在使用苯磺酸氨氯地平单药治疗血压控制不佳的高血压患者中，两种固定剂量的苯磺酸氨氯地平与替米沙坦复方制剂（CKD-828）对比苯磺酸氨氯地平单药治疗的疗效和安全性：一项为期8周的多中心、随机、双盲、III期临床研究。
Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan (CKD-828) versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy: an 8-week, multicenter, randomized, double-blind, Phase III clinical study.
作者信息
Ihm Sang-Hyun, Jeon Hui-Kyung, Cha Tae-Joon, Hong Taek-Jong, Kim Sang-Hyun, Lee Nae-Hee, Yoon Jung Han, Yoon Namsik, Hwang Kyung-Kuk, Jo Sang-Ho, Youn Ho-Joong
机构信息
Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Seoul.
Division of Cardiology, Department of Internal Medicine, Kosin University College of Medicine.
出版信息
Drug Des Devel Ther. 2016 Nov 23;10:3817-3826. doi: 10.2147/DDDT.S116847. eCollection 2016.
PURPOSE
To evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy.
PATIENTS AND METHODS
Eligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ≥90 mmHg) to receive CKD-828 2.5/40 mg (n=63), CKD-828 2.5/80 mg (n=63), or S-amlodipine 2.5 mg (n=61) for 8 weeks. The primary efficacy endpoint, mean sitDBP change from baseline to Week 8, was compared between the combination (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) and S-amlodipine monotherapy groups. The safety was assessed based on adverse events, vital signs, and physical examination findings.
RESULTS
After the 8-week treatment, changes in sitDBP/systolic BP (SBP) were -9.67±6.50/-12.89±11.78, -10.72±6.19/-13.79±9.41, and -4.93±7.26/-4.55±11.27 mmHg in the CKD-828 2.5/40 mg (<0.0001/<0.0001), CKD-828 2.5/80 mg (<0.0001/<0.0001), and S-amlodipine 2.5 mg (<0.0001/=0.0027) groups, respectively, which were all significant BP reductions. At Week 8, the CKD-828 2.5/40 mg (sitDBP/SBP: =0.0002/<0.0001) and CKD-828 2.5/80 mg (sitDBP/SBP: =0.0001/<0.0001) showed superior BP-lowering effects to S-amlodipine 2.5 mg (<0.001). At Week 4, all groups showed significant antihypertensive effects but both CKD-828 combinations (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) exhibited superior BP-lowering effects to that of S-amlodipine 2.5 mg (sitDBP/SBP: =0.0028/=0.0001 and <0.0001/=0.0012, respectively). The adverse event incidence was significantly lower in the CKD-828 2.5/40 mg (9.52%, =0.0086) than in the S-amlodipine 2.5 mg group (27.87%) and increasing the telmisartan dose induced no unexpected adverse events, suggesting the safety of CKD-828.
CONCLUSION
CKD-828 is an effective and safe option for patients with inadequate responses to S-amlodipine monotherapy.
目的
评估CKD - 828（一种由S - 氨氯地平（苯磺酸氨氯地平的活性更强的异构体，为钙通道阻滞剂）和替米沙坦（长效血管紧张素受体阻滞剂）组成的固定剂量复方制剂）对接受氨氯地平单药治疗血压控制不佳的高血压患者的降压疗效及安全性。
患者与方法
符合条件的患者（N = 187）在接受4周2.5 mg氨氯地平单药治疗后无反应（坐位舒张压[sitDBP]≥90 mmHg），随后接受CKD - 828 2.5/40 mg（n = 63）、CKD - 828 2.5/80 mg（n = 63）或氨氯地平2.5 mg（n = 61）治疗8周。比较联合治疗组（CKD - 828 2.5/40 mg和CKD - 828 2.5/80 mg）与氨氯地平单药治疗组从基线到第8周的主要疗效终点，即坐位舒张压的平均变化。根据不良事件、生命体征及体格检查结果评估安全性。
结果
治疗8周后，CKD - 828 2.5/40 mg组（<0.0001/<0.0001）、CKD - 828 2.5/80 mg组（<0.0001/<0.0001）和氨氯地平2.5 mg组（<0.0001/=0.0027）的坐位舒张压/收缩压（SBP）变化分别为 - 9.67±6.50/-12.89±11.78、 - 10.72±6.19/-13.79±9.41和 - 4.93±7.26/-4.55±11.27 mmHg，血压均显著降低。在第8周时，CKD - 828 2.5/40 mg组（坐位舒张压/收缩压：=0.0002/<0.0001）和CKD - 828 2.5/80 mg组（坐位舒张压/收缩压：=0.0001/<0.0001）的降压效果优于氨氯地平2.5 mg组（<0.001）。在第4周时，所有组均显示出显著的降压效果，但两种CKD - 828复方制剂（CKD - 828 2.5/40 mg和CKD - 828 2.5/80 mg）的降压效果均优于氨氯地平2.5 mg组（坐位舒张压/收缩压：分别为=0.0028/=0.0001和<0.0001/=0.0012）。CKD - 828 2.5/40 mg组的不良事件发生率（9.52%，=0.0086）显著低于氨氯地平2.5 mg组（27.87%），且增加替米沙坦剂量未引发意外不良事件，表明CKD - 828具有安全性。
结论
对于氨氯地平单药治疗反应不佳的患者，CKD - 828是一种有效且安全的选择。
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