Dabigatran sigurniji za AF, najčešći poremećaj nepravilnog srčanog ritma

Veliko opservacijsko ispitivanje istraživača iz američke FDA je pokazalo da je dabigatran (150 mg dvaput dnevno) povezan s nižim stopama intrakranijalnog krvarenja i velikog ekstrakranijalnog krvarenja, uključujući veliko gastrointestinalno krvarenje naspram rivaroksabana (20 mg jedanput dnevno) u bolesnika s atrijskom fibrilacijom (AF).1 Ispitivanje predstavlja, do danas, najveće opservacijsko ispitivanje koje uspoređuje dva lijeka, a analizirani podaci dobiveni su na više od 118 000 bolesnika s AF-om.1 Na osnovi podataka objavljenih u magazinu JAMA Internal Medicine, popratna napomena urednika Parksa i Redberga sugerira da bi liječnici trebali “propisivati dabigatran prije nego rivaroksaban za bolesnike s atrijskom fibrilacijom.”2

U ispitivanju, čiji su autori Graham i njegovi suradnici iz Uprave za lijekove (FDA) u SAD-u, su retrospektivno uspoređivali rizike od moždanog udara, krvarenja i smrtnosti na 118 891 bolesnika s AF-om, najčešćim poremećajem nepravilnog srčanog ritma. Ključni ishodi su sljedeći1:

U ispitivanju, čiji su autori Graham i njegovi suradnici iz Uprave za lijekove (FDA) u SAD-u, su retrospektivno uspoređivali rizike od moždanog udara, krvarenja i smrtnosti na 118 891 bolesnika s AF-om, najčešćim poremećajem nepravilnog srčanog ritma. Ključni ishodi su sljedeći1:

“Ova posljednja analiza jasno ističe povoljan profil sigurnosti dabigatrana i koristi koje se nude širokom spektru bolesnika s AF-om u redovnoj kliničkoj praksi,” izjavio je profesor Jörg Kreuzer, dopredsjednik za medicinska pitanja, zadužen za kardiovaskularno terapijsko područje, u Boehringer Ingelheimu. “Ispitivanje nudi vrijedne informacije liječnicima, s ciljem podrške u odabiru liječenja za maksimalnu korist bolesnika. Potvrđuje rezultate drugih ispitivanja provedenih u stvarnoj kliničkoj praksi koji su objavljeni u prethodnom razdoblju ove godine, te se nadovezuje na obilje podataka koji podupiru pozitivan profil sigurnoti i djelotvornosti dabigatrana.”

Pozitivan profil sigurnosti dabigatrana, koji je izvorno utemeljen u ispitivanju RE-LY®l3,4, se opetovano potvrđuje u kliničkoj praksi stvarnog okruženja putem određenog broja ispitivanja iz različitih izvora.5-18 Nadalje, dabigatran je jedini oralni antikoagulans koji ne pripada antagonistima dichtienganhmina K, a koji ima odobren i široko dostupan specifični antagonist namijenjen primjeni u hitnim situacijama, kada se zahtijeva trenutno poništavanje antikoagualcije.19,20 Radi se o Idarucizumabu (Praxbind®) koji je u značajnoj mjeri dostupan u više od 5 500 bolnica širom svijeta, uključujući više od 2 500 bolnica u Europi.21

REFERENCE

  1. Graham DJ. et al. Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation. JAMA Intern Med. Published online 3 October 2016. doi:10.1001/jamainternmed.2016.5954

  1. Parks A.L and Redberg R.F. Editor’s Note: . JAMA Intern Med. Published online 3 October 2016. doi:10.1001/jamainternmed.2016.6429
  2. Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
  3. Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875–6.
  4. Al-Khalili F. et al. The safety and persistence of non-dichtienganhmin-K antagonist oral anticoagulants in atrial fibrillation patients treated in a well structured atrial fibrillation clinic. Curr Med Res Opin. 2016;32:779–85.
  5. Amin A. et al. Early Comparison of Major Bleeding, Stroke and Associated Medical Costs Among Treatment-Naive Non-Valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban or Warfarin. Abstract #745. 57th Annual Meeting & Exposition of the American Society of Hematology, 5-8 December 2015, Orlando, USA.
  6. Chan Y-H. et al. Cardiovascular, Bleeding, and Mortality Risks of Dabigatran in Asians With Nonvalvular Atrial Fibrillation. 2016;47:441–9.
  7. Deitelzweig S. et al. An early evaluation of bleeding-related hospital readmissions among hospitalized patients withnonvalvular atrial fibrillation treated with direct oral anticoagulants. Curr Med Res Opin. 2016;32:573–82.
  8. Gorst-Rasmussen A. et al. Rivaroxaban versus warfarin and dabigatran in atrial fibrillation: comparative effectiveness and safety in Danish routine care. Pharmacoepidemiol Drug Saf. doi:10.1002/pds.4034.
  9. Graham DJ. et al. Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated With Dabigatran or Warfarin for Nonvalvular Atrial Fibrillation. 2015;131:157–64.
  10. Larsen TB. et al. Bleeding Events Among New Starters and Switchers to Dabigatran Compared with Warfarin in Atrial Fibrillation. Am J Med. 2014;127:650–6.
  11. Larsen TB. et al. Comparative effectiveness and safety of non-dichtienganhmin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016;353:i3189.
  12. Lin I. et al. Real-world bleeding risk among nonvalvular atrial fibrillation (NVAF) patients prescribed apixaban, dabigatran, rivaroxaban and warfarin: analysis of electronic health records. Abstract #P6215, presented at the ESC Congress 2015, 29 August-2 September 2015, London, UK.
  13. Lip GYH. et al. Real world comparison of major bleeding risk among non-valvular atrial fibrillation patients newly initiated on apixaban, warfarin, dabigatran or rivaroxaban: A 1:1 propensity-score matched analysis. Abstract #1268-349, presented at The 65th American College of Cardiology Annual Scientific Session, 2-4 April 2016, Chicago, USA.
  14. Pan X. et al. What do real world data say about safety and resource use of oral antagonists? Early analysis of newly anticoagulated non-valvular atrial fibrillation patients using either apixaban, dabigatran, rivaroxaban or warfarin. Abstract #1268-361, presented at The 65th American College of Cardiology Annual Scientific Session, 2-4 April 2016, Chicago, USA.
  15. Seeger JD. et al. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost. 2015;114:1277–89.
  16. Tepper P. et al. Real-world comparison of bleeding risks among nonvalvular atrial fibrillation patients on apixaban, dabigatran, rivaroxaban: cohorts comprising new initiators and/or switchers from warfarin. Abstract #1975, presented at the ESC Congress 2015, 29 August-2 September, London, UK.
  17. Villines TC. et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114:1290-8.
  18. Idarucizumab European Summary of Product Characteristics, 2016.
  19. Idarucizumab U.S. Prescribing Information, 2015.
  20. Boehringer Ingelheim Data on File.
  21. Dabigatran etexilate European Summary of Product Characteristics, 2016.
  22. Dabigatran etexilate U.S. Prescribing Information, 2015.
  23. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
  24. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353(10):1028–40.
  25. Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45(5):555–63.
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