Drug updated on 6/25/2024
| 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
- Dabigatran etexilate (Pradaxa) is indicated for reducing the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, treating and preventing deep venous thrombosis (DVT) and pulmonary embolism (PE), prophylaxis post-hip replacement surgery, and treatment of venous thromboembolic events in pediatric patients aged 8 to less than 18 years.
- Ten systematic reviews/meta-analyses provided insights into Pradaxa's safety and effectiveness compared to other anticoagulants, including Direct Oral Anticoagulants (DOACs) and Vitamin K Antagonists (VKAs).
- Dabigatran was associated with fewer thromboembolic events compared to VKA in patients aged ≥75 years with atrial fibrillation and demonstrated a significantly lower risk of intracranial hemorrhage compared to VKA. For PE/DVT treatment or prevention, its efficacy was similar to conventional anticoagulation without a significant difference in major bleeding outcomes.
- It has displayed a favorable safety profile across diverse patient populations, such as those undergoing hip replacement surgery or at risk for DVT/PE. There may be an increased risk of gastrointestinal bleeding, but overall, reduced rates of major bleeding were noted, especially beneficial for older populations or those with renal considerations where age and renal function can affect its concentrations, thus impacting its safety and efficacy.
- Subgroup analysis revealed that dabigatran maintains its effectiveness among specific subsets like older adults (>75 years old), individuals with diabetes mellitus, or undergoing percutaneous coronary interventions (PCIs). Dual therapy with this drug was found to be less risky regarding major bleedings/intracranial hemorrhages without any significant difference in ischemic events among AF patients undergoing PCI procedures.
- Compared to VKAs and within the DOAC class, dabigatran was often positioned favorably in terms of stroke prevention, systemic embolism, and major bleeding incidents. It also provides an effective alternative with a safety profile that supports its use over traditional VKAs for VTE prophylaxis after hip or knee replacement surgeries.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pradaxa (dabigatran etexilate) Prescribing Information. | 2021 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |