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PS-BPC12-2: efficacy and safety of single-pill combination of olomaxâ (olmesartan, amlodipine, and rosuvastatin) in hypertensive patients with LOW-to-moderate cardiovascular risk

Byung Jin Kim, K. Cha, Wook-Hyun Cho, E. Kim, I. Chae, S. Choi, M. Kim, S. H. Kim et al.

Journal of Hypertension, 2023

106 participants · 1 citation

Abstract

Objective: Of the ten hypertensive patients who have to take statins in Korea, about two are not actually prescribed. The use of polypills including lipid-lowering and blood pressure (BP)-lowering drug improves medication adherence, and consequently ameliorates in cardiovascular risk levels. This study was to evaluate the efficacy and safety of single-pill triple-combination of olmesartan/amlodipine/rosuvastatin (OLOMAX®) in comparison to single-pill dual-combination of olmesartan/amlodipine (SEVIKAR®) in hypertensive patients with low-to-moderate cardiovascular risk. Design and method: This multicenter, active-control, randomized study included 106 hypertensive patients with low-to-intermediate cardiovascular risk, who were randomly assigned to receive either OLOMAX®(20/5/5 mg, treatment 1), OLOMAX®(20/5/10 mg, treatment 2), or SEVIKAR®(20/5 mg, control) once daily for 8 weeks. The low and moderate cardiovascular risk groups were defined according to the definition of the 4th Korean dyslipidemia treatment guidelines. Primary endpoint was assessed as the difference of the percent change of LDL-C(low-density lipoprotein-cholesterol) level at 8 weeks from baseline among the three groups. Results: The difference in the least square mean % change of LDL-C in the treatment 1 and 2 groups compared to the control group at 8 weeks was -32.6 ± 3.7% and -45.9 ± 3.3%, respectively (all p 0.05). Conclusions: Single-pill triple-combination of olmesartan/amlodipine/rosuvastatin were…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 106 participants or records.

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