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 daily					Dabigatran 150 mg Twice daily					Warfarin
	LA (n=320)	HR vs warfarin (95% CI)	non-LA (n=5695)	HR vs warfarin (95% CI)	Interaction p value	LA (n=320)	HR vs warfarin (95% CI)	Non-LA (n=5756)	HR vs warfarin (95% CI)	Interaction p value	LA (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 embolism	10	1.09	173	0.89	0.67	5	0.54	129	0.65	0.75	9	193
	(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)
Stroke	9	0.98	162	0.91	0.88	3	0.32	119	0.66	0.30	9	177
	(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 stroke	9	2.20	143	1.09	0.25	3	0.73	100	0.75	0.97	4	130
	(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 stroke	0	–	14	0.33	0.98	0	–	12	0.28	0.98	3	42
	(0.00)		(0.12)	(0.18 to 0.60)		(0.00)		(0.10)	(0.15 to 0.53)		(0.56)	(0.37)
Myocardial infarction*	0	–	87	1.35	0.97	2	0.97	87	1.33	0.76	2	64
	(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 cause	33	0.98	413	0.90	0.75	29	0.85	409	0.88	0.90	33	454
	(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.