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.
Mr. Brown is professor emeritus of clinical pharmacy and a clinical pharmacist at Purdue University College of Pharmacy, Nursing, and Health Sciences, Department of Pharmacy Practice, in West Lafayette, Indiana. This column’s information is based on current studies and references, but it may be changed without notice with newer studies or with different patient populations.
References:
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