Table 1 Clinical studies with dabigatran etexilate
From: Pharmacological basis and clinical evidence of dabigatran therapy
Study | Phase | N | Indication | Efficacy | Safety |
|---|---|---|---|---|---|
Bistro I [4] | I | 289 | HR or KR | 20.8% VTE in 12.5 mg/12 h vs. 0% 300 mg/12 h | 10% bleeding in 300 mg/12 h |
Bistro II [7] | II | 1973 | HR or KR | Lower VTE in 150 mg/12 h, 225 mg/12, 300 mg/24 h, compared to enoxaparin 40 mg/24 h | Lower bleeding than heparin in 50 mg/12 h |
RE-MODEL [12] | III | 2076 | KR | Similar for 150 and 220 mg/24 h compared to enoxaparin 40 mg/24 h | Similar bleeding rate |
RE-NOVATE [13] | III | 3463 | HR | Similar efficacy among the same groups | Similar bleeding rate |
RE-MOBILIZE [14] | III | 2596 | KR | Lower VTE in enoxaparin 30 mg/12 h compared to dabigatran 150 and 220 mg | Similar bleeding rate |
Friedman et al., [15] | MA | 8135 | HR and KR | Similar VTE risk among groups (3 trials) | Similar bleeding rate |
RE-COVER [16] | III | 2564 | DVT/PE | Similar efficacy for dabigatran 150 mg/12 h compared to warfarin | Lower bleeding in the dabigatran group |
PETRO [8] | II | 502 | AF | 2% thromboembolic events when the lowest dose was used (50 mg/12 h) | Lower bleeding in 50 mg than 150 mg and 300 mg (twice a day) |
RE-LY [10] | III | 18113 | AF | Dose of 150 mg/12 h had lower thromboembolic events than warfarin. No difference for 110 mg/12 h | Lower major bleeding rate for the dose of 110 mg/12 h, compared to warfarin. |