Statins may be safer than perceived, review suggests

A recent literature review from the European Atherosclerosis Society Consensus Panel published in the European Heart Journal (DOI: has appraised the evidence for the most well recognised adverse effects of long-term statin therapy.

The panel of 27 authors performed a literature search of randomised controlled trials and genetic studies published between 2000 and 2017 reporting adverse effects of statins. They assessed the risks of specific adverse events associated with long-term statin use, including diabetes, cognitive effects, impaired hepatic and renal function, cataracts and haemorrhagic stroke.

They found that statin therapy was associated with a modest increase in the risk of new-onset diabetes, by about one additional case per thousand patients per year of exposure. For comparison, the authors note that statins prevent about five new cardiovascular events per 1000 patients per year. The risk of new-onset diabetes is greatest in those with precipitating factors such as metabolic syndrome or prediabetes.

Statin therapy was not associated with adverse effects on cognitive function, deterioration of renal function or the development of cataracts. In 0.5–2% of patients, statin use was associated with mild increases in liver enzymes but these are unlikely to be clinically relevant. However, the authors add that severe idiosyncratic liver injury can occur, although this is rare.

A small increase in the risk of haemorrhagic stroke in patients with a history of stroke was suggested by the Stroke Prevention by Aggressive Reduction of Cholesterol Levels (SPARCL) study; however, this finding has not been confirmed in other controlled studies. In contrast, statins reduce the risk of first and subsequent ischaemic stroke by 15–35% per mmol/L reduction in LDL cholesterol.

The review authors conclude that “clinicians should be reassured by the long-term safety of statins and the low risk of clinically relevant adverse effects” and that “the established cardiovascular benefits of statin therapy far outweigh the risk of any such adverse effects”.

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