Smeeth Liam, Douglas Ian, Hall Andrew J, Hubbard Richard, Evans Stephen
Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Br J Clin Pharmacol. 2009 Jan;67(1):99-109. doi: 10.1111/j.1365-2125.2008.03308.x. Epub 2008 Nov 5.
To assess the effect of statins on a range of health outcomes.
We undertook a population-based cohort study to assess the effect of statins on a range of health outcomes using a propensity score-based method to control for differences between people prescribed and not prescribed statins. We validated our design by comparing our results for vascular outcomes with the effects established in large randomized trials. The study was based on the United Kingdom Health Improvement Network database that includes the computerized medical records of over four and a half million patients.
People who initiated treatment with a statin (n = 129,288) were compared with a matched sample of 600,241 people who did not initiate treatment, with a median follow-up period of 4.4 years. Statin use was not associated with an effect on a wide range of outcomes, including infections, fractures, venous thromboembolism, gastrointestinal haemorrhage, or on specific eye, neurological or autoimmune diseases. A protective effect against dementia was observed (hazard ratio 0.80, 99% confidence interval 0.68, 0.95). There was no effect on the risk of cancer even after > or =8 years of follow-up. The effect sizes for statins on vascular end-points and mortality were comparable to those observed in large randomized trials, suggesting bias and confounding had been well controlled for.
We found little evidence to support wide-ranging effects of statins on health outcomes beyond their established beneficial effect on vascular disease.
评估他汀类药物对一系列健康结局的影响。
我们开展了一项基于人群的队列研究，采用基于倾向评分的方法来控制服用和未服用他汀类药物人群之间的差异，以评估他汀类药物对一系列健康结局的影响。我们通过将血管结局的研究结果与大型随机试验中确定的效果进行比较，验证了我们的设计。该研究基于英国健康改善网络数据库，该数据库包含超过450万患者的计算机化医疗记录。
将开始使用他汀类药物治疗的人群（n = 129,288）与600,241名未开始治疗的匹配样本进行比较，中位随访期为4.4年。使用他汀类药物与对一系列结局无影响相关，包括感染、骨折、静脉血栓栓塞、胃肠道出血，或对特定的眼部、神经或自身免疫性疾病。观察到对痴呆症有保护作用（风险比0.80，99%置信区间0.68，0.95）。即使经过≥8年的随访，对癌症风险也没有影响。他汀类药物对血管终点和死亡率的效应大小与大型随机试验中观察到的相当，表明偏差和混杂因素已得到很好的控制。
我们几乎没有发现证据支持他汀类药物对健康结局有广泛影响，超出了其对血管疾病已确定的有益作用。
