Combined use of amlodipine and folic acid are significantly more efficacious than amlodipine alone in lowering plasma homocysteine and blood pressure among hypertensive patients with hyperhomocysteinemia and intolerance to ACEI: A multicenter, randomized, double‐blind, parallel‐controlled clinical trial

氨氯地平 医学 高同型半胱氨酸血症 血压 内科学 同型半胱氨酸 随机对照试验 冲程(发动机) 优势比 胃肠病学 机械工程 工程类
作者
Huihui Bao,Xiao Huang,Ping Li,Chang‐Sheng Sheng,Jin Zhang,Zhirong Wang,Demin Song,Lihua Hu,Congcong Ding,Zaihua Cheng,Chen Yao,Guangliang Chen,Yimin Cui,Xianhui Qin,Genfu Tang,Xiaobin Wang,Yong Huo,Xiaoshu Cheng,Ji-Guang Wang
出处
期刊:Journal of Clinical Hypertension [Wiley]
卷期号:25 (8): 689-699 被引量:5
标识
DOI:10.1111/jch.14697
摘要

Hyperhomocysteinemia with hypertension can synergistically increase the risk of stroke. The China stroke primary prevention trial showed that combining 0.8 mg folic acid (FA) with angiotensin-converting enzyme inhibitor (ACEI) can effectively lower plasma total homocysteine (tHcy) and blood pressure (BP); and reduce first stroke risk by additional 21% compared to ACEI alone. However, intolerance to ACEI is common in Asians and amlodipine can be alternative. This is a multicenter, randomized, double-blind, parallel-controlled clinical trial (RCT) which evaluated whether amlodipine combined with FA is more efficacious than amlodipine alone in lowering tHcy and BP among Chinese hypertensive with hyperhomocysteinemia and intolerance to ACEI. 351 Eligible patients were randomly assigned by 1:1:1 ratio to receive amlodipine-FA tablet daily (amlodipine 5 mg/FA 0.4 mg, A group); amlodipine 5 mg/FA 0.8 mg tablet daily (B group); amlodipine 5 mg daily (C group, control group). Follow-up was conducted at 2, 4, 6, and 8 weeks. The primary outcome was efficacy of lowering both tHcy and BP at the end of 8-week treatment. Compared with C group, A group had a significantly higher rate of lowering both tHcy and BP (23.3% vs. 6.0%; Odds Ratio [OR], 8.68; 95% CI, 3.04-24.78, P < .001); B group also had a higher rate of lowering both tHcy and BP (20.3% vs. 6.0%; OR: 5.90; 95% CI, 2.11-16.47, P < .001). This RCT showed amlodipine combined with FA compared with amlodipine alone, each had significantly higher efficacy of lowering both tHcy and BP. No difference was found in BP-lowering and occurrence of adverse events between the three groups.
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