December 03, 2019
By Reuters Staff
NEW YORK (Reuters Health) - Patients with atrial fibrillation commonly use nonsteroidal anti-inflammatory drugs (NSAIDs) along with oral anticoagulants, a practice that increases their risk of bleeding, according to findings from the ARISTOTLE trial.
The concomitant use of NSAIDs and vitamin K antagonists (VKA) is associated with an increased risk of bleeding in patients with atrial fibrillation (AF), but little is known about whether NSAIDs affect bleeding risk in patients with AF treated with non-VKA oral anticoagulants (NOACs) like apixaban, rivaroxaban and edoxaban.
Dr. Sana M. Al-Khatib of Duke Clinical Research Institute, Duke University, in Durham, North Carolina, and colleagues examined the use of NSAIDs in patients with AF anticoagulated with apixaban or warfarin in their post-hoc analysis of the ARISTOTLE randomized controlled trial of more than 18,000 patients with AF and at least one additional risk factor for stroke.
At baseline, 4.8% of the 17,423 patients included in this analysis reported use of NSAIDs, and an additional 13.2% of patients reported the use of NSAIDs during follow-up.
Overall, the use of NSAIDs was not significantly associated with major bleeding, gastrointestinal bleeding, or clinically relevant non-major (CRNM) bleeding.
After excluding baseline use of NSAIDs, however, the use of NSAIDs during the trial was associated with 61% higher risk of major bleeding and 70% higher risk of CRNM bleeding (but not with a significantly higher risk of gastrointestinal bleeding), compared with NSAID non-use, the researchers report in Circulation, online November 21.
NSAID use during the trial did not appear to be associated with a significant change in the safety or efficacy of apixaban relative to warfarin.
"This study warrants more investigation of the effect of NSAIDs on the outcomes of patients treated with apixaban," the authors conclude.
Bristol-Myers Squibb and Pfizer funded the ARISTOTLE trial and had various relationships with several authors of the new report.
Dr. Al-Khatib did not respond to a request for comments.
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