Effects of Folic Acid Therapy on the New-Onset Proteinuria in Chinese Hypertensive Patients A Post Hoc Analysis of the Renal Substudy of CSPPT (China Stroke Primary Prevention Trial)
Effects of Folic Acid Therapy on the New-Onset Proteinuria in Chinese Hypertensive Patients A Post Hoc Analysis of the Renal Substudy of CSPPT (China Stroke Primary Prevention Trial)
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叶酸治疗对中国高血压患者新发蛋白尿的影响CSPPT（中国脑卒中一级预防试验）肾脏亚组研究的事后分析
DOI：
10.1161/hypertensionaha.117.09404
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发表时间：
2017
期刊：
影响因子：
8.3
通讯作者：
Qin Xianhui
中科院分区：
文献类型：
--
作者：
Li Youbao;Liang Min;Wang Guobao;Wang Binyan;He Mingli;Tang Genfu;Yin Delu;Xu Xin;Huo Yong;Cui Yimin;Hou Fan Fan;Qin Xianhui
我们的目的是验证在高血压患者中，依那普利和叶酸联合治疗比单用依那普利更有效地预防新发蛋白尿的假设。这是一项CSPPT（中国卒中一级预防试验）肾脏亚研究的事后分析。共有13071名无蛋白尿的符合条件的参与者随机接受双盲治疗，每日服用含有10mg依那普利和0.8 mg叶酸的单片（n=6511）或单独服用10mg依那普利（n=6560）。主要终点为新发蛋白尿，定义为出院时尿试纸读数≥1+。次要结局包括主要结局、全因死亡和肾小球滤过率估计年下降率的综合。在平均4.4年的治疗后，依那普利组和依那普利-叶酸组的主要事件分别发生在213名（3.9%）和188名（3.5%）参与者中（优势比为0.90；95%可信区间为0.74-1.11）。然而，在基线时患有糖尿病的参与者中，叶酸治疗导致原发性事件（依那普利-叶酸组为3.7%，依那普利组为7.4%；优势比为0.48；95%可信区间为0.29-0.81）和复合事件（优势比为0.62；95%可信区间为0.42-0.92）的风险显著降低，估计肾小球滤过率的年下降速度减慢55%（0.5%对1.1% /年；P=0.002）。在基线时无糖尿病的患者中，所有结果在组间无差异。综上所述，与单用依那普利相比，依那普利-叶酸治疗可显著降低糖尿病合并高血压患者蛋白尿的发生。临床试验注册网址：http://www.ClinicalTrials.gov。唯一标识符：NCT00794885。
We aimed to test the hypothesis that treatment with enalapril and folic acid is more effective in preventing new-onset proteinuria than enalapril alone among hypertensive patients. This is a post hoc analysis of the renal substudy of the CSPPT (China Stroke Primary Prevention Trial). A total of 13 071 eligible participants without proteinuria were randomized to receive a double-blind daily treatment of a single tablet containing 10-mg enalapril and 0.8-mg folic acid (n=6511) or 10-mg enalapril alone (n=6560). The primary outcome was new-onset proteinuria, defined as a urine dipstick reading of ≥1+ at the exit visit. Secondary outcomes included a composite of the primary outcome and all-cause death and the annual rate of estimated glomerular filtration rate decline. After a median 4.4 years of treatment, the primary event occurred in 213 (3.9%) and 188 (3.5%) participants, respectively, in the enalapril and the enalapril–folic acid group (odds ratio, 0.90; 95% confidence interval, 0.74–1.11). However, among participants with diabetes mellitus at baseline, folic acid therapy resulted in a significant reduction in the risk for the primary event (3.7% in the enalapril–folic acid group versus 7.4% in the enalapril group; odds ratio, 0.48; 95% confidence interval, 0.29–0.81) and the composite event (odds ratio, 0.62; 95% confidence interval, 0.42–0.92) and a 55% slower annual rate of estimated glomerular filtration rate decline (0.5% versus 1.1% per year;P=0.002). Among those without diabetes mellitus at baseline, there were no between-group differences in all the outcomes. In conclusion, enalapril–folic acid therapy, compared with enalapril alone, significantly reduced the development of proteinuria in diabetic patients with hypertension.Clinical Trial RegistrationURL: http://www.ClinicalTrials.gov. Unique identifier: NCT00794885.