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

Author:

Bao Huihui1,Huang Xiao1ORCID,Li Ping1,Sheng Changsheng2ORCID,Zhang Jin2,Wang Zhirong3,Song Demin4,Hu Lihua1,Ding Congcong1,Cheng Zaihua1,Yao Chen5,Chen Guangliang6,Cui Yimin7,Qin Xianhui8ORCID,Tang Genfu9,Wang Xiaobin10,Huo Yong11ORCID,Cheng Xiaoshu1,Wang Jiguang2

Affiliation:

1. Department of Cardiology The Second Affiliated Hospital of Nanchang University Nanchang China

2. The Shanghai Institute of Hypertension Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai China

3. Affiliated Hospital of Xuzhou Medical College Xuzhou China

4. Anqing Municipal Hospital Anqing China

5. Peking University Clinical Research Institute Peking University Health Science Center Beijing China

6. College of Integrated Chinese and Western Medicine Anhui University of Chinese Medicine Hefei China

7. Department of Pharmacy Peking University First Hospital Beijing China

8. National Clinical Research Study Center for Kidney Disease the State Key Laboratory for Organ Failure Research Renal Division Nanfang Hospital Southern Medical University Guangzhou China

9. School of Health Administration Anhui Medical University Hefei China

10. Department of Population Family and Reproductive Health Johns Hopkins University Bloomberg School of Public Health Baltimore Maryland USA

11. Department of Cardiology Peking University First Hospital Beijing China

Abstract

AbstractHyperhomocysteinemia 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.

Funder

National Basic Research Program of China

National Natural Science Foundation of China

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine,Endocrinology, Diabetes and Metabolism,Internal Medicine

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