title: Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation.
abstract: OBJECTIVE
  Intracranial hemorrhage rates are higher in Asians than non-Asians, especially in patients receiving warfarin. This randomized evaluation of long-term anticoagulation therapy subgroup analysis assessed dabigatran etexilate (DE) and warfarin effects on stroke and bleeding rates in patients from Asian and non-Asian countries.
  
  
  METHODS
  There were 2782 patients (15%) from 10 Asian countries and 15 331 patients from 34 non-Asian countries. A Cox regression model, with terms for treatment, region, and their interaction was used.
  
  
  RESULTS
  Rates of stroke or systemic embolism in Asians were 3.06% per year on warfarin, 2.50% per year on DE 110 mg BID (DE 110), and 1.39% per year on DE 150 mg BID (DE 150); in non-Asians, the rates were 1.48%, 1.37%, and 1.06% per year with no significant treatment-by-region interactions. Hemorrhagic stroke on warfarin occurred more often in Asians than non-Asians (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.3-4.7; P=0.007), with significant reductions for DE compared with warfarin in both Asian (DE 110 versus warfarin HR, 0.15; 95% CI, 0.03-0.66 and DE 150 versus warfarin HR, 0.22; 95% CI, 0.06-0.77) and non-Asian (DE 110 versus warfarin HR, 0.37; 95% CI, 0.19-0.72 and DE 150 versus warfarin HR, 0.28; 95% CI, 0.13-0.58) patients. Major bleeding rates in Asians were significantly lower on DE (both doses) than warfarin (warfarin 3.82% per year, DE 110 2.22% per year, and DE 150 2.17% per year).
  
  
  CONCLUSIONS
  Hemorrhagic stroke rates were higher on warfarin in Asians versus non-Asians, despite similar blood pressure, younger age, and lower international normalized ratio values. Hemorrhagic strokes were significantly reduced by DE in both Asians and non-Asians. DE benefits were consistent across Asian and non-Asian subgroups.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00262600.
authors.affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. hori-ma@mc.pref.osaka.jp
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Hori
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
authors.forename: Jun
authors.initials: J
authors.lastname: Zhu
authors.forename: Li Sheng
authors.initials: LS
authors.lastname: Liu
authors.forename: Chu-Pak
authors.initials: CP
authors.lastname: Lau
authors.forename: Prem
authors.initials: P
authors.lastname: Pais
authors.forename: Denis
authors.initials: D
authors.lastname: Xavier
authors.forename: Sung Soon
authors.initials: SS
authors.lastname: Kim
authors.forename: Razali
authors.initials: R
authors.lastname: Omar
authors.forename: Antonio L
authors.initials: AL
authors.lastname: Dans
authors.forename: Ru San
authors.initials: RS
authors.lastname: Tan
authors.forename: Jyh-Hong
authors.initials: JH
authors.lastname: Chen
authors.forename: Supachai
authors.initials: S
authors.lastname: Tanomsup
authors.forename: Mitsunori
authors.initials: M
authors.lastname: Watanabe
authors.forename: Masahide
authors.initials: M
authors.lastname: Koyanagi
authors.forename: Michael D
authors.initials: MD
authors.lastname: Ezekowitz
authors.forename: Paul A
authors.initials: PA
authors.lastname: Reilly
authors.forename: Lars
authors.initials: L
authors.lastname: Wallentin
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects*; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects; D001208:Asia / Q000453:epidemiology / Q000208:ethnology; D044466:Asian People / Q000208:ethnology; D001281:Atrial Fibrillation / Q000188:drug therapy*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects*; D002545:Brain Ischemia / Q000453:epidemiology / Q000209:etiology; D000069604:Dabigatran; D005260:Female; D006801:Humans; D020300:Intracranial Hemorrhages / Q000453:epidemiology / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects*; D020521:Stroke / Q000453:epidemiology / Q000209:etiology*; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D001562:Benzimidazoles; D011725:Pyridines; D014859:Warfarin; D000069604:Dabigatran
keywords: Asia; RE-LY; atrial fibrillation; bleeding; dabigatran; intracranial hemorrhage; warfarin