Efficacy and Safety of a Single-Pill Triple Combination of Olmesartan, Amlodipine, and Rosuvastatin in Hypertensive Patients with Low-to-Moderate Cardiovascular Risk: A Multicenter, Randomized, Open-Label, Active-Control, Phase IV Clinical Trial

J Cardiovasc Pharmacol Ther. 2023 Jan-Dec:28:10742484231205204. doi: 10.1177/10742484231205204.

Abstract

Introduction: This study evaluated the efficacy and safety of a single-pill triple-combination of olmesartan/amlodipine/rosuvastatin (Olme/Amlo/Rosu) in comparison with a single-pill dual-combination of olmesartan/amlodipine (Olme/Amlo) in hypertensive patients with low-to-moderate cardiovascular risk.

Methods: This multicenter, active-control, randomized study included 106 hypertensive patients at low-to-moderate cardiovascular risk who were randomly assigned to receive either Olme/Amlo/Rosu 20/5/5 mg (Treatment 1), Olme/Amlo/Rosu 20/5/10 mg (Treatment 2), or Amlo/Olme 20/5 mg (Control) once daily for 8 weeks. The primary endpoint was the difference of the percent change in low-density lipoprotein cholesterol (LDL-C) level at 8 weeks from baseline in the 3 groups.

Results: The difference in the least square mean percent change (standard deviation) of LDL-C in the Treatment 1 and 2 groups compared with the Control group at 8 weeks was -32.6 (3.7) % and -45.9 (3.3) %, respectively (P < .001). The achievement rates of LDL-C level <100 mg/dL at 8 weeks were significantly different between the 3 groups (65.8%, 86.7%, and 6.3% for Treatment 1, 2, and Control groups, respectively, P < .001). The results of total cholesterol, triglycerides, high-density lipoprotein cholesterol, apolipoprotein B, and apolipoprotein B/apolipoprotein A1 were superior in the Treatment 1 and 2 groups compared with the Control group. Serious adverse drug reaction did not occur in the 3 groups. Medication adherence rates were excellent in the 3 groups (98.0% for Treatment 1 group, 99.7% for Treatment 2 group, and 96.3% for the Control group, P > .05).

Conclusion: Single-pill triple-combination of olmesartan/amlodipine/rosuvastatin was superior to the single-pill dual-combination of amlodipine/olmesartan in LDLC-lowering effects, with excellent safety profiles and adherence rates, in hypertensive patients at low-to-moderate cardiovascular risk.Trial Registration: CLinicalTrials.gov identifier NCT04120753.

Keywords: dyslipidemia; hypertension; low-density lipoprotein cholesterol; randomized controlled trial; single-pill combination.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Clinical Trial, Phase IV

MeSH terms

  • Amlodipine
  • Antihypertensive Agents / adverse effects
  • Apolipoproteins / pharmacology
  • Apolipoproteins / therapeutic use
  • Blood Pressure
  • Cardiovascular Diseases* / drug therapy
  • Cholesterol, LDL
  • Double-Blind Method
  • Drug Combinations
  • Drug Therapy, Combination
  • Heart Disease Risk Factors
  • Humans
  • Hypertension* / diagnosis
  • Hypertension* / drug therapy
  • Risk Factors
  • Rosuvastatin Calcium / adverse effects
  • Treatment Outcome

Substances

  • Amlodipine
  • Rosuvastatin Calcium
  • olmesartan
  • Antihypertensive Agents
  • Cholesterol, LDL
  • Apolipoproteins
  • Drug Combinations

Associated data

  • ClinicalTrials.gov/NCT04120753