Study finds statin therapy results in minimal side effects versus placebo

An analysis of randomised controlled trials (RCTs) that was published in the European Journal of Preventive Cardiology suggests only a "small minority" of symptoms reported on statins are genuinely due to the cholesterol drugs themselves, and that almost all would occur just as frequently on placebo. Researcher Judith Finegold noted that the findings do not necessarily support the wider prescription of statins, but that in order for patients to make appropriate decisions regarding their use, "we must first make sure they have top quality, unbiased information…This is why we call on drug regulators to highlight in the long lists of side effects those few whose rate is incrementally greater than that experienced with [placebo]."

The authors stated that unlike when determining a statin's efficacy, conclusions drawn about their potential side effects are not always based on data from blinded RCTs testing the drug against placebo. However, they said clinicians nonetheless "often assume symptoms occurring with statins are caused by statins, encouraging discontinuation." As part of the systematic review testing that assumption, researchers identified 29 trials comparing statins and placebo for cardiovascular prevention that reported side effects separately in the two arms.

Researchers found that in 14 primary prevention trials involving 46 262 patients, statins raised the absolute risk of new-onset diabetes by 0.5 percent, but reduced the risk of death by a similar extent. They noted that while only the development of diabetes was significantly higher on statins than placebo, "only 1 in 5 of new cases were actually caused by statins." Meanwhile, an analysis of 15 secondary prevention trials, which altogether enrolled 37 618 participants, showed statin use was associated with a 1.4-percent lower risk of death, while no statin-attributable symptoms were noted. Investigators added that the incidence of serious adverse events and study withdrawals was similar between the statin and placebo groups.

The study follows recent draft guidance by the National Institute for Health and Care Excellence recommending increased use of statins among people at risk of heart disease, stroke or peripheral arterial disease. In November, the American Heart Association and the American College of Cardiology issued similar guidelines that some experts predict could more than double the number of US patients on statin therapy.

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