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
Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine and Medial Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Republic of Korea.
J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231205204. doi: 10.1177/10742484231205204.
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.
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.
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 ( < .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, < .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, > .05).
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. CLinicalTrials.gov identifier NCT04120753.
本研究评估了奥美沙坦/氨氯地平/瑞舒伐他汀单片三联组合制剂（奥美沙坦/氨氯地平/瑞舒伐他汀）与奥美沙坦/氨氯地平单片双联组合制剂（奥美沙坦/氨氯地平）相比，在心血管风险低至中度的高血压患者中的疗效和安全性。
这项多中心、活性对照、随机研究纳入了106例心血管风险低至中度的高血压患者，他们被随机分配接受每日一次的奥美沙坦/氨氯地平/瑞舒伐他汀20/5/5毫克（治疗1组）、奥美沙坦/氨氯地平/瑞舒伐他汀20/5/10毫克（治疗2组）或氨氯地平/奥美沙坦20/5毫克（对照组），疗程为8周。主要终点是3组在8周时低密度脂蛋白胆固醇（LDL-C）水平相对于基线的变化百分比差异。
治疗1组和治疗2组在8周时与对照组相比，LDL-C的最小二乘均值变化百分比（标准差）差异分别为-32.6（3.7）%和-45.9（3.3）%（P<0.001）。3组在8周时LDL-C水平<100毫克/分升的达标率有显著差异（治疗1组、治疗2组和对照组分别为65.8%、86.7%和6.3%，P<0.001）。治疗1组和治疗2组的总胆固醇、甘油三酯、高密度脂蛋白胆固醇、载脂蛋白B以及载脂蛋白B/载脂蛋白A1的结果优于对照组。3组均未发生严重药物不良反应。3组的用药依从率都很高（治疗1组为98.0%，治疗2组为99.7%，对照组为96.3%，P>0.05）。
在心血管风险低至中度的高血压患者中，奥美沙坦/氨氯地平/瑞舒伐他汀单片三联组合制剂在降低LDL-C方面优于氨氯地平/奥美沙坦单片双联组合制剂，且安全性良好，依从率高。ClinicalTrials.gov标识符：NCT04120753。
