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March 11, 2015
Even Limited Use of NSAIDs Increases Bleeding, CV
Events in MI Patients

Hellerup, Denmark—Using nonsteroidal anti-inflammatory drugs (NSAIDs)—even in the short term—increases risks of bleeding and cardiovascular events in patients receiving antithrombotic therapy after a heart attack, according to a new study.

The research, published recently in the Journal of the American Medical Association, notes that guidelines recommend that all patients with myocardial infarction (MI) be prescribed dual antithrombotic therapy, such as aspirin and clopidogrel, for up to a year afterwards and then be instructed to stay on one agent.

In the United States, more than 70 million prescriptions are written for NSAIDs each year and, although OTCs weren’t included in this study, another $30 billion worth are sold OTC.

In addition to increasing bleeding risks, certain NSAIDs may also impede the antithrombotic effects of aspirin and increase risk of cardiovascular events, warns the study, led by researchers from Copenhagen University Hospital Gentofte. The authors emphasize that the risks have significant public health ramifications, considering the widespread use of NSAIDs.

To examine the risk of bleeding and cardiovascular events among patients with prior MI on concurrent antithrombotic therapy and NSAIDs, researchers employed nationwide administrative registries in Denmark from 2002 to 2011, including patients 30 years or older admitted with first-time MI and alive 30 days after hospital discharge. The study then determined if the patients had subsequent treatment with aspirin, clopidogrel, or other oral anticoagulants and their combinations and if NSAIDs were used at the same time.

Of the 61,971 patients, average age 68 years, 34% filled at least one NSAID prescription. With 29.2% of the patients dying during a median follow-up of 3.5 years, 5,288 bleeding events (8.5%) and 18,568 cardiovascular events (30%) occurred.

NSAID treatment appeared to double the risk of bleeding compared to no NSAID use. The crude incidence rates of bleeding, measured in events per 100 person-years, were 4.2 with concomitant NSAID treatment and 2.2 without. By the same measure, the rates of cardiovascular events were 11.2 with NSAID therapy versus 8.3 without.

The increased risks occurred with combined use of NSAIDs and antithrombotic therapy, regardless of which antithrombotic agents were used, types of NSAIDs, or duration of use, according to the study.

“There was no safe therapeutic window for concomitant NSAID use, because even short-term (0-3 days) treatment was associated with increased risk of bleeding compared with no NSAID use,” the authors write. “Confirming previous studies and despite increased bleeding complications, NSAIDs were not associated with decreased cardiovascular risk.”

While the authors call for more research to confirm the findings, they also warn that “appropriate caution” should be used when prescribing NSAIDs for patients who have recently suffered a MI.

In an accompanying editorial, Charles L. Campbell, MD, of the University of Tennessee-Chattanooga, and David J. Moliterno, MD, of the University of Kentucky, Lexington, suggest, “The cumulative evidence available is an important reminder that the while NSAIDs can be helpful and at times necessary medications for satisfactory quality of life, use of these medications among patients with a history of a recent MI is likely to be associated with clinically meaningful bleeding and ischemic risks.”

“Because the present study tracked only prescription NSAID use,” Campbell and Moliterno add, “it is plausible that an even greater health care effect might occur in many countries, such as the United States, where NSAIDs are widely available as over-the-counter medications and physicians may be unaware whether their patients are taking NSAIDs.”


U.S. Pharmacist Social Connect