NOAC-trials5–8 | SPC19–22 | FDA23–26 | ESC guidelines27 | EHRA guidelines28 | |
Dabigatran | RE-LY: 150 mg b.d. No dose reduction in trial. 110 mg b.d. No dose reduction in trial. | 150 mg b.d. → 110 mg b.d.
Consider dose reduction in case of:
| 150 mg b.d. → 75 mg b.d.
| 150 mg b.d. → 110 mg b.d. Not reported | 150 mg b.d. → 110 mg b.d.
Consider dose reduction in case of≥2 of the following criteria:
|
Rivaroxaban | ROCKET-AF: 20 mg o.d. → 15 mg o.d.
J-ROCKET-AF: 15 mg o.d. →10 mg o.d.
| 20 mg o.d. → 15 mg o.d.
| 20 mg o.d. → 15 mg o.d.
| 20 mg o.d. → 15 mg o.d.
| 20 mg o.d. → 15 mg o.d.
Consider dose reduction in case of ≥2 of the following criteria:
|
Apixaban | ARISTOTLE: 5 mg b.d. → 2.5 mg b.d.
| 5 mg b.d. → 2.5 mg b.d.
| 5 mg b.d. → 2.5 mg b.d.
| 5 mg b.d. → 2.5 mg b.d.
| 5 mg b.d. → 2.5 mg b.d.
Consider dose reduction in case of ≥2 of the following criteria:
|
Edoxaban | ENGAGE AF-TIMI 48: 60 mg o.d. → 30 mg o.d.
30 mg o.d. → 15 mg o.d.
| 60 mg o.d. → 30 mg o.d.
| 60 mg o.d. → 30 mg o.d.
| 60 mg o.d. → 30 mg o.d.
30 mg o.d. → 15 mg o.d.
| 60 mg o.d. → 30 mg o.d.
Consider dose reduction in case of ≥2 of the following criteria:
|
AF, atrial fibrillation; b.d., two times a day; CrCl, creatinine clearance; EHRA, European Heart Rhythm Association; ESC, European Society of Cardiology; FDA, Food and Drugs Administration; GERD, gastro-oesophageal reflux disease; NOAC, non-vitamin K antagonist oral anticoagulant; o.d., once daily; SPC, Summary of Product Characteristics.