Drug updated on 4/16/2024
| Dosage Form | Capsule (oral: 75mg, 110 mg, 150 mg) |
| Drug Class | Direct thrombin inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated.
Summary
- Dabigatran etexilate (Pradaxa) is an oral direct thrombin inhibitor used in preventing thromboembolism in patients with atrial fibrillation and several other conditions including deep venous thrombosis (DVT), pulmonary embolism (PE), and for the prophylaxis of DVT and PE post hip replacement surgery.
- A systematic review found that age, body weight, and creatinine clearance significantly correlated to peak concentration of Pradaxa. The pooled dabigatran concentrations were within the suggested range by guidelines which may improve safety monitoring during therapy.
- Another study compared Pradaxa's risk profile against vitamin K antagonists through a meta-analysis of randomized controlled trials; it was not associated with increased risks such as major bleeding or fatal adverse reactions but did show an elevated risk for gastrointestinal bleeding.
- In non-Asian patients with non-valvular atrial fibrillation, real-world data showed that Pradaxa reduced the risk of ischemic stroke when compared to vitamin K antagonists especially at 150 mg dosage twice daily; this dose also indicated a trend towards lower myocardial infarction risks.
- Safety outcomes from these studies suggest that both doses - 110mg & 150mg - reduce major bleeding risks when compared to Vitamin K Antagonist along with intracranial bleeding & fatal bleedings but slightly increase gastrointestinal bleedings' likelihoods.
- The information provided comes from three Systematic Reviews / Meta-Analyses documents focusing on various aspects related to efficacy, safety profiles, dosages impacts etc., providing comprehensive insights into usage considerations for Dabigatran etexilate (Pradaxa).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pradaxa (dabigatran etexilate) Prescribing Information. | 2021 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| A systematic review and meta-analysis of dabigatran peak and trough concentration in adults. | 2022 | British Journal of Clinical Pharmacology |
| Safety of dabigatran as an anticoagulant: a systematic review and meta-analysis. | 2021 | Frontiers in Pharmacology |
| Effectiveness and safety of dabigatran compared to vitamin K antagonists in non-asian patients with atrial fibrillation: a systematic review and meta-analysis. | 2021 | Clinical Drug Investigation |