Safety 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) | |||||||
| Major bleeding | 11 | 0.63 | 331 | 0.81 | 0.52 | 15 | 0.86 | 384 | 0.94 | 0.81 | 17 | 404 |
| (2.01) | (0.29 to 1.34) | (2.92) | (0.70 to 0.94) | (2.72) | (0.43 to 1.72) | (3.34) | (0.81 to 1.08) | (3.18) | (3.59) | |||
| Gastrointestinal major bleeding | 4 | 0.65 | 130 | 1.09 | 0.43 | 13 | 2.12 | 174 | 1.45 | 0.45 | 6 | 119 |
| (0.73) | (0.18 to 2.29) | (1.15) | (0.85 to 1.40) | (2.36) | (0.81 to 5.58) | (1.52) | (1.15 to 1.83) | (1.12) | (1.06) | |||
| Life-threatening major bleeding | 6 | 0.83 | 141 | 0.66 | 0.68 | 5 | 0.69 | 174 | 0.81 | 0.80 | 7 | 211 |
| (1.09) | (0.28 to 2.48) | (1.24) | (0.53 to 0.82) | (0.91) | (0.22 to 2.18) | (1.52) | (0.66 to 0.99) | (1.31) | (1.87) | |||
| Intracranial haemorrhage | 1 (0.18) | 0.19 (0.02 to 1.67) | 26 (0.23) | 0.30 (0.19 to 0.47) | 0.70 | 0 (0.00) | – | 38 (0.33) | 0.44 (0.30 to 0.64) | 0.98 | 5 (0.93) | 85 (0.75) |
| Minor bleeding | 70 | 0.70 | 1496 | 0.79 | 0.47 | 76 | 0.77 | 1711 | 0.92 | 0.25 | 93 | 1838 |
| (12.8) | (0.52 to 0.96) | (13.2) | (0.74 to 0.85) | (13.8) | (0.57 to 1.04) | (14.9) | (0.86 to 0.98) | (17.4) | (16.3) | |||
| Total bleeding | 75 | 0.68 | 1680 | 0.79 | 0.35 | 83 | 0.76 | 1911 | 0.91 | 0.23 | 102 | 2064 |
| (13.7) | (0.50 to 0.91) | (14.8) | (0.74 to 0.84) | (15.1) | (0.57 to 1.02) | (16.6) | (0.86 to 0.97) | (19.1) | (18.3) | |||
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. The outcomes of major and intracranial haemorrhages were adjudicated by two independent investigators who were unaware of the treatment assignments.
LA, Latin American.