Physicians' Academy for Cardiovascular Education

EAS Consensus Panel: CV benefits of statin therapy far outweigh any adverse effects

Adverse effects of statin therapy: perception vs. the evidence – focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract

Literature - Mach F, Ray KK, Wiklund O, et al., European Atherosclerosis Society Consensus Panel - Eur Heart J, Published: 27 April 2018.

Introduction and methods

The efficacy of statin treatment to lower LDL-c and to prevent both first and recurrent CV events is well-established [1-3]. Also, large randomized controlled trials (RCTs) have clearly demonstrated the benefit/risk ratio of this treatment [3,4]. In light of the possible advent of a statin-containing polypill, thus potentially more widespread use, the evidence related to possible unintended effects of long-term statin therapy needs critical appraisal.

This is an objective appraisal of adverse effects attributed to statins, in order to differentiate the perception from the reality of potential risks associated with statin therapy, with a focus on glucose homeostasis, and cognitive, renal and hepatic function, as well as the risk of hemorrhagic stroke and cataract.

Statin-associated muscle symptoms (SAMS) are the most commonly reported adverse effects in clinical practice. It is often debated whether SAMS represents real or nocebo effects, as a consequence of negative expectations. The ASCOT-LLA study published that a nocebo effect may explain the higher incidence of SAMS in observational studies vs RCTs [5]. Others have described a higher rate when treatment was blinded, as compared with when patients knew they were on a statin. From these different observations, it may be concluded that clinicians should be cautious about attributing muscle symptoms to statin therapy, without further investigation of the origin of symptoms.

This article is the report of a literature search covering 2000-2017, and the content resulted from a consensus of considered opinions and insights of the expert members of the panel. The article elaborates on the available evidence. SAMS were discussed before in a previous EAS Consensus Document [6]. Here, we summarize the take home messages per topic.

Main results


Based on the objective appraisal of the literature on potential adverse effects of statins, the Consensus Panel concludes that statin treatment is remarkably safe. Although long-term statin treatment confers a modest risk of new onset DM, per case of DM, five new CVD events are avoided with statin therapy.

The authors conclude by saying that clinicians should be reassured by the long-term safety of statins, and the low risk of clinically relevant adverse effects. The established CV benefits of statin therapy far outweigh the risk of any adverse effect.


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