Dabigatran – an effective drug with proven efficacy and a high safety profile Review article
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Published:
Mar 1, 2026
Keywords:
anticoagulation, DOAC, idarucizumab, dabigatran, atrial fibrillation
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Abstract
Dabigatran is a direct thrombin inhibitor with proven efficacy in reducing the risk of thromboembolic events and – importantly – it has a specific antidote, idarucizumab. This review discusses the clinical use of dabigatran in patients with atrial fibrillation, particularly those with a history of stroke and liver failure, as well as in patients after percutaneous coronary intervention who have an indication for anticoagulation. Despite its unique benefits, the drug requires careful dose adjustment in patients with chronic kidney disease. The description also incorporates a practical neurologist’s perspective on the use of dabigatran in secondary prevention of ischemic stroke and on the risk of bleeding events.
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How to Cite
Skwarek, A., Golenia, A., & Ozierański, K. (2026). Dabigatran – an effective drug with proven efficacy and a high safety profile. Medycyna Faktow (J EBM), 19(4(69), 527-532. https://doi.org/10.24292/01.MF.0425.07
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References
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5. Fischer U, Koga M, Strbian D et al.; ELAN Investigators. Early versus Later Anticoagulation for Stroke with Atrial Fibrillation. N Engl J Med. 2023; 388(26): 2411-21.
6. Oldgren J, Åsberg S, Hijazi Z et al.; National TIMING Collaborators. Early Versus Delayed Non-Vitamin K Antagonist Oral Anticoagulant Therapy After Acute Ischemic Stroke in Atrial Fibrillation (TIMING): A Registry-Based Randomized Controlled Noninferiority Study. Circulation. 2022; 146(14): 1056-66.
7. Cannon CP, Bhatt DL, Oldgren J et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017; 377(16): 1513-24.
8. Vrints C, Andreotti F, Koskinas KC et al. 2024 ESC Guidelines for the management of chronic coronary syndromes: Developed by the task force for the management of chronic coronary syndromes of the European Society of Cardiology (ESC) Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024; 45(36): 3415-537.
9. Pollack CV, Reilly PA, van Ryn J et al. Idarucizumab for Dabigatran Reversal – Full Cohort Analysis. N Engl J Med. 2017; 377(5): 431-41.
10. van der Wall SJ, van Rein N, van den Bemt BJF et al. Performance of idarucizumab as antidote of dabigatran in daily clinical practice. EP Europace. 2018; 21: 414-20.
11. Violi F, Vestri A, Menichelli D et al. Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Advanced Liver Disease: An Exploratory Meta‐Analysis. Hepatology Communications. 2020; 4: 1034-40.
12. Khalid A, Mautong H, Hasnol H et al. S1589 Risks and Benefits of DOACS vs Warfarin in Patients With AF and Liver Disease – A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2023; 118: S1201-2.
13. Lee S-R, Lee H-J, Choi EK et al. Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Liver Disease. J Am Coll Cardiol. 2019; 73 25: 3295-308.
14. Elhosseiny S, Al Moussawi H, Chalhoub JM et al. Direct Oral Anticoagulants in Cirrhotic Patients: Current Evidence and Clinical Observations. Can J Gastroenterol Hepatol. 2019; 2019: 4383269.
15. European Medicines Agency (EMA). Charakterystyka Produktu Medycznego Pradaxa (dabigatran etexilate).
2. Risks for Stroke, Bleeding, and Death in Patients With Atrial Fibrillation Receiving Dabigatran or Warfarin in Relation to the CHADS2 Score: A Subgroup Analysis of the RE-LY Trial. Ann Intern Med. 2011; 155(10): 660-7.
3. Panichpisal K, Szarek M, Sareen A. Dabigatran for stroke prevention in patients with atrial fibrillation and previous stroke or transient ischemic attack: does dose matter? Fut Neurol. 2011; 6: 155-8.
4. Liang M, Jin J, Zhao R et al. Dabigatran-based versus warfarin-based triple antithrombotic regimen with a 1-month intensification after coronary stenting in patients with nonvalvular atrial fibrillation (COACH-AF PCI). BMC Med. 2025; 23(1): 643.
5. Fischer U, Koga M, Strbian D et al.; ELAN Investigators. Early versus Later Anticoagulation for Stroke with Atrial Fibrillation. N Engl J Med. 2023; 388(26): 2411-21.
6. Oldgren J, Åsberg S, Hijazi Z et al.; National TIMING Collaborators. Early Versus Delayed Non-Vitamin K Antagonist Oral Anticoagulant Therapy After Acute Ischemic Stroke in Atrial Fibrillation (TIMING): A Registry-Based Randomized Controlled Noninferiority Study. Circulation. 2022; 146(14): 1056-66.
7. Cannon CP, Bhatt DL, Oldgren J et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017; 377(16): 1513-24.
8. Vrints C, Andreotti F, Koskinas KC et al. 2024 ESC Guidelines for the management of chronic coronary syndromes: Developed by the task force for the management of chronic coronary syndromes of the European Society of Cardiology (ESC) Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024; 45(36): 3415-537.
9. Pollack CV, Reilly PA, van Ryn J et al. Idarucizumab for Dabigatran Reversal – Full Cohort Analysis. N Engl J Med. 2017; 377(5): 431-41.
10. van der Wall SJ, van Rein N, van den Bemt BJF et al. Performance of idarucizumab as antidote of dabigatran in daily clinical practice. EP Europace. 2018; 21: 414-20.
11. Violi F, Vestri A, Menichelli D et al. Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Advanced Liver Disease: An Exploratory Meta‐Analysis. Hepatology Communications. 2020; 4: 1034-40.
12. Khalid A, Mautong H, Hasnol H et al. S1589 Risks and Benefits of DOACS vs Warfarin in Patients With AF and Liver Disease – A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2023; 118: S1201-2.
13. Lee S-R, Lee H-J, Choi EK et al. Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Liver Disease. J Am Coll Cardiol. 2019; 73 25: 3295-308.
14. Elhosseiny S, Al Moussawi H, Chalhoub JM et al. Direct Oral Anticoagulants in Cirrhotic Patients: Current Evidence and Clinical Observations. Can J Gastroenterol Hepatol. 2019; 2019: 4383269.
15. European Medicines Agency (EMA). Charakterystyka Produktu Medycznego Pradaxa (dabigatran etexilate).