New Anticoagulants (Dabigatran, Apixaban, Rivaroxaban) for Stroke Prevention in Atrial Fibrillation

Aguilar, Maria I.; Kuo, Ruth; Freeman, William D.

doi:10.1016/j.ncl.2013.03.001

Cited by 5 publications

(1 citation statement)

References 35 publications

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“…In recent years, multiple non-vitamin K dependent oral anticoagulants (NOACs), which do not require frequent laboratory monitoring and dose adjustments, have been approved on the basis of large, randomised controlled trials (7). Dabigatran, a direct thrombin inhibitor (8), was the first such agent approved by the US Food and Drug Administration (FDA) in 2010 for stroke and systemic embolism risk reduction in nonvalvular AF (NVAF) patients on the basis of the Randomized Evaluation of Long-Term Anticoagulation therapy (RE-LY) trial (9,10).…”

Section: Introductionmentioning

confidence: 99%

A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system

Villines

Schnee²,

Fraeman³

et al. 2015

Thromb Haemost

107

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Dabigatran is approved for stroke risk reduction in patients with nonvalvular atrial fibrillation (NVAF). Data from diverse clinical practice settings will help establish whether the risk:benefit ratio seen in clinical trials is comparable with routine clinical care. This study aimed to compare the safety and effectiveness of dabigatran and warfarin in clinical practice. We undertook a propensity score-matched (PSM) cohort study (N=12,793 per group; mean age 74) comparing treatment with dabigatran or warfarin in the US Department of Defense claims database, October 2009 to July 2013. Treatment-naïve patients with first prescription claim for dabigatran (either FDA-approved dose) or warfarin between October 2010 and July 2012 (index) and a diagnosis of NVAF during the 12 months before index date were included. Primary outcomes were stroke and major bleeding. Secondary outcomes included ischaemic and haemorrhagic stroke, major gastrointestinal (GI), urogenital or other bleeding, myocardial infarction (MI) and death. Time-to-event was investigated using Kaplan-Meier survival analyses. Outcomes comparisons were made utilising Cox-proportional hazards models of PSM groups. Dabigatran users experienced fewer strokes (adjusted hazard ratio [95 % confidence intervals] 0.73 [0.55-0.97]), major intracranial (0.49 [0.30-0.79]), urogenital (0.36 [0.18-0.74]) and other (0.38 [0.22-0.66]) bleeding, MI (0.65 [0.45-0.95]) and deaths (0.64 [0.55-0.74]) than the warfarin group. Major bleeding (0.87 [0.74-1.03]) and major GI bleeding (1.13 [0.94-1.37]) was similar between groups and major lower GI bleeding events were more frequent (1.30 [1.04-1.62]) with dabigatran. In conclusion, compared with warfarin, dabigatran treatment was associated with a lower risk of stroke and most outcomes measured, but increased incidence of major lower GI bleeding.

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Section: Introductionmentioning

confidence: 99%