期刊
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
卷 313, 期 13, 页码 1325-1335出版社
AMER MEDICAL ASSOC
DOI: 10.1001/jama.2015.2274
关键词
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资金
- 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]
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% Cl, 0.68-0.93), first ischemic stroke (2.2% with enalapril-folic acid vs 2.8% with enalapril alone; HR, 0.76; 95% Cl, 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% Cl, 0.69-0.92). The risks of hemorrhagic stroke (HR, 0.93; 95% Cl, 0.65-1.34), MI (HR, 1.04; 95% Cl, 0.60-1.82), and all-cause deaths (HR, 0.94; 95% Cl, 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.
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