Dabigatran Linked to More Bleeding Events Than Warfarin in Atrial Fibrillation — Physician’s First Watch

Medical News |
November 4, 2014

Dabigatran Linked to More Bleeding Events Than Warfarin in Atrial Fibrillation

By Amy Orciari Herman

Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD

Dabigatran is associated with greater bleeding risks than warfarin among older adults with atrial fibrillation, according to a retrospective analysis in JAMA Internal Medicine.

Using Medicare data on adults who were newly diagnosed with atrial fibrillation in 2010-2011, researchers compared outcomes in some 1300 who filled prescriptions for dabigatran and 8100 who filled prescriptions for warfarin. During roughly 6 to 7.5 months' follow-up, dabigatran users had significantly higher bleeding risks than warfarin users in terms of any bleeding (33% vs. 27%), major bleeding (9% vs. 6%), and gastrointestinal bleeding (17% vs. 10%). Intracranial hemorrhage occurred more often with warfarin (0.6% vs. 1.8%).

The risk for major bleeding with dabigatran was particularly high for blacks and patients with chronic kidney disease, while the increased risk for intracranial bleeding with warfarin was limited to those aged 75 and older.

The authors conclude: "Before more evidence is available, dabigatran should be prescribed with caution in high-risk patients."

Reader Comments (5)

Asim Ahmed Elnour Other Healthcare Professional, Pharmacology/Pharmacy

1. Mortality data of intracranila hemorrhage is the major concern
2. Bleeding, minor or major can be managed, awaiting Dabi antidote.
3. The higher incidence of bleeding in those with CKD is questionnable as Dabi is contraindicated below 30 mL/minute GFR
4. The fear of Dabi utility because of bleeding incidences does not preclude it is value , warfarin is associated with patient stressful from INR, clinic visits in a busy life.
5. Dabi is taking the turn over Warfarin and its unique mechanism as opposed to factor 10 inhibitor is more efficacious in preventing fatal and nonfatal cause mortality.
6. With time clinicians will be more expert to select their patients

CARLO SAITTO Physician, Health Law/Ethics/Public Policy, Local Health Authority RMC Rome Italy

Actually a new treatment should prove more effective and possibly cost-effective than older ones. Equivalence at higher cost is not enough. However side effects and adverse effects can be balanced by better overall treatment outcomes. Dabigratan is being increasingly used, a sound overall assessment is badly needed

Steven Shulman Physician, Anesthesiology, Rutgers- NJMS

Looking at the list of complications, I am concerned the rate of intracranial hemorrhage was tripled with warfarin use. This seemed to be the most catastrophic complication reported. This finding needs more detailed statistical analysis to be reported.

Barbara Mandell MD Physician, Internal Medicine, NY

welcome news to the skeptics like myself

Matias Cordoba Physician, Internal Medicine, Argentina

This publication makes no sense and is outdated. Recently, the FDA published its analysis (Circulation) in more than 135,000 patients (many more than in this analysis) and data are encouraging regarding the use of dabigatran. Moreover, the authors of the articles to which you refer deny the existence of this new data to the FDA. This NEJM Journal Watch should check these things before posting.

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