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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.

Author information

1
Bordeaux PharmacoEpi, INSERM CIC1401, Université de Bordeaux, CHU de Bordeaux, 33076, Bordeaux, France.
2
CHU de Dijon, Service de Cardiologie, 21079, Dijon, France.
3
INSERM U1219, Université de Bordeaux, 33076, Bordeaux, France.
4
CHU de Rouen, Unité de Biostatistique, 76031, Rouen, France.
5
Hôpital Nord, Unité de Recherche Clinique Innovation et Pharmacologie, 42055, Saint-Etienne, France.

Abstract

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.

KEYWORDS:

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

PMID:
30499605
DOI:
10.1002/cpt.1318

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