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Mixed treatment comparison of dronedarone, amiodarone, sotalol, flecainide, and propafenone, for the management of atrial fibrillation
Abstract
AIMS: Mixed treatment comparisons (MTC) were performed to assess the relative efficacy and tolerability of the main anti-arrhythmic drugs used for the treatment of atrial fibrillation (AF)/flutter. METHODS AND RESULTS: Electronic databases were systematically searched to identify randomized controlled trials (RCTs) examining amiodarone, dronedarone, flecainide, propafenone, sotalol, or placebo for the treatment of AF. Thirty-nine RCTs met inclusion criteria and were combined using MTC models to provide direct and indirect comparisons in a single analysis. Results are presented vs. placebo. Amiodarone had the largest effect in reducing AF recurrence (OR 0.22, 95% CI 0.16-0.29). Amiodarone was associated with the highest rate of patients experiencing at least one serious adverse event (OR 2.41, 95% CI 0.96-6.06) and treatment withdrawals due to adverse events (OR 2.91, 95% CI 1.66-5.11). Dronedarone was associated with the lowest rate of proarrhythmic events including bradycardia (OR 1.45, 95% CI 1.02-2.08). Dronedarone significantly reduced the risk of stroke (OR 0.69, 95% CI 0.57-0.84). Trends towards increased mortality for sotalol (OR 3.44, 95% CI 1.02-11.59) and amiodarone (OR 2.17, 95% CI 0.63-7.51) were found, which were stronger when small studies randomizing <100 subjects per group were excluded. CONCLUSIONS: Amiodarone has been demonstrated to be the most effective drug in maintaining sinus rhythm. Differences in outcomes between the anti-antiarrhythmic drugs were reported, with sotalol and possibly amiodarone increasing mortality and dronedarone possibly decreasing the incidence of serious adverse events and proarrhythmia.
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“Quinidine and disopyramide have been associated with an increase in all-cause mortality (OR 2.39; 95% CI 1.03-5.59;number needed to harm 109; 95% CI 34-4985) at 1-year follow-up, 580, 661 likely due to ventricular arrhythmias (torsades de pointes).580,661”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [661]
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“The most commonly used AAD for rhythm control in all these trials was amiodarone, which was shown in the studies to have a low pro-arrhythmic potential, with its adverse side effects being mainly extra-cardiac [59].”
BackgroundMethodInfluentialNew Directions in Antiarrhythmic Drug Therapy for Atrial Fibrillation
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“Similarly, a mixed treatment comparison of dronedarone, amiodarone, sotalol, flecainide and propafenone identified dronedarone as the drug associated with the lowest rates of proarrhythmic events [103].”
ResultSafety and Efficacy of Dronedarone in the Treatment of Atrial Fibrillation/Flutter
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BackgroundRate Control in Atrial Fibrillation
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“effective AAD for the maintenance of sinus rhythm, it is less effective for acute cardioversion [111].”
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“, 2003) and particularly sinus rhythm maintenance (Roy et al., 2000; Wyse et al., 2002; Singh et al., 2005; Freemantle et al., 2011).”
BackgroundBoriani, G., Blomström‐Lundqvist, C., Hohnloser, S. H., Bergfeldt, L., Botto, G. L., Capucci, A., Lozano, I. F., Goette, A., Israel, C. W., Merino, J. L., et al. (2019) · EP Europace · doi:10.1093/europace/euz193 · Cited by 46
“08).(21) A recent retrospective analysis of the German IQVIA database (2010–2017) involved 3498 patients receiving a first prescription of dronedarone and 17 724 patients receiving a first prescription of other AADs (amiodarone, flecainide, propafenone, or sotalol).”
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“published a mixed treatment comparisons of contemporary antiarrhythmic drugs for which they performed a comprehensive meta-analysis of 39 randomized controlled trials examining amiodarone, dronedarone, flecainide, propafenone, sotalol, or placebo for the treatment of AF [19].”
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“even suggests potential increased mortality associated with amiodarone use in contrast to a potential reduction of serious adverse events and proarrhythmia by dronedarone.(15) The reduced number of acute coronary syndromes in patients with AF and CHD who were randomized to dronedarone is probably not unexpected based…”
ResultInfluentialA review on dronedarone: Pharmacological, pharmacodynamic and pharmacokinetic profile
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“[49, 53-60] This suggests that meta-”
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“It has to be mentioned that the ESC guidelines present heterogeneous study results [56,57] regarding the all-cause mortality under sotalol while the AHA guidelines are reporting a raised mortality under sotalol based on a retrospective analysis [58].”
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Banerjee, A., Marín, F. R., & Lip, G. Y. H. (2011) · Stroke · doi:10.1161/strokeaha.111.617886 · Cited by 28
Amos, T. B., Keith, S. W., Canale, S. D., Orsi, P., Maggio, M. G., Baccarini, S., Gonzi, G., Liu, M., & Maio, V. (2014) · Journal of Clinical Pharmacy and Therapeutics · doi:10.1111/jcpt.12212 · Cited by 29
“Severe toxic effects have been reported with the use of antiarrhythmics, especially among older patients, due to their potentially fatal side effects.(29,30) Caution and proactive monitoring should be used by primary care physicians while prescribing antiarrhythmics in older patients.”
BackgroundAntiarrhythmic Drug Therapy for Atrial Fibrillation
Sardar, M. R., Saeed, W., & Kowey, P. R. (2016) · Heart Failure Clinics · doi:10.1016/j.hfc.2015.08.017 · Cited by 28
Wasmer, K., BREITHARDT, G. E., & Eckardt, L. (2014) · European Heart Journal · doi:10.1093/eurheartj/ehu113 · Cited by 29
Comparative effectiveness of antiarrhythmic drugs for rhythm control of atrial fibrillation
Qin, D., Leef, G. C., Alam, M. B., Rattan, R., Munir, M. B., Patel, D. R., Khattak, F. H., ADELSTEIN, E. C., Jain, S. K., & Saba, S. (2015) · Journal of Cardiology · doi:10.1016/j.jjcc.2015.07.001 · Cited by 29
“All rights AF [7–10], and is often achieved using antiarrhythmic drugs (AAD) that alter the function of membrane channels in cardiac myocytes [11,12,7,13,14].”
BackgroundInfluentialHindricks, G., Potpara, T., Dagres, N., Arbelo, E., Bax, J. J., Blomström‐Lundqvist, C., Boriani, G., Castellà, M., Dan, G., Dilaveris, P., et al. (2021) · Revista Española de Cardiología · doi:10.1016/j.recesp.2020.10.022 · Cited by 34
Rodrigues, M., Alves, G., Ferreira, A., Queiroz, J. A., & Falcão, A. C. (2012) · Journal of Chromatographic Science · doi:10.1093/chromsci/bms149 · Cited by 27
Propafenone suppresses esophageal cancer proliferation through inducing mitochondrial dysfunction.
Zheng, W.-B., Li, Y., Wang, Y., Yang, J., Zheng, C., Huang, X., Li, B., & He, Q. (2017) · Europe PMC (PubMed Central) · Cited by 25
Flecainide How and When: A Practical Guide in Supraventricular Arrhythmias
Lavalle, C., Magnocavallo, M., Straito, M., Santini, L., Forleo, G. B., Grimaldi, M., Badagliacca, R., Lanata, L., & Ricci, R. P. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10071456 · Cited by 24
Field, M. E., Holmes, D. N., Page, R. L., Fonarow, G. C., Matsouaka, R., Turakhia, M. P., Lewis, W. R., & Piccini, J. P. (2021) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.120.008961 · Cited by 23
“The 6 criteria used were (1) flecainide and propafenone should not be used in patients with CAD, (2) flecainide, propafenone, dronedarone, sotalol should not be used in patients with HF, (3) flecainide, propafenone, dofetilide, sotalol should not be used in patients with severe LVH (which was defined as a previous dia…”
MethodMedical treatment of atrial fibrillation
Camm, A. J., Camm, C. F., & Savelieva, I. (2011) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0b013e32834f23e1 · Cited by 22
Ablation for Atrial Fibrillation in Heart Failure with Reduced Ejection Fraction
Liang, J. J., & Callans, D. J. (2018) · Cardiac failure review · doi:10.15420/cfr.2018:3:1 · Cited by 23
“The study showed that dofetilide was more effective in converting AF to sinus rhythm and maintaining sinus rhythm compared with placebo and dofetilide reduced the risk of HF hospitalisation (RR 0.75, 95 % CI [0.63– 0.89]).17 Although there was no overall difference in mortality compared with placebo among all patients…”
MethodInfluentialLane, D. A., Andrade, J. G., Arbelo, E., Boriani, G., Hendriks, J., Lee, S., Lip, G. Y. H., Mant, J., & Middeldorp, M. E. (2026) · The Lancet · doi:10.1016/s0140-6736(25)02166-x · Cited by 25
Sicouri, S., Pourrier, M., Gibson, J. K., Lynch, J. J., & Antzelevitch, C. N. (2011) · Heart Rhythm · doi:10.1016/j.hrthm.2011.10.021 · Cited by 21
Rate control strategies for atrial fibrillation
Alobaida, M., & Alrumayh, A. (2021) · Annals of Medicine · doi:10.1080/07853890.2021.1930137 · Cited by 28
“In post-myocardial infarction patients with left ventricle dysfunction, sotalol was associated with a higher mortality compared to the placebo group, which is probably because of ventricular arrhythmias [65,66].”
BackgroundHuang, J., Wu, B., Qin, P., Cheng, Y., Zhang, Z., & Chen, Y. (2023) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2023.1270452 · Cited by 26
Fumagalli, S., Nieuwlaat, R., Tarantini, F., de Vos, C. B., Werter, C. J. P. J., Heuzey, J. L., Marchionni, N., & Crijns, H. J. G. M. (2012) · Aging Clinical and Experimental Research · doi:10.1007/bf03654822 · Cited by 21
Wang, F., Zhou, B., Sun, H., & Wu, X. (2023) · Frontiers in Pharmacology · doi:10.3389/fphar.2023.1170039 · Cited by 21
“The negative signal of dronedarone in ventricular arrhythmia/TdP shown in our study is updated and more consistent with clinical research andmeta-analysis (Hohnloser et al., 2009; Freemantle et al., 2011; Lafuente-Lafuente et al., 2012; Friberg, 2018; Reimold and Reynolds, 2018; Valembois et al., 2019; Tisdale et al.,…”
MethodResultExecutive Summary of the II Brazilian Guidelines for Atrial Fibrillation
de Magalhães, L. P., Figueiredo, M. J. D. O., Cintra, F. D., Saad, E., Kuniyoshi, R. R., Filho, A. M. L., d’Ávila, A., de Paola, Â. A. V., Kalil, C., Moreira, D. A. R., et al. (2016) · Arquivos Brasileiros de Cardiologia · doi:10.5935/abc.20160190 · Cited by 19
Shetty, S. S., & KRUMERMAN, A. K. (2022) · Cardiovascular Diabetology · doi:10.1186/s12933-022-01552-2 · Cited by 20
“Current pharmacotherapies targeting ion channels to treat AF have their own arrhythmogenic potentials [10, 11] and invasive interventional procedures (while highly effective), are not scalable given the vast numbers of AF patients needing treatment.”
BackgroundLin, C., Lin, Y., Lo, L., Chen, Y., Chong, E. Y., Chang, S., Chung, F., Chao, T., Hu, Y., Tuan, T., et al. (2015) · Heart Rhythm · doi:10.1016/j.hrthm.2015.04.018 · Cited by 19
Antiarrhythmic Drug Therapy to Avoid Implantable Cardioverter Defibrillator Shocks
Abboud, J., & Ehrlich, J. R. (2016) · Arrhythmia & Electrophysiology Review · doi:10.15420/aer.2016.10.2 · Cited by 19
“The Danish Investigations of Arrhythmia and Mortality on Dofetilide with Congestive Heart Failure (DIAMOND-CHF) trial suggested a mortality benefit for patients with heart failure with an LVEF 35 % who converted from AF to sinus rhythm on dofetilide.23 The trial was designed to study safety and efficacy of this class…”
BackgroundInfluentialRodrigues, M., Alves, G., Abrantes, J. A., & Falcão, A. C. (2012) · Food and Chemical Toxicology · doi:10.1016/j.fct.2012.11.012 · Cited by 19
Corneal Densitometry as a Novel Technique for Monitoring Amiodarone Therapy
Alnawaiseh, M., Zumhagen, L., Zumhagen, S., Schulte, L., Rosentreter, A., Schubert, F., Eter, N., & Mönnig, G. (2016) · Ophthalmology · doi:10.1016/j.ophtha.2016.08.001 · Cited by 19
Ablation as First-line Therapy for Atrial Fibrillation
Andrade, J. G. (2023) · European Cardiology Review · doi:10.15420/ecr.2023.04 · Cited by 20
Safety and efficacy of vernakalant for acute cardioversion of atrial fibrillation: an update
Dobrev, D., & Tsuji, Y. (2013) · Vascular Health and Risk Management · doi:10.2147/vhrm.s43720 · Cited by 18
Milojévic, K., Beltramini, A., Nagash, M., Muret, A., Richard, O., & Lambert, Y. (2019) · Journal of Emergency Medicine · doi:10.1016/j.jemermed.2018.12.010 · Cited by 17
“There are many pharmacological options for the treatment of RAF (10,19,36).”
BackgroundMethodEfficacy and adverse effects of sotalol in adults with congenital heart disease
Moore, B. M., Cordina, R., McGuire, M. A., & Celermajer, D. S. (2018) · International Journal of Cardiology · doi:10.1016/j.ijcard.2018.06.066 · Cited by 19
Dharmarathne, G., Kazi, S., King, S., & Jayasinghe, T. N. (2024) · Microorganisms · doi:10.3390/microorganisms12112246 · Cited by 19
Actualización detallada de las guías de la ESC para el manejo de la fibrilación auricular de 2012
Camm, A. J., Lip, G. Y. H., Caterina, R. D., Savelieva, I., Atar, D., Hohnloser, S. H., Hindricks, G., Kirchhof, P. F., Bax, J. J., Baumgartner, H., et al. (2012) · Revista Española de Cardiología · doi:10.1016/j.recesp.2012.11.001 · Cited by 16
Tadros, R., Nattel, S., & Andrade, J. G. (2016) · Cardiac Electrophysiology Clinics · doi:10.1016/j.ccep.2016.02.008 · Cited by 16
Kipp, R. T., Askari, M., Fan, J., Field, M. E., & Turakhia, M. P. (2018) · JACC. Clinical electrophysiology · doi:10.1016/j.jacep.2018.08.025 · Cited by 16
Singh, J. P., Blomström‐Lundqvist, C., Turakhia, M. P., Camm, A. J., Fazeli, M. S., Kreidieh, B., Crotty, C., & Kowey, P. R. (2023) · Clinical Cardiology · doi:10.1002/clc.24011 · Cited by 15
“Direct comparisons between dronedarone and sotalol are limited, however, some evidence has shown that sotalol use is associated with a higher risk of ventricular proarrhythmia and increased overall mortality, recently recognized in the 2020 European Society of Cardiology (ESC) AF guidelines.(3,7,8,10)”
BackgroundResultInfluentialEfficacy and safety of dronedarone in the treatment of patients with atrial fibrillation
Khan, M. H., Rochlani, Y. M., & Aronow, W. S. (2017) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2017.1387246 · Cited by 15
“Of all the antiarrhythmic agents, amiodarone is the best studied but, like rhythm control itself, remains a double-edged sword with the greatest potential to maintain patients in sinus rhythm, along with a significant adverse effect profile [8], particularly with regard to thyroid and pulmonary toxicity.”
BackgroundChinese Guidelines for the Diagnosis and Management of Atrial Fibrillation
Ma, C., Wu, S., Liu, S., & Han, Y. (2024) · 老年心脏病学杂志：英文版 · doi:10.26599/1671-5411.2024.03.009 · Cited by 17
Qin, D., Leef, G. C., Alam, M. B., Rattan, R., Munir, M. B., Patel, D. R., Khattak, F. H., Vaghasia, N., ADELSTEIN, E. C., Jain, S. K., et al. (2015) · Journal of the American Heart Association · doi:10.1161/jaha.115.001793 · Cited by 15
Wharton, J. M., Piccini, J. P., Koren, A., Huse, S., & Ronk, C. J. (2022) · Journal of the American Heart Association · doi:10.1161/jaha.120.020506 · Cited by 14
“13,30 However, a randomized prospective trial comparing the 2 drugs has not been performed in nonablated patients with AF.”
Metadata
- Authors
- Freemantle, N., Lafuente-Lafuente, C., Mitchell, S., Eckert, L., & Reynolds, M.
- Affiliations
- University of Birmingham (GB)
- Sanofi (France) (FR)
- Beth Israel Deaconess Medical Center (US)
- Corresponding author
- Eckert, L.
- Venue
- Europace
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-01-11
- Volume
- 13
- Issue
- 3
- Pages
- 329-345
- ISSN
- 1099-5129 (ISSN-L)
- 1532-2092
- OpenAlex
- W2010627883
- Cited by
- 245
- References
- 65
- Citations by year
- 2026: 5 · 2025: 14 · 2024: 18 · 2023: 14 · 2022: 20 · 2021: 14 · 2020: 12 · 2019: 12 · 2018: 15 · 2017: 12 · 2016: 24 · 2015: 19 · 2014: 22 · 2013: 7 · 2012: 25
- FWCI
- 14.47
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- EP Europace (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
- Keywords
- atrial fibrillation, antiarrhythmic drugs, dronedarone, amiodarone, sotalol, flecainide, propafenone, atrial flutter, atrial fibrillation recurrence, drug-induced arrhythmia, stroke prevention, mortality, drug tolerability, sinus rhythm maintenance
- MeSH terms
- Dronedarone, Aged, Amiodarone, Anti-Arrhythmia Agents, Atrial Fibrillation, Female, Flecainide, Humans, Male, Middle Aged, Propafenone, Sotalol, Randomized Controlled Trials as Topic, Treatment Outcome
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