Efficacy and Safety of Fixed-Dose Perindopril Arginine/Amlodipine in Hypertensive Patients Not Adequately Controlled with Amlodipine 5 mg or Perindopril tert-Butylamine 4 mg Monotherapy

Cardiology. 2016;134(1):1-10. doi: 10.1159/000441348. Epub 2016 Jan 16.

Abstract

Objectives: To assess the blood pressure-lowering efficacy and tolerability of perindopril/amlodipine fixed-dose combinations in Chinese patients with mild-to-moderate essential hypertension not adequately controlled with monotherapy alone.

Methods: In 2 separate double-blind studies, patients received a 4-week run-in monotherapy of amlodipine 5 mg or perindopril 4 mg, respectively. Those whose blood pressure was uncontrolled were then randomized to receive the fixed-dose combination of perindopril 5 mg/amlodipine 5 mg (Per/Amlo group) or remain on the monotherapy for 8 weeks. Patients who were uncontrolled at the week 8 (W8) visit were up-titrated for the Per/Amlo combination, or received additional treatment if on monotherapy, for a further 4 weeks. The main efficacy assessment was at 8 weeks.

Results: After 8 weeks, systolic blood pressure (SBP; primary criterion) was statistically significantly lower in the Per/Amlo group (vs. Amlo 5 mg, p = 0.0095; vs. Per 4 mg, p < 0.0001). Uncontrolled patients at W8 who received an up-titration of the Per/Amlo combination showed a further SBP reduction. These changes were mirrored by reassuring reductions in diastolic blood pressure. The fixed-dose combinations were well tolerated.

Conclusions: Single-pill combinations of perindopril and amlodipine provide hypertensive patients with a convenient and effective method of reducing blood pressure.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Amlodipine* / administration & dosage
  • Amlodipine* / adverse effects
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / adverse effects
  • Blood Pressure / drug effects*
  • Double-Blind Method
  • Drug Combinations
  • Drug Monitoring
  • Drug Therapy, Combination
  • Essential Hypertension
  • Female
  • Humans
  • Hypertension* / diagnosis
  • Hypertension* / drug therapy
  • Male
  • Middle Aged
  • Perindopril* / administration & dosage
  • Perindopril* / adverse effects
  • Treatment Outcome

Substances

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