Efficacy and Safety Outcomes of Direct Oral Anticoagulants and Amiodarone in Patients with Atrial Fibrillation
Autor: | Carola Maraboto, John D. Fisher, Kevin J. Ferrick, David F. Briceno, Soo G. Kim, Jay N. Gross, Bradley Peltzer, Jorge Romero, Florentino Lupercio, Andrew Krumerman, Pedro A. Villablanca, Luigi Di Biase |
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Rok vydání: | 2017 |
Předmět: |
medicine.medical_specialty
Administration Oral Amiodarone Hemorrhage 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Atrial Fibrillation medicine Humans Drug Interactions 030212 general & internal medicine Stroke Randomized Controlled Trials as Topic business.industry Warfarin Anticoagulants Atrial fibrillation General Medicine medicine.disease Clinical trial Concomitant Relative risk Cardiology Drug Therapy Combination business Anti-Arrhythmia Agents medicine.drug |
Zdroj: | The American journal of medicine. 131(5) |
ISSN: | 1555-7162 |
Popis: | Background Direct oral anticoagulants (DOACs) and amiodarone are widely used in the treatment of nonvalvular atrial fibrillation. The DOACs are P-glycoprotein (P-gp) and cytochrome p-450 (CYP3A4) substrates. Direct oral anticoagulant levels may be increased by the concomitant use of potent dual P-gp/CYP3A4 inhibitors, such as amiodarone, which can potentially translate into adverse clinical outcomes. We aimed to assess the efficacy and safety of drug–drug interaction by the concomitant use of DOACs and amiodarone. Methods We performed a systematic review of MEDLINE, the Cochrane Central Register of Clinical Trials, and Embase, limiting our search to randomized controlled trials of patients with atrial fibrillation that have compared DOACs versus warfarin for prophylaxis of stroke or systemic embolism, to analyze the impact on stroke or systemic embolism, major bleeding, and intracranial bleeding risk in patients with concomitant use of amiodarone. Risk ratio (RR) 95% confidence intervals were measured using the Mantel-Haenszel method. The fixed effects model was used owing to heterogeneity ( I 2 ) Results Four trials with a total of 71,683 patients were analyzed, from which 5% of patients (n = 3212) were concomitantly taking DOAC and amiodarone. We found no statistically significant difference for any of the clinical outcomes (stroke or systemic embolism [RR 0.85; 95% CI, 0.67-1.06], major bleeding [RR 0.91; 95% CI, 0.77-1.07], or intracranial bleeding [RR 1.10; 95% CI, 0.68-1.78]) among patients taking DOAC and amiodarone versus DOAC without amiodarone. Conclusion On the basis of the results of this meta-analysis, co-administration of DOACs and amiodarone, a dual P-gp/CYP3A4 inhibitor, does not seem to affect efficacy or safety outcomes in patients with atrial fibrillation. |
Databáze: | OpenAIRE |
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