Association Between Use of Non–Vitamin K Oral Anticoagulants With and Without Concurrent Medications and Risk of Major Bleeding in Nonvalvular Atrial Fibrillation

Chang, Shang‐Hung; Chou, I-Jun; Yeh, Yung‐Hsin; Chiou, Meng-Jiun; Wen, Ming‐Shien; Kuo, Chi‐Tai; See, Lai‐Chu; Kuo, Chang‐Fu

doi:10.1001/jama.2017.13883

Cited by 320 publications

(391 citation statements)

References 46 publications

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“…However, apixaban was still more effective as compared to warfarin, while in terms of major bleeding, its benefits decreased with increasing number of concomitant drugs. A study in Taiwan found an increased bleeding risk in patients with nonvalvular atrial fibrillation (NVAF) taking a DOAC along with amiodarone, fluconazole, rifampin, or phenytoin (medications with a common metabolic pathway) compared to a DOAC alone …”

Section: Introductionmentioning

confidence: 99%

Warfarin vs. apixaban in nonvalvular atrial fibrillation, and analysis by concomitant antiarrhythmic medication use: A national retrospective study

Wanat

Wang

Paranjpe

et al. 2019

Research and Practice in Thrombosis and Haemostasis

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BackgroundNo real‐world data exist on outcomes in patients on anticoagulants and concomitant antiarrhythmic medications. This study aims to compare the safety and effectiveness of apixaban and warfarin, first in patients with nonvalvular atrial fibrillation (NVAF) and then in patients on concurrent antiarrhythmic medications.MethodsA retrospective cohort study was conducted using a large US electronic medical record database (2012‐2016). Patients with NVAF on warfarin or apixaban were included. The primary endpoint was a composite of stroke (ischemic or hemorrhagic) or systemic embolism. The primary safety endpoint was major bleeding (ISTH definition). Patients were matched using propensity scoring. Univariate survival analyses were conducted by using the log‐rank test and Kaplan‐Meier survival curves. A subgroup analysis was conducted to assess outcomes on patients on concurrent antiarrhythmic medications.ResultsA total of 332 100 patients with NVAF were identified, and 20 378 were included in the propensity‐matching analysis. No baseline differences were seen in age, comorbidities, or CHA 2 DS 2‐VASc score. The primary endpoint occurred in 122 (1.2%) patients on apixaban compared to 166 (1.63%) on warfarin (hazard ratio, 0.84; 95% confidence interval [CI], 0.79‐0.88). Major bleeding occurred at a lower rate in the apixaban group (n = 600, 5.89%) compared to warfarin (n = 887, 8.71%) (odds ratio, 0.65; 95% CI, 0.58‐0.73). In patients on concurrent antiarrhythmic medications (n = 2498), there was no difference in thrombotic (1.04% vs. 1.37%; P = 0.42) or bleeding events (5.29% vs. 6.89%; P = 0.08).ConclusionApixaban was associated with reduced stroke/systemic embolism and bleeding when compared with warfarin. No difference was seen in thrombotic or bleeding events in patients on concurrent antiarrhythmic medications.

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Section: Introductionmentioning

confidence: 99%

Warfarin vs. apixaban in nonvalvular atrial fibrillation, and analysis by concomitant antiarrhythmic medication use: A national retrospective study

Wanat

Wang

Paranjpe

et al. 2019

Research and Practice in Thrombosis and Haemostasis

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“…,19 A nationwide observational cohort study in Taiwan demonstrated that use of atorvastatin was associated with a significantly lower incidence rate for major bleeding in patients with NVAF who were also taking dabigatran, rivaroxaban, or apixaban 20. These patterns TA B L E 1 Baseline characteristics and cumulative bleeding events of statin users and non-users…”

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confidence: 98%

Statins and the risk of bleeding in patients taking dabigatran

Lin

et al. 2019

Acta Neurol Scand

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Objectives: Dabigatran etexilate is a direct thrombin inhibitor that clinicians increasingly prescribe to prevent stroke in patients with non-valvular atrial fibrillation (NVAF). Clinicians also commonly prescribe statins for primary and secondary prevention of cardiovascular diseases. Little is known about the bleeding risk in patients taking a statin and dabigatran together. The aim of this study was to evaluate the safety and persistence of dabigatran after co-medication with statins. Materials and Methods:We performed a prospective, multicenter registry study of stroke patients with NVAF who initiated dabigatran therapy within 3 months after a clinically evident ischemic cerebrovascular event between 2013 and 2017. The main outcome measure was symptomatic bleeding after 90, 180, and 360 days. Results:In total, 652 patients (336 statin users, 316 non-users) were followed for 1 year after dabigatran therapy. Cox multivariate analysis demonstrated that male sex, prior use of aspirin, and concurrent use of an antiarrhythmic drug were associated with a higher risk of bleeding at 360 days. After adjusting time-dependent covariates, statin users had a significantly lower bleeding risk (adjusted hazard ratio: 0.11, P < 0.001) than non-users. Kaplan-Meier analysis indicated that patients prescribed with statins had a higher rate of bleeding-free survival (P = 0.028). Conclusion:For secondary prevention of stroke in patients with NVAF who are taking dabigatran etexilate, co-prescription with a statin was associated with a lower risk of bleeding complications. Future research is needed to determine the pharmacological mechanism underlying this effect. K E Y W O R D Santicoagulant, atrial fibrillation, bleeding, co-medication, dabigatran, statin

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“…Recently, an interesting and complex study was published on JAMA (Chang et al, ) about the bleeding risk associated with the use DOACs and 12 concurrent medications commonly prescribed that sharing common metabolic pathways with DOACs (e.g. P‐glycoprotein competitors and CYP3A4 inhibitors).…”

mentioning

confidence: 99%

Direct oral anticoagulant agents: Are they so safe?

Manfrēdi

2018

Oral Diseases

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Association Between Use of Non–Vitamin K Oral Anticoagulants With and Without Concurrent Medications and Risk of Major Bleeding in Nonvalvular Atrial Fibrillation

Cited by 320 publications

References 46 publications

Warfarin vs. apixaban in nonvalvular atrial fibrillation, and analysis by concomitant antiarrhythmic medication use: A national retrospective study

Warfarin vs. apixaban in nonvalvular atrial fibrillation, and analysis by concomitant antiarrhythmic medication use: A national retrospective study

Statins and the risk of bleeding in patients taking dabigatran

Direct oral anticoagulant agents: Are they so safe?

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