Dabigatran etexilate

(Pradaxa®)

Dabigatran etexilate

Drug updated on 11/5/2024

Dosage FormCapsule (oral; 75 mg, 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

Latest News

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Summary
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  • 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 TitleYearSource
Pradaxa (dabigatran etexilate) Prescribing Information.2023Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

Systematic Reviews / Meta-Analyses

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 guidelines2024Circulation
American college of gastroenterology-canadian association of gastroenterology clinical practice guideline: management of anticoagulants and antiplatelets during acute gastrointestinal bleeding and the periendoscopic period2022Journal of the Canadian Association of Gastroenterology
2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC)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 surgeons2019Circulation
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 society2019Journal of the American College of Cardiology