Discontinuing Statins in Older Adults without Cardiovascular Disease

BackgroundWhether 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. MethodsWe 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. ResultsA 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. ConclusionsAmong 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.)

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Journal
New England Journal of Medicine
Published
2026-11-07
DOI
https://doi.org/10.1056/nejmoa2606634
Primary Topic
Lipoproteins and Cardiovascular Health
Type
article
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0.00

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article

Discontinuing Statins in Older Adults without Cardiovascular Disease

Rosalinde K. E. Poortvliet, Pierre Poulizac, Luise Adam, Jacobijn Gussekloo et al.
New England Journal of Medicine
Lipoproteins and Cardiovascular Health
article

Discontinuing Statins in Older Adults without Cardiovascular Disease

Rosalinde K. E. Poortvliet, Pierre Poulizac, Luise Adam, Jacobijn Gussekloo, Maria Monika Wertli, Marie Méan, Luca Gabutti, Lara Brockhus, Jürg Hans Beer, Roxane de La Harpe, Drahomir Aujesky, Nicolas Rodondi, Philipp Schüetz, Nathalie Schwab, Dina Zekry, Claudia Gregoriano, Manuel R. Blum, Stéphanie Baggio, Sven Trelle, Martin Feller, Moa Lina Haller, Tamar Itach, Sebastian Carballo, Bariş Gencer, Fabrice Bonnet, Rita F. Redberg, Simon P. Mooijaart, Julia B. Bardoczi, Philip Greenland, Philipp Aebi, Julian Simon Flury, Douglas Charles Bauer, Alan Gary Haynes
article en

Abstract

BackgroundWhether 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. MethodsWe 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. ResultsA 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. ConclusionsAmong 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.)

New England Journal of Medicine
Northwestern University (US), University of Geneva (CH), University of Bern (CH), Université de Bordeaux (FR), Inserm (FR), University of California, San Francisco (US), University of Basel (CH), University of Zurich (CH), Leiden University Medical Center (NL), University Hospital of Bern (CH), Centre Hospitalier Universitaire Vaudois (CH), Centre Hospitalier Universitaire de Bordeaux (FR), Ospedale regionale di Lugano (CH), Ente Ospedaliero Cantonale (CH), Privatklinik Meiringen (CH), Bordeaux Population Health (FR), University Hospital of Geneva (CH), Hôpital Saint-André (FR), Spitäler Schaffhausen (CH), Kantonsspital Baden (CH), Northwestern Medicine (US), Kantonsspital Aarau (CH), Università della Svizzera italiana (CH), University of Lausanne (CH)
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Gottfried und Julia Bangerter-Rhyner-Stiftung
Good health and well-being
Openalex Percentile: Top 13%
Lipoproteins and Cardiovascular Health
DOISourceOpenAlex
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