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 Trialopen access
- Authors
- Kim, Byung Jin; Cha, Kwang Soo; Cho, Wook Hyun; Kim, Eung Ju; Choi, Seung-Hyuk; Kim, Moo Hyun; Kim, Sang-Hyun; Park, Jun-Bean; Park, Seong-Mi; Sohn, Il Suk; Ryu, Kyu Hyung; Chae, In-Ho
- Issue Date
- Oct-2023
- Publisher
- SAGE Publications
- Keywords
- dyslipidemia; hypertension; low-density lipoprotein cholesterol; randomized controlled trial; single-pill combination
- Citation
- Journal of Cardiovascular Pharmacology and Therapeutics, v.28
- Indexed
- SCIE
SCOPUS
- Journal Title
- Journal of Cardiovascular Pharmacology and Therapeutics
- Volume
- 28
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/64306
- DOI
- 10.1177/10742484231205204
- ISSN
- 1074-2484
1940-4034
- 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:
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Collections - 2. Clinical Science > Department of Cardiology > 1. Journal Articles
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