Bleeding in the brain, or intracranial hemorrhage (ICH), is a major concern for patients receiving antithrombotic drugs because it may render a patient physically and/or mentally disabled for life or even prove fatal.
A further analysis of RELY2 data suggests that patients with nonvalvular atrial fibrillation receiving dabigatran etexilate (Pradaxa, Boehringer Ingelheim) 150 mg twice daily are not at a higher risk of stroke than those taking warfarin. Dabigatran cut the composite end point of stroke or peripheral embolic events by 34% per year compared with warfarin (P <.001). Also, the overall risk of dying from ICH was 70% less for patients who received dabigatran than with warfarin.
1. Food and Drug Administration website. FDA drug safety communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone. April 10, 2012. www.fda.gov/Drugs/DrugSafety/ucm299305. Accessed May 1, 2012.
2. Hart RG, Diener HC, Yang S, et al. Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: The RE-LY trial. Stroke 2012: DOI:10.1161/?STROKEAHA.112.650614.3.
3. Turpie AG, Jamal W, Schmidt A, et al. XAMOS: A non-interventional study comparing oral rivaroxaban with conventional regimens for thromboprophylaxis after major orthopaedic surgery of the hip and knee. British Society of Hematology 2012 Scientific Meeting; April 16-18, 2012; Glasgow, Scotland
4. The EINSTEIN-PE investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012; 366:1287-1297.
5. Pradaxa (dabigatran etexilate) package insert. Boehringer Ingleheim, Inc. 2010.
6. Rivoraxaban (Xarelto) package insert. Bayer