Statin Discontinuation Noninferior in Adults 75+

August 13, 2026 at 13:58

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Discontinuing statin therapy was noninferior to continuation for 3-year all-cause mortality among adults aged 75 years or older who were taking statins for primary prevention and had no history of atherosclerotic cardiovascular disease (ASCVD), according to findings from the SAGA/SITE trial published online in The Lancet Healthy Longevity.

The multicenter, open-label, parallel-group, phase 3 randomized trial enrolled participants through 297 primary care offices. Eligible adults had used any statin for at least 1 year, had no ASCVD history, and could provide informed consent. Participants were assigned in a 5:4 ratio to continue or stop therapy and were followed for 36 months.

Investigators randomized 1180 participants between June 15, 2016, and January 7, 2020; 1160 were included in the primary estimand analysis. The continuation group included 639 participants and the discontinuation group 521. Median age was 80 years, 66.8% were women, 29.5% had diabetes, and 77.2% had hypertension.

At 36 months, 48 of 604 participants (7.9%) in the continuation group and 35 of 484 (7.2%) in the discontinuation group had died. The absolute between-group difference in all-cause mortality was −0.68 percentage points (95% CI, −3.95 to 2.60). The upper confidence limit remained below the prespecified noninferiority margin of 5 percentage points.

Adverse events were reported in 461 of 631 participants (73.1%) in the continuation group and 390 of 527 (74.0%) in the discontinuation group. Noncardiovascular adverse events occurred in 72.3% and 72.7%, respectively. Investigators said the findings support individualized decisions about statin discontinuation for older adults matching the trial population; people with previous ASCVD, diagnosed dementia, or a progressive disease with a life expectancy of 3 months or less were outside the study population.