Prediction of rates of thromboembolic and major bleeding outcomes with dabigatran or warfarin among patients with atrial fibrillation: new initiator cohort study.

ABSTRACT:

Objectives

 To compare stratified event rates from randomized controlled trials with predicted event rates from models developed in observational data, and assess their ability to accurately capture observed rates of thromboembolism and major bleeding for patients treated with dabigatran or warfarin as part of routine care.

Design

 New initiator cohort study.

Setting

 Data from United Health (October 2009 to June 2013), a commercial healthcare claims database in the United States.

Participants

 21 934 adults with atrial fibrillation initiating dabigatran (150 mg dose only) or warfarin treatment as part of routine care.

Main outcome measures

 Predicted annual rates of thromboembolism or major bleeding, based on estimates from randomized controlled trials,

SUBMITTER: Wang SV 

PROVIDER: S-EPMC4878389 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature