Oxford research finds most statin side-effects not caused by the drug
Study calls for updates to patient information leaflets
Most side-effects commonly attributed to statins are not caused by the drug itself, according to a new study by researchers from the University of Oxford.
Academics suggest that patient information leaflets should be revised following their comprehensive review of the side-effects associated with statins.
Statins are widely prescribed to lower cholesterol levels, reducing the risk of heart attack and stroke, however, concerns over side-effects have led to hesitancy among potential users.
The study involved analysing data from 123,940 individuals who participated in 19 clinical trials comparing statins and placebos.
Participants were monitored for an average of 4.5 years after commencing treatment.
Researchers found no significant increase in risk for conditions such as memory loss, depression, sleep problems, weight gain, nausea, fatigue or headaches, which often appear in statin leaflets.
Lead author Christina Reith, associate professor at Oxford Population Health, said: "What we were able to show reliably was that statins did not make these commonly experienced events occur more often.
"So, for example, the percentage of people suffering memory loss per year was similar to those taking statin therapy as to those not, equally.
"The percentage of people suffering sleep problems per year was similar for those taking statin therapy as for those not.
"This means we now have really good evidence that although these things may happen to people while they take statins, statins are not the cause of these problems."
She added: "Our study provides reassurance that, for most people, the risk of side-effects is greatly outweighed by the benefits of statins.
"What we hope to see happen is that statin drug labels are revised alongside related information to enable doctors and patients to make better-informed decisions going forward."
Though statins can cause a slight rise in blood sugar levels, potentially hastening the onset of diabetes in individuals at high risk, researchers examined 66 "undesirable outcomes" formerly linked to statins and found only four truly associated with the drug.
These include a minor increased risk of abnormal liver blood tests, about 0.1%, however, researchers observed no heightened risk for serious liver disease.
An increased risk of swelling in the legs, ankles, and feet (known as oedema), as well as changes in urine, were also noted.
In additional analysis on 30,724 participants exploring more intensive versus less intensive statin therapy, a small risk for abnormal liver blood tests was identified, but no additional urinary issues or chances of oedema were detected.
Professor David Preiss, also from Oxford Population Health, said during an interview: "I'm not suggesting that there are no harms at all. Any drug has some side effects and statins are no different, but compared to most drugs they are incredibly well tolerated and very effective.
"We hope this will help us to address this issue where high risk people who may previously have decided not to take the therapy because they're concerned, might now be more encouraged to take the treatment."