Table 1

Efficacy outcomes with dabigatran etexilate versus warfarin in Latin American (n=956) and non-Latin American (n=17 157) patients

Dabigatran 110 mg twice dailyDabigatran 150 mg Twice dailyWarfarin
LA (n=320)HR vs warfarin
(95% CI)
non-LA (n=5695)HR vs warfarin
(95% CI)
Interaction p valueLA (n=320)HR vs warfarin
(95% CI)
Non-LA (n=5756)HR vs warfarin
(95% CI)
Interaction p valueLA (n=316)Non-LA (n=5706)
Event number (%/year)Event number (%/year)Event number (%/year)Event number (%/year)Event number (%/year)Event number (%/year)
Stroke or systemic embolism101.091730.890.6750.541290.650.759193
(1.82)(0.44 to 2.67)(1.52)(0.72 to 1.09)(0.91)(0.18 to 1.62)(1.12)(0.52 to 0.82)(1.68)(1.71)
Stroke90.981620.910.8830.321190.660.309177
(1.64)(0.39 to 2.46)(1.43)(0.73 to 1.12)(0.54)(0.09 to 1.20)(1.04)(0.52 to 0.83)(1.68)(1.57)
Ischaemic stroke92.201431.090.2530.731000.750.974130
(1.64)(0.63 to 7.14)(1.26)(0.86 to 1.39)(0.54)(0.16 to 3.26)(0.87)(0.58 to 0.98)(0.75)(1.15)
Haemorrhagic stroke0140.330.980120.280.98342
(0.00)(0.12)(0.18 to 0.60)(0.00)(0.10)(0.15 to 0.53)(0.56)(0.37)
Myocardial infarction* 0871.350.9720.97871.330.76264
(0.00)(0.77)(0.98 to 1.86)(0.36)(0.14 to 6.90)(0.76)(0.97 to 1.84)(0.37)(0.57)
Death from any cause330.984130.900.75290.854090.880.9033454
(6.02)(0.60 to 1.58)(3.64)(0.79 to 1.03)(5.27)(0.52 to 1.40)(3.56)(0.77 to 1.01)(6.17)(4.03)
  • P values for treatment-by-region interaction are calculated by using Cox regression model with the terms for treatment, region and treatment-by-region interaction.

  • *Myocardial infarction (MI) includes silent MI.

  • LA, Latin American.