Drug updated on 9/4/2024
| Dosage Form | Capsule (oral; 75mg, 110 mg, 150 mg) |
| Drug Class | Direct thrombin inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
- Indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days.
- Indicated to reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated.
- Indicated for the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery.
- Indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days.
- Indicated to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated.
Latest News
Summary
- Pradaxa (dabigatran etexilate) is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation; for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days; to reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated; for the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery; for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days; and to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated.
- This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
- Atrial Fibrillation in Older Adults: Dabigatran, along with other DOACs, showed no significant differences in reducing stroke and systemic embolism risks compared to VKAs in patients aged ≥75 years with atrial fibrillation. High-dose DOAC regimens, including dabigatran, were associated with lower risks of stroke or systemic embolism compared to VKAs, with similar bleeding risks for low-dose regimens.
- Pulmonary Embolism (PE): Dabigatran showed no clear difference in efficacy compared to conventional anticoagulation in preventing recurrent PE, VTE, and DVT. Additionally, no significant difference was noted between oral DTIs (including dabigatran) and oral factor Xa inhibitors in preventing these outcomes.
- Non-Valvular Atrial Fibrillation: Dabigatran was associated with a reduced risk of stroke or systemic embolism, ischemic stroke, and all-cause mortality compared to VKAs. It showed similar effectiveness to apixaban and rivaroxaban in reducing these risks.
- Diabetes Mellitus (DM) and Atrial Fibrillation: The risk index for stroke/SEE, major bleeding, and cardiovascular death was comparable between patients treated with warfarin or DOACs, including dabigatran.
- Dabigatran was associated with a lower risk of intracranial hemorrhage compared to VKAs and rivaroxaban, while the risks of major bleeding were similar between each DOAC and VKA in older adults with atrial fibrillation.
- In patients with non-valvular atrial fibrillation, dabigatran showed a reduced risk of major bleeding, intracranial hemorrhage, and fatal bleeding compared to VKAs but had an increased risk of gastrointestinal bleeding. Compared to other DOACs, dabigatran, along with apixaban and edoxaban, showed a reduced risk of major bleeding, except when compared to rivaroxaban.
- In patients undergoing dual antiplatelet therapy and anticoagulation post-PCI, dual therapy with an antiplatelet and NOACs (including dabigatran) was associated with a lower risk of intracranial hemorrhage and major bleeding compared to triple therapy with DAPT and either VKAs or NOACs.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pradaxa (dabigatran etexilate) Prescribing Information. | 2021 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |