Drug updated on 11/5/2024
| Dosage Form | Capsule (oral; 75 mg, 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
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- In atrial fibrillation (AF) patients, no significant differences were found in major bleeding events and serious adverse events (SAEs) between NOACs (novel oral anticoagulants), including dabigatran, and warfarin, with a relative risk (RR) of 0.87 (p=0.22) for major bleeding events and an RR of 1.01 (p=0.35) for SAEs.
- In venous thromboembolism (VTE) patients with renal insufficiency, desirudin posed a higher bleeding risk compared to dabigatran etexilate during VTE prophylaxis, while aspirin was noted as the safest treatment in the extension phase.
- 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. | 2023 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Effectiveness of Novel Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis | 2024 | Cureus |
| Anticoagulant for treatment and prophylaxis of venous thromboembolism patients with renal dysfunction: A systematic review and network meta-analysis | 2022 | Frontiers in Medicine |
| A systematic review and meta-analysis of dabigatran peak and trough concentration in adults | 2022 | British Journal of Clinical Pharmacology |