Concomitant Oral Anticoagulant and Nonsteroidal Anti-Inflammatory Drug Therapy in Patients With Atrial Fibrillation.

Autor: Kent AP; Department of Internal Medicine, Bridgeport Hospital, Yale New Haven Health, Bridgeport, Connecticut., Brueckmann M; Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany; University of Heidelberg, Mannheim, Germany., Fraessdorf M; Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany., Connolly SJ; McMaster University and Hamilton Health Sciences, Population Health Research Institute, Hamilton, Ontario, Canada., Yusuf S; McMaster University and Hamilton Health Sciences, Population Health Research Institute, Hamilton, Ontario, Canada., Eikelboom JW; McMaster University and Hamilton Health Sciences, Population Health Research Institute, Hamilton, Ontario, Canada., Oldgren J; Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden., Reilly PA; Clinical Development, Cardiology, Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut., Wallentin L; Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden., Ezekowitz MD; Sidney Kimmel Medical College at Thomas Jefferson University and Lankenau and Bryn Mawr Hospitals, Philadelphia, Pennsylvania. Electronic address: michael.ezekowitz@comcast.net.
Jazyk: angličtina
Zdroj: Journal of the American College of Cardiology [J Am Coll Cardiol] 2018 Jul 17; Vol. 72 (3), pp. 255-267. Date of Electronic Publication: 2018 Jul 09.
DOI: 10.1016/j.jacc.2018.04.063
Abstrakt: Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used medications that can potentially increase the risk of bleeding and thrombosis.
Objectives: This study quantified the effect of NSAIDs in the RE-LY (Randomized Evaluation of Long Term Anticoagulant Therapy) trial.
Methods: This was a post hoc analysis of NSAIDs in the RE-LY study, which compared dabigatran etexilate (DE) 150 and 110 mg twice daily (b.i.d.) with warfarin in patients with atrial fibrillation. Treatment-independent, multivariate-adjusted Cox regression analysis assessed clinical outcomes by comparing NSAID use with no NSAID use. Interaction analysis was obtained from treatment-dependent Cox regression modeling. Time-varying covariate analysis for NSAID use was applied to the Cox model.
Results: Among 18,113 patients in the RE-LY study, 2,279 patients used NSAIDs at least once during the trial. Major bleeding was significantly elevated with NSAID use (hazard ratio [HR]: 1.68; 95% confidence interval [CI]: 1.40 to 2.02; p < 0.0001). NSAID use did not significantly alter the risk of major bleeding for DE 150 or 110 mg b.i.d. relative to warfarin (p interaction  = 0.63 and 0.93, respectively). Gastrointestinal major bleeding was significantly elevated with NSAID use (HR: 1.81; 95% CI: 1.35 to 2.43; p < 0.0001). The rate of stroke or systemic embolism (stroke/SE) with NSAID use was significantly elevated (HR: 1.50; 95% CI: 1.12 to 2.01; p = 0.007). The use of NSAIDs did not significantly alter the relative efficacy on stroke/SE for DE 150 or 110 mg b.i.d. relative to warfarin (p interaction  = 0.59 and 0.54, respectively). Myocardial infarction rates were similar with NSAID use compared with no NSAID use (HR: 1.22; 95% CI: 0.77 to 1.93; p = 0.40). Patients were more frequently hospitalized if they used an NSAID (HR: 1.64; 95% CI: 1.51 to 1.77; p < 0.0001).
Conclusions: The use of NSAIDs was associated with increased risk of major bleeding, stroke/SE, and hospitalization. The safety and efficacy of DE 150 and 110 mg b.i.d. relative to warfarin were not altered. (Randomized Evaluation of Long Term Anticoagulant Therapy [RE-LY]; NCT00262600).
(Copyright © 2018. Published by Elsevier Inc.)
Databáze: MEDLINE
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