Cholesterol-lowering drugs called statins, used by millions worldwide, are far safer than previously thought, a major review has found. Leaflets included in statin packs should be updated to reflect this and avoid deterring people from taking the life-saving medication, say the researchers.
The review, published in The Lancet, analysed data from trials involving more than 120,000 participants who were given either statins or a placebo. Researchers found that most side effects commonly listed in patient leaflets, including memory loss, depression, sleep disturbance, weight gain, and impotence, are not caused by the drugs.
Statins are highly effective at lowering “bad” LDL cholesterol levels and have consistently been shown to reduce the risk of cardiovascular disease, which causes about 10 million deaths globally each year and a quarter of all deaths in the UK, according to Oxford University researchers.
While all medicines carry some risk, adverse effects from statins were found to be rare. Reports of side effects were almost identical between patients taking statins and those on placebo, indicating the drugs were not the cause. In the review, only four of 66 potential side effects had any association with statin use, and even then, they occurred in a very small number of patients. These were minor liver test changes, minor liver abnormalities, changes in urine, and tissue swelling, including swollen ankles. No cases of severe liver disease such as hepatitis or liver failure were reported.
Muscle damage and small increases in blood sugar levels, which could contribute to diabetes in susceptible individuals, were also found to be rare.
Lead author Prof Christina Reith said that fears about statin safety have prevented many people from starting or continuing treatment. “Ongoing confusion and concern about side effects mean many people are not willing to start them or stop them. This is a major issue,” she said. Prof Reith added that the study provides “reassurance that, for most people, the risk of side effects is greatly outweighed by the benefits.”
Senior author Prof Sir Rory Collins called for immediate revisions to statin information in patient leaflets. “Now that we know that statins do not cause the majority of side effects listed, statin information requires rapid revision to help patients and doctors make better-informed health decisions,” he said.
Prof Bryan Williams of the British Heart Foundation noted that negative publicity around unproven side effects has caused many people to miss out on the protective benefits of statins. “We are absolutely delighted to see the outcomes of this study. These findings should provide very powerful reassurance,” he said.
Experts emphasise that statins save lives and strongly encourage patients to discuss any concerns with their doctors.
