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A study published in The Lancet Healthy Longevity looks at the discontinuation of statins for cardiovascular disease prevention in adults aged 75 or over.
Prof Bryan Williams, Chief Scientific and Medical Officer at the BHF said:
“This study provides good insights into statin use among older adults particularly, but is only of modest size, including only 1,100 participants with an average age of 80 and a strong representation of women. Importantly, the findings relate specifically to people aged 75 and over who had no history of cardiovascular disease and were taking statins for primary prevention, to help prevent a first heart attack or stroke.
“While the trial suggests that stopping statins may not lead to worse outcomes than continuing them over three years in this population of very elderly adults, the study findings should not be interpreted as evidence that statins are no longer beneficial. On the contrary, for the many millions of patients taking statins in the UK, they are life saving medications. Indeed, overwhelming evidence from decades of research shows that statins reduce the risk of heart attacks, strokes and risk of premature death from cardiovascular diseases. This includes meta-analyses using individual participant data from randomised controlled trials that included older patients. Such analyses are considered the ‘gold standard’ for evidence-based research.
“It is important to note that these findings are not relevant to many millions of people taking statins, particularly those with a history of heart attack, stroke or other cardiovascular conditions that out them at high risk. Any decisions about changing or stopping statins should be only taken together with your doctor who can advise on the balance of benefits and risks in terms of reducing your future risk of heart attack and stroke.”
Prof Borislava Mihaylova, Professor of Health Economics, University of Oxford, said:
“The study is substantially statistically underpowered, with too small sample size and short follow-up duration, and should not be used to inform clinical decision-making. Statin treatment is widely prescribed to reduce heart attacks and strokes. In addition to the above limitations, the emphasis on all-cause mortality in the study, rather than major cardiovascular disease events, is unhelpful.”
Prof Robert Storey, Professor of Cardiology, University of Sheffield, said:
“This study looked at whether stopping treatment with a statin in people over the age of 75 years affects the risk of dying over the subsequent 3 years. Although the study found no significant effect of stopping a statin on mortality risk, there are many limitations to the study and it should not be used to inform decision-making in the majority of people treated with a statin in this age group.
“Firstly, the study was too small and follow-up was too short to get a clear idea of the benefits of statin treatment. Studies looking at any benefits of cholesterol treatment on life expectancy need to include many thousands of people whereas this study only included just over one thousand people and there were only 521 people in the group that were asked to stop their statin, with only 388 of these actually completing 3 years of follow-up.
“Secondly, statins tend to have more impact on the risk of heart attack than the risk of dying overall. In this study, heart attack occurred in 1.4% of those who continued their statin compared with 2.1% of those who stopped their statin. Even though the study was not large enough to get a very accurate idea of the actual risk of heart attack, these data should at least raise a note of caution about stopping statins.
“Thirdly, even though the study included people over the age of 75 years, more than half of the study participants were over the age of 80 years and therefore had a high risk of dying from conditions other than cardiovascular disease.
“Fourthly, the study authors clearly point out that stopping a statin did not lead to an improvement in quality of life or reduction in symptoms that might be considered side-effects of statins so there was no evidence of a detrimental effect of continuing treatment with a statin.
“Finally, the study struggled to recruit participants, presumably since many of the people approached were not happy with the concept of stopping a beneficial treatment just on the basis of their age, and this means that the people included may not be well representative of the over-75s consulting their doctors about the need for continued statin treatment.
“Overall the circumstances in which these study results will help with decision-making are very limited and there is a risk that it will promote stopping of statins in people over 75 who may otherwise benefit from reduced heart attack risk.”
Comments from our friends at SMC Spain:
Carlos Guijarro, former president of the Spanish Society of Arteriosclerosis (SEA) and a doctor in the Internal Medicine Unit at the Fundación Alcorcón University Hospital, said:
Does the press release accurately reflect the study?
“The press release is technically correct, but I believe it conveys the same error as the paper: in reality, the authors have not demonstrated that discontinuing statins is inferior (or superior) to continuing them, because 1) the study’s power is much lower than anticipated (only half the expected number of patients were recruited); 2) mortality was half that expected, so the study’s power must have fallen from 90 per cent to less than 50 per cent, meaning the study’s ability to detect the primary endpoint is on a par with flipping a coin, if not even lower.
I believe the press release should be extremely cautious: I would say that the study has not had sufficient power to assess whether, in older people, discontinuing statins affects mortality: there is not enough robust data to say that it affects mortality, nor that it improves or worsens patients’ quality of life, particularly if they are French octogenarians without cardiovascular disease who regularly visit their GPs (external validity).
The headline is a clear example of the risk posed by this paper. “Stopping statins in adults over 75 with no history of heart disease or stroke does not increase the risk of death”
Is the study of good quality? Are the conclusions supported by solid data?
“The study design is of good quality (in theory), but its execution is hampered by a loss of statistical power (i.e. the ability to prove the working hypothesis) which, roughly speaking, is halved due to recruiting only half the intended number of patients, and perhaps a further 50 per cent because the incidence of the primary outcome is half that estimated, along with other statistical reasons that are not appropriate to discuss in a press release. I therefore believe the conclusion of the paper should be much more cautious.
How does this study fit in with the existing evidence?
“This study is a commendable effort to discontinue a widely used chronic treatment with limited evidence of benefit in the elderly; however, apart from the weakness of the results mentioned above, it contrasts with the very robust evidence from intervention studies.
“This study involved 1,200 patients followed up for three years, and its inconclusive result contrasts with the consistent benefits of the meta-analysis also published in The Lancet, which included 186,000 patients, of whom around 14,000 were over 75 years of age and were followed up for 4.9 years.
“Furthermore, population-based studies indicate that discontinuing statins is associated with an increase in cardiovascular morbidity and mortality. It is true that these are observational rather than interventional studies, and whilst their methodological quality is lower due to potential biases, they involve tens of thousands of patients.”
Have the authors taken confounding factors into account? Are there any significant limitations that need to be considered?
“I have already mentioned the limitations regarding statistical power. Furthermore, the external validity is questionable: the cohort consists of French octogenarians who regularly visit their GP and who have a mortality rate of less than 10 per cent at three years (with or without statins).
This may have nothing to do with other populations of octogenarians.”
What are the implications for the real world?
“As the accompanying editorial suggests, what seems clear is that withdrawing statins from elderly people who tolerate them well offers them no real benefit: it does not improve their quality of life, nor does it alleviate other symptoms. Whether this alters the risk of mortality (or not) cannot be concluded from this study. It should not be interpreted (which carries an extreme risk) as proof that statins cease to be effective at the age of 80. It remains in a zone of uncertainty, but one should not over-interpret a negatively biased, underpowered study that is unable to robustly assess its own primary objective.
“It certainly leaves doctors with the option of discussing with patients what to do when faced with complex decisions regarding the elderly, as should always be the case.
“Therefore, this study carries a high risk of being misinterpreted on social media platforms that are highly active in their opposition to statins, without a solid scientific basis.”
1 – https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31942-1/fulltext
‘Discontinuation of statins for primary prevention of atherosclerotic cardiovascular disease in adults aged 75 years or older (SAGA/SITE): a multicentre, open-label, pragmatic, non-inferiority randomised trial’ by Fabrice Bonnet et al. was published in The Lancet Healthy Longevity at 23:30 UK time Tuesday 11 August 2026.
DOI: 10.1016/j.lanhl.2026.100888
Declared interests
Prof Bryan Williams: Awaiting declarations of interest
Prof Borislava Mihaylova: “I do not have any ‘commercial’ CoI. Few related to topic collaborations/ other grants:
– I am a member of the CTT Collaboration. I am a member of ESC Clinical Practice Guidelines Committee.
– I was PI on a NIHR HTA grant (completed) # 17/140/02 Cost-effectiveness of statin therapies evaluated using individual participant data
– I am co-investigator on a NIHR global health NIHR156161: Reducing non-communicable diseases in Thailand
– I have other unrelated NIHR/ BHF/Barts Charity grants.”
Prof Robert Storey: “I advise pharmaceutical companies but, since statins are available as generic medications from many pharmaceutical manufacturers, I do not have any relevant disclosures for these comments.”
Carlos Guijarro: “I have been working in the field of dyslipidaemia and statins for over 30 years; I have received payments for consultancy and lectures (of a modest amount) from numerous pharmaceutical companies in the field of vascular risk, including those that sell or have sold statins: MSD; Pfizer; or other lipid-lowering drugs; I have never been employed by any pharmaceutical company nor do I hold shares in any of them. I have contributed to consensus documents and guidelines on lipid-lowering therapy for the Spanish Society of Arteriosclerosis (of which I was president from 2023 to 2025) and, on occasion, for the Spanish Societies of Cardiology and Internal Medicine (of which I am also a member). I have published over 200 articles in international journals, mainly focusing on cardiovascular risk and dyslipidaemia, and the majority of these are based on my own independent research.”