A Randomized Controlled Trial on the Efficacy and Safety of a Calcium-Channel Blocker and an Angiotensin-Converting Enzyme Inhibitor in Chinese and European Patients with Hypertension.

IF 3.2 3区医学 Q2 PERIPHERAL VASCULAR DISEASE American Journal of Hypertension Pub Date : 2025-03-17 DOI:10.1093/ajh/hpae152

Wei Zhang, Chang-Yuan Liu, Grzegorz Bilo, Davide Soranna, Antonella Zambon, Konstantinos G Kyriakoulis, Anastasios Kollias, Isabella Ceravolo, Silvia Cassago, Martino F Pengo, Antonios Destounis, George S Stergiou, Ji-Guang Wang, Gianfranco Parati

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Abstract

Background: In a post hoc analysis of a multinational, randomized trial, we investigated whether the efficacy and safety of nifedipine-gastrointestinal therapeutic system (GITS) and ramipril differed between Chinese and European patients with hypertension.

Methods: Previously treated (after 2-week washout) and untreated patients with clinic blood pressure (BP) ≥ 140/90 mmHg (systolic/diastolic), daytime ambulatory BP ≥ 135/85 mmHg and standard deviation of home systolic BP > 7 mmHg, and/or daytime BP > 12 mmHg were randomly assigned to treatment based on nifedipine-GITS 30 mg or ramipril 10 mg for 12 months. Clinic, ambulatory and home BP were measured at baseline, 10 weeks and 12 months after randomization.

Results: A total of 67 Chinese and 101 European patients were analyzed and they differed in age (50.9 vs. 54.6 years, respectively), body mass index (24.5 vs. 27.0 kg/m2), clinic diastolic BP (87.9 vs. 92.5 mmHg), heart rate (75.0 vs. 70.8 beats/minute), and nighttime diastolic BP (79.3 vs. 75.9 mmHg) (all P < 0.05). However, within each ethnicity, patients were comparable for clinical characteristics between the nifedipine-GITS and ramipril groups (P > 0.05). In both the Chinese and European patients, BP was similarly reduced with nifedipine-GITS and ramipril, except that daytime systolic/diastolic BP reductions were 7.4/4.1 mmHg greater in the ramipril than nifedipine-GITS group in Chinese (P = 0.02). The safety profile differed between the Chinese and European patients (P for drug*ethnicity interaction ≤ 0.05) for all adverse events (lower incidence on nifedipine-GITS in Chinese), ankle edema (higher on nifedipine-GITS in Europeans), and dry cough (higher on ramipril in Chinese).

Conclusion: In the Chinese and European patients with hypertension, nifedipine-GITS and ramipril had similar BP lowering efficacy, but different safety profile and tolerability.

Clinical trials registration: Identifier at clinicaltrials.gov NCT02499822 (Registration date: 16 July 2015).

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钙通道阻滞剂和血管紧张素转换酶抑制剂在中国和欧洲高血压患者中的有效性和安全性的随机对照试验。

背景：在一项多国随机试验的事后分析中，我们调查了硝苯地平胃肠道治疗系统（GITS）和雷米普利在中国和欧洲高血压患者中的疗效和安全性是否存在差异。方法：既往治疗（2周洗脱期后）和未治疗的临床血压(BP)≥140/90 mmHg（收缩压/舒张压），日间动态血压≥135/85 mmHg，家庭收缩压标准偏差bbb7 mmHg和/或日间血压>2 mmHg的患者随机分配到硝苯地平GITS 30 mg或雷米普利10 mg治疗12个月。在随机分组后的基线、10周和12个月分别测量临床、动态和家庭血压。结果：共分析67例中国患者和101例欧洲患者，年龄（50.9岁vs 54.6岁）、体重指数（24.5 vs 27.0 kg/m2）、临床舒张压（87.9 vs 92.5 mmHg）、心率（75.0 vs 70.8次/分钟）和夜间舒张压（79.3 vs 75.9 mmHg）存在差异（均P0.05）。在中国和欧洲患者中，硝苯地平GITS和雷米普利的降压效果相似，但雷米普利组的白天收缩压/舒张压降压比硝苯地平GITS组的中国患者高7.4/4.1 mmHg （P=0.02）。在所有不良事件（中国人硝苯地平组发生率较低）、踝关节水肿（欧洲人硝苯地平组发生率较高）和干咳（中国人雷米普利组发生率较高）的安全性方面，中国和欧洲患者存在差异（药物*种族相互作用P≤0.05）。结论：在中国和欧洲高血压患者中，硝苯地平GITS与雷米普利降压效果相似，但安全性和耐受性不同。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American Journal of Hypertension 医学-外周血管病

CiteScore

6.90

自引率

6.20%

发文量

144

审稿时长

3-8 weeks

期刊介绍： The American Journal of Hypertension is a monthly, peer-reviewed journal that provides a forum for scientific inquiry of the highest standards in the field of hypertension and related cardiovascular disease. The journal publishes high-quality original research and review articles on basic sciences, molecular biology, clinical and experimental hypertension, cardiology, epidemiology, pediatric hypertension, endocrinology, neurophysiology, and nephrology.