Trial in 1,880 older adults without cardiovascular disease finds statin discontinuation noninferior to continuation

Researchers published a randomized trial online Nov. 7 in the New England Journal of Medicine, timed to the American Heart Association Scientific Sessions in Chicago. Nicolas Rodondi of the University of Bern and colleagues enrolled 1,880 adults aged 70 and older who had at least two chronic conditions but no known cardiovascular disease. They were randomly assigned to stop statins and other lipid-lowering therapies or continue them. The study followed participants for a median of 103 weeks to see whether discontinuation changed the time to a first cardiovascular event.

The primary comparison used restricted mean event-free survival, a way of measuring how many event-free weeks groups accumulated over two years. The difference favoring continuation was 2.0 weeks, and noninferiority was met with a P value below 0.001. During the median 103 weeks, the composite of nonfatal myocardial infarction, nonfatal ischemic stroke, or death from any cause occurred in 12.7% of the discontinuation group and 9.2% of the continuation group. Serious adverse events were reported in 43.0% and 39.8%, respectively.

The trial's design is stronger than an observational study because randomization reduces confounding, but its result is a noninferiority finding, not proof that stopping is identical to continuing. The absolute composite event difference was 3.5 percentage points, while the relative increase in the discontinuation group was about 38% from the continuation group's 9.2% baseline. The authors said this small increased risk means no general stopping recommendation can be made, and that patients and clinicians should decide together. The source summary did not list funding.

For adults aged 70 and older with multiple chronic conditions and no prior cardiovascular disease, the study turns a routine medication decision into a shared one. In a group where polypharmacy is common, stopping therapy changes pill burden and the treatment plan, while the modest increase in events means the choice is not risk-free. The trial covers a median of about two years, so its conclusions apply to this selected group and timeframe rather than to people with established cardiovascular disease.