Table 2.
Summary of PD effect (Emax) of dabigatran on aPTT prolongation, INR, TT and ECT in the single- and multiple-dose studies
aPTT Mean, range | INR Mean, range | TT Mean, range | ECT Mean, range | |||||
---|---|---|---|---|---|---|---|---|
Dabigatran etexilate dose (mg) | Emax | CV% | Emax | CV% | Emax | CV% | Emax | CV% |
1.25 | 1.19 | |||||||
Single-dose study | 1.18–1.39 | 7.1% | 1.14–1.25 | 4.1 | ||||
10 | 1.16 | 5.5% | 1.14 | 6.8% | 2.77 | 53.9% | 1.39 | 12.8% |
1.10–1.25 | 1.09–1.29 | 1.63–5.62 | 1.21–1.68 | |||||
30 | 1.25 | 9.2% | 1.22 | 4.5% | 10.5 | 19.9% | 2.42 | 14.0% |
1.15–1.46 | 1.17–1.32 | 7.94–13.7 | 1.98–2.94 | |||||
100 | 1.58 | 4.6% | 1.30 | 8.9% | 19.3 | 41.5% | 3.28 | 19.8% |
1.48–1.69 | 1.11–1.39 | 13.1–35.1 | 2.69–4.49 | |||||
200 | 1.81 | 7.3% | 1.47 | 7.6% | 56.5 | 29.1% | 5.30 | 26.1% |
1.67–2.03 | 1.31–1.63 | 23.0–64.5 | 3.65–6.87 | |||||
400 | 2.08 | 12.1% | 1.88 | 13.4% | ||||
1.79–2.41 | 1.61–2.18 | Emax,ss | CV% | Emax,ss | CV% | |||
Emax,ss | CV% | Emax,ss | CV% | Emax,ss | CV% | Emax,ss | CV% | |
Multiple-dose study | ||||||||
50 | 1.46 | 6.1% | 1.31 | 4.1% | 7.81 | 29.3% | 2.16 | 14.4% |
1.40–1.61 | 1.23–1.40 | 4.96–10.3 | 1.80–2.56 | |||||
100 | 1.92 | 7.0% | 1.73 | 5.5% | 13.9 | 15.9% | 3.75 | 14.9% |
1.80–2.11 | 1.59–1.92 | 10.3–17.4 | 3.05–4.37 | |||||
200 | 2.34 | 8.2% | 1.78 | 9.7% | 26.9 | 7.6% | 5.20 | 9.6% |
2.00–2.57 | 1.46–2.00 | 23.6–30.1 | 4.49–6.27 | |||||
400 | 3.12 | 10.8% | 3.49 | 31.7% | 29.1 | 13.4% | 9.49 | 14.5% |
2.77–3.72 | 2.34–5.50 | 24.0–35.9 | 7.87–11.9 |