Risks associated with statin therapy - A systematic overview of randomized clinical trials
Risks associated with statin therapy - A systematic overview of randomized clinical trials
复制标题
DOI：
10.1161/circulationaha.106.624890
复制
发表时间：
2006-12-19
期刊：
影响因子：
37.8
通讯作者：
Krumholz, Harlan M.
中科院分区：
文献类型：
--
作者：
Kashani, Amir;Phillips, Christopher O.;Krumholz, Harlan M.
背景-尽管他汀类药物降低心血管事件的风险，但对不良反应的担忧可能会阻止医生开这些药物的处方。我们对随机他汀类药物试验进行了系统的概述，以量化与治疗相关的肌肉骨骼、肾脏和肝脏并发症的风险。方法和结果-通过MEDLINE数据库的电子检索确定了1966年至2005年12月期间的主要他汀类药物试验。我们纳入了记录在案的高脂血症成人的英文报告；双盲，随机分配>= 100例患者接受他汀类药物单药治疗与安慰剂；肌痛、肌酸激酶升高、横纹肌溶解、转氨酶升高以及因不良事件而停药的报道。在35项试验的774 102名受试者中（随访1至65个月），他汀类药物治疗（不包括西伐他汀）没有导致肌痛（风险差/1000例[RD]， 2.7; 95% CI, -3.2至8.7）、肌酸激酶升高（RD, 0.2; 95% CI, -0.6至0.9）、纹纹肌溶解（RD, 0.4; 95% CI, -0.1至0.9）或因任何不良事件而停药（RD, -0.5; 95% CI, -4.3至3.3）的绝对风险显著增加。转氨酶升高的绝对风险显著高于他汀类药物治疗（RD, 4.2; 95% CI, 1.5 - 6.9）。结论：根据已发表的临床试验数据，与安慰剂相比，他汀类药物治疗与转氨酶升高的小风险相关，但与肌痛、肌酸激酶升高、横纹肌溶解或停药无关。需要进一步的研究来确定这些已发表的临床试验的结果是否与常规实践中的结果相似，特别是在年龄较大、合并症更严重或接受他汀类药物剂量高于这些临床试验中大多数患者的患者中。
Background - Although statins reduce the risk of cardiovascular events, concerns about adverse effects may deter physicians from prescribing these agents. We performed a systematic overview of randomized statin trials to quantify the risks of musculoskeletal, renal, and hepatic complications associated with therapy.Methods and Results - Major statin trials were identified by electronic search of the MEDLINE database from 1966 to December 2005. We included English language reports of adults with documented hyperlipidemia; double-blind, random allocation of >= 100 patients to statin monotherapy versus placebo; and reports of myalgia, creatine kinase elevations, rhabdomyolysis, transaminase elevations, and discontinuation due to adverse events. Among 74 102 subjects enrolled in 35 trials (follow-up range, 1 to 65 months), statin therapy (excluding cerivastatin) did not result in significant absolute increases in risks of myalgias (risk difference/1000 patients [RD], 2.7; 95% CI, -3.2 to 8.7), creatine kinase elevations (RD, 0.2; 95% CI, -0.6 to 0.9), rhabdomyolysis (RD, 0.4; 95% CI, -0.1 to 0.9), or discontinuation due to any adverse event (RD, -0.5; 95% CI, -4.3 to 3.3). The absolute risk of transaminase elevations was significantly higher with statin therapy (RD, 4.2; 95% CI, 1.5 to 6.9).Conclusions - On the basis of data available from published clinical trials, statin therapy is associated with a small excess risk of transaminase elevations, but not of myalgias, creatine kinase elevations, rhabdomyolysis, or withdrawal of therapy compared with placebo. Further study is necessary to determine whether the results from these published clinical trials are similar to what occurs in routine practice, particularly among patients who are older, have more severe comorbid conditions, or receive higher statin doses than most patients in these clinical trials.