Table 3.
Comparison of placebo-corrected changes from baseline (∆∆) of QTcl, QT and heart rate over time in healthy subjects treated with dabigatran etexilate 150 mg, dabigatran etexilate 600 mg and moxifloxacin 400 mg
| Time | ∆∆QTcI (ms) | ∆∆QT (ms) | ∆∆HR (bpm) |
|---|---|---|---|
| Dabigatran etexilate 150 mg (n = 40) | |||
| 1:00 | −0.1 (−2.5 to 2.2) | −0.7 (−4.0 to −2.6) | 0.7 (−0.5 to 1.8) |
| 1:30 | −1.4 (−3.2 to 0.4) | −0.6 (−3.3 to 2.1) | −0.3 (−1.4 to 0.8) |
| 2:00 | −0.7 (−2.9 to 1.6) | −0.2 (−2.9 to 2.6) | −0.3 (−1.5 to 0.8) |
| 3:00 | −1.1 (−3.3 to 1.2) | −1.9 (−4.9 to 1.0) | 0.6 (−0.8 to 0.2) |
| 6:00 | −0.4 (−3.0 to 2.2) | −0.5 (−3.8 to 2.7) | 0.1 (−1.4 to 1.2) |
| 12:00 | 0.9 (−1.7 to 3.5) | 1.3 (−1.8 to 4.5) | −0.4 (−1.7 to 0.9) |
| 24:00 | −0.1 (−1.9 to 1.7) | −0.2 (−2.8 to 2.5) | −0.1 (−1.1 to 1.0) |
| Dabigatran etexilate 600 mg (n = 40) | |||
| 1:00 | −1.5 (−3.8 to 0.9) | −1.8 (−5.2 to 1.5) | 0.5 (−0.6 to 1.6) |
| 1:30 | −1.7 (−3.5 to 0.2) | −0.6 (−3.3 to 2.1) | −0.3 (−1.5 to 0.8) |
| 2:00 | −2.6 (−4.8 to −0.4) | −0.9 (−3.7 to 1.8) | −1.1 (−2.2 to 0.1) |
| 3:00 | −1.1 (−3.3 to 1.1) | −2.9 (−5.8 to 0.1) | 1.5 (−0.1 to 2.9) |
| 6:00 | −0.8 (−3.4 to 1.8) | −1.1 (−4.3 to 2.2) | 0.6 (−0.7 to 1.9) |
| 12:00 | 0.4 (−2.2 to 3.0) | 1.0 (−2.1 to 4.2) | −0.2 (−1.5 to 1.1) |
| 24:00 | −1.6 (−3.4 to 0.2) | −3.1 (5.7 to 0.5) | 1.1 (0.0 to 2.2) |
| Moxifloxacin 400 mg (n = 40) | |||
| 1:00 | 11.1 (8.4 to 13.8) | 8.3 (4.7 to 11.9) | 2.4 (0.9 to 3.8) |
| 1:30 | 12.8 (10.2 to 15.6) | 11.9 (8.3 to 15.5) | 1.3 (0.1 to 2.5) |
| 2:00 | 14.1 (11.7 to 16.5) | 13.6 (10.4 to 16.9) | 0.4 (−1.0 to 1.7) |
| 3:00 | 14.1 (11.4 to 16.7) | 10.3 (6.9 to 13.8) | 2.7 (1.1 to 4.4) |
| 6:00 | 10.4 (8.0 to 12.8) | 9.2 (6.1 to 12.2) | 1.5 (0.1 to 2.8) |
Placebo-corrected changes from baseline are expressed as mean (90 % CI)
bpm beats per minute, HR heart rate, QTcI individually heart-rate–corrected QT interval