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

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 < 0.001). There was significant difference in the achievement rate of LDL-C levels < 100 mg/dL at 8 weeks between the three groups (65.8% for the treatment 1 group, 86.7% for the treatment 2 group, and 6.25% for the control group, p < 0.001). The results of total cholesterol, triglycerides, high-density lipoprotein-cholesterol, apolipoprotein B, and apolipoprotein B/apolipoprotein A1 showed the superiority in the treatment 1 and 2 groups compared to the control group. Meanwhile, there was no significant difference in systolic and diastolic BPs and diabetes-related variables including fasting glucose, fructosamine, and hemoglobinA1c at 8 weeks between the three groups. Adverse drug reaction (ADR) developed only 1 case (constipation) in the treatment 1 group and serious ADR did not occur in the three groups. Medication adherence rates were highly excellent in the three groups (98.0% for the treatment 1 group, 99.7% for the treatment 2 group, and 96.3% for the control group, p > 0.05). Conclusions: Single-pill triple-combination of olmesartan/amlodipine/rosuvastatin were superior to single-pill dual-combination of olmesartan/amlodipine in LDL-C lowering effect, with similar BP reduction effects and excellent safety profiles in hypertensive patients with low to moderate cardiovascular risk.