Key result
Single-pill olmesartan/amlodipine/rosuvastatin reduces LDL-C by up to ~46% versus olmesartan/amlodipine alone.
Why the study?
The study evaluated the efficacy and safety of a single-pill triple-combination of olmesartan/amlodipine/rosuvastatin compared with olmesartan/amlodipine dual combination in hypertensive patients with low-to-moderate cardiovascular risk.
Does a single-pill triple combination of olmesartan, amlodipine, and rosuvastatin reduce LDL-C levels in hypertensive patients with low-to-moderate cardiovascular risk compared to olmesartan/amlodipine alone?
RCT (n=106)
Open-label
randomly assigned
Yes
Does a single-pill triple combination of olmesartan, amlodipine, and rosuvastatin reduce LDL-C levels in hypertensive patients with low-to-moderate cardiovascular risk compared to olmesartan/amlodipine alone?
Effect estimate: Difference -32.6% and -45.9%
p-value: p=< .001
A single-pill triple combination of olmesartan, amlodipine, and rosuvastatin significantly reduced LDL-C levels compared to olmesartan and amlodipine alone in hypertensive patients with low-to-moderate cardiovascular risk, with excellent safety and adherence.
Supports single-pill triple therapy for better LDL-C control in hypertensive patients; extends evidence for combination regimens in low-to-moderate risk groups.
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.
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Kim et al. (2023) conducted an RCT in Hypertension with low-to-moderate cardiovascular risk (n=106). Olmesartan/amlodipine/rosuvastatin vs. Amlodipine/olmesartan 20/5 mg once daily was evaluated on difference of the percent change in low-density lipoprotein cholesterol (LDL-C) level at 8 weeks from baseline (Difference -32.6% and -45.9%, p=< .001). A single-pill triple-combination of olmesartan/amlodipine/rosuvastatin was superior to amlodipine/olmesartan in lowering LDL-C (difference in percent change -32.6% and -45.9%; P<0.001).
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