perindopril / administration & dosage*
  • Perindopril / adverse effects

Substances

  • Antihypertensive Agents
  • Drug Combinations
  • amlodipine, perindopril drug combination
  • Amlodipine
  • Perindopril