Post Hoc Analyses of Randomized Clinical Trial for the Effect of Clopidogrel Added to Aspirin on Kidney Function.
Post Hoc Analyses of Randomized Clinical Trial for the Effect of Clopidogrel Added to Aspirin on Kidney Function.
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DOI：
10.2215/cjn.00100117
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发表时间：
2017-07
期刊：
影响因子：
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通讯作者：
Jesse C. Ikeme;P. Pergola;R. Scherzer;M. Shlipak;O. Benavente;C. Peralta
中科院分区：
文献类型：
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作者：
Jesse C. Ikeme;P. Pergola;R. Scherzer;M. Shlipak;O. Benavente;C. Peralta
背景和目的尽管慢性肾脏病的负担很大，但几乎没有可以阻止疾病进展的特效疗法。在动物模型中，氯吡格雷已成为一种保护肾功能的潜在疗法。氯吡格雷对人类肾功能的影响尚未确定。设计、设置、参与者和测量皮质下小卒中的二级预防研究随机选择有腔隙性中风病史的参与者接受阿司匹林或阿司匹林加氯吡格雷治疗。我们分别使用广义估计方程和区间删失比例风险回归方法比较了年度EGFR值下降和EGFR值快速下降(≥较基线下降30%)的发生率。我们还根据基线EGFR、收缩压目标和随机后时间对我们的分析进行了分层。结果在随机分组中，中位年龄为62岁(四分位数范围，55-71岁)，36%有糖尿病病史，90%有高血压，EGFR中位数为81(四分位数范围，65-94)ml/min/1m2。服用阿司匹林和氯吡格雷的患者肾功能的年平均变化为-1.39(95%可信区间，-1.15至-1.62)毫升/分钟每1.73平方米/年，而只服用阿司匹林的患者肾功能年变化为-1.52(95%可信区间，-1.30至-1.74)毫升/分钟(P=0.42)。服用氯吡格雷加阿司匹林的受试者中有21%的人肾功能迅速下降，而服用阿司匹林加安慰剂的受试者中这一比例为22%(风险比为0.94；95%可信区间为0.79至1.10；P=0.42)。研究结果不受基线EGFR、随机化后时间或收缩压目标的影响(交互作用的所有P值均为0.3)。结论与单用阿司匹林相比，氯吡格雷与阿司匹林联用对既往腔隙性卒中患者肾功能下降无影响。
BACKGROUND AND OBJECTIVES Despite the high burden of CKD, few specific therapies are available that can halt disease progression. In animal models, clopidogrel has emerged as a potential therapy to preserve kidney function. The effect of clopidogrel on kidney function in humans has not been established. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS The Secondary Prevention of Small Subcortical Strokes Study randomized participants with prior lacunar stroke to treatment with aspirin or aspirin plus clopidogrel. We compared annual eGFR decline and incidence of rapid eGFR decline (≥30% from baseline) using generalized estimating equations and interval-censored proportional hazards regression, respectively. We also stratified our analyses by baseline eGFR, systolic BP target, and time after randomization. RESULTS At randomization, median age was 62 (interquartile range, 55-71) years old; 36% had a history of diabetes, 90% had hypertension, and the median eGFR was 81 (interquartile range, 65-94) ml/min per 1 m2. Persons receiving aspirin plus clopidogrel had an average annual change in kidney function of -1.39 (95% confidence interval, -1.15 to -1.62) ml/min per 1.73 m2 per year compared with -1.52 (95% confidence interval, -1.30 to -1.74) ml/min per 1.73 m2 per year among persons receiving aspirin only (P=0.42). Rapid kidney function decline occurred in 21% of participants receiving clopidogrel plus aspirin compared with 22% of participants receiving aspirin plus placebo (hazard ratio, 0.94; 95% confidence interval, 0.79 to 1.10; P=0.42). Findings did not vary by baseline eGFR, time after randomization, or systolic BP target (all P values for interaction were >0.3). CONCLUSIONS We found no effect of clopidogrel added to aspirin compared with aspirin alone on kidney function decline among persons with prior lacunar stroke.