Study questions side-effects of statins

Published: 13-Mar-2014

Drugs taken to lower risk of heart attacks may have fewer side effects than claimed, say researchers


Statins have virtually no side effects, with users experiencing fewer adverse symptoms than if they had taken a placebo, according to a study by researchers from the National Heart and Lung Institute at London's Imperial College.

The study analysed 29 randomised controlled trials (RCTs), involving more than 80,000 patients taking the cholesterol-lowering drugs.

Among a list of side effects assessed, including nausea, renal disorder, muscle problems and aches, insomnia, fatigue and gastrointestinal disturbance – only the risk of diabetes was found to be slightly raised by the drugs.

The authors of the report, published in the European Journal of Preventive Cardiology, are calling on drug regulators to provide clear evidence to patients about claims over side effects.

They said: 'Patients and doctors need clear reliable information about benefits and risks to make informed decisions,' adding that those reporting side effects while taking statins need reliable confirmation that a symptom is truly caused by the drug.

Patients and doctors need clear reliable information about benefits and risks to make informed decisions

Overall, the study found serious adverse effects in 14.6% of patients receiving statins and 14.9% given placebo in the primary prevention trials (46,262 participants), and in 9.9% of those on statins and 11.2% on placebo in the secondary prevention trials (37,618 participants). Similarly, comparable numbers of patients withdrew from the trials because of symptomatic adverse events (around 12–15%).

The researchers acknowledged that many patients taking statins report side effects, in contrast to the study results.

Dr Judith Finegold, part of the research team, said: 'We clearly found that many patients in these trials – whose patients are usually well motivated volunteers who didn't know if they were getting a real or placebo tablet – that many did report side effects while taking placebo.

'In the general population, where patients are being prescribed a statin for an asymptomatic condition, why would it be surprising that even higher rates of side effects are reported?

'Most people in the general population, if you repeatedly ask them a detailed questionnaire, will not feel perfectly well in every way on every day. Why should they suddenly feel well when taking a tablet after being warned of possible adverse effects?'

Dr Finegold said the results would not necessarily add weight to the argument for the wider prescription of statins.

She said: 'We believe that patients should be empowered to make their own decisions, but 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 a dummy tablet.'

Full bibliographic information

Finegold JA, Manisty CH, Goldacre B, et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prevent Cardiol 2014; DOI: 10.1177/2047487314525531

You may also like