Dabigatran etexilate

(Pradaxa®)

Pradaxa®

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Drug updated on 5/17/2024

Dosage FormCapsule (oral; 75mg, 110 mg, 150 mg)
Drug ClassDirect 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.

Summary
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  • 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 TitleYearSource
Pradaxa (dabigatran etexilate) Prescribing Information.2021Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of direct oral anticoagulants for stroke prevention in older patients with atrial fibrillation: a network meta-analysis of randomized controlled trials.2023Journal of the American Heart Association
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of pulmonary embolism.2023The Cochrane Database of Systematic Reviews
Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis.2023The Cochrane Database of Systematic Reviews
A systematic review and meta-analysis of dabigatran peak and trough concentration in adults.2022British Journal of Clinical Pharmacology
Real-world evidence comparing oral anticoagulants in non-valvular atrial fibrillation: a systematic review and network meta-analysis.2022Future Cardiology
Safety of dabigatran as an anticoagulant: a systematic review and meta-analysis.2021Frontiers 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.2021Clinical Drug Investigation
Risk of stroke vs. intracerebral hemorrhage in patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention: a systematic review and meta-analysis of randomized controlled trials comparing dual vs. triple antithrombotic therapy.2021Journal of Stroke and Cerebrovascular Diseases
A systematic review of the efficacy and safety of direct oral anticoagulants in atrial fibrillation patients with diabetes using a risk index.2021Journal of Clinical Medicine
Clinical effectiveness and safety of aspirin for venous thromboembolism prophylaxis after total hip and knee replacement: a systematic review and meta-analysis of randomized clinical trials.2020JAMA Internal Medicine

Clinical Practice Guidelines

Document TitleYearSource
2023 ACC/AHA/ACCP/HRS guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines.2024Circulation
American college of gastroenterology-canadian association of gastroenterology clinical practice guideline: management of anticoagulants and antiplatelets during acute gastrointestinal bleeding and the periendoscopic period.2022Journal of the Canadian Association of Gastroenterology
American college of gastroenterology-canadian association of gastroenterology clinical practice guideline: management of anticoagulants and antiplatelets during acute gastrointestinal bleeding and the periendoscopic period.2022The American Journal of Gastroenterology
2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation.2020European Heart Journal
2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the american college of cardiology/american heart association task force on clinical practice guidelines and the heart rhythm society in collaboration with the society of thoracic surgeons.2019Circulation
2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the american college of cardiology/american heart association task force on clinical practice guidelines and the heart rhythm society.2019Journal of the American College of Cardiology