Discontinuing Statins in Older Adults without Cardiovascular Disease

Background Whether discontinuing statin therapy in older adults with at least two chronic conditions but no known cardiovascular disease affects the time to a first cardiovascular event is not well characterized. Methods We conducted an international, open-label, randomized, controlled trial that enrolled adults at least 70 years of age who were taking statins for primary prevention. Participants were randomly assigned in a 1:1 ratio to either discontinue or continue statin therapy and other lipid-lowering therapies. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal ischemic stroke, or death from any cause, whichever occurred first. The primary analysis assessed noninferiority on the basis of the between-group difference in restricted mean event-free survival time at 2 years, with a noninferiority margin of −5.2 weeks. Results A total of 1880 participants underwent randomization: 938 were assigned to the discontinuation group and 942 to the continuation group. The mean age of the participants was 77.5 years, and 46.9% were women. The between-group difference in the restricted mean event-free survival time at 2 years was −2.0 weeks (95% confidence interval, −3.7 to −0.3; P<0.001 for noninferiority). Over a median follow-up of 103 weeks, 119 participants (12.7%) in the discontinuation group and 87 (9.2%) in the continuation group had a primary-outcome event. At least one serious adverse event occurred in 43.0% of the participants in the discontinuation group and in 39.8% in the continuation group. Conclusions Among older adults with at least two chronic conditions but no known cardiovascular disease, discontinuation of statin therapy was noninferior to continuation with respect to major cardiovascular events or death from any cause at 2 years. (Funded by the Swiss National Science Foundation; STREAM ClinicalTrials.gov number, NCT05178420.)