TL;DR
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In the STREAM trial, stopping statins in adults 70 and older taking them to prevent a first cardiovascular event met the study’s two-year non-inferiority criterion. Cardiovascular events were numerically more common after discontinuation, and stopping did not improve measured quality-of-life outcomes, leaving the decision to individual discussions with clinicians.
The STREAM randomized trial found that adults aged 70 and older taking statins to prevent a first cardiovascular event could stop treatment without significantly reducing average event-free time over two years, meeting the trial’s non-inferiority criterion. But cardiovascular events were numerically more frequent after discontinuation, and researchers reported no improvement in quality-of-life measures, so the findings do not establish that stopping is equally safe over the longer term.
STREAM included 1,880 adults aged 70 or older who had at least two chronic conditions, no established cardiovascular disease, and were taking statins for primary prevention. Participants were randomly assigned to stop or continue treatment. Their average age was 77.5 years, 46.9% were women, and nearly one-third had diabetes. More than half were recruited through primary care rather than hospitals.
Over two years, the trial’s composite outcome—heart attack, ischemic stroke, or death—occurred in 10.7% of participants assigned to stop statins and 8.2% assigned to continue. The difference was not statistically significant under the study’s primary analysis. Average event-free survival was 96.5 weeks after discontinuation and 98.5 weeks with continuation; the result met the prespecified non-inferiority test, with P<0.001. The event-rate difference is a numerical finding, not proof that stopping caused additional events.
Across the available follow-up, with a median of 103 weeks, cardiovascular events were also numerically higher in the discontinuation group: 12.7% versus 9.2%. The researchers found no meaningful difference in measured patient-centered outcomes such as pain, falls, or sarcopenia. Serious adverse events were reported in 43.0% of the discontinuation group and 39.8% of the continuation group.
The Trade-Off Behind Stopping Statins
The findings address a practical question for older adults who take statins despite having no diagnosed cardiovascular disease: whether reducing medication burden can be done without an unacceptable increase in risk. STREAM offers randomized evidence that stopping met the study’s two-year non-inferiority standard in its particular group of older adults with multiple conditions. That result may inform conversations about treatment priorities, competing health problems, and expected lifespan.
However, the numerical event differences and lack of quality-of-life improvement make the result more qualified than a simple endorsement of stopping. The trial did not show that discontinuation improves how participants feel, and it cannot settle the longer-term cardiovascular effects. The decision is therefore a patient-specific clinical discussion, not a general recommendation for all older statin users.
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How the STREAM Trial Was Designed
STREAM was an open-label European non-inferiority trial conducted from 2021 through 2025. Participants and clinicians knew whether statins were stopped or continued. At enrollment, average LDL cholesterol was 88.9 mg/dL in both groups. Most participants used moderate-intensity statins; smaller proportions used low- or high-intensity treatment.
In a subset of 235 participants whose lipids were measured at 12 months, LDL cholesterol averaged 176.0 mg/dL after discontinuation and 99.4 mg/dL with continuation. The trial was presented at the American Heart Association’s annual meeting in Chicago and published at the same time in the New England Journal of Medicine. Its results add to the evidence from the SITE/SAGA trial, which also reported no significant mortality increase after statin discontinuation but did not find a quality-of-life improvement.
“Generally safe”
— Nicolas Rodondi, MD, MAS, University of Bern
Limits of the Safety Evidence
STREAM’s non-inferiority result applies to its specified outcome, population, and two-year assessment; it does not prove that stopping and continuing have identical effects or establish safety over a longer period. The trial was not blinded, and the investigators reported substantial treatment crossovers, which can complicate interpretation. The reported subgroup findings—including potentially more favorable results for participants with diabetes and relatively healthy people recruited outside hospitals—do not establish who benefits from stopping.
The trial also cannot resolve how other cardiovascular prevention medicines used during follow-up may have affected outcomes. Researchers said those co-treatments could bias results and called for additional randomized trials focused on specific drugs. It remains unclear whether the numerical difference in cardiovascular events reflects a true treatment effect or chance, and whether outcomes would change with longer follow-up.
Further Trials and Individual Reviews
The STREAM investigators said additional randomized discontinuation trials are needed, with closer assessment of other preventive medicines taken during follow-up. In the meantime, the results are likely to inform clinician-patient discussions rather than prompt a broad change in treatment. People considering stopping a prescribed statin should discuss their cardiovascular risk, other conditions, treatment goals, and alternatives with a qualified clinician; the trial does not establish a one-size-fits-all approach.
Key Questions
Did STREAM prove that stopping statins is safe for everyone over 70?
No. It studied adults aged 70 and older with at least two chronic conditions who were taking statins for primary prevention. Its two-year result met a defined non-inferiority test, but it does not establish safety for every older adult or over longer periods.
Were cardiovascular events more common after stopping?
They were numerically more common in the discontinuation group: 10.7% versus 8.2% over two years, and 12.7% versus 9.2% across a median 103 weeks of available follow-up. These figures do not by themselves prove that stopping caused the difference.
Did participants feel better after stopping statins?
The trial reported no meaningful difference in measured outcomes including pain, falls, and sarcopenia. It did not find a quality-of-life benefit from discontinuation.
Should an older adult stop a statin based on this study?
The study does not give a universal recommendation. Its authors and presenters emphasized individual decision-making. Anyone considering a change should discuss it with a qualified clinician who can review their health and treatment goals.
Source: medpagetoday.com
