META-ANALYSIS OF SAFETY OF DABIGATRAN AND WARFARIN FOR TREATMENT OF ATRIAL FIBRILLATION

Author(s)

Aggarwal S*, Segal J Novel Health Strategies, Bethesda, MD, USA

OBJECTIVES:  Atrial fibrillation (AF) is an irregular and often rapid heart rate that commonly causes poor blood flow to the body. Dabigatran and Warfarin have shown safety and efficacy for treatment of AF. The objective of this study was to conduct meta-analysis and present evidence for safety of Dabigatran versus Warfarin for treatment of AF. METHODS: For this meta-analysis we included randomized controlled trials (RCTs) evaluating Dabigatran for the treatment of AF. We included studies that were: (1) a RCT in humans; (2) an investigation of patients with nonvalvular atrial fibrillation; (3) an evaluation of dabigatran compared with warfarin or each other; and (4) a report of results of stroke or systemic emboli and major bleeding. A systematic literature search for dabigatran trials was undertaken for the databases Pubmed, Embase, Biosis, Google Scholar, and Cochrane. Data was collected for the study size, interventions, year and total bleeding events. For meta-analysis, random effects and fixed effects models were used to obtain cumulative statistics. RESULTS: Two RCTs with a total of 12,268 patients were identified. The pooled event rate for Dabigatran for total bleeding events was 31.9% (95% CI 31%-33%). The pooled response rate for Warfarin for total bleeding events was 35.1% (95% CI 34%-37%). The cumulative relative risk  for total bleeding events with Dabigatran  versus Warfarin was 0.91 (95% CI 0.89-0.93) CONCLUSIONS: Meta-analysis shows Dabigatran has a slightly lower rate of total bleeding events compared to Warfarin.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PCV17

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Cardiovascular Disorders, Respiratory-Related Disorders

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