一项关于非洛沙坦、氨氯地平、瑞舒伐他汀联合治疗对单药治疗非洛沙坦疗效欠佳的原发性高血压合并血脂异常患者的疗效和安全性的随机、双盲、多中心III期研究。
A randomized, double-blind, multicenter, phase III study on the efficacy and safety of a combination treatment involving fimasartan, amlodipine, rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy.
作者信息
Jeon Eun-Seok, Lim Sang Wook, Kim Seok-Yeon, Yang Hyoung-Mo, Kim Moo Hyun, Rhee Moo-Yong, Han Seung Hwan, Shin Jinho, Kim Kwang-Il, Jeong Jin-Ok, Sung Ki Chul, Hong Geu Ru, Kim Hyung-Seop, Kwon Kihwan, Kang Tae-Soo, Lee Hae-Young, Han Su-Eun
机构信息
Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Division of Cardiology, Bundang Cha Hospital, Cha University, Seongnam, Republic of Korea.
出版信息
Clin Hypertens. 2022 Dec 1;28(1):40. doi: 10.1186/s40885-022-00223-4.
BACKGROUND
To assess the efficacy and safety of a combination therapy involving fimasartan, amlodipine, and rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond to fimasartan monotherapy.
METHODS
This phase III, randomized, double-blind, multicenter study was conducted in adults aged 19-70 years. Patients who voluntarily consented were screened for eligibility to enroll in the study. Patients who failed to respond to 4 weeks of fimasartan monotherapy were randomized with a 1:1:1 ratio to the fimasartan 60 mg/amlodipine 10 mg + rosuvastatin 20 mg (FMS/ALD + RSV) as study group, fimasartan 60 mg/amlodipine 10 mg (FMS/ALD) as control 1 group, and fimasartan 60 mg + rosuvastatin 20 mg (FMS + RSV) as control 2 group. The primary efficacy endpoints were the change in the sitting systolic blood pressure and the rate of change in the low-density lipoprotein cholesterol (LDL-C) level from baseline to 8 weeks. The adverse events, adverse drug reactions, physical examination findings, laboratory test results, electrocardiograms, and vital signs were evaluated to assess safety in the study.
RESULTS
Of 138 randomized patients, 131 were conducted efficacy analysis, and 125 completed the study. For the change in LDL-C and sitting SBP (SiSBP) as primary efficacy assessments, the change in LDL-C at week 8 was significantly reduce in the FMS/ALD + RSV group than in the control 1 group (P < 0.001). The change in SiSBP at week 8 were greater reduce in the FMS/ALD + RSV group than in the FMS + RSV group (both P < 0.001). For the safety evaluation, there were no differences among the treatment groups in the incidence of adverse drug reactions.
CONCLUSIONS
The fimasartan/amlodipine + rosuvastatin combination therapy can effectively and safely lower blood pressure and improve lipid levels in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy.
TRIAL REGISTRATION
NCT03156842, Registered 17 May 2017.
背景
评估在对单一使用阿齐沙坦治疗无效的原发性高血压和血脂异常患者中，阿齐沙坦、氨氯地平和瑞舒伐他汀联合治疗的疗效和安全性。
方法
这项III期随机双盲多中心研究纳入了19至70岁的成年人。自愿同意的患者接受筛选以确定是否符合纳入研究的条件。对单一使用阿齐沙坦治疗4周无效的患者按1:1:1的比例随机分为阿齐沙坦60mg/氨氯地平10mg + 瑞舒伐他汀20mg（FMS/ALD + RSV）作为研究组、阿齐沙坦60mg/氨氯地平10mg（FMS/ALD）作为对照组1、阿齐沙坦60mg + 瑞舒伐他汀20mg（FMS + RSV）作为对照组2。主要疗效终点为从基线到8周时坐位收缩压的变化以及低密度脂蛋白胆固醇（LDL-C）水平的变化率。评估不良事件、药物不良反应、体格检查结果、实验室检查结果、心电图和生命体征以评估研究中的安全性。
结果
138例随机分组的患者中，131例进行了疗效分析，125例完成了研究。作为主要疗效评估指标，FMS/ALD + RSV组在第8周时LDL-C的变化较对照组1显著降低（P < 0.001）。FMS/ALD + RSV组在第8周时坐位收缩压（SiSBP）的变化较FMS + RSV组降低更明显（均P < 0.001）。在安全性评估方面，各治疗组之间药物不良反应的发生率没有差异。
结论
对于对单一使用阿齐沙坦治疗反应不佳的原发性高血压和血脂异常患者，阿齐沙坦/氨氯地平 + 瑞舒伐他汀联合治疗可有效且安全地降低血压并改善血脂水平。
试验注册
NCT03156842，于2017年5月17日注册。
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