Table 1.
Recommended doses of DOACs in NVAF and VTE patients according to phase-3 randomized controlled trials (RCTs)
| NVAF | VTE | |||
|---|---|---|---|---|
| Standard dose | Dose reduction | Standard dose | Dose reduction | |
| Apixaban | 5 mg bid | 2.5 mg bid if: age ≥ 80 yrs, weight ≤ 60 kg, creatinine ≥ 1.5 mg/dl (at least two); eGFR 15–29 ml/min (single criterion) | 10 mg bid for 7 days followed by 5 mg bid |
No in acute VTEa Extended treatment: possible 2.5 mg bid after 3–6 months |
| Edoxaban | 60 mg od | 30 mg od if eGFR 15–49 ml/min, weight ≤ 60 kg, concomitant potent P-Gp inhibitor | 60 mg od preceded by LMWH for 5 days | 30 mg od if dose reduction criteria as for AF satisfied |
| Rivaroxaban | 20 mg od | 15 mg od if eGFR 15–49 ml/min | 15 mg bid for 21 days followed by 20 mg od |
No in acute VTEb Extended treatment: possible 10 mg od after 3–6 months |
| Dabigatran | 150 mg bid/110 mg bid | 110 mg bid if age ≥ 80 yrs, concomitant verapamil, increased bleeding riskc | 150 mg bid preceded by LMWH for 5 days | Nod |
Adapted from [3]
bid twice a day, od once daily, eGFR estimated glomerular filtration rate, LMWH low molecular weight heparin, P-Gp P-glycoprotein, RCT randomized controlled trial, SmPc summary of product characteristics (from European Medicines Agency), yrs years
aPer SmPc: it should be used with caution in patients eGFR 15–29 ml/min
bPer SmPc: in patients with eGFR 15–49 ml/min reduced dose 15 mg od should be considered only if risk of bleeding outweighs risk for recurrent DVT/PE (based on pharmacokinetics/ pharmacodynamic analyses; not studied in this setting)
cPer SmPc: no prespecified dose reduction criteria in phase-3 RCT
dPer SmPc: possible dose-reduction criteria as for AF (based on pharmacokinetics/pharmacodynamic analyses; not studied in this setting)