Table 4.
Summary of primary outcome results (Time to stable INR, supra = therapeutic INR, sub-terapeutic INRs, vitamin K given, and serious adverse events)
| Proportion in INR range | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Dosing | Day 3 (95% CI) |
Day 5 95% (CI) |
Mean time to time in range Days (SD) |
INR ≥4 unless otherwise stated % |
Vit K Given N (%) |
Serious Adverse Events N (%) |
Other primary endpoints | ||||
| 5 mg v 10 mg | ||||||||||||
| Harrison | 5 mg | 42% | 67%δ | - | - | 1(4%) | 0 | |||||
| 10 mg | 36% | 80%δ | - | - | 4(16%) | 0 | ||||||
| Crowther |
5 mg |
50% (26 to 75) | 88%(75 to 102) | - |
- |
1(3%) |
- |
INR 2.0-3.0 for 2 consecutive days & not >3.0; | p < .003 | |||
| 10 mg |
33% (-2 to 68) | 69% (39 to 99) | - |
- |
0 |
- |
10 mg (24%) v 5 mg (66%) RR 2.22 (95% CI 1.3-3.7) |
|||||
| Kovacs |
5 mg |
3%* |
46% (36 to 57)** P<.001 |
5.6 (1.4) |
INR ≥5 11% |
- |
2 (2%) |
|||||
| 10 mg |
25%* |
83% (74 to 89)** |
4.2 (1.1) |
9% |
- |
4 (4%) |
||||||
| Quiroz | 5 mg | - | 52%** | Median 5 | INR >5 0% |
- | 0 | |||||
| 10 mg | - | 56%** | Median 5 | 0% | - | 1 (4%) | ||||||
| *taken from the published graph δ includes discharged with INR in-range from (Ann Int Med Vol 127, 4, pg 133) ** in-range by day 5 |
||||||||||||
| 5 mg vs. other doses | ||||||||||||
| Ageno | 5 mg | - | - | 2.0 (1.0) | P < .0001 | - | 3 (3%) | 0 | INR > 2.6 5 mg (42%) |
p < .05 | ||
| 2.5 mg | - | - | 2.7 (1.2) | P < .0001 | - | 5 (6%) | 0 | 2.5 mg (26%) | p < .05 | |||
| Shine | Std (5 mg) | - | 63% δ | 5 (0.9) ψ | P = .007 | "high" INR 2% | - | 1 (2%) | ||||
| Calc | - | 77% δ | 4.2 (0.9)ψ | P = .007 | INR >4.4 5% | - | 1 (2%) | |||||
|
δ INR within range on or before day 6 ψ completers only |
||||||||||||
| Age trials | ||||||||||||
| Roberts | Age adjusted | 47%* | 3.7 (1.3) Φ | 6% | - | 0 Φ | INR 2.0 - 3.0 for 2 consecutive days | |||||
| Fennerty | 25%* | 4.3 (1.2) Φ | 32% | - | 0 Φ | Age v Fennerty; | p = 0.003 | |||||
| INR >4.5 | Mean days in range (SD) | |||||||||||
| Gedge | Age 65-75 yrs |
- | - | 4.6 (1.6) | P = .03 | 3% P < .05 | 0 | 0 | Age | 3.0 (1.3) | p = 0.03 | |
| New Fennerty 65-75 yrs | - | - | 3.8 (0.8) | P = .03 | 20% P < .05 | ^ | 0 | New Fennerty | 2.7 (1.3) | p = 0.03 | ||
| INR >4.5 | Mean days in range (SD) | |||||||||||
| Age >75 yrs |
- | - | 4.5 (1.4) | P = .003 | 3% P < .01 | 0 | 0 | Age | 2.9 (1.1) | p = 0.04 | ||
| New Fennerty >75 yrs |
- | - | 3.5 (0.7) | P = .003 | 37% P < .01 | ^ | 0 | New Fennerty | 2.4 (1.3) | p = 0.04 | ||
| *taken from the published graph Φ author correspondence ^ 1 (age not stated) |
||||||||||||
| Genotyping | ||||||||||||
| Hillman | Model | - | - | - | 33% | 0 | 2 (10%) | % time INR in range 5 mg 42% |
||||
| 5 mg | - | - | - | 30% | 2 (doses) | 5 (28%) | Model 42% | |||||
| Anderson | Model | - | 70% | - | 30% | - | 4 (4%) | average % of INR outside range 10 mg 33% |
||||
| 10 mg | - | 68% | - | 37% | - | 5 (5%) | Model 31% | |||||
| % time INR in range | ||||||||||||
| Caraco | Model | 1% * | 49% * | 4.8 (1.5) | P < .001 | - | 0 | 0 | 5 mg 25% | P < 0.001 | ||
| STD 5 mg | 1% * | 11% * | 7.5 (3.1) | P < .001 | - | 1 (1%) | 1 (1%) | Model 45% | P < 0.001 | |||
| *taken from the published graph | ||||||||||||