(Photo by Shane Maritch on Shutterstock)
In a nutshell
Current guidelines restricting aspirin based on age alone may be flawed; researchers argue decisions should be based on individual cardiovascular risk rather than arbitrary age cutoffs.
The ASPREE trial that led to age-based restrictions was terminated early and used unusual endpoints, making it an “uninformative” basis for sweeping guideline changes.
Patients with higher cardiovascular risk (above 10% over 10 years) may benefit from aspirin regardless of age, and should discuss individual risks and benefits with their healthcare provider.
BOCA RATON, Fla. — For decades, aspirin has been a cornerstone of heart disease prevention. But recent guidelines advise against daily aspirin for adults over 60 or 70. Now, a provocative new paper challenges these recommendations, calling them “misinformed” and based on questionable evidence.
Researchers from Florida Atlantic University argue that doctors should consider each patient’s individual risk profile rather than applying blanket age cutoffs when it comes to aspirin. With cardiovascular disease killing nearly 18 million people worldwide annually, these recommendations affect millions of older adults who might benefit from this inexpensive medication.
“The reliable evidence indicates that, to do the most good for the most patients in primary prevention of heart attacks and strokes, health care providers should make individual clinical judgments about prescribing aspirin on a case-by-case basis and based on benefit-to-risk not just age alone,” said co-author Dr. Charles H. Hennekens, a professor of medicine and preventive medicine at FAU’s Schmidt College of Medicine, in a statement.
The Controversial ASPREE Trial: What You Should Know
The debate centers on a major study called ASPREE (Aspirin in Reducing Events in the Elderly), which examined aspirin use in adults 70 and older. The trial was stopped early after just four years—despite being planned for 12 years—and showed slightly higher mortality in the aspirin group.
These findings prompted the American Heart Association/American College of Cardiology to recommend aspirin only for patients under 70, and the U.S. Preventive Services Task Force later restricted it further to those under 60.
But Wittes and colleagues identify several problems with this influential trial:
ASPREE used an unusual combined endpoint (death, dementia, and disability) different from standard heart outcomes used in previous aspirin studies
The trial’s early termination may have prevented detection of benefits that emerge with longer treatment
The unexpected finding of increased cancer deaths contradicts previous evidence suggesting aspirin might protect against certain cancers
In their paper, published in the journal Clinical Trials, researchers outline why they believe that both guideline committees were “unduly influenced by the uninformative, not null, results of the ASPREE trial.” As Hennekens notes, “It seems counterintuitive among patients taking aspirin long term to stop it just because a birth milestone is reached. Finally, absence of evidence does not equate to evidence of absence of effect.”
Whether or not you should take aspirin should be more about your individual health, not your age, doctors suggest. (Photo by fizkes on Shutterstock)
Risk vs. Age: A Better Approach to Aspirin Decisions
About 40% of American adults over 40 have metabolic syndrome—a combination of obesity, high blood pressure, abnormal cholesterol, and insulin resistance. These individuals face a 16-18% ten-year risk of heart problems, making them likely candidates for aspirin’s benefits. Yet under current guidelines, those over 60 or 70 are advised against it based solely on age.
Instead, the researchers propose that cardiovascular risk should determine who takes aspirin. For people with a 10-year cardiovascular risk above 10%, aspirin’s benefits typically outweigh its risks, regardless of age.
The authors emphasize that aspirin should complement lifestyle changes and medications like statins—not replace them. Doctors should weigh individual risk factors and potential benefits, considering age as just one factor among many.
Why Guidelines Matter
This debate highlights a fundamental tension in modern medicine: simple rules versus personalized care. Age-based cutoffs are easy to remember but may not serve all patients well. More tailored approaches potentially provide better care but require more time and clinical judgment.
For patients, especially those over 60 with multiple heart risk factors, this controversy creates uncertainty. Should they follow official guidelines or pursue a more individualized approach?
“While patient preference is always important to consider in decision-making, this assumes even greater relevance among patients in whom the absolute benefits and risks of aspirin are similar,” said Hennekens. “Patient preference may include consideration of whether the prevention of a first heart attack or stroke is more important consideration to them than their risk of a significant gastrointestinal bleed.”
The researchers argue that each patient deserves careful assessment of their specific situation—regardless of age. For a 75-year-old with several risk factors and low bleeding risk, daily aspirin might still make sense despite current guidelines.
“Guidelines for aspirin in primary prevention do not seem to be justified,” said Hennekens. “As is generally the case, the primary care provider has the most complete knowledge about the overall benefits and risks for each patient and should make individual clinical decisions.”
According to the U.S. Centers for Disease Control and Prevention, more than 859,000 Americans die of heart attacks or stroke every year, accounting for more than one-third of all U.S. deaths. These diseases take an enormous economic toll, costing $213.8 billion annually to the healthcare system and $137.4 billion in lost productivity from premature death alone.
The debate continues about aspirin’s role in preventive care, but one thing remains certain: this inexpensive pill still generates remarkable controversy. And like the research behind it, these decisions rarely fall into simple categories—they exist in shades of gray, requiring careful thought rather than rigid rules.
Paper Notes
Study Limitations
The authors acknowledge several constraints to their critique. They don’t present new clinical data, instead relying on previously published trials and meta-analyses. Their argument partly depends on the quality of these previous studies, which have their own limitations. Additionally, the authors don’t provide detailed quantitative analysis of exactly how much benefit older adults might get from aspirin or precisely which older adults would benefit most. Their argument focuses more on principles of evidence interpretation and guideline development rather than specific risk calculations or treatment algorithms. The paper also doesn’t address potential challenges of shifting from simple age-based guidelines to more individualized risk assessment approaches.
Funding and Disclosures
The authors declare they received no financial support for their article. However, they disclose various relationships with pharmaceutical companies and research organizations. Several authors serve as consultants or advisory board members for pharmaceutical companies, and some chair data monitoring committees for clinical trials. The authors specifically note they hold no stock in any pharmaceutical or medical device company. These disclosures support transparency, allowing readers to assess potential conflicts that might influence the authors’ perspective on aspirin use.
Publication Information
The article “Aspirin in primary prevention: Undue reliance on an uninformative trial led to misinformed clinical guidelines” was published in Clinical Trials in 2025. The authors include Janet Wittes, David L. DeMets, KyungMann Kim, Dennis G. Maki, Marc A. Pfeffer, J. Michael Gaziano, Panagiota Kitsantas, Charles H. Hennekens, and Sarah K. Wood, representing various institutions including Florida Atlantic University, University of Wisconsin-Madison, Harvard Medical School, Brigham and Women’s Hospital, and the VA Boston Healthcare System. The paper presents a scholarly critique rather than original research, focusing on how clinical trial evidence is interpreted and translated into practice guidelines.