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Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial.

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WOS被引频次:175
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成果类型:
期刊论文
作者:
Huo, Yong;Li, Jianping;Qin, Xianhui;Huang, Yining;Wang, Xiaobin;Gottesman, Rebecca F.;Tang, Genfu;Wang, Binyan;Chen, Dafang;He, Mingli;Fu, Jia;Cai, Yefeng;Shi, Xiuli;Zhang, Yan;Cui, Yimin;Sun, Ningling;Li, Xiaoying;Cheng, Xiaoshu;Wang, Jian'an;Yang, Xinchun;Yang, Tianlun;Xiao, Chuanshi;Zhao, Gang;Dong, Qiang;Zhu, Dingliang;Wang, Xian;Ge, Junbo;Zhao, Lianyou;Hu, Dayi;Liu, Lisheng;Hou, Fan Fan
通讯作者:
Huo, Y
作者机构:
[He, Mingli] First Peoples Hosp, Dept Neurol, Lianyungang, Peoples R China.
[Qin, Xianhui; Wang, Binyan; Hou, Fan Fan] Southern Med Univ, Natl Clin Res Ctr Kidney Dis, State Key Lab Organ Failure Res, Renal Div,Nanfang Hosp, Guangzhou, Guangdong, Peoples R China.
[Qin, Xianhui; Wang, Binyan; Tang, Genfu] Anhui Med Univ, Inst Biomed, Hefei, Peoples R China.
[Xiao, Chuanshi] Shanxi Med Univ, Hosp 1, Dept Cardiol, Taiyuan, Peoples R China.
[Wang, Jian'an] Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Cardiol, Hangzhou 310003, Zhejiang, Peoples R China.
通讯机构:
[Huo, Yong] Peking Univ, Hosp 1, Dept Cardiol, 8 Xishiku St, Beijing 100034, Peoples R China.
语种:
英文
期刊:
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
ISSN:
0098-7484
年:
2015
卷:
313
期:
13
页码:
1325-1335
文献类别:
WOS:Article
所属学科:
ESI学科类别:临床医学;WOS学科类别:Medicine, General & Internal
入藏号:
WOS:000352315900019;PMID:25771069
基金类别:
Shenzhen AUSA Pharmed Co Ltd; National Science and Technology Major Projects Specialized for "Major New Drugs Innovation and Development" during the 12th Five-Year Plan Period: China Stroke Primary Prevention Trial [zx09101105]; Major State Basic Research Development Program of China (973 program) [2012 CB517703]; Clinical Center [zx09401013]; National Natural Science Foundation of China [81473052, 81441091, 81402735]; National Clinical Research Center for Kidney Disease, Nanfang Hospital, Nanfang Medical University, Guangzhou, China; State Key Laboratory for Organ Failure Research, Nanfang Hospital, Nanfang Medical University, Guangzhou, China; Department of Development and Reform, Shenzhen Municipal Government [SFG 20201744]
机构署名:
本校为其他机构
院系归属:
湘雅医院(第一临床学院)
摘要:
IMPORTANCE: Uncertainty remains about the efficacy of folic acid therapy for the primary prevention of stroke because of limited and inconsistent data. OBJECTIVE: To test the primary hypothesis that therapy with enalapril and folic acid is more effective in reducing first stroke than enalapril alone among Chinese adults with hypertension. DESIGN, SETTING, AND PARTICIPANTS: The China Stroke Primary Prevention Trial, a randomized, double-blind clinical trial conducted from May 19, 2008, to August 24, 2013, in 32 communities in Jiangsu and Anhui provinces in China. A total of 20,702 adults with hypertension without history of stroke or myocardial infarction (MI) participated in the study. INTERVENTIONS: Eligible participants, stratified by MTHFR C677T genotypes (CC, CT, and TT), were randomly assigned to receive double-blind daily treatment with a single-pill combination containing enalapril, 10 mg, and folic acid, 0.8 mg (n = 10,348) or a tablet containing enalapril, 10 mg, alone (n = 10,354). MAIN OUTCOMES AND MEASURES: The primary outcome was first stroke. Secondary outcomes included first ischemic stroke; first hemorrhagic stroke; MI; a composite of cardiovascular events consisting of cardiovascular death, MI, and stroke; and all-cause death. RESULTS: During a median treatment duration of 4.5 years, compared with the enalapril alone group, the enalapril-folic acid group had a significant risk reduction in first stroke (2.7% of participants in the enalapril-folic acid group vs 3.4% in the enalapril alone group; hazard ratio [HR], 0.79; 95% CI, 0.68-0.93), first ischemic stroke (2.2% with enalapril-folic acid vs 2.8% with enalapril alone; HR, 0.76; 95% CI, 0.64-0.91), and composite cardiovascular events consisting of cardiovascular death, MI, and stroke (3.1% with enalapril-folic acid vs 3.9% with enalapril alone; HR, 0.80; 95% CI, 0.69-0.92). The risks of hemorrhagic stroke (HR, 0.93; 95% CI, 0.65-1.34), MI (HR, 1.04; 95% CI, 0.60-1.82), and all-cause deaths (HR, 0.94; 95% CI, 0.81-1.10) did not differ significantly between the 2 treatment groups. There were no significant differences between the 2 treatment groups in the frequencies of adverse events. CONCLUSIONS AND RELEVANCE: Among adults with hypertension in China without a history of stroke or MI, the combined use of enalapril and folic acid, compared with enalapril alone, significantly reduced the risk of first stroke. These findings are consistent with benefits from folate use among adults with hypertension and low baseline folate levels. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00794885.
参考文献:
Albert CM, 2008, JAMA-J AM MED ASSOC, V299, P2027, DOI 10.1001/jama.299.17.2027
Meschia JF, 2014, STROKE, V45, P3754, DOI 10.1161/STR.0000000000000046
Lonn E, 2006, NEW ENGL J MED, V354, P1567
Wilcken B, 2003, J MED GENET, V40, P619, DOI 10.1136/jmg.40.8.619
Lloyd-Jones D, 2010, CIRCULATION, V121, pE46, DOI 10.1161/CIRCULATIONAHA.109.192667

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