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In the European STREAM trial, stopping statins in adults aged 70 or older met the study’s non-inferiority criterion for event-free survival over two years. Cardiovascular events were nevertheless numerically more frequent after discontinuation, and stopping treatment did not improve measured quality-of-life outcomes.
The European STREAM randomized trial found that adults aged 70 or older who stopped statins used for primary prevention did not have a statistically significant reduction in event-free survival compared with those who continued treatment over two years. The strategy met the trial’s non-inferiority criterion, but cardiovascular events were numerically more frequent after discontinuation, and the study found no improvement in patient-centered outcomes such as pain or falls.
STREAM enrolled 1,880 people aged 70 and older who had at least two chronic conditions, no known cardiovascular disease, and were taking statins to prevent a first cardiovascular event. Participants were randomized to stop or continue their medication. Their average age was 77.5, 46.9% were women, and nearly one-third had diabetes. The trial ran from 2021 to 2025 and was presented at the American Heart Association’s annual meeting in Chicago; it was also published in the New England Journal of Medicine.
On an intention-to-treat analysis, mean event-free survival over two years was 96.5 weeks after discontinuation and 98.5 weeks with continued statin treatment. The result met the prespecified non-inferiority test, with P<0.001. That statistical finding does not mean the groups had identical outcomes or prove that stopping statins carries no risk. The primary outcome combined heart attack, ischemic stroke and death.
Primary endpoint events occurred in 10.7% of the discontinuation group and 8.2% of the continuation group. Across the available follow-up, with a median of 103 weeks, cardiovascular events were 12.7% and 9.2%, respectively. These are numerical differences reported by the investigators; the supplied report does not establish that they represent a statistically significant increase. Serious adverse events occurred in 43.0% of those who stopped treatment and 39.8% of those who continued.
The Trade-Off Behind Stopping Statins
The findings matter because statin use in later life often involves balancing preventive treatment against other health conditions, medication burden and a person’s priorities. STREAM offers randomized evidence about stopping a drug in older adults with multiple chronic conditions, but its results do not support treating discontinuation as risk-free: event rates were numerically higher in the group assigned to stop.
The trial also found no improvement in measured outcomes including pain, falls and sarcopenia. That weakens the expectation that stopping a statin will, by itself, ease these problems. The study therefore points toward individualized discussion rather than a general rule to stop or continue treatment. Its results describe the participants and follow-up studied, not every older adult taking a statin.
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Who Took Part in STREAM
STREAM focused on primary prevention: participants were taking statins without a prior cardiovascular disease diagnosis. More than half were recruited through primary care rather than hospitals. At the start of the trial, average LDL cholesterol was 88.9 mg/dL in both groups, and most participants were taking moderate-intensity statins.
Among a subset of 235 participants whose cholesterol was measured at 12 months, LDL cholesterol averaged 176.0 mg/dL after stopping and 99.4 mg/dL with continued treatment. The investigators also cited possible biological mechanisms by which discontinuation could affect cardiovascular risk, including changes involving blood vessel function and inflammation. Those mechanisms were proposed explanations, not proof of why the trial’s event rates differed.
STREAM follows the SITE/SAGA randomized study, which the report says did not find a significant increase in mortality after discontinuation but also found no quality-of-life improvement. SITE/SAGA fell short of its planned enrollment, according to the report. Together, the trials add evidence to a question where decisions may depend on health status, treatment goals and competing risks.
“Generally safe”
— Nicolas Rodondi, MD, MAS, of Inselspital, University of Bern, presenting the STREAM results
Limits on Interpreting the Risk
The trial was open-label, so participants and researchers knew whether statins had been stopped or continued. Investigators also reported substantial crossovers during the study. These features can complicate interpretation of a randomized comparison, and the trial was not designed to settle every question about which older patients may benefit from stopping.
The reported event-rate differences were numerical; the supplied account does not give a statistical significance result for those comparisons. The study also cannot establish that discontinuation is safe over longer periods than its follow-up. A cholesterol measurement was available for only a subset of participants, and the reported subgroup observations—including findings involving people with diabetes and healthier participants recruited outside hospitals—do not establish a universal recommendation.
More Trials and Individual Decisions
The STREAM investigators said additional randomized trials are needed to study discontinuation of specific medicines in older adults. They also called for assessment of other cardiovascular preventive medications used during follow-up, since such co-treatments could bias results.
For now, the report supports discussing the trade-offs with a qualified clinician rather than stopping or continuing a statin based on age alone. The decision may depend on a person’s health conditions, treatment goals and preferences. The supplied report does not identify a further STREAM follow-up date or a new clinical guideline prompted by the findings.
Key Questions
Did STREAM prove that stopping statins is safe for everyone over 70?
No. The trial met its two-year non-inferiority criterion in a defined group of adults aged 70 or older with multiple chronic conditions and no diagnosed cardiovascular disease. That does not prove discontinuation is risk-free or that the result applies to every older adult.
Were cardiovascular events higher after participants stopped statins?
They were numerically higher in the discontinuation group: 10.7% versus 8.2% for the primary endpoint, and 12.7% versus 9.2% across the available follow-up. The supplied report does not establish that these differences were statistically significant.
Did stopping statins improve quality of life or symptoms?
The trial found no difference in measured patient-centered outcomes such as pain, falls and sarcopenia between the groups. Its results do not indicate that stopping statins improved those outcomes.
What should an older adult do about their statin?
STREAM does not provide an individual treatment recommendation. A person should discuss the potential benefits and risks of continuing or stopping treatment with a qualified clinician, taking their health and preferences into account.
Source: medpagetoday.com
