A major review of adverse events attributed to statin therapy has found that the majority of conditions listed on packaging labels for the medication—including cognitive impairment, depression, sleep disturbance, and peripheral neuropathy—are not attributable to the medication.
Statin labelling should be revised “to better support informed, evidence-based decision making”, authors of the study have claimed in response to the finding, noting that “widespread confusion” about statin safety hinders the ability of doctors and patients to make informed decisions about initiating or continuing the therapy.
Through the study, researchers at Oxford Population Health (University of Oxford, Oxford, UK) gathered data from 23 large-scale randomised studies from the Cholesterol Treatment Trialists’ collaboration, which included 123,940 participants in 19 clinical trials comparing the effects of statin therapies against a placebo, alongside 30,724 participants in four trials comparing more intensive versus less intensive statin therapy.
Reporting the findings of the study in The Lancet, the researchers detail that they found similar numbers of reports for those taking the statins and those taking the placebo for almost all the conditions listed in package leaflets as possible side effects. The number of reports of cognitive or memory impairment, for example, was 0.2% in those taking the statins, but also 0.2% in those taking the placebo. This means that while people may notice these problems whilst taking statins, there is no good evidence that they are caused by the statin, they state.
The findings led the study team to conclude that there was no statistically significant excess risk from statin therapy for almost all the conditions listed in package leaflets as potential side effects, and that taking a statin did not cause any meaningful excess of memory loss or dementia, depression, sleep disturbance, erectile dysfunction, weight gain, nausea, fatigue or headache, and many other conditions.
They did show a small increase in risk (about 0.1%) for liver blood test abnormalities. However, there was no increase in liver disease such as hepatitis or liver failure, indicating that the liver blood test changes do not typically lead to more serious liver problems.
“Statins are life-saving drugs used by hundreds of millions of people over the past 30 years. However, concerns about the safety of statins have deterred many people who are at risk of severe disability or death from a heart attack or stroke. Our study provides reassurance that, for most people, the risk of side effects is greatly outweighed by the benefits of statins,” Christina Reith (Oxford Population Health, University of Oxford, Oxford, UK), the study’s senior author, said.
A previous randomised study, presented at the 2020 scientific session of the American Heart Association (AHA) and published in the New England Journal of Medicine (NEJM), had shown that patients who stopped taking statins due to side effects reported similar symptoms to those who unknowingly took placebo tablets, which they said suggested a potential psychological rather than pharmacological effect of the statin therapy.
