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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
- Source :
- Journal of Cardiovascular Pharmacology and Therapeutics, Vol 28 (2023)
- Publication Year :
- 2023
- Publisher :
- SAGE Publishing, 2023.
-
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 .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.
Details
- Language :
- English
- ISSN :
- 19404034 and 10742484
- Volume :
- 28
- Database :
- Directory of Open Access Journals
- Journal :
- Journal of Cardiovascular Pharmacology and Therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.58853559ce9d4f90a1c5621271649894
- Document Type :
- article
- Full Text :
- https://doi.org/10.1177/10742484231205204