lation of RE-MODEL and RE-NOVATE (5539 patients treated), 51 % suffered from concomitant hypertension, 9 % from concomitant diabetes, 9 % from concomitant coronary artery disease and 20 % had a history of venous insufficiency. None of these diseases showed an impact on the effects of dabigatran on VTE-prevention or bleeding rates.
Data for the major VTE and VTE-related mortality endpoint were homogeneous with regards to the primary efficacy endpoint and are shown in table 5.
Data for the total VTE and all cause mortality endpoint are shown in table 6.
Data for adjudicated major bleeding endpoints are shown in table 7 below.
Table 5: Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopaedic surgery studies
Trial
Dabigatran etexilate
220 mg
Dabigatran etexilate
150 mg
Enoxaparin
40 mg
RE-NOVATE (hip)
N
909
888
917
Incidences (%)
28 (3.1)
38 (4.3)
36 (3.9)
Risk ratio over enoxaparin
0.78
1.09
95 % CI
0.48, 1.27
0.70, 1.70
RE-MODEL (knee)
N
506
527
511
Incidences (%)
13 (2.6)
20 (3.8)
18 (3.5)
Risk ratio over enoxaparin
0.73
1.08
95 % CI
0.36, 1.47
0.58, 2.01
Table 6: Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies
Trial
Dabigatran etexilate
220 mg
Dabigatran etexilate
150 mg
Enoxaparin
40 mg
RE-NOVATE (hip)
N
880
874
897
Incidences (%)
53 (6.0)
75 (8.6)
60 (6.7)
Risk ratio over enoxaparin
0.9
1.28
95 % CI
(0.63, 1.29)
(0.93, 1.78)
RE-MODEL (knee)
N
503
526
512
Incidences (%)
183 (36.4)
213 (40.5)
193 (37.7)
Risk ratio over enoxaparin
0.97
1.07
95 % CI
(0.82, 1.13)
(0.92, 1.25)
Table 7: Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies
Trial
Dabigatran etexilate
220 mg
Dabigatran etexilate
150 mg
Enoxaparin
40 mg
RE-NOVATE (hip)
Treated patients N
1146
1163
1154
Number of MBE N(%)
23 (2.0)
15 (1.3)
18 (1.6)
RE-MODEL (knee)
Treated patients N
679
703
694
Number of MBE N(%)
10 (1.5)
9 (1.3)
9 (1.3)
Paediatric population
The European Medicines Agency has waived the obligation to submit the results of studies with Pradaxa in all subsets of the paediatric population in prevention of thromboembolic events in the granted indication.
5.2 Pharmacokinetic properties
After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma. The cleavage of the prodrug dabigatran etexilate by esterase-cat
