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...

Full description

Bibliographic Details
Main Authors: 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
Format: Article
Language:English
Published: Wiley 2023-08-01
Series:The Journal of Clinical Hypertension
Subjects:
Online Access:https://doi.org/10.1111/jch.14697
_version_ 1797645213288628224
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.
first_indexed 2024-03-11T14:43:06Z
format Article
id doaj.art-27d774c3577547febcb1c65e94d267b2
institution Directory Open Access Journal
issn 1524-6175
1751-7176
language English
last_indexed 2024-03-11T14:43:06Z
publishDate 2023-08-01
publisher Wiley
record_format Article
series The Journal of Clinical Hypertension
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
work_keys_str_mv AT huihuibao combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT xiaohuang combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT pingli combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT changshengsheng combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT jinzhang combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT zhirongwang combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT deminsong combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT lihuahu combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT congcongding combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT zaihuacheng combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT chenyao combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT guangliangchen combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT yimincui combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT xianhuiqin combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT genfutang combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT xiaobinwang combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT yonghuo combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT xiaoshucheng combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic
AT jiguangwang combineduseofamlodipineandfolicacidaresignificantlymoreefficaciousthanamlodipinealoneinloweringplasmahomocysteineandbloodpressureamonghypertensivepatientswithhyperhomocysteinemiaandintolerancetoaceiamulticenterrandomizeddoubleblindparallelcontrolledclinic