Statin Discontinuation in Adults >=75, Study finds No Clear Benefit of Stopping

In order to confirm the non-inferiority of statin discontinuation, a multicenter, open-label, parallel-group, phase 3 randomized control trial was carried out (ClinicalTrials.gov: NCT02547883). From June 15, 2016, to January 7, 2020, 1,180 individuals were allocated into two groups at a ratio of 5:4, depending on whether they continued with or stopped taking their present statins. The exclusion criteria included progressive fatal disease with an estimated survival time of 3 months or less, clinical dementia diagnosis, homozygous or double heterozygous familial hypercholesterolemia, or inability to give informed consent.

The primary estimand analysis comprised 1,160 patients (639 patients in the continuation group and 521 patients in the discontinuation group) who were eligible according to the criteria and followed their prescribed therapeutic regimen within 90 days after enrollment. The average age of the participants was 80 years (IQR: 78-84), with 775 (66.8%) being women, 342 (29.5%) having diabetes mellitus, and 896 (77.2%) having hypertension. The primary outcome was death due to any cause after 36 months of follow-up using a prespecified non-inferiority margin of 5.0%.

Key findings:

• Out of the total 1,180 randomized participants, 1,160 participants were analyzed in the primary analysis, where 639 participants were assigned to continue taking the statins, whereas 521 participants were asked to stop taking the statins.
• In the 36-month follow-up period, 48 (7.9%) out of 604 participants assigned to continue the use of statins, and 35 (7.2%) of 484 participants assigned to discontinue statins died.
• Thus, the difference in all-cause mortality between the two groups was −0.68% (95% CI −3.95 to 2.60%).
• Since the upper limit of the 95% CI (+2.60%) was lower than the prespecified 5.0% margin, non-inferiority was demonstrated.
• The adverse events happened in 461 (73.1%) of 631 participants assigned to the continuation group, and 390 (74.0%) out of 527 participants assigned to discontinuation.

Statin discontinuation among adult patients aged 75 years or older undergoing primary prevention treatment without a past medical history of ASCVD has been proven to be as safe as continued therapy based on the risk of all-cause mortality within three years.

Reference:

Bonnet, F., Poulizac, P., Rousselot, N., Couffinhal, T., Galli, G., Berdaï, D., Vandenhende, M.-A., Rousset, M., Coueron, R., Bénard, A., Joseph, J.-P., Adam, C., Aimé, B., Alexandre, B., Allaoui, K., Amendola, M., Angoulvant, C., Archambault, P., Ariza, M., … Zimmermann, S. (2026). 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, 100884. https://doi.org/10.1016/j.lanhl.2026.100884