This is a guest post from the authors of apaper on statinspublished on Saturday inBMC Medicine。Statins have击中头条新闻在过去的几周中很多。在这里，作者将我们的审查和分析结果带入了这些药物的意外影响。

他汀类药物在临床实践中广泛使用，其对心血管疾病（CVD）的二次预防疗效的功效是充分的，但是在低风险个体中，它们在初级预防中的扩展使用必须与潜在无意外影响的风险保持平衡。自从新的指导草案从National Institute for Health and Care Excellence (NICE)recommends lowering the 10-year risk threshold for considering statin therapy from 20% to 10% risk of developing CVD.

Evidence on unintended effects reported by randomised controlled trials (RCTs) and their associated meta-analyses is often insufficient. In RCTs not all harmful effects can be easily anticipated, but even if measured their reporting is inadequate. Under-reporting of unintended effects may affect the interpretation of the net clinical benefit, particularly among people at low cardiovascular risk.

Arecent meta-analysis of 29 RCTs, involving more than 80,000 patients taking statins, concluded that almost all reported symptoms occurred just as frequently when patients were administered placebo, even for unintended effects commonly attributed to statins such as肌病。但是，对于大多数事件，从对14个主要预防RCT中的2个报告的分析得出结论。唯一新的开发糖尿病was significantly higher on statins than placebo.

In addition to inadequate reporting of the unintended effects in the statin trials, people who are prescribed statins in general practice are not always similar to trial participants – they tend to be older, to have multiple pathology, and therefore may be more likely to suffer the unintended effects.

Inour study, we systematically assessed unintended effects of statins from 90 observational studies in the general population, with comparison of the findings – where possible – with those derived from RCTs. Observational studies are more likely to include a broad representation of the population treated with statins, and provide reliable estimates of the incidence of effects experienced in the general population, important in evaluating the public health impact of an intervention.

We found no increased risk of周围神经病, depression, common eye diseases, renal disorders, or arthritis associated with taking statins.

在我们研究的研究中，质量较高的研究未显示汀类药物对骨折，静脉血栓栓塞或肺炎的保护作用。痴呆症和认知障碍的几率较低与他汀类药物的使用有关，但在高质量的研究中受到了减弱，表明这些明显的保护作用可能并不强大。有证据表明肌病，肝酶和糖尿病增加。

In our study, the estimates derived from high quality observational data were consistent with the findings from RCTs for the same outcome, indicating that observational studies can provide reliable and relevant evidence on unintended effects of statins to add to the evidence from RCTs for health care guidance.

The absolute excess risk of the observed harmful unintended effects of statins is very small compared to the beneficial effects of statins on major cardiovascular events in evidence derived from randomized trials and from observational studies.

The new draft NICE guidance and the publishedAmerican College of Cardiology/American Heart Association (ACC/AHA) guideline可能会导致在更广泛的人群中汀类药物的使用增加。在制药行业支持的随机试验中，他汀类药物对他汀类药物的意外影响的不一致的定义和未报告降低了对证据基础的信心，但是高度不太可能造成毒品造成的严重威胁生命的危害。

It is also clear that statins reduce cardiovascular events in people at the risk thresholds defined by NICE and ACC/AHA. Patients and doctors should be reassured that no major or minor potential unintended effects of statins were found in our review of observational studies, which included patients more typical of those treated in routine medical practice. In the future it is hoped that the pharmaceutical industry will refine their approach to collection of data and reporting of unintended effects of drugs.

作者：Ana Filipa Macedo，Fiona Claire Taylor，Juan P Casas，Alma Adler，David Prieto-Merino和Shah Ebrahim来自London School of Hygiene and Tropical Medicine。