Blood-pressure Lowering Efficacy and Safety of Perindopril / Indapamide / Amlodipine Single-pill Combination in Hypertensive Patients: Phase III Trial in India

J Assoc Physicians India. 2020 Oct;68(10):39-43.

Abstract

Background: Hypertension is the biggest contributor to global burden of disease and mortality. Increasing compliance with antihypertensive treatment and achieving a wide BP control in the population represents a major challenge for clinical practice. The benefits of single pill combination versus free-equivalent combination has been demonstrated in several meta-analyses and is now strongly supported by the latest 2018 ESC/ESH guidelines. The RAAS blocker with CCB and thiazide like diuretic is proposed as the optimal combination in patients inadequately controlled by two drugs.

Objective: To assess the blood pressure control rate, safety, tolerability and quality of life with triple-drug SPC in patients with grade II/ III hypertension.

Methods: Hypertensive patients uncontrolled (BP ≥ 140/90 mmHg) on two-drug therapy were recruited in an open-label, phase III clinical trial conducted in outpatient setting in India with 6 months treatment period. No other antihypertensive medication except the study medication was received by the patients.

Results: Out of 218 evaluable patients the observed average blood pressure reduction achieved from baseline to end of study at 6 months was Systolic Blood Pressure (SBP) 28.5 mm Hg / Diastolic Blood Pressure (DBP) 13.8 mm Hg. The quality of life (QoL) questionnaire demonstrated improvement in QoL for all patients.

Conclusion: This study showed the clinical efficacy, safety and acceptability of the perindopril/indapamide/amlodipine SPC in patients with grade 2/3 hypertension inadequately controlled with two-drug therapy. The clinical effectiveness was observed in more than 96 % patients. The benefit of single-pill combination (SPC) therapy in hypertension control was reconfirmed in this study.

Publication types

  • Clinical Trial, Phase III

MeSH terms

  • Amlodipine / pharmacology
  • Antihypertensive Agents / therapeutic use
  • Blood Pressure / drug effects
  • Drug Combinations
  • Humans
  • Hypertension / drug therapy*
  • Indapamide*
  • India
  • Perindopril / adverse effects
  • Quality of Life
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Drug Combinations
  • Amlodipine
  • Indapamide
  • Perindopril