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Clin Pharmacol Ther. 2018 Nov 30. doi: 10.1002/cpt.1318. [Epub ahead of print]

Comparative effectiveness and safety of standard or reduced dose dabigatran versus rivaroxaban in non-valvular atrial fibrillation.

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Bordeaux PharmacoEpi, INSERM CIC1401, Université de Bordeaux, CHU de Bordeaux, 33076, Bordeaux, France.
CHU de Dijon, Service de Cardiologie, 21079, Dijon, France.
INSERM U1219, Université de Bordeaux, 33076, Bordeaux, France.
CHU de Rouen, Unité de Biostatistique, 76031, Rouen, France.
Hôpital Nord, Unité de Recherche Clinique Innovation et Pharmacologie, 42055, Saint-Etienne, France.


Dabigatran and rivaroxaban at standard (SD) or reduced doses (RD) have been compared to warfarin in non-valvular atrial fibrillation (NVAF), but not to each other. This was a new user study of SD and RD dabigatran or rivaroxaban for NVAF in the French healthcare database, matched on gender, age, date of first dispensing, and high-dimensional propensity score, followed 2 years. Hazard ratios [95% Confidence Intervals] of stroke or systemic embolism (SSE), major bleeding (MB) or death, were computed. In matched SD patients (8,290 per arm), mean age 67, HR for dabigatran vs. rivaroxaban were SSE 0.92 [0.67-1.26], MB 0.59 [0.39-0.90], death 0.84 [0.65-1.11]. In RD patients (7639 per arm), mean age 80, HR for dabigatran vs. rivaroxaban were SSE 0.73 [0.59-0.94], MB 0.74 [0.57-0.96], death 0.95 [0.83-1.09]. In conclusion, at either dose dabigatran had similar or better effectiveness than rivaroxaban, but lower bleeding risk. Death rates were not different. This article is protected by copyright. All rights reserved.


benefits; comparative effectiveness; dabigatran; dose-effect; pharmacoepidemiology; risks; rivaroxaban


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