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Stroke History Did Not Change Safety, Effectiveness of Dabigatran

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Subgroup Analysis Offers Guidance

This subgroup analysis of the RE-LY trial is important because it begins to fill the void of data on the benefit of oral coagulation for secondary stroke prevention and the safety of oral coagulation in patients with a previous ischemic stroke or TIA, according to Dr. Deidre A. Lane and Dr. Gregory Y.H. Lip of the University of Birmingham (England).

The analysis offers some guidance to physicians when deciding which dose of dabigatran to prescribe after going through an individualized stroke and bleeding risk assessment.

"Because of the necessary trade-off between stroke prevention and bleeding with both doses of dabigatran, consultation with patients regarding their preferences for treatment dose will be even more important to ascertain their threshold for stroke prevention over increased bleeding risk or vice versa," the doctors wrote.

Editor’s Note: The approved dosages and indications differ between the countries in which dabigatran was approved.

Dr. Lane and Dr. Lip wrote their comments in an editorial accompanying the paper (Lancet Neurol. 2010 Nov. 8 [doi:10.1016/S1474-4422(10)70275-1]). Both report having received funding for research and lecturing from different manufacturers of drugs used for the treatment of atrial fibrillation, including Boehringer Ingelheim.


 

FROM THE LANCET NEUROLOGY

The analysis offers some guidance to physicians when deciding which dose of dabigatran to prescribe after going through an individualized stroke and bleeding risk assessment.

"Because of the necessary trade-off between stroke prevention and bleeding with both doses of dabigatran, consultation with patients regarding their preferences for treatment dose will be even more important to ascertain their threshold for stroke prevention over increased bleeding risk or vice versa," Dr. Lane and Dr. Lip of the University of Birmingham (England) wrote.

Boehringer Ingelheim GmbH funded the study and is marketing dabigatran as Pradaxa. Dr. Diener and some of his authors disclosed financial relationships with this company and others that manufacture or market drugs for the prevention or treatment of stroke. One author is an employee of Boehringer Ingelheim.

Dr. Lane and Dr. Lip both reported having received funding for research and lecturing from different manufacturers of drugs used for the treatment of atrial fibrillation, including Boehringer Ingelheim.

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