Dronedaron – nadzieja czy rozczarowanie? Artykuł przeglądowy
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Opublikowane:
mar 31, 2011
Słowa kluczowe:
migotanie przedsionków, dronedaron, amiodaron, leki antyarytmiczne, niewydolność serca
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Abstrakt
Migotanie przedsionków występuje u 1–2% populacji i stanowi najczęstsze utrwalone zaburzenie rytmu serca. Jednym z najbardziej skutecznych leków w prewencji napadów migotania przedsionków i utrzymywania rytmu zatokowego jest amiodaron. Jego długotrwałe stosowanie wiąże się jednak z dużym ryzykiem wystąpienia poważnych działań niepożądanych, takich jak: zaburzenia rytmu serca, zaburzenia czynności tarczycy, wątroby czy uszkodzenie tkanki płucnej. Dronedaron jest nowym lekiem antyarytmicznym, podobnym pod względem budowy i mechanizmu działania do amiodaronu, ale pozbawionym niekorzystnego wpływu na tarczycę i płuca. W styczniu 2011 r. amerykańska Agencja do spraw Żywności i Leków (Food and Drug Administration) ogłosiła informację dotyczącą dwóch przypadków ciężkiego uszkodzenia wątroby u pacjentów leczonych dronedaronem. W ciągu dwóch tygodni od wystąpienia pierwszych objawów konieczne było przeszczepienie narządu. Również dane dotyczące skuteczności leku nie przyniosły tak spektakularnych wyników, jak oczekiwano. Wydaje się zatem, że dronedaron, mimo pokładanych w nim ogromnych nadziei, nie spełnia naszych oczekiwań jako lek, który łączyłby skuteczność amiodaronu ze znacznie lepszym profilem bezpieczeństwa.
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Pakuła , M., Wrzosek , K., & Rosiak , M. (2011). Dronedaron – nadzieja czy rozczarowanie? . Kardiologia W Praktyce, 5(1), 18-25. Pobrano z https://journalsmededu.pl/index.php/kwp/article/view/1613
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Utwór dostępny jest na licencji Creative Commons Uznanie autorstwa – Użycie niekomercyjne – Bez utworów zależnych 4.0 Międzynarodowe.
Copyright: © Medical Education sp. z o.o. This is an Open Access article distributed under the terms of the Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). License (https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
Address reprint requests to: Medical Education, Marcin Kuźma (marcin.kuzma@mededu.pl)
Bibliografia
1. Stewart S., Hart C.L., Hole D.J., McMurray J.J.: Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart 2001, 86: 516-521.
2. Fuster V., Ryden L.E., Cannom D.S. et al.: ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation. Europace 2006, 8: 651-745.
3. Kathofen S., Thomas D., Karle C.: The Novel Antiarrhythmic Drug Dronedarone: Comparison with Amiodarone. Cardiovascular Drug Reviews 2005, 23: 217-230.
4. Ezekowitz M.D.: Maintaining Sinus Rhythm-Making Treatment Better Than the Disease. N. Engl. J. Med. 2007, 357: 1039-1041.
5. Miyasaka Y., Barnes M.E., Gersh B.J. et al.: Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation 2006, 114: 119-125.
6. Naccarelli G.V., Varker H., Lin J., Schulman K.L.: Increasing prevalence of atrial fibrillation and flutter in the United States. Am. J. Cardiol. 2009, 104: 1534-1539.
7. Lloyd-Jones D.M., Wang T.J., Leip E.P. et al.: Lifetime risk for development of atrial fibrillation/The Framingham Heart Study. Circulation 2004, 110: 1042-1046.
8. Coplen S.E., Antman E.M., Berlin J.A. et al.: Efficacy and safety of quindine therapy for maintenance of sinus rhythm after cardioversion: a meta-analysis of randomized control trials. Circulation 1990, 82: 1106-1116.
9. Naccarelli G.V., Wolbrette D.L., Patel H.M., Luck J.C.: Amiodarone: Clinical trials. Curr. Opin. Cardiol. 2000, 15: 64-72.
10. Khan M.H.: Oral class III antiarrhythmics: what is new? Curr. Opin. Cardiol. 2004, 19: 47-51.
11. FDA. FDA approves Multaq to Treat Heart Rhythm Disorder/Press release. 2009 July [online].
12. Center for Drug Evaluation and Research. Briefing information for the March 18, 2009 meeting of the Cardiovascular and Renal Drugs Advisory Committee (Online). February 19, 2009 (cited July 15, 2009) [online] 13. Touboul P., Brugada J., Capucci A., Crijns H.J., Edvardsson N., Hohnloser S.H.: Dronedarone for prevention of atrial fibrillation: A dose-ranging study. Eur. Heart J. 2003, 24: 1481-1487.
14. Tschuppert Y., Buclin T., Rothuizen L.E., Decosterd L.A., Galleyrand J., Gaud C., Biollaz J.: Effect of dronedarone on renal function in healthy subjects. Br. J. Clin. Pharmacol. 2007, 64: 785-791.
15. Klotz U.: Antiarrhythmics elimination and dosage considerations in hepatic impairment. Clin. Pharmacokinet. 2007, 46: 985-996.
16. Center for Drug Evalution and Research. Multaq (dronedarone) prescribing information (Online). July 1, 2009 (cited July 15, 2009) [online] .
17. Center for Drug Evalution and Research. Cordarone (amiodarone) prescribing information (Online). April 21, 2009 (cited July 15, 2009) [online].
18. Lalevee N., Nargeot J., Barrere-Lemarie S., Gautier P., Richard S.: Effects of amiodarone and dronedarone on voltage-dependent sodium current in human cardiomyocytes. J. Cardiovasc. Electrophysiol. 2003, 14: 885-890.
19. Altomare C., Barbuti A., Viscomi C., Baruscotti M., DiFrancesco D.: Effects of dronedarone on acetylcholineactivated current in rabbit SAN cells. Br. J. Pharmacol. 2000, 130: 1315-1320.
20. Guiraudou P., Pucheu S.C., Gayraud R. et al.: Involvement of nitric oxide in amiodarone- and dronedarone-induced coronary vasodilation in guinea pig heart. Eur. J. Pharmacol. 2004, 496: 119-127.
21. Gautier P., Guillemare E., Marion A., Bertrand J.P., Tourneur Y., Nisato D.: Electrophysiologic characterization of dronedarone in guinea pig ventricular cells. J. Cardiovasc. Pharmacol. 2003, 41: 191-202.
22. Sun W., Sarma J.S., Singh B.N.: Electrophysiological effects of dronedarone (SR33589), a noniodinated benzofuran derivative, in the rabbit heart: Comparison with amiodarone. Circulation 1999, 100: 2276-2281.
23. Manning A., Thisse V., Hodeige D., Richard J., Heyndrickx J.P., Chatelain P.: SR 33589, a new amiodarone-like antiarrhythmic agent: Electrophysiological effects in anesthetized dogs. J. Cardiovasc. Pharmacol. 1995, 25: 252-261.
24. Rochetaing A., Barbe C., Kreher P.: Beneficial effects of amiodarone and dronedarone (SR 33589b), when applied during low-flow ischemia, on arrhythmia and functional parameters asssessed during reperfusion in isolated rat hearts. J. Cardiovasc. Pharmacol. 2001, 38: 500-511.
25. Singh B.N., Connolly S.J., Crijns H.J. et al.: Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N. Engl. J. Med. 2007, 357: 987-999.
26. Coplen S.E., Antman E.M., Berlin J.A., Hewitt P., Chalmers T.C.: Efficacy and safety of quinidine therapy for maintenance of sinus rhythm after cardioversion. A meta-analysis of randomized control trials. Circulation 1990, 82: 1106-16.
27. Doyle J.F., Ho K.M.: Benefits and risks of long-term amiodarone therapy for persistent atrial fibrillation: a meta-analysis. Mayo Clin. Proc. 2009, 84: 234-42.
28. Singh B.N., Singh S.N., Reda D.J. et al.: Amiodarone versus sotalol for atrial fibrillation. N. Engl. J. Med. 2005, 352: 1861-72.
29. Maintenance of sinus rhythm in patients with atrial fibrillation: an AFFIRM substudy of the first antiarrhythmic drug. J. Am. Coll. Cardiol. 2003, 42: 20-9.
30. Roy D., Talajic M., Dorian P. et al.: Amiodarone to prevent recurrence of atrial fibrillation. Canadian Trial of Atrial Fibrillation Investigators. N. Engl. J. Med. 2000, 342: 913-20.
31. Hohnloser S.H., Crijns H.J., van Eickels M. et al.: Effect of dronedarone on cardiovascular events in atrial fibrillation. N. Engl. J. Med. 2009, 360: 668-678.
32. Davy J.M., Herold M., Hoglund C. et al.: Dronedarone for the control of ventricular rate in permanent atrial fibrillation: The efficacy and safety of dronedarone for the control of ventricular rate during atrial fibrillation (ERATO) study. Am. Heart J. 2008, 156: 527e1-527e9.
33. ClinicalTrials.gov. Efficacy and safety of dronedarone versus amiodarone for the maintenance of sinus rhythm in patients with atrial fibrillation (DIONYSIS) (Online). March 16, 2009 (cited July 15, 2009) [online].
34. Kober L., Torp-Pedersen C., McMurray J.J. et al.: Increased mortality after dronedarone therapy for severe heart failure. N. Engl. J. Med. 2008, 358: 2678-2687.
35. Sanofi-Aventis. Multaq (dronedarone) FDA Caridovascular and Renal Drugs Division Advisory Committee Meeting presentation (Online). March 18, 2009 (cited July 15, 2009) [online].
36. Camm A.J., Kirchhof P., Lip H.Y.H. et al.: Guidelines for the management of atrial fibrillation The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS) [online].
37.Wann S., Curtis A.B., Craig T. et al.: 2011 ACCF/ /AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline): A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines [online].
38. Multaq (dronedarone) – Drug Safety Communication: Risk of Severe Liver Injury (Online) January 14, 2011 [online].
2. Fuster V., Ryden L.E., Cannom D.S. et al.: ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation. Europace 2006, 8: 651-745.
3. Kathofen S., Thomas D., Karle C.: The Novel Antiarrhythmic Drug Dronedarone: Comparison with Amiodarone. Cardiovascular Drug Reviews 2005, 23: 217-230.
4. Ezekowitz M.D.: Maintaining Sinus Rhythm-Making Treatment Better Than the Disease. N. Engl. J. Med. 2007, 357: 1039-1041.
5. Miyasaka Y., Barnes M.E., Gersh B.J. et al.: Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation 2006, 114: 119-125.
6. Naccarelli G.V., Varker H., Lin J., Schulman K.L.: Increasing prevalence of atrial fibrillation and flutter in the United States. Am. J. Cardiol. 2009, 104: 1534-1539.
7. Lloyd-Jones D.M., Wang T.J., Leip E.P. et al.: Lifetime risk for development of atrial fibrillation/The Framingham Heart Study. Circulation 2004, 110: 1042-1046.
8. Coplen S.E., Antman E.M., Berlin J.A. et al.: Efficacy and safety of quindine therapy for maintenance of sinus rhythm after cardioversion: a meta-analysis of randomized control trials. Circulation 1990, 82: 1106-1116.
9. Naccarelli G.V., Wolbrette D.L., Patel H.M., Luck J.C.: Amiodarone: Clinical trials. Curr. Opin. Cardiol. 2000, 15: 64-72.
10. Khan M.H.: Oral class III antiarrhythmics: what is new? Curr. Opin. Cardiol. 2004, 19: 47-51.
11. FDA. FDA approves Multaq to Treat Heart Rhythm Disorder/Press release. 2009 July [online].
12. Center for Drug Evaluation and Research. Briefing information for the March 18, 2009 meeting of the Cardiovascular and Renal Drugs Advisory Committee (Online). February 19, 2009 (cited July 15, 2009) [online] 13. Touboul P., Brugada J., Capucci A., Crijns H.J., Edvardsson N., Hohnloser S.H.: Dronedarone for prevention of atrial fibrillation: A dose-ranging study. Eur. Heart J. 2003, 24: 1481-1487.
14. Tschuppert Y., Buclin T., Rothuizen L.E., Decosterd L.A., Galleyrand J., Gaud C., Biollaz J.: Effect of dronedarone on renal function in healthy subjects. Br. J. Clin. Pharmacol. 2007, 64: 785-791.
15. Klotz U.: Antiarrhythmics elimination and dosage considerations in hepatic impairment. Clin. Pharmacokinet. 2007, 46: 985-996.
16. Center for Drug Evalution and Research. Multaq (dronedarone) prescribing information (Online). July 1, 2009 (cited July 15, 2009) [online] .
17. Center for Drug Evalution and Research. Cordarone (amiodarone) prescribing information (Online). April 21, 2009 (cited July 15, 2009) [online].
18. Lalevee N., Nargeot J., Barrere-Lemarie S., Gautier P., Richard S.: Effects of amiodarone and dronedarone on voltage-dependent sodium current in human cardiomyocytes. J. Cardiovasc. Electrophysiol. 2003, 14: 885-890.
19. Altomare C., Barbuti A., Viscomi C., Baruscotti M., DiFrancesco D.: Effects of dronedarone on acetylcholineactivated current in rabbit SAN cells. Br. J. Pharmacol. 2000, 130: 1315-1320.
20. Guiraudou P., Pucheu S.C., Gayraud R. et al.: Involvement of nitric oxide in amiodarone- and dronedarone-induced coronary vasodilation in guinea pig heart. Eur. J. Pharmacol. 2004, 496: 119-127.
21. Gautier P., Guillemare E., Marion A., Bertrand J.P., Tourneur Y., Nisato D.: Electrophysiologic characterization of dronedarone in guinea pig ventricular cells. J. Cardiovasc. Pharmacol. 2003, 41: 191-202.
22. Sun W., Sarma J.S., Singh B.N.: Electrophysiological effects of dronedarone (SR33589), a noniodinated benzofuran derivative, in the rabbit heart: Comparison with amiodarone. Circulation 1999, 100: 2276-2281.
23. Manning A., Thisse V., Hodeige D., Richard J., Heyndrickx J.P., Chatelain P.: SR 33589, a new amiodarone-like antiarrhythmic agent: Electrophysiological effects in anesthetized dogs. J. Cardiovasc. Pharmacol. 1995, 25: 252-261.
24. Rochetaing A., Barbe C., Kreher P.: Beneficial effects of amiodarone and dronedarone (SR 33589b), when applied during low-flow ischemia, on arrhythmia and functional parameters asssessed during reperfusion in isolated rat hearts. J. Cardiovasc. Pharmacol. 2001, 38: 500-511.
25. Singh B.N., Connolly S.J., Crijns H.J. et al.: Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N. Engl. J. Med. 2007, 357: 987-999.
26. Coplen S.E., Antman E.M., Berlin J.A., Hewitt P., Chalmers T.C.: Efficacy and safety of quinidine therapy for maintenance of sinus rhythm after cardioversion. A meta-analysis of randomized control trials. Circulation 1990, 82: 1106-16.
27. Doyle J.F., Ho K.M.: Benefits and risks of long-term amiodarone therapy for persistent atrial fibrillation: a meta-analysis. Mayo Clin. Proc. 2009, 84: 234-42.
28. Singh B.N., Singh S.N., Reda D.J. et al.: Amiodarone versus sotalol for atrial fibrillation. N. Engl. J. Med. 2005, 352: 1861-72.
29. Maintenance of sinus rhythm in patients with atrial fibrillation: an AFFIRM substudy of the first antiarrhythmic drug. J. Am. Coll. Cardiol. 2003, 42: 20-9.
30. Roy D., Talajic M., Dorian P. et al.: Amiodarone to prevent recurrence of atrial fibrillation. Canadian Trial of Atrial Fibrillation Investigators. N. Engl. J. Med. 2000, 342: 913-20.
31. Hohnloser S.H., Crijns H.J., van Eickels M. et al.: Effect of dronedarone on cardiovascular events in atrial fibrillation. N. Engl. J. Med. 2009, 360: 668-678.
32. Davy J.M., Herold M., Hoglund C. et al.: Dronedarone for the control of ventricular rate in permanent atrial fibrillation: The efficacy and safety of dronedarone for the control of ventricular rate during atrial fibrillation (ERATO) study. Am. Heart J. 2008, 156: 527e1-527e9.
33. ClinicalTrials.gov. Efficacy and safety of dronedarone versus amiodarone for the maintenance of sinus rhythm in patients with atrial fibrillation (DIONYSIS) (Online). March 16, 2009 (cited July 15, 2009) [online].
34. Kober L., Torp-Pedersen C., McMurray J.J. et al.: Increased mortality after dronedarone therapy for severe heart failure. N. Engl. J. Med. 2008, 358: 2678-2687.
35. Sanofi-Aventis. Multaq (dronedarone) FDA Caridovascular and Renal Drugs Division Advisory Committee Meeting presentation (Online). March 18, 2009 (cited July 15, 2009) [online].
36. Camm A.J., Kirchhof P., Lip H.Y.H. et al.: Guidelines for the management of atrial fibrillation The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS) [online].
37.Wann S., Curtis A.B., Craig T. et al.: 2011 ACCF/ /AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline): A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines [online].
38. Multaq (dronedarone) – Drug Safety Communication: Risk of Severe Liver Injury (Online) January 14, 2011 [online].