Department of Epidemiology, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, Zurich, Switzerland; School of Public Health, Mekelle University, Ayder, Mekelle, Ethiopia.
Department of Epidemiology, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, Zurich, Switzerland.
Am Heart J. 2019 Apr;210:18-28. doi: 10.1016/j.ahj.2018.12.007. Epub 2019 Jan 10.
The current guidelines of statins for primary cardiovascular disease (CVD) prevention were based on results from systematic reviews and meta-analyses that suffer from limitations.
We searched in PubMed for existing systematic reviews and individual open-label or double-blinded randomized controlled trials that compared a statin with a placebo or another, which were published in English until January 01, 2018. We performed a random-effect pairwise meta-analysis of all statins as a class and network meta-analysis for the specific statins on different benefit and harm outcomes.
In the pairwise meta-analyses, statins as a class showed statistically significant risk reductions on non-fatal MI (risk ratio [RR] 0.62, 95% CI 0.53-0.72), CVD mortality (RR 0.80, 0.71-0.91), all-cause mortality (RR 0.89, 0.85-0.93), non-fatal stroke (RR 0.83, 0.75-0.92), unstable angina (RR 0.75, 0.63-0.91), and composite major cardiovascular events (RR 0.74, 0.67-0.81). Statins increased statistically significantly relative and absolute risks of myopathy (RR 1.08, 1.01-1.15; Risk difference [RD] 13, 2-24 per 10,000 person-years); renal dysfunction (RR 1.12, 1.00-1.26; RD 16, 0-36 per 10,000 person-years); and hepatic dysfunction (RR 1.16, 1.02-1.31; RD 8, 1-16 per 10,000 person-years). The drug-level network meta-analyses showed that atorvastatin and rosuvastatin were most effective in reducing CVD events while atorvastatin appeared to have the best safety profile.
All statins showed statistically significant risk reduction of CVD and all-cause mortality in primary prevention populations while increasing the risk for some harm risks. However, the benefit-harm profile differed by statin type. A quantitative assessment of the benefit-harm balance is thus needed since meta-analyses alone are insufficient to inform whether statins provide net benefit.
他汀类药物在预防主要心血管疾病 (CVD) 中的当前指南是基于系统评价和荟萃分析的结果，这些结果存在局限性。
我们在 PubMed 中搜索了已发表的英文系统评价和开放标签或双盲随机对照试验，这些试验比较了他汀类药物与安慰剂或其他药物的效果，搜索截至 2018 年 1 月 1 日。我们对所有他汀类药物进行了随机效应配对荟萃分析，并对特定他汀类药物在不同的获益和危害结局方面进行了网络荟萃分析。
在配对荟萃分析中，他汀类药物作为一个类别，在非致死性心肌梗死 (RR 0.62，95%CI 0.53-0.72)、CVD 死亡率 (RR 0.80，0.71-0.91)、全因死亡率 (RR 0.89，0.85-0.93)、非致死性卒中 (RR 0.83，0.75-0.92)、不稳定型心绞痛 (RR 0.75，0.63-0.91) 和主要心血管复合事件 (RR 0.74，0.67-0.81) 方面显示出统计学显著的风险降低。他汀类药物增加了肌病 (RR 1.08，1.01-1.15；风险差异 [RD] 13，每 10000 人年 2-24)、肾功能障碍 (RR 1.12，1.00-1.26；RD 16，每 10000 人年 0-36) 和肝功能障碍 (RR 1.16，1.02-1.31；RD 8，每 10000 人年 1-16) 的相对和绝对风险。药物水平的网络荟萃分析显示，阿托伐他汀和瑞舒伐他汀在降低 CVD 事件方面最有效，而阿托伐他汀似乎具有最佳的安全性。
所有他汀类药物在一级预防人群中均显示出 CVD 和全因死亡率的统计学显著降低，但增加了某些危害风险。然而，他汀类药物的获益-危害特征因药物类型而异。因此，需要对获益-危害平衡进行定量评估，因为仅进行荟萃分析不足以说明他汀类药物是否提供净获益。
