Atorvastatin at a dose of 40 milligrams daily reduces the relative risk of major cardiovascular events in adults aged 70 and older without pre-existing cardiovascular disease, diabetes, or dementia, according to findings from the STAREE trial presented at the European Society of Cardiology Congress 2026 and published simultaneously in The New England Journal of Medicine.
STAREE Trial Findings on Statins in Older Adults
The Australian randomized trial evaluated participants older than 70, autosuficientes y sin demencia, diabetes, enfermedades cardiovasculares ni otra discapacidad física with a mean age of 74.7 years, comparing daily atorvastatin against a placebo over a median follow-up of 5.9 years. According to trial data, major cardiovascular events occurred in 297 participants taking atorvastatin compared to 412 in the placebo group, yielding a hazard ratio of 0.70. However, the study found no significant effect on disability-free survival, physical disability, or all-cause mortality. Dr. Sophia Zoungas of Monash University noted that the trial addresses a long-standing evidentiary gap regarding primary prevention in populations over 70.
Conversely, Dr. John M. Mandrola highlighted that the absolute risk reduction remains small, calculating a number needed to treat of 37 over six years to prevent one major adverse cardiovascular event.
LIBREXIA ACS Trial Results for Milvexian
In cardiac research presented at the same congress and published in The New England Journal of Medicine, the experimental oral factor XIa inhibitor milvexian failed to reduce cardiovascular events when administered within seven days following an acute coronary syndrome. The Phase 3 LIBREXIA ACS trial was halted for futility after an interim analysis based on 556 adjudicated efficacy endpoints. Dr. Marc S. Sabatine of Harvard Medical School observed that while the trial confirmed the drug’s anticoagulant activity without increasing fatal or intracranial bleeding, the chosen 25 mg twice-daily dose may have provided insufficient inhibition for the acute coronary setting.
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Regulatory Suspension of Avacopán in the United Kingdom
The regulatory action mirrors decisions by the European Medicines Agency and follows the retraction of the pivotal ADVOCATE trial published in The Lancet Rheumatology. Investigations by the US Food and Drug Administration indicated that primary endpoint data from the trial were compromised by unblinded personnel re-evaluating patient subsets, leading regulatory bodies to determine that available evidence no longer supports a positive benefit-risk balance for treating severe antineutrophil cytoplasmic autoantibody-associated vasculitis.
Frequently Asked Questions
- What did the STAREE trial determine about statins in older adults? The trial found that 40 mg of atorvastatin daily reduced major cardiovascular events in adults over 70 without prior heart disease, though it did not improve overall survival or reduce physical disability.
- Why was milvexian’s evaluation in acute coronary syndrome stopped? The LIBREXIA ACS trial was halted for futility because the addition of milvexian to standard antiplatelet therapy did not reduce cardiovascular events within seven days of an acute coronary syndrome.
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