The SAGA/SITE trial found stopping statins was non-inferior to continuing them for 3-year mortality in adults 75 and older without ASCVD.
Written By: Anamika Koshti, PharmD
Reviewed By: Pharmacally Editorial Team
Statins are widely used to lower cholesterol and reduce the risk of heart attacks and strokes. However, evidence supporting their use for primary prevention becomes less certain in very old adults, particularly those who have never had a heart attack, stroke, or other established atherosclerotic cardiovascular disease (ASCVD).
As people age, treatment decisions may also become more complex because of other health conditions, multiple medications, life expectancy, and individual preferences. The question is therefore not simply whether statins lower LDL cholesterol, but whether continuing treatment still provides enough overall benefit for an individual older adult.
A study published in The Lancet Healthy Longevity examined this question in the SAGA/SITE trial (NCT02547883), the first randomized trial to directly evaluate whether statins can be discontinued in adults aged 75 or older who are taking them for primary prevention.
What Did the SAGA/SITE Trial Test?
The multicentre randomized trial enrolled 1,180 adults aged 75 or older in France who had been taking a statin for at least one year for primary prevention and had no previous ASCVD.
Participants were assigned either to continue their statin or discontinue treatment and were followed for 36 months. The median age was 80 years, 66.8% were women, 29.5% had diabetes, and 77.2% had hypertension.
The main question was whether stopping statins would result in no more than a prespecified increase in all-cause mortality over three years.
What Happened When Statins Were Stopped?
After three years, 7.2% of participants who discontinued statins had died compared with 7.9% of those who continued treatment.
The difference in mortality was −0.68 percentage points, with a 95% confidence interval of −3.95 to 2.60. This met the trial’s prespecified criteria for non-inferiority, meaning that discontinuing statins did not result in a sufficiently greater risk of death to be considered worse than continuing treatment within the study’s predefined margin.
Major cardiovascular events were also not significantly different between the groups, occurring in 5.0% of participants who discontinued statins and 4.4% of those who continued.
However, stopping treatment had a clear effect on cholesterol levels. LDL cholesterol increased by approximately 50%, from about 115 mg/dL to 171 mg/dL after discontinuation.
Did Stopping Statins Improve Quality of Life?
Not significantly.
The study did not find a meaningful improvement in quality-of-life measures among participants who stopped treatment. Overall adverse-event rates were also similar between the two groups.
This means that although discontinuation did not increase three-year mortality in the study population, the findings do not show that stopping statins necessarily makes older adults feel better or reduces treatment-related adverse events.
What Should Older Adults Take from These Findings?
The results are most relevant to adults aged 75 or older who have never had ASCVD and are taking a statin solely for primary prevention.
For these patients, the study suggests that discontinuing a statin can be considered as part of an individualized discussion with a healthcare professional. The decision should take into account the person’s cardiovascular risk, other health conditions, life expectancy, medication burden, and preferences.
The findings should not be interpreted as a recommendation for all adults over 75 to stop statins. They also do not apply directly to people taking statins for secondary prevention after a heart attack, stroke, or other established ASCVD.
What Are the Important Limitations?
The trial was smaller than originally planned, with 1,180 participants enrolled instead of the planned 2,430. This reduced the precision of some analyses, particularly subgroup comparisons. Non-inferiority was not established in every prespecified subgroup because confidence intervals were wide.
The follow-up was also limited to three years, so the study cannot determine whether the same findings would persist over a substantially longer period.
The study does not settle the question for every older adult. Instead, it provides clinicians and patients with additional evidence to weigh when deciding whether the potential benefits of continued statin therapy justify ongoing treatment later in life.
Reference
About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.