Findings from a major Oxford University study could change the lives of millions.
Around eight million people in the UK take statins (Image: Getty)
Statins are not responsible for the majority of side effects listed in package leaflets and millions more people should be taking them, according to researchers. A landmark study found “incontrovertible evidence” that the cholesterol-busting drugs did not cause many conditions they have been linked to, including memory loss or dementia, depression, sleep disturbance and weight gain.
Oxford University researchers said decades of misleading information may have put millions off taking the daily pills. They can slash the risk of heart attacks and strokes by up to half for those at the highest risk. Experts are now calling for an overhaul of labelling and NHS advice to ensure both patients and doctors are aware of the game-changing findings.
Professor Bryan Williams, chief scientific and medical officer at the British Heart Foundation, said the study was an “outstanding evaluation of the best available data”.
He added: “Nobody is disputing the fact that patients get adverse effects throughout their life, the big question is, ‘Are they related to the drug they are taking?’ The answer here is, in large part, ‘No’.
“Many of those other things that trouble patients…have nothing to do with the treatment with statins. That is a very powerful message both for the public and for patients, and hopefully will lead to perhaps the six, seven, eight million people who should be on statins reappraising their thoughts about them.
“There’s probably a shortfall close to half — 50% of patients who would benefit from these extraordinary drugs are not receiving them, for whatever reason.”
One of the most common statins, Atorvastatin, was the most dispensed drug in England with 73 million items in 2024/25, according to NHS prescribing data.
Eight million people in the UK are thought to take the cheap pills, which slow down the production of LDL-cholesterol in the liver.
The National Institute for Health and Care Excellence (NICE) told the NHS in 2023 that up to 15 million additional people might benefit.
Patient information leaflets list dozens of potential side effects. The team at Oxford Population Health reviewed records relating to more than 150,000 people who took part in 23 large-scale randomised-controlled trials — considered the gold standard for evaluating the effects of medicines.
On top of the known side effects of muscle symptoms and a small increase in risk of being diagnosed with diabetes, researchers found that only four of 66 “undesirable outcomes” previously linked to statins were actually associated with the drug.
Study leader Professor Christina Reith said: “There is no significant excess risk with statins for almost all the conditions listed in statins packaging as potential side effects.
“We were able to show there has been no increase in memory loss, depression, sleep disturbance, erectile dysfunction, weight gain, nausea, fatigue or headache and numerous other conditions.
“That’s not to say that people taking statins did not experience these medical events. That’s not surprising; these are common problems. However, what we were able to show reliably was that statins did not make these commonly experienced events occur more often.
BHF expert Bryan Williams talks about the impact of statins in the UK
“This means that we now have really good evidence that although these things may well happen to people while they take statins, that statins are not the cause of these problems.”
The study, published in The Lancet medical journal, identified a small 0.1% increase in risk of liver blood test abnormalities for patients taking the pills. However, there was no increased risk of liver diseases or failure.
The other side effects identified by the research were a small increased risk of abnormal levels of liver enzymes, changes to urine and edema, or swelling caused by fluid.
Previous analysis by the same researchers found that around one in four people experienced muscle symptoms, regardless of whether they were on the medicine. Muscle symptoms were reported by 27.1% of people taking statins and 26.6% of those on a placebo dose.
Statins are also known to cause a small increase in blood sugar levels, so people already at high risk may develop diabetes sooner.
Prof Reith said patient information leaflets often listed side effects that were only seen in less reliable observational studies.
She added: “When patients take a package insert out, it’s astonishing people take drugs at all in many ways because it is quite alarming.
“We would hope there’s a wider message here for drug regulators to think about how drug labels should be best constructed to best inform patients and doctors about the true benefits and risks of therapy.”
Study co-author Professor Sir Rory Collins, an emeritus professor of medicine and epidemiology at Oxford, said the Medicines and Healthcare products Regulatory Agency (MHRA) was “leading the world in changing labels” but still took around four years to act on the team’s findings about muscle symptoms.
Sir Rory said there was now “incontrovertible evidence” that most side effects previously linked to statins were not caused by the drugs.
He added: “The NHS also needs to change the website so that it provides people with the correct information.”
The belief that statins can cause “nasty side effects” too often leads both doctors and patients to decide against using them, Sir Rory said. He also rejected the suggestion that drugs should be avoided in favour of other interventions such as lifestyle changes.
Lowering cholesterol and blood pressure can slash risk of a heart attack (Image: Getty)
He added: “A massive proportion of the population take vitamins and supplements for which there is no evidence of benefit, there’s actually evidence of a lack of benefit. So I find this over-medicalisation concept rather daft.
“If you’re at high risk (and age is a huge driver of risk), if you’ve already had a heart attack or stroke, or if you have a genetic predisposition, family history, the question is: Why would you not [take statins]?
Prof Williams said statins had played a key role in the “dramatic expansion of life expectancy” in the UK over recent decades.
He added: “When I started out as a doctor, we would be on the coronary care unit looking at patients in their 40s and 50s dying of cardiovascular disease.
“When I was a junior doctor on the coronary care unit, 70% of people who came into that unit did not go home. Nowadays, 80% of patients at least go home.
“There has been a complete transformation and I can’t emphasise enough how much of that has been driven by prevention, largely due to the big three: cholesterol, blood pressure management and smoking cessation.
“They have had an unbelievably powerful effect on the health of the nation, but it’s at risk. Our nation is adopting unhealthier lifestyles and, to some extent, trying to run up an icy slope to bring those risk factors back down again.”
Dr Emily Herrett, an associate professor at the London School of Hygiene & Tropical Medicine who was not involved in the research, said: “This evidence should reassure both patients and clinicians. Many people stop statins because of perceived side effects or fear of side effects, but this study shows that symptoms occurring during statin use would probably have occurred even if the patient was not taking statins.
“Anyone who develops new symptoms while taking statins should talk to their GP, but it’s important to know that the chances of these symptoms being caused by the statin itself are very low.”
Consultant cardiologist Professor Riyaz Patel, of University College London, said the findings “should be made available to anyone who takes or prescribes a statin as it will hopefully allay many concerns”.
We have made great strides in the last 20 years, says PROF BRYAN WILLIAMS
It is unimaginable now, but in my early years as a doctor, people routinely died in their forties and fifties from cardiovascular disease.
Many more people now avoid preventable heart attacks and strokes, or survive following these medical events, as a direct result of taking statins.
But although statins are a major reason for the great strides we have made in cardiovascular disease over the past 20 years, years of misinformation on their so-called side effects have made people fearful. This can prevent them taking a tried and tested treatment which could save their lives.
I am delighted the evidence from this new Lancet study will allow us to reassure the public. The takeaway message is that side effects from statins are few and rare.
It is vital that people do not wrongly link these medications to problems like sleep disturbances, erectile dysfunction and memory problems. Because we really need statins, when every five minutes someone has a heart attack or stroke in the UK.
There is a reason these safe and cheap drugs are among the most prescribed treatments. Statins are game-changing, and even more beneficial when combined with a healthy diet and exercise.
Patients who are worried about statin side effects should always speak to their doctor and never have their genuine concerns dismissed. A GP will check if there is a health problem or medication issue.
But the small number of side effects actually caused by statins, the evidence now irrefutably shows, are greatly outweighed by the huge benefit of reducing heart attacks and strokes.
After the age of 50, your risk of heart disease roughly trebles every 10 years. I want to see even fewer people turning up on hospital wards following heart attacks and strokes which were entirely preventable.
There is absolutely no doubt about it — statins save lives.
– Professor Bryan Williams is chief scientific and medical officer at the British Heart Foundation
