Faculty of Health Sciences, University of Ottawa, Ottawa, Canada.
QJM. 2011 Feb;104(2):109-24. doi: 10.1093/qjmed/hcq165. Epub 2010 Oct 7.
Statins represent the largest selling class of cardiovascular drug in the world. Previous randomized trials (RCTs) have demonstrated important clinical benefits with statin therapy.
We combined evidence from all RCTs comparing a statin with placebo or usual care among patients with and without prior coronary heart disease (CHD) to determine clinical outcomes.
We searched independently, in duplicate, 12 electronic databases (from inception to August 2010), including full text journal content databases, to identify all statin versus inert control RCTs. We included RCTs of any statin versus any non-drug control in any populations. We abstracted data in duplicate on reported major clinical events and adverse events. We performed a random-effects meta-analysis and meta-regression. We performed a mixed treatment comparison using Bayesian methods.
We included a total of 76 RCTs involving 170,255 participants. There were a total of 14,878 deaths. Statin therapy reduced all-cause mortality, Relative Risk (RR) 0.90 [95% confidence interval (CI) 0.86-0.94, P ≤ 0.0001, I(2)=17%]; cardiovascular disease (CVD) mortality (RR 0.80, 95% CI 0.74-0.87, P<0.0001, I(2)=27%); fatal myocardial infarction (MI) (RR 0.82, 95% CI 0.75-0.91, P<0.0001, I(2)=21%); non-fatal MI (RR 0.74, 95% CI 0.67-0.81, P ≤ 0.001, I(2)=45%); revascularization (RR 0.76, 95% CI 0.70-0.81, P ≤ 0.0001); and a composite of fatal and non-fatal strokes (0.86, 95% CI 0.78-0.95, P=0.004, I(2)=41%). Adverse events were generally mild, but 17 RCTs reported on increased risk of development of incident diabetes [Odds Ratio (OR) 1.09; 95% CI 1.02-1.17, P=0.001, I(2)=11%]. Studies did not yield important differences across populations. We did not find any differing treatment effects between statins.
Statin therapies offer clear benefits across broad populations. As generic formulations become more available efforts to expand access should be a priority.
他汀类药物是世界上销量最大的心血管药物。以前的随机对照试验（RCT）已经证明了他汀类药物治疗的重要临床益处。
我们综合了所有在有或没有既往冠心病（CHD）的患者中比较他汀类药物与安慰剂或常规治疗的 RCT 的证据，以确定临床结局。
我们独立地、重复地搜索了 12 个电子数据库（从成立到 2010 年 8 月），包括全文期刊内容数据库，以确定所有他汀类药物与惰性对照的 RCT。我们纳入了任何他汀类药物与任何人群中的非药物对照的 RCT。我们重复提取报告的主要临床事件和不良事件的数据。我们进行了随机效应荟萃分析和荟萃回归。我们使用贝叶斯方法进行了混合治疗比较。
我们共纳入了 76 项 RCT，涉及 170255 名参与者。共有 14878 人死亡。他汀类药物治疗降低了全因死亡率，相对风险（RR）0.90[95%置信区间（CI）0.86-0.94，P≤0.0001，I(2)=17%]；心血管疾病（CVD）死亡率（RR 0.80，95%CI 0.74-0.87，P<0.0001，I(2)=27%）；致命性心肌梗死（MI）（RR 0.82，95%CI 0.75-0.91，P<0.0001，I(2)=21%）；非致命性 MI（RR 0.74，95%CI 0.67-0.81，P≤0.001，I(2)=45%）；血运重建（RR 0.76，95%CI 0.70-0.81，P≤0.0001）；致命性和非致命性中风的复合终点（0.86，95%CI 0.78-0.95，P=0.004，I(2)=41%）。不良事件通常较轻，但 17 项 RCT 报告了发生糖尿病的风险增加[比值比（OR）1.09；95%CI 1.02-1.17，P=0.001，I(2)=11%]。研究结果在不同人群中没有显著差异。我们没有发现他汀类药物之间存在不同的治疗效果。
他汀类药物在广泛的人群中都有明显的益处。随着通用配方的普及，应优先努力扩大其获取途径。
