他汀类药物与肾脏相关严重不良事件的风险：来自 IDEAL、TNT、CARDS、ASPEN、SPARCL 及其他安慰剂对照试验的分析。
Statin and the risk of renal-related serious adverse events: Analysis from the IDEAL, TNT, CARDS, ASPEN, SPARCL, and other placebo-controlled trials.
机构信息
Division of Cardiology, New York University School of Medicine, New York, New York.
Pfizer, New York, New York.
出版信息
Am J Cardiol. 2014 Jun 15;113(12):2018-20. doi: 10.1016/j.amjcard.2014.03.046. Epub 2014 Apr 3.
A recent study has shown an association between high-potency statins and risk of acute kidney injury. However, these data are from observational studies, and it is not clear if similar signal is seen from randomized controlled trials. We evaluated the risk of renal-associated serious adverse events (SAEs) using statins versus placebo trials and the high-dose versus low-dose statin trials that were available to us. The outcome of interest was renal-related SAEs. The incidence of adverse events relating to kidney injury was determined through review of the adverse event database. The following outcomes were evaluated: (1) renal-related SAEs within 120 days of randomization (primary outcome), (2) renal-related SAEs after 120 days of randomization (secondary), and (3) drug discontinuation due to renal-related SAEs (secondary). There was no difference in the incidence of renal-related SAEs at 120 days (0.04% vs 0.10%, p = 0.162) between atorvastatin and placebo in the 24 placebo-controlled trials (10,345 patients on atorvastatin (10 to 80 mg/day) versus 8,945 patients on placebo) or in the high-dose versus low-dose statin trials including the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) study (0.05% vs 0.02%, p = 0.625) or the Treating to New Targets (TNT) trial (0.0% vs 0.04%, p = 0.500) trial. Results were similar for renal-related SAEs after 120 days (placebo controlled trials [0.38% vs 0.36%, p = 0.905], IDEAL trial [0.56% vs 0.65%, p = 0.683], or the TNT trial [0.76% vs 1.04%, p = 0.168]) and for drug withdrawal due to renal-related SAE (placebo controlled trials [0.05% vs 0.04%, p = 1.00], IDEAL trial [0.02% vs 0.0%, p = 0.499], or the TNT trial [0.08% vs 0.12%, p = 0.754]). In conclusion, the results from clinical trials with data from 149,882 patient-years of follow-up fail to show any increase in renal-related SAEs with statins compared with controls.
最近的一项研究表明，强效他汀类药物与急性肾损伤的风险之间存在关联。然而，这些数据来自观察性研究，尚不清楚随机对照试验是否也存在类似的信号。我们评估了可用的他汀类药物与安慰剂试验以及高剂量与低剂量他汀类药物试验中与肾脏相关的严重不良事件（SAE）的风险。感兴趣的结局是与肾脏相关的 SAE。通过审查不良事件数据库来确定与肾脏损伤相关的不良事件的发生率。评估了以下结局：（1）随机分组后 120 天内的与肾脏相关的 SAE（主要结局），（2）随机分组后 120 天以上的与肾脏相关的 SAE（次要结局），以及（3）因与肾脏相关的 SAE 而停药（次要结局）。在 24 项安慰剂对照试验（阿托伐他汀治疗组 10345 例（10 至 80mg/天），安慰剂组 8945 例）中，阿托伐他汀与安慰剂相比，在 120 天时（0.04%比 0.10%，p=0.162）或在高剂量与低剂量他汀类药物试验（包括递增降低终点的降脂治疗研究（IDEAL）和强化降脂治疗达到新目标研究（TNT））中，与肾脏相关的 SAE 发生率无差异（0.05%比 0.02%，p=0.625）。在 120 天后，与肾脏相关的 SAE 的结果也相似（安慰剂对照试验组[0.38%比 0.36%，p=0.905]，IDEAL 试验组[0.56%比 0.65%，p=0.683]，或 TNT 试验组[0.76%比 1.04%，p=0.168]）以及因与肾脏相关的 SAE 而停药（安慰剂对照试验组[0.05%比 0.04%，p=1.00]，IDEAL 试验组[0.02%比 0.0%，p=0.499]，或 TNT 试验组[0.08%比 0.12%，p=0.754]）。总之，来自 149882 患者年随访数据的临床试验结果并未显示他汀类药物与对照组相比，与肾脏相关的 SAE 发生率增加。
Zotero 插件