A large review of randomized trials indicates that statins do not cause the majority of side effects listed on their labels. Symptoms such as memory problems and depression occurred at similar rates in statin users and those taking placebos. The findings aim to address concerns that have led some patients to avoid these heart-protecting medications.
Heart disease causes about 20 million deaths annually worldwide, including a quarter of deaths in the UK. Statins, which lower LDL cholesterol, reduce risks of heart attacks and strokes but have faced hesitation due to potential side effects.
Researchers from the Cholesterol Treatment Trialists' Collaboration analyzed 23 randomized trials involving 154,664 participants. This included 123,940 people in 19 trials comparing statins to placebos and 30,724 in four trials comparing higher- versus lower-intensity statin therapy. The trials, each with at least 1,000 participants, followed patients for a median of nearly five years and were double-blind to minimize bias.
The review found no statistically significant increase in most reported side effects for statin users compared to placebo groups. For example, cognitive or memory problems were reported at 0.2% yearly in both groups. Other symptoms without excess risk included dementia, depression, sleep problems, erectile dysfunction, weight gain, nausea, fatigue, and headaches.
A small 0.1% rise in abnormal liver blood tests occurred with statins, but this did not lead to higher rates of serious liver issues like hepatitis or failure. Earlier work by the team noted that only about 1% of muscle symptoms in the first year were attributable to statins, with no further excess risk. Statins also slightly elevate blood sugar, potentially accelerating diabetes onset in high-risk individuals.
Christina Reith, Associate Professor at Oxford Population Health and lead author, stated, "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."
Professor Bryan Williams of the British Heart Foundation added, "These findings are hugely important and provide authoritative, evidence-based reassurance for patients. Statins are lifesaving drugs, which have been proven to protect against heart attacks and strokes. Among the large number of patients assessed in this well-conducted analysis, only four side effects out of 66 were found to have any association with taking statins, and only in a very small proportion of patients."
Professor Sir Rory Collins, senior author, remarked, "Statin product labels list certain adverse health outcomes as potential treatment-related effects based mainly on information from non-randomised studies which may be subject to bias. We brought together all of the information from large randomised trials to assess the evidence reliably. Now that we know that statins do not cause the majority of side effects listed in package leaflets, statin information requires rapid revision to help patients and doctors make better-informed health decisions."
The collaboration is coordinated by Oxford Population Health and the University of Sydney's National Health and Medical Research Council Clinical Trials Centre. Funding came from the British Heart Foundation, UKRI Medical Research Council, and Australian National Health and Medical Research Council.
