To aspirin or not to aspirin…That is the question

To Aspirin or Not to Aspirin…That is the Question

Most of us who have potential cardiovascular issues are told by our physicians to take a low-dose aspirin every day as a precaution. But now, that long-established advice is being refuted by new clinical studies, as reported broadly in highly respected medical journals and in the news.

A recent study refuting the previously documented benefits of low-dose aspirin therapy has been garnering significant attention. The study by McNeil and colleagues actually appears as three distinct articles in the Oct. 18, 2018 edition of the highly respected New England Journal of Medicine (NEJM).

All three papers report on findings from the same 19,114 healthy elderly (a mean 74 years) subjects from Australia and the United States; the first focuses on disability-free survival, the next on primary prevention of cardiovascular events, and the third on all-cause mortality.

In short, in the 100mg daily aspirin group there were 1) no prolongations of disability-free survival 2) no significant improvements in cardiovascular risk 3) significantly higher all-cause mortality linked to cancer-related deaths, and 4) significantly more major bleeding events. Aside from the very impressive accomplishment of three papers in the same revered journal, there are several things to consider here.

Diabetes, bleeding and prevention

First, in the same edition of the NEJM there was yet a fourth paper studying in 15,480 diabetic patients. This study found a statistically lower incidence of serious vascular events in the aspirin group that was counterbalanced by a statistically higher incidence of bleeding risk. In McNeil’s study population, only 11% of the patients in each arm had documented diabetes. These are important considerations when making an aspirin decision for patients with diabetes.

Second, it’s essential to differentiate primary prevention (stopping a first event from occurring) from secondary prevention (stopping a subsequent cardiovascular event after you’ve already had one). Both of the aforementioned studies which culminated in the four NEJM papers begin with statements on the preponderance of data showing aspirin’s benefits in secondary prevention of cardiovascular events. These new studies do not refute aspirin’s benefits in secondary prevention.

Third, in August 2018 Lancet published a similar study on aspirin for primary prevention of cardiovascular events among 12,546 patients. Patients with high risk of diabetes were excluded from this study. The data showed no benefits of aspirin and a higher incidence of gastrointestinal bleeding. The authors concluded the event incidence rate was too low to draw any conclusions about aspirin’s impact. This study was funded by Bayer.

Our recommendation

Physicians and patients must now carefully consider the abundance of very recent, evidence-based data before routinely considering an aspirin regimen, especially for primary prevention or for patients with diabetes. At RxLive®, we strongly believe that in most cases aspirin is NOT recommended for primary prevention, and that having a private consultation with a skilled clinical pharmacist such as ours is strongly advised. Contact us anytime so we can help.

Kristen Engelen, PharmD
Kristen Engelen, PharmD
Kristen Engelen, PharmD, is the chief pharmacy officer of RxLive and a certified consultant pharmacist; she has over a decade of experience in retail pharmacy settings. Kristen became an RxLive co-founder because of her passion for geriatric pharmacy, with a focus on the intersection of pharmacy and aging.