Stopping statin treatment in adults aged 75 years or older who had no history of heart disease or stroke did not result in a higher three-year death rate than continuing treatment in a French randomized trial published in The Lancet Healthy Longevity. The SAGA/SITE study enrolled 1,160 adults receiving statins for primary prevention and provides randomized evidence for a question that has remained uncertain because people older than 75 have been sparsely represented in statin prevention trials.
The trial tested statin deprescribing in adults without prior cardiovascular disease
Statins lower low-density lipoprotein cholesterol (LDL-C) and reduce the risk of atherosclerotic cardiovascular disease (ASCVD), which develops when cholesterol-rich plaque accumulates in arteries. Their role in primary prevention is well established in many middle-aged adults, but the evidence becomes less certain at older ages because relatively few randomized trials have enrolled large numbers of adults older than 75.
Fabrice Bonnet and colleagues conducted a multicenter, open-label, pragmatic, non-inferiority randomized trial through general practices in France. The study enrolled 1,160 adults aged 75 years or older who were taking a statin but had no history of heart disease or stroke, then randomly assigned them either to discontinue or continue treatment. This distinction matters: the study addressed primary prevention, not people taking statins after a heart attack, stroke, or other established ASCVD.
The clinical question also differs from a medication safety problem. A statin recall, for example, concerns specific affected products or lots. Deprescribing asks whether the expected preventive benefit of a medication still justifies continuing it as a person’s age, health status, medication burden, and priorities change.
Three-year mortality was similar after stopping or continuing statins
After three years, 35 of 484 participants in the discontinuation group had died, a rate of 7.2%, compared with 48 of 604 participants who continued statins, a rate of 7.9%. The trial therefore did not show higher all-cause mortality over the three-year follow-up among participants assigned to stop treatment.
Major cardiovascular events, including heart attacks and strokes, also did not differ significantly between the groups during follow-up. Physical and mental quality-of-life measures remained similar. Those results are clinically relevant because one rationale for deprescribing in later life is to reduce medication burden without sacrificing outcomes that matter to patients.
The findings should not be read as evidence that cholesterol no longer matters after age 75. Three months after treatment was stopped, average LDL-C had risen from 115 mg/dL to 171 mg/dL, an increase of about 50%. LDL-C did not materially change in the continuation group. The biological effect of withdrawing statin therapy was therefore clear even though a corresponding increase in deaths or major cardiovascular events was not detected within three years.
The randomized result differs from earlier observational evidence
Earlier studies had raised concern about discontinuation. A 2019 French nationwide cohort study followed 120,173 adults who turned 75 while taking statins for primary prevention. In that observational analysis, stopping statins was associated with a 33% higher adjusted risk of hospital admission for a cardiovascular event. Because treatment was not randomly assigned, however, people who stopped could differ from those who continued in ways that influence cardiovascular risk despite statistical adjustment.
The new randomized design reduces that form of confounding and therefore adds a different level of evidence. It also arrives as prevention guidance increasingly emphasizes individualized decisions in later life. The 2026 American College of Cardiology and American Heart Association dyslipidemia guideline notes that randomized evidence in adults older than 75 remains limited and recommends balancing ASCVD prevention against multimorbidity, frailty, polypharmacy, functional decline, life expectancy, and patient preferences.
That broader risk discussion overlaps with other cardiovascular decisions, including how cholesterol and cardiovascular risk change across the life course and how treatments such as GLP-1 drugs can affect cardiovascular outcomes beyond their original indications.
What the evidence cannot yet answer
Three years is a meaningful follow-up period, but preventive statin benefits can accumulate over longer periods. The investigators therefore caution that the trial cannot establish whether stopping treatment changes cardiovascular disease or mortality risk beyond the study window. A rise in LDL-C may take longer than three years to translate into a detectable difference in clinical events.
The study was also open-label, meaning participants and clinicians knew which treatment had been assigned. Although death is an objective endpoint, knowledge of treatment can influence other aspects of care. The trial was conducted in France, so its findings may not transfer perfectly to populations with different baseline cardiovascular risk, prescribing patterns, health systems, or demographic characteristics.
Most importantly, these results apply to older adults using statins for primary prevention. They should not be extrapolated to people with previous myocardial infarction, stroke, or established ASCVD, for whom statins are used as secondary prevention and the expected cardiovascular benefit is different.
The result supports a conversation, not an automatic stop date
The trial does not establish age 75 as a point at which statins should routinely be discontinued. Instead, it provides evidence that, for selected adults aged 75 or older without prior cardiovascular disease, stopping a statin did not worsen three-year survival in this study even though LDL-C rose substantially.
For an individual patient, the decision still depends on baseline cardiovascular risk, tolerance of treatment, other medications, frailty, life expectancy, and preferences about preventive therapy. The study authors’ framing is therefore appropriately narrow: discontinuation should be considered through individualized, shared decision-making rather than adopted as a general recommendation for older adults.
References
- Bonnet F, et al. 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. The Lancet Healthy Longevity, 2026. DOI: 10.1016/j.lanhl.2026.100884
- Giral P, Neumann A, Weill A, Coste J. Cardiovascular effect of discontinuing statins for primary prevention at the age of 75 years: a nationwide population-based cohort study in France. European Heart Journal, 2019;40:3516-3525. DOI: 10.1093/eurheartj/ehz458