Table 3.
Real‐world studies summary: quantitative data from patients with atrial fibrillation
| Authors/study (country) | n | DOACS TOTAL | DABIGATRAN | RIVAROXABAN | APIXABAN | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adjusted | Not adjusted | Underdosed | Appropriate | Overdosed | Underdosed | Appropriate | Overdosed | Underdosed | Appropriate | Overdosed | ||
| Barra et al. 5 (USA) | 205 | 94 (45.9%) | 111 patients (54.1%) | NA | 19/59 (32.2% of dabigatran users) | NA | 48/122 (39.3% of rivaroxaban users) | 72/122 (59.0% of rivaroxaban users) | 2/122 (1.7% of rivaroxaban users) | 21/24 (87.5% of apixaban users | 3/24 (12.5% of apixaban users) | NA |
| Andreu Cayuelas et al. 9 (Spain) | 692 | 485 (70.1%) | 207 (29.9%) | NA | 77% of dabigatran users | NA | NA | 69% of rivaroxaban users | NA | NA | 67% of apixaban users | NA |
| Yao et al. 11 (USA) | 14 865 | 12 487 (84%) | 2378 (16%): 12%underdosed; 4% overdosed | 414/4653 (8.9% of patients without RIn) | Total of 3 DOACs combined: 84% | 28/71 (39.4% of those with RIn) | 815/5399 (15.1% of patients without RIn) | Total of 3 DOACs combined: 84% | 425/1029 (41.3% of those with RIn) | 551/3340 (16.5% of patients without RIn) | Total of 3 DOACs combined: 84% | 181/373 (48.5% of those with RIn) |
| Shin et al. 28 (USA) | 3206 | 1811 patients (57%) | 1367 patients (43%): 28% overdosed; 15% underdosed | 107/890 (12% of dabigatran users) | 83% (reduced dose) and 88% (full dose) | 17% (among those who needed dose reduction) | 155/1546 (10% of rivaroxaban users) | 65% (reduced dose) and 90% (full dose) | 35% (among those who needed dose reduction) | 235/1307 (18% of apixaban users) | 85% (reduced dose) and 82% (full dose) | 15% (among those who needed reduced dose) |
| Carlin et al. 44 (Canada) | 47 | 22 (46.8%) | 25 (53.2%) | NA | NA | NA | NA | NA | NA | 19/25 (76.0% of patients that are not adjusted) | 22/47 (46.8%) | 6/25 (24.0%) |
| Bando et al. 47 /SRRT (Japan) | 1339 (453 elderly) | 333/453 (73.5% of elderly group) | 120/453 (26.5% of elderly group) | NA | NA | NA | 93/453 (20.5%)a | 333/453 (73.5%)a | 19/453 (4.0%)a | NA | NA | NA |
| Pattullo et al. 48 (Australia) | 131 | 78 (59.5%) | 53 (40.5%): 13 overdosed (9.9%); 19 underdosed (14.5%); 21 CIn (16.1%) | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Camm et al. 49 /XANTUS (Europe, Israel and Canada) | 6784 | 3650 (53.8%) | NA | NA | NA | NA | 592/6784 (8.7%) | 3650/6784 (53.8%) | 230/640 (36.0% of patients with RIn) | NA | NA | NA |
| Brun Guinda et al. 50 (Spain) | 137 | 94 (68.6%) | 43 (31.4%) | NA | NA | NA | 43/112 (38.4% of patients without RIn) | 94/137 (68.6%) | 0 | NA | NA | NA |
| Pharithi et al. 51 (Ireland) | 301 | 154 (51.2%) | 147 (48.8%): 65 underdosed (21.6%); 5 overdosed (1.7%); 36 CIn (11.9%)b | 24/106 (22.7% of dabigatran users)c | 45/106 (42.5% of dabigatran users) | 21/106 (19.8% of dabigatran users): 20 CIn (18.9%); 1 overdosed (< 1.0%) | 24/154 (15.6% of rivaroxaban users)d | 87/154 (56.5% of rivaroxaban users) | 20/155 (13.0% of rivaroxaban users): 16 CIn (10.4%); 4 overdosed (2.6%) | 9/41 (22.0% of apixaban users) | 30/41 (73.2% of apixaban users) | 0/41 (0% of apixaban users)e |
| EDOXABAN | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Authors | n | Underdosed | Appropriate | Overdosed | ||||||||
| Okumura et al. 25 /SAKURA AF (Japan) | 1689 | 9/30 (30.0% of edodoxaban users | 19/30 (63.3% of edoxaban users) | 2 patients (6.7% of edoxaban users) | ||||||||
ClCr was unknown in 8 patients (from the 453) so the dose adjustment was not evaluated.
Also in 10 patients (3.3%) was founded inappropriate frequency and in 31 (10.3%) possible drug interactions that can lead to not adjusted doses.
Also 8 patients (7.5%) had inappropriate frequency and 8 (7.5%) had possible drug interactions that can result in a not adjusted dose.
In 2 patients (1.3%), there was an inappropriate frequency and in 21 (13.6%) possible drug interactions that can be considered nonadjustment.
Also 2 patients (4.8%) were taking drugs that can affect DOACs action and consequently the appropriateness of dose adjustment.
AF = atrial fibrillation; CIn = contraindicated; CrCI = creatinine clearance; DOACs = direct oral anticoagulants; NA = nonavailable data; RIn = renal indication for dose reduction.