他汀类药物治疗降低LDL胆固醇对血管疾病低风险人群的影响:27项随机试验个体数据的荟萃分析

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Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, Voysey M, Gray A, Collins R, Baigent C

他汀类药物治疗降低LDL胆固醇对血管疾病低风险人群的影响:27项随机试验个体数据的荟萃分析

《柳叶刀》2012年8月11日;380(9841):581-90。doi: 10.1016 / s0140 - 6736(12) 60367 - 5。2012年5月17日。

PubMed ID
22607822 (PubMed视图
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摘要

背景:他汀类药物可降低LDL胆固醇并预防血管事件，但其对低风险血管事件人群的净效应仍不确定。方法:本荟萃分析纳入了22项他汀类药物与对照试验的个体参与者数据(n=134,537;平均LDL胆固醇差1.08 mmol/L;中位随访时间为4.8年)和5项他汀类药物多效对照试验(n=39,612;差值0.51 mmol/L;5.1年)。主要血管事件包括主要冠状动脉事件(即非致死性心肌梗死或冠状动脉死亡)、中风或冠状动脉血运重建术。参与者根据对照治疗(无他汀类药物或低强度他汀类药物)的基线5年主要血管事件风险分为5类(<5%，>/=5%至<10%，>/=10%至<20%，>/=20%至<30%，>/=30%);估计每1.0 mmol/L LDL胆固醇降低率比(RR)。结果:他汀类药物降低LDL胆固醇降低了主要血管事件的风险(RR 0.79, 95% CI 0.77-0.81，每1.0 mmol/L降低)，很大程度上与年龄、性别、基线LDL胆固醇或既往血管疾病以及血管和全因死亡率无关。 The proportional reduction in major vascular events was at least as big in the two lowest risk categories as in the higher risk categories (RR per 1.0 mmol/L reduction from lowest to highest risk: 0.62 [99% CI 0.47-0.81], 0.69 [99% CI 0.60-0.79], 0.79 [99% CI 0.74-0.85], 0.81 [99% CI 0.77-0.86], and 0.79 [99% CI 0.74-0.84]; trend p=0.04), which reflected significant reductions in these two lowest risk categories in major coronary events (RR 0.57, 99% CI 0.36-0.89, p=0.0012, and 0.61, 99% CI 0.50-0.74, p<0.0001) and in coronary revascularisations (RR 0.52, 99% CI 0.35-0.75, and 0.63, 99% CI 0.51-0.79; both p<0.0001). For stroke, the reduction in risk in participants with 5-year risk of major vascular events lower than 10% (RR per 1.0 mmol/L LDL cholesterol reduction 0.76, 99% CI 0.61-0.95, p=0.0012) was also similar to that seen in higher risk categories (trend p=0.3). In participants without a history of vascular disease, statins reduced the risks of vascular (RR per 1.0 mmol/L LDL cholesterol reduction 0.85, 95% CI 0.77-0.95) and all-cause mortality (RR 0.91, 95% CI 0.85-0.97), and the proportional reductions were similar by baseline risk. There was no evidence that reduction of LDL cholesterol with a statin increased cancer incidence (RR per 1.0 mmol/L LDL cholesterol reduction 1.00, 95% CI 0.96-1.04), cancer mortality (RR 0.99, 95% CI 0.93-1.06), or other non-vascular mortality. INTERPRETATION: In individuals with 5-year risk of major vascular events lower than 10%, each 1 mmol/L reduction in LDL cholesterol produced an absolute reduction in major vascular events of about 11 per 1000 over 5 years. This benefit greatly exceeds any known hazards of statin therapy. Under present guidelines, such individuals would not typically be regarded as suitable for LDL-lowering statin therapy. The present report suggests, therefore, that these guidelines might need to be reconsidered. FUNDING: British Heart Foundation; UK Medical Research Council; Cancer Research UK; European Community Biomed Programme; Australian National Health and Medical Research Council; National Heart Foundation, Australia.

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