The Cardiologist Contorting To Compliment the STAREE Trial

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The New England Journal of Medicine recently published its print edition featuring the long-awaited STAREE trial, alongside an editorial authored by Dr. Martin Mortensen. STAREE set out to answer a fundamental, patient-centered question for millions of aging adults: Can statins help healthy people 70 and older live longer, preserve cognitive function, or prevent disability?

To appreciate why STAREE matters, you have to understand that over 90% of the statin trial literature driving clinical guidelines originates from pharmaceutical companies. Drug manufacturers design studies around tightly controlled, easily measurable markers carefully engineered to secure regulatory approvals and support marketing claims. But a commercially viable, marketable endpoint does not automatically translate into a meaningful clinical benefit for a human being taking a daily pill.

STAREE flipped that approach on its head. Publicly funded and conducted across Australian primary care practices with roughly 10,000 enrolled participants aged 70 and older, the trial asked a far more rigorous question. While the investigators measured traditional cardiovascular events, those outcomes were explicitly treated as an intermediary step. The true goal was disability-free survival—a hard composite of all-cause mortality, incident dementia, and physical disability. The trial tested whether reducing cardiovascular events translated into a tangible improvement in the duration and quality of older adults’ lives.

The answer was a resounding, unambiguous “no.” STAREE demonstrated no reduction in death, no reduction in dementia, no reduction in disability, and no reduction in the composite combining all three. On the outcome it was designed to test, the trial was a complete failure.

Enter the accompanying editorial. Despite these definitive findings, Dr. Mortensen summarizes STAREE as providing “compelling evidence for the benefit and safety of initiating statin therapy in relatively healthy older adults.” Arriving at an enthusiastic, green-light recommendation from a trial that completely missed its primary patient-centered endpoint requires a masterclass in rhetorical and analytical contortion.

First, the editorial obscures the fact that the trial investigators moved the goalposts mid-study. Mortensen opens his analysis by focusing heavily on the trial’s cardiovascular composite endpoint, presenting it as a combination of cardiovascular death, nonfatal heart attack, stroke, or coronary revascularization. What readers are not told is that revascularization was not part of the original outcome. According to the original protocol and registry, the outcome was strictly limited to cardiovascular death, nonfatal heart attack, and stroke. Enrollment began in 2015. Revascularization was tacked on in 2024—nine years into the study—after investigators realized event rates were falling short of projections. So they moved the goal posts.

Expanding an endpoint mid-trial to capture procedural numbers is critical context, but the editorial presents it as if it were the plan all along.

Second, the editorial equates procedural interventions with true clinical preservation. The statistically significant reductions touted in the study were driven almost entirely by nonfatal heart attacks and coronary revascularizations. Cardiovascular mortality itself was not reduced in the slightest. Placing a stent in a stable coronary artery is a procedure that is subjectively chosen, and proven not to reduce heart attacks, strokes, or death.

So how, pray tell, can it act as a surrogate for those outcomes?

Third, when Mortensen directly confronts the trial’s central primary outcome—the complete lack of impact on disability-free survival—he labels it a “neutral finding that warrants a nuanced interpretation.” Calling the failure of a 10,000-person, multi-year trial’s main outcome ‘neutral’ is pure gas-lighting. Thousands of seniors participated precisely so we could learn whether statins preserve independent living. that failure isn’t an incidental or ‘neutral’ footnote—it is the core finding of the entire enterprise.

Fourth, the editorial performs a complete logical inversion by reframing a lack of harm as a positive justification for intervention. Mortensen points out that statins did not statistically increase death or dementia, and declares victory. The drugs were supposed to reduce both, and failed. But Mortensen uses the absence of benefit to reassure clinicians about prescribing statins.

Gas-lighting.

Mortensen’s mandatory disclosures reveal active financial relationships with major pharmaceutical manufacturers Novartis and Eli Lilly. Once again, the Death Star selected an editorialist with commercial ties to companies that sell cholesterol-lowering drugs, to provide commentary on cholesterol-lowering trial results. While Mortensen may sincerely believe his conclusions serve public health, good intentions do not compensate for an unpersuasive, contorted interpretation.

Mortensen concludes by advocating for informed, shared decision-making in practice—a principle on which we agree. However, genuine shared decision-making cannot happen when trial results are repackaged to hide their primary failures. Telling an older patient “your cholesterol is high, take this pill” is not shared decision-making. Honest consent requires informing patients that while statins may lower the risk of certain nonfatal and procedural events, large-scale public trials prove they do not help healthy older adults live longer, prevent dementia, or avoid disability—all while carrying established risks of diabetes and muscle problems.

STAREE asked the right question, and came to the right answer. Perhaps the commentary should do the same.