From the Guidelines
Dabigatran dosing is 150 mg twice daily for most patients, as this dose has been shown to be superior to warfarin in preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation 1.
Key Considerations
- Renal function: For patients with severe renal insufficiency (creatinine clearance 15 to 30 mL/min), a dose of 75 mg twice daily is recommended, although this dose was not evaluated in the RE-LY trial 1.
- Bleeding risk: In patients at high risk of bleeding, a dose of 110 mg twice daily may be considered, as it has been associated with a lower risk of major bleeding compared to the 150 mg dose 1.
- Ischemic stroke risk: For patients at high risk of ischemic stroke, the 150 mg twice daily dose is recommended due to its superior efficacy compared to warfarin, but bleeding risk should be carefully assessed and monitored 1.
Dosing Summary
- Standard dose: 150 mg twice daily
- Renal insufficiency: 75 mg twice daily (for creatinine clearance 15 to 30 mL/min)
- High bleeding risk: 110 mg twice daily (where available)
- High ischemic stroke risk: 150 mg twice daily (with careful bleeding risk assessment and monitoring)
From the FDA Drug Label
2.2 Recommended Dabigatran Etexilate Capsules Dose for Adults IndicationDosage Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF CrCl >30 mL/min: 150 mg twice daily CrCl 15 to 30 mL/min: 75 mg twice daily CrCl <15 mL/min or on dialysis: Dosing recommendations cannot be provided CrCl 30 to 50 mL/min with concomitant use of P-gp inhibitors: Reduce dose to 75 mg twice daily if given with P-gp inhibitors dronedarone or systemic ketoconazole CrCl <30 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration Treatment of DVT and PE CrCl >30 mL/min: 150 mg twice daily CrCl ≤30 mL/min or on dialysis: Dosing recommendations cannot be provided CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients For patients with creatinine clearance (CrCl) >30 mL/min, the recommended dose of dabigatran etexilate capsules is 150 mg taken orally, twice daily. For patients with severe renal impairment (CrCl 15 to 30 mL/min), the recommended dose of dabigatran etexilate capsules is 75 mg twice daily
The dosing for Dabigatran is as follows:
- For patients with CrCl >30 mL/min: 150 mg twice daily
- For patients with severe renal impairment (CrCl 15 to 30 mL/min): 75 mg twice daily
- For patients with CrCl <15 mL/min or on dialysis: dosing recommendations cannot be provided
- For patients with CrCl 30 to 50 mL/min and concomitant use of P-gp inhibitors: reduce dose to 75 mg twice daily
- For patients with CrCl <30 mL/min and concomitant use of P-gp inhibitors: avoid coadministration 2
From the Research
Dabigatran Dosing
- The recommended dosing for dabigatran is 150 mg twice daily for patients with atrial fibrillation who have a high risk of embolism and a low risk of bleeding 3.
- A study published in 2012 found that dabigatran 150 mg twice daily reduced the rate of stroke or systemic embolism by one-third compared to warfarin, with a similar rate of major bleeding 4, 5.
- The same study found that dabigatran 110 mg twice daily had a similar rate of stroke or systemic embolism to warfarin, but reduced the rate of major bleeding by one-fifth 5.
- A more recent study published in 2023 proposed a dosing regimen for dabigatran based on renal function range, with five different dosing schedules corresponding to specified renal function ranges 6.
- Another study published in 2012 discussed the properties, clinical efficacy, safety, and positioning of dabigatran in the prevention of stroke, and noted that dabigatran was recently approved in Japan for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation 7.
Key Findings
- Dabigatran 150 mg twice daily is a commonly recommended dose for patients with atrial fibrillation 3, 4, 5.
- The dose of dabigatran may need to be adjusted based on renal function range 6.
- Dabigatran has been shown to be effective in reducing the rate of stroke or systemic embolism in patients with atrial fibrillation, with a similar or lower rate of major bleeding compared to warfarin 4, 5, 7.