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
Abstract 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...
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Language: | English |
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Wiley
2023-08-01
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Series: | The Journal of Clinical Hypertension |
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Online Access: | https://doi.org/10.1111/jch.14697 |
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author | Huihui Bao Xiao Huang Ping Li Changsheng 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 Jiguang Wang |
author_facet | Huihui Bao Xiao Huang Ping Li Changsheng 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 Jiguang Wang |
author_sort | Huihui Bao |
collection | DOAJ |
description | Abstract 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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issn | 1524-6175 1751-7176 |
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spelling | doaj.art-27d774c3577547febcb1c65e94d267b22023-10-30T13:25:57ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762023-08-0125868969910.1111/jch.14697Combined 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 trialHuihui Bao0Xiao Huang1Ping Li2Changsheng Sheng3Jin Zhang4Zhirong Wang5Demin Song6Lihua Hu7Congcong Ding8Zaihua Cheng9Chen Yao10Guangliang Chen11Yimin Cui12Xianhui Qin13Genfu Tang14Xiaobin Wang15Yong Huo16Xiaoshu Cheng17Jiguang Wang18Department of Cardiology The Second Affiliated Hospital of Nanchang University NanchangChinaDepartment of Cardiology The Second Affiliated Hospital of Nanchang University NanchangChinaDepartment of Cardiology The Second Affiliated Hospital of Nanchang University NanchangChinaThe Shanghai Institute of Hypertension Ruijin Hospital Shanghai Jiaotong University School of Medicine ShanghaiChinaThe Shanghai Institute of Hypertension Ruijin Hospital Shanghai Jiaotong University School of Medicine ShanghaiChinaAffiliated Hospital of Xuzhou Medical College XuzhouChinaAnqing Municipal Hospital AnqingChinaDepartment of Cardiology The Second Affiliated Hospital of Nanchang University NanchangChinaDepartment of Cardiology The Second Affiliated Hospital of Nanchang University NanchangChinaDepartment of Cardiology The Second Affiliated Hospital of Nanchang University NanchangChinaPeking University Clinical Research Institute Peking University Health Science Center BeijingChinaCollege of Integrated Chinese and Western Medicine Anhui University of Chinese Medicine HefeiChinaDepartment of Pharmacy Peking University First Hospital BeijingChinaNational Clinical Research Study Center for Kidney Disease the State Key Laboratory for Organ Failure Research Renal Division Nanfang Hospital Southern Medical University GuangzhouChinaSchool of Health Administration Anhui Medical University HefeiChinaDepartment of Population Family and Reproductive Health Johns Hopkins University Bloomberg School of Public Health BaltimoreMarylandUSADepartment of Cardiology Peking University First Hospital BeijingChinaDepartment of Cardiology The Second Affiliated Hospital of Nanchang University NanchangChinaThe Shanghai Institute of Hypertension Ruijin Hospital Shanghai Jiaotong University School of Medicine ShanghaiChinaAbstract 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.https://doi.org/10.1111/jch.14697amlodipine‐folic acidblood pressurehypertension with hyperhomocysteinemiarandomized clinical trialtotal homocysteine |
spellingShingle | Huihui Bao Xiao Huang Ping Li Changsheng 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 Jiguang Wang 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 The Journal of Clinical Hypertension amlodipine‐folic acid blood pressure hypertension with hyperhomocysteinemia randomized clinical trial total homocysteine |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | amlodipine‐folic acid blood pressure hypertension with hyperhomocysteinemia randomized clinical trial total homocysteine |
url | https://doi.org/10.1111/jch.14697 |
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