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首页> 外文期刊>The Lancet >Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins.
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Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins.

机译：降胆固醇治疗的功效和安全性：他汀类药物14项随机试验中90,056名参与者的数据进行了前瞻性荟萃分析。

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BACKGROUND: Results of previous randomised trials have shown that interventions that lower LDL cholesterol concentrations can significantly reduce the incidence of coronary heart disease (CHD) and other major vascular events in a wide range of individuals. But each separate trial has limited power to assess particular outcomes or particular categories of participant. METHODS: A prospective meta-analysis of data from 90,056 individuals in 14 randomised trials of statins was done. Weighted estimates were obtained of effects on different clinical outcomes per 1.0 mmol/L reduction in LDL cholesterol. FINDINGS: During a mean of 5 years, there were 8186 deaths, 14,348 individuals had major vascular events, and 5103 developed cancer. Mean LDL cholesterol differences at 1 year ranged from 0.35 mmol/L to 1.77 mmol/L (mean 1.09) in these trials. There was a 12% proportional reduction in all-cause mortality per mmol/L reduction in LDL cholesterol (rate ratio [RR] 0.88, 95% CI 0.84-0.91; p<0.0001). This reflected a 19% reduction in coronary mortality (0.81, 0.76-0.85; p<0.0001), and non-significant reductions in non-coronary vascular mortality (0.93, 0.83-1.03; p=0.2) and non-vascular mortality (0.95, 0.90-1.01; p=0.1). There were corresponding reductions in myocardial infarction or coronary death (0.77, 0.74-0.80; p<0.0001), in the need for coronary revascularisation (0.76, 0.73-0.80; p<0.0001), in fatal or non-fatal stroke (0.83, 0.78-0.88; p<0.0001), and, combining these, of 21% in any such major vascular event (0.79, 0.77-0.81; p<0.0001). The proportional reduction in major vascular events differed significantly (p<0.0001) according to the absolute reduction in LDL cholesterol achieved, but not otherwise. These benefits were significant within the first year, but were greater in subsequent years. Taking all years together, the overall reduction of about one fifth per mmol/L LDL cholesterol reduction translated into 48 (95% CI 39-57) fewer participants having major vascular events per 1000 among those with pre-existing CHD at baseline, compared with 25 (19-31) per 1000 among participants with no such history. There was no evidence that statins increased the incidence of cancer overall (1.00, 0.95-1.06; p=0.9) or at any particular site. INTERPRETATION: Statin therapy can safely reduce the 5-year incidence of major coronary events, coronary revascularisation, and stroke by about one fifth per mmol/L reduction in LDL cholesterol, largely irrespective of the initial lipid profile or other presenting characteristics. The absolute benefit relates chiefly to an individual's absolute risk of such events and to the absolute reduction in LDL cholesterol achieved. These findings reinforce the need to consider prolonged statin treatment with substantial LDL cholesterol reductions in all patients at high risk of any type of major vascular event.
机译：背景：先前的随机试验结果表明，降低LDL胆固醇浓度的干预措施可以在很多个体中显着降低冠心病（CHD）和其他主要血管事件的发生率。但是，每个单独的试验都无法评估特定结果或特定类别的参与者。方法：对他汀类药物的14项随机试验中90,056人的数据进行了前瞻性荟萃分析。对LDL胆固醇每降低1.0 mmol / L，对不同临床结果的影响得到加权估计。结果：在平均5​​年中，有8186人死亡，有重大血管事件的14348人，有5103人患了癌症。在这些试验中，一年的平均LDL胆固醇差异为0.35 mmol / L至1.77 mmol / L（平均值1.09）。 LDL胆固醇每降低一mmol / L，全因死亡率降低12％（比率[RR] 0.88，95％CI 0.84-0.91; p <0.0001）。这反映出冠状动脉死亡率降低了19％（0.81，0.76-0.85; p <0.0001），非冠状动脉血管性死亡率（0.93，0.83-1.03; p = 0.2）和非血管性死亡率（0.95）无明显降低，0.90-1.01; p = 0.1）。致命或非致命性卒中（0.73，0.73，0.74-0.80; p <0.0001），需要进行冠状动脉血运重建的患者（0.76，0.73-0.80; p <0.0001）相应减少0.78-0.88; p <0.0001），并结合起来，在任何此类重大血管事件中占21％（0.79，0.77-0.81; p <0.0001）。根据所达到的LDL胆固醇的绝对降低，主要血管事件的比例降低存在显着差异（p <0.0001），但没有其他差异。这些收益在第一年就很显着，但在随后的几年里却更大。综观所有年份，与基线时已存在冠心病的患者相比，每降低1000 mmol / L LDL胆固醇的总体减少量，相当于每1000人发生重大血管事件的参与者减少了48（95％CI 39-57）没有这种病史的参与者中，每1000名参与者中有25（19-31）人。没有证据表明他汀类药物会增加总体上或任何特定部位的癌症发生率（1.00、0.95-1.06; p = 0.9）。解释：他汀类药物疗法可以安全地将LDL胆固醇每mmol / L降低的5年主要冠状动脉事件，冠状动脉血运重建和中风的发生率降低约五分之一，而与初始脂质分布或其他表现特征无关。绝对利益主要与个人发生此类事件的绝对风险以及所达到的LDL胆固醇的绝对降低有关。这些发现加强了在任何类型的主要血管事件高风险的所有患者中，应考虑延长他汀类药物治疗的时间，同时大幅降低LDL胆固醇。

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