Lancet. 2015 Apr 11;385(9976):1397-405. doi: 10.1016/S0140-6736(14)61368-4. Epub 2015 Jan 9.
Whether statin therapy is as effective in women as in men is debated, especially for primary prevention. We undertook a meta-analysis of statin trials in the Cholesterol Treatment Trialists' (CTT) Collaboration database to compare the effects of statin therapy between women and men.
We performed meta-analyses on data from 22 trials of statin therapy versus control (n=134,537) and five trials of more-intensive versus less-intensive statin therapy (n=39,612). Effects on major vascular events, major coronary events, stroke, coronary revascularisation and mortality were weighted per 1.0 mmol/L reduction in LDL cholesterol and effects in men and women compared with a Cox model that adjusted for non-sex differences. For subgroup analyses, we used 99% CIs to make allowance for the multiplicity of comparisons.
46,675 (27%) of 174,149 randomly assigned participants were women. Allocation to a statin had similar absolute effects on 1 year lipid concentrations in both men and women (LDL cholesterol reduced by about 1.1 mmol/L in statin vs control trials and roughly 0.5 mmol/L for more-intensive vs less-intensive therapy). Women were generally at lower cardiovascular risk than were men in these trials. The proportional reductions per 1.0 mmol/L reduction in LDL cholesterol in major vascular events were similar overall for women (rate ratio [RR] 0.84, 99% CI 0.78-0.91) and men (RR 0.78, 99% CI 0.75-0.81, adjusted p value for heterogeneity by sex=0.33) and also for those women and men at less than 10% predicted 5 year absolute cardiovascular risk (adjusted heterogeneity p=0.11). Likewise, the proportional reductions in major coronary events, coronary revascularisation, and stroke did not differ significantly by sex. No adverse effect on rates of cancer incidence or non-cardiovascular mortality was noted for either sex. These net benefits translated into all-cause mortality reductions with statin therapy for both women (RR 0.91, 99% CI 0.84-0.99) and men (RR 0.90, 99% CI 0.86-0.95; adjusted heterogeneity p=0.43).
In men and women at an equivalent risk of cardiovascular disease, statin therapy is of similar effectiveness for the prevention of major vascular events.
UK Medical Research Council, British Heart Foundation, Australian National Health and Medical Research Council, European Community Biomed Program.
关于他汀类药物治疗在女性中的效果是否与男性相当，尚存争议，尤其是在一级预防方面。我们对胆固醇治疗试验者（CTT）协作数据库中的他汀类药物试验进行了荟萃分析，以比较女性和男性使用他汀类药物的效果。
我们对 22 项他汀类药物治疗与对照组（n=134537）和 5 项更强化与更弱化他汀类药物治疗试验（n=39612）的数据进行了荟萃分析。主要血管事件、主要冠状动脉事件、卒中和冠状动脉血运重建的效果按 LDL 胆固醇每降低 1.0mmol/L 进行加权，男性和女性的效果则通过调整非性别差异的 Cox 模型进行比较。对于亚组分析，我们使用 99%CI 来考虑多重比较的影响。
在 174149 名随机分配的参与者中，有 46675 名（27%）为女性。在他汀类药物治疗与对照组的试验中，他汀类药物治疗对 1 年血脂浓度的绝对影响在男性和女性中相似（LDL 胆固醇降低约 1.1mmol/L），而更强化与更弱化治疗之间约为 0.5mmol/L。在这些试验中，女性的心血管风险总体上低于男性。女性和男性的主要血管事件每降低 1.0mmol/L LDL 胆固醇的比例减少相似（女性的比值比[RR]为 0.84，99%CI 为 0.78-0.91，调整后的性别异质性 p 值为 0.33），5 年绝对心血管风险低于 10%预测值的女性和男性的 RR 也相似（调整后的异质性 p=0.11）。同样，主要冠状动脉事件、冠状动脉血运重建和卒中等的比例减少在性别间无显著差异。在两性中均未观察到癌症发病率或非心血管死亡率的不利影响。这些净效益转化为女性（RR 0.91，99%CI 0.84-0.99）和男性（RR 0.90，99%CI 0.86-0.95）使用他汀类药物治疗的全因死亡率降低，调整后的性别异质性 p 值为 0.43。
在心血管疾病风险相当的女性和男性中，他汀类药物治疗在预防主要血管事件方面具有相似的效果。
英国医学研究理事会、英国心脏基金会、澳大利亚国家健康与医学研究理事会、欧洲共同体生物医学计划。
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