French study finds stopping statins at 75 doesn't increase mortality in low-risk patients

Aug 11, 2026

The French SAGA/SITE randomized controlled trial reveals that stopping statins in healthy adults aged 75 and older does not increase 3-year mortality. Among 1,160 participants, 7.2% of those who discontinued statins died compared to 7.9% who continued, confirming non-inferiority. While stopping statins triggered a 50% jump in LDL cholesterol, it did not lead to a significant increase in heart attacks or strokes, supporting individualized clinical decisions.

Statin discontinuation trial design

▪Participants in the SAGA/SITE trial were randomly assigned in an unbalanced 5:4 ratio to either continue or discontinue their statin therapy and were followed up for 36 months.
▪The SAGA/SITE trial enrolled 1,160 participants aged 75 years or older with no history of atherosclerotic cardiovascular disease who had been prescribed statins for primary prevention for at least one year.
▪The SAGA/SITE study was a multicentre, open-label, parallel-group, phase 3 randomised controlled trial conducted across 297 primary care offices in France to evaluate the non-inferiority of statin cessation in adults aged 75 years or older.

All-cause mortality outcomes

▪The absolute difference in all-cause mortality between the statin continuation and discontinuation groups at 36 months was -0.68%, which did not exceed the prespecified 5% non-inferiority margin.
▪At 36 months, 7.2% of participants in the statin discontinuation group and 7.9% of participants in the statin continuation group had died, demonstrating that discontinuation was non-inferior to continuation.

Cardiovascular event rates

▪The SAGA/SITE trial found no significant difference in major cardiovascular events, including heart attacks and strokes, between participants who stopped statins and those who continued.
▪Prior non-randomized cohort studies from 2021 in Denmark and Italy showed an approximate 30% higher risk for fatal and nonfatal cardiovascular outcomes after statins were discontinued in older adults.

LDL cholesterol level changes

▪The SAGA/SITE trial authors noted that scientific literature shows the link between cholesterol levels and cardiovascular events weakens as individuals age.
▪After three months of statin discontinuation, the SAGA/SITE trial participants who stopped statins experienced a 50% increase in LDL cholesterol, climbing from 115 to 171 mg/dL, while the continuation group saw no change.

French population health characteristics

▪The SAGA/SITE trial was conducted in France, which has universal health care, a higher longevity than the United States, and the lowest burden of cardiovascular mortality among high-income countries.
▪The 3-year mortality rates of 7.2% and 7.9% observed in the SAGA/SITE trial groups were approximately half of the French national average mortality rate of 15% for that age group.

Statin side effects profile

▪Adverse events occurred in 73.1% of participants in the statin continuation group and 74.0% of participants in the statin discontinuation group during the SAGA/SITE trial.
▪Statins are associated with muscle pain in approximately 1% of users and a small increase in blood sugar levels that can transition patients on the cusp into type 2 diabetes.