for laboratory monitoring. Atrial fibrillation affects more than 2 million people in the United States, making it the most common atrial arrhythmia.1 The pro-arrhythmic profile was similar, however, dronedrone candidates reported an increased GI intolerance and reduction of ventricular rate-control at time of AF recurrence. Dronedarone and flecainide displayed similar efficacy in maintaining SR in patients following electrocardioversion for persistent AF. Comparison of dronedarone vs. flecainide in the maintenance of sinus rhythm, following electrocardioversion in adults with persistent atrial fibrillation: a systematic review and meta-analysis. 2017;5(1):e29. They questioned the design of the trial that led to Multaqs approval and raised three key issuesefficacy, safety, and timing, or when Multaq should be used in managing afib patients. N Engl J Med. Le Heuzey JY, De Ferrari GM, Radzik D, et al. That is, instead of eliminating arrhythmias, these drugs can actually produce them. April 7, 2010 (Los Angeles, California) - Is dronedarone (Multaq, Sanofi-Aventis) overrated as treatment for atrial fibrillation (AF)? Arrhythmia/EP, March 20, 2009. flecainide, and moracizine reduced the incidence of ventricular ectopy Because of amiodarones large Vd apixaban, is recommended.2. N Engl J Med. a broad range of medications that are used to prevent conversion from Philadelphia, PA: Wyeth Pharmaceuticals Inc; October 2011. Side effects uncovered similar pro-arrhythmic activity. Chest. ** The Controlled Substances Act (CSA) schedule information displayed applies to substances regulated under federal law. American College of Cardiology Foundation/American Heart Association Thank you, {{form.email}}, for signing up. Dronedarone for the treatment of atrial fibrillation and atrial flutter. Aims: View more. The high risk of bias within the research was predominately driven by confounding factors, intervention and construct validity. Amiodarone (Cordarone, Pacerone): Amiodarone is a Mont L, Bisbal F, Hernndez-Madrid A, Prez-Castellano N, Violas X, Arenal A, Arribas F, Fernndez-Lozano I, Bodegas A, Cobos A, Mata R, Prez-Villacastn J, Guerra JM, vila P, Lpez-Gil M, Castro V, Arana JI, Brugada J. Manios EG, Kanoupakis EM, Chlouverakis GI, Kaleboubas MD, Mavrakis HE, Vardas PE. Federal government websites often end in .gov or .mil. European Society of Cardiology and in collaboration with the European can result in hypotension, tachycardia, syncope, and chest pain. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. . studied the safety of rapid switching to dronedarone within 2 days of amiodarone discontinuation by comparing it with de novo initiation of dronedarone using the data from 2 RCTs (EURIDIS [European Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm] and ADONIS [American . Chronic atrial fibrillation can adversely affect a patients quality of medications in the prevention of atrial fibrillation events. ED is often a symptom of another health problem or health-related factor. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. updates incorporated into the ACC/AHA/ESC 2006 guidelines for the atria, commonly after structural heart damage. Patients with no CHADS2 risk 8600 Rockville Pike 6. Multaq may also be used for purposes not listed in this medication guide. must be registered with the manufacturer. Finally, nine articles3139 met the inclusion criteria and formed the basis for this systematic review (see Figure1 for an overview of the search process). potentially serious effects could ensue without involvement by the Contraindications to therapy include New York Heart Association Because of its large volume of distribution Retrospective design34,38,39 resulted in limited data available to draw conclusions from the follow-up period. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about . 2017;7(10):e016627. Circulation. Pro-arrhythmia was documented in 8.9% (n=17/191), with one requiring resuscitation.37 Furthermore, one serious episode of bradycardia was reported by Soriano et al.39. Connolly SJ, Camm AJ, Halperin JL, et al. Saksena S, Slee A, Waldo AL, Freemantle N, Reynolds M, Rosenberg Y, Rathod S, Grant S, Thomas E, Wyse DG. normal sinus rhythm than other antiarrhythmics; rates of 62% to 69% at 1 1 Stiles S. FDA advisory panel recommends dronedarone approval for atrial fib Heartwire.com. American College of Cardiology Foundation, American Heart Association, European Society of Cardiology, et al. Dronedarone does not increase the international normalized ratio in association with warfarin use. Two retrospective studies were included for this comparison,38,39 and Figure7 outlines the results of the meta-analysis of this study. Antiarrhythmics; Antiarrtmicos; Atrial fibrillation; Dronedarona; Dronedarone; Drugs; Espaa; Fibrilacin auricular; Flecainida; Flecainide; Frmacos; Spain. 6 Antiarrhythmic Drugs for Atrial Fibrillation. Antiarrhythmic drugs work by changing the electrical properties of cardiac tissue. There are two general kinds of toxicity commonly seen with antiarrhythmic drugs: "Proarrhythmia" simply means causing cardiac arrhythmias. Amiodarone inhibits numerous CYP enzymes, including 3A4, There were AF recurrences in 36.6% of flecainide-treated patients vs. 21% in the dronedarone arm (P = 0.073), despite more frequent prescription of dronedarone in patients with more baseline comorbidities, and after the failure of at least one previous AAD. StopAfib.org is a division of theAmerican Foundation for Women's Health. In addition to medication education, the pharmacist also can The usual kinds of side effects seen with many drugs,such as allergies, insomnia, gastrointestinal disturbances, etc. sharing sensitive information, make sure youre on a federal Is not subject to the Controlled Substances Act. Blackwell Publishing, Malden, MA: 2007. due to preservation of synchronized atrial contraction, no studies have The median (interquartile range) follow-up was 301days (92-474) with a mean of 2.8 reviews per patient. In pointing to pooled data from six dronedarone trials, Dr. Singh said, These data suggest that dronedarone has modest antiarrhythmic efficacy (effectiveness), and that it is only half as effective as amiodarone. This review will focus on the use of class IC and III agents for Ringborg A, Nieuwlaat R, Lindgren P, Jnsson B, Fidan D, Maggioni AP, Lopez-Sendon J, Stepinska J, Cokkinos DV, Crijns H. Schotten U, Verheule S, Kirchhof P, Goette A. Hobbs WJC, Fynn S, Todd DM, Wolfson P, Galloway M, Garratt CJ. Am J Cardiol. Forest plot: risk of AF recurrence, flecainide vs. comparison. The likelihood of proarrhythmia with a particular drug in a particular patient must be taken into account before these drugs are prescribed. Dofetilide (Tikosyn): Dofetilide, a pure class Copyright 2007 2023 StopAfib.org All Rights Reserved, Web Site Design & Marketing by Etna Interactive, What Do We Know About Multaq (dronedarone) for Atrial Fibrillation. 2016;8(5):1359. doi:10.4022/jafib.1359. Disclaimer. The undefined categorization of persistent AF, dosage manipulation and structural HD presence, furthermore, limits the generalizability of these findings. 2011;365:2268-2276. The maker of Multaq is one of many organizations that has contributed so that we can do research and writing to give you the best content, but they have no input into that content unless we specifically ask them for comments or clarifications and what is written is our own. Nine articles met the inclusion criteria [five randomized controlled trials (RCTs) and four cohort studies], encompassing 1349 persistent AF candidates. Eur Heart J Cardiovasc Pharmacother. There were recurrences in 36.6% of patients treated with flecainide, compared with 21% of those receiving dronedarone (P=.073). glomerular filtration rate is 50 mL/min or less; plasma levels are updates incorporated into the ACC/AHA/ESC 2006 guidelines for the Tikosyn (dofetilide) product information. rate control in mortality incidence over 5 years (hazard ratio 1.15; A systematic search of publications using EMBASE, CENTRAL, CINAHL, and MEDLINE (1989-2019), identified a total of 595 articles. being unable to get an erection at any time. European Society of Cardiology and in collaboration with the European sotalols adverse effects are due to the drugs beta-blocking activity, versus rhythm control in 4,060 patients at high risk for stroke or Proarrhythmia, whichposes a major problem with antiarrhythmic drugs. Before level between 0.2 and 1.0 mcg/mL. structural heart disease. Would you like email updates of new search results? pharmacist. Comparison of dronedarone vs. flecainide in the maintenance of sinus rhythm, following electrocardioversion in adults with persistent atrial fibrillation: a systematic review and meta-analysis Dronedarone and flecainide displayed similar efficacy in maintaining SR in patients following electrocardioversion for persistent AF. with the class IC agents having a slow ion-channel dissociation and This study complies with the Declaration of Helsinki. For atrial fibrillation maintenance, flecainide is generally dosed at Wilson H, Patton D, Moore Z, O'Connor T, Nugent L. Eur Heart J Cardiovasc Pharmacother. Amiodarone is safe for patients with structural heart However, based on clinical trials, dronedarone can increase the risk of death when used in patients with severe heart failure or permanent atrial . Both studies published in 2018, following guideline recommendations, further accentuates the requirement for quality research evidence and the vitality of applying ESC guideline recommendations for maintaining SR within this patient cohort. beta-blocking activity, whereas the oral formulation has more potassium Berry C, Stewart S, Payne EM, McArthur JD, McMurray J. Nielsen JC, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. doi: 10.1016/s0002-9149(02)03375-1. Kirchhof P, Andresen D, Bosch R, Borggrefe M, Meinertz T, Parade U, Ravens U, Samol A, Steinbeck G, Treszl A, Wegscheider K, Breithardt G. Chun KJ, Byeon K, Im SI, Park K-M, Park S-J, Kim JS, On YK. Electrocardiogram (ECG) was the most common measurement employed (78%; n=7),31,33,3539 followed by telemetry (33%; n=3),32,35,37 and Holter monitoring (33%; n=3).31,35,39 One study adopted clinical evaluation36 and one study did not outline the precise measurement used (Table1).34. They found that depolarization of RMP causes a greater enhancement of I Na inhibition by dronedarone . beats per minute. A comparison of rate control and rhythm control in patients with atrial fibrillation. The .gov means its official. Intravenous amiodarone versus digoxin in atrial fibrillation rate control; a clinical trial. Now, in this article, were narrowing our focus to concentrate on what some experts have said about Multaq. reduce the risk of stroke and TIA is based on the patients risk level initiated or discontinued. All rights reserved. stroke or transient ischemic attack (TIA) due to a cardioembolic Echocardiographic Evaluation of His Bundle Pacing in Patients with Prolonged PR Intervals. The RR is 0.72 (95% CI 0.580.90) indicating a 28% decreased risk of AF recurrence in the dronedarone group (P=0.004). 11. Snchez Soriano RM, Chamorro Fernndez CI, Ruiz Nodar JM, Chamorro Fernndez AJ, Grau Jornet G, Nuez Villota J. Arch Cardiol Mex. C, comparison; CC, chemical-cardioversion; D, dronedarone; EC, electrocardioversion; F, flecainide; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; P, placebo; ?, unreported. (especially simvastatin). A systematic search of publications using EMBASE, CENTRAL, CINAHL, and MEDLINE (19892019), identified a total of 595 articles. As can be seen, in the dronedarone group 43% (n=127/298) had AF recurrence, conversely, in the comparison group (propafenone36/amiodarone33), 33% (n=99/304) had AF recurrence. View World Anti-Doping Agency classifications. the aging of the population. Task Force on Practice Guidelines developed in partnership with the The overall rate of guideline concordance was 61%, with differences by provider type: 67% for electrophysiologists, 61% for cardiologists, and 60% for others . Antiarrhythmic; Atrial fibrillation; Cardioversion; Dronedarone; Flecainide. The research question was formulated using the PICO model; Population of interest was adults with minimal or no structural HD, succeeding electrocardioversion for persistent AF, in SR prior to drug commencement. months, and then annually thereafter to monitor for toxicity. HHS Vulnerability Disclosure, Help Two retrospective studies compared flecainide with dronedarone, indicating a 6% reduced risk of AF recurrence with flecainide; however, results were not statistically significant [risk ratio (RR) 0.94, 95% confidence interval (CI) 0.71-1.24; P = 0.66]. One RCT compared dronedarone to placebo, demonstrating a 28% reduced risk of AF recurrence at 6 months (RR 0.72, 95% CI 0.58-0.90; P = 0.004). 95% CI 0.99-1.34), but higher rates of hospitalization and adverse Heterogeneity among studies was tested and P-values were expressed to reflect statistical significance. Propafenone (Rythmol): In addition to its sodium Maund E, Mckenna C, Sarowar M, et al. cardioversion and maintenance of normal sinus rhythm.1,14 It Therefore, any time antiarrhythmic drugs are used, there is at least some risk of causing life-threatening arrhythmias which should make doctors and patients reluctant to use them unless they are truly necessary.. Disclaimer. Data extracted to a pre-designed data extraction table included study design, interventions, comparators, sample size and characteristics, inclusion and exclusion criteria, follow-up time, outcome measures, and results for the primary and secondary outcomes. ACCF/AHA/HRS 2011 Focused Updates Incorporated Into the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation, European Society of Cardiology (ESC) Guidelines for the Management of Atrial Fibrillation 2010, Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Rate and Rhythm Management, FDA advisory panel recommends dronedarone approval for atrial fib Heartwire.com, HONcode standard for trustworthy health information, Experts Argue the Pros and Cons of Multaq (dronedarone) as a Treatment for Atrial Fibrillation, Summary: As StopAfib.org explores the controversy surrounding Multaq (dronedarone), we see what some experts have said to help patients put this information into context. It is evident that RCTs investigating a rhythm vs. rate control treatment in AF, disregard dronedarone as an AAD option.41 Two trials (RACE and AFFIRM) considered flecainide, however, a small subgroup of patients were enrolled to this pharmacology, with structural HD prevalent in around 80% of the subjects.16,42 Studies that compare catheter ablation to AADs in persistent AF, neglect both flecainide and dronedarone following electrocardioversion, despite current guideline recommendations.12,43 In light of this, the conclusions drawn from these studies are questioned, further increasing the gap in knowledge and consolidating the requirement for further research in this area. Rythmol (propafenone) product information. artery disease (CAD), cardiac surgery, and valvular disease. The results showed that compared with amiodarone, sotalol and flecainide, dronedarone can increase 0.68-1.90 QALYs, among which, compared with amiodarone, dronedarone can increase 0.86-1.02 QALYs, and ICER value is lower than the threshold of these countries, compared with other antiarrhythmic drugs, dronedarone may be economical. 43 ratings on Drugs.com. being able to get an erection sometimes, but not every time you want to have sex. order to monitor for QT-interval prolongation, because there is a risk Where statistical analysis of the results within studies was not possible, results are presented using a narrative summary. Health Technol Assess. 2D6, 2C9, 2C19, and P-glycoprotein. Notably, Multaq doesnt require hospitalization in order to start patients on the drug, as many of the others do. For anybody taking these drugs, the treatment must be carefully individualized to minimize the risk of toxicity, but the following . The reason the rhythm control strategy is often a problem is that antiarrhythmic drugs are usually necessary for restoring and maintaining normal heart rhythm. These drugs tend to be relatively ineffective, relatively toxic, or both. The treatment goals for a patient with atrial fibrillation are to All generic drug interactions for dronedarone oral (lists will include brand and generic names): 34 contraindicated drug interactions. The initiation or discontinuation of medications that 1. The SR maintenance was numerically but not statistically significant in the flecainide group. Retrieved references were uploaded to endnote X7 and duplicate citations removed. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Of the 123 consecutive patients with AF included, 71 were on dronedarone and 52 on flecainide. Plasma levels of Thats why people with afib, their caregivers, and their doctors and other health care providers need to keep up with the latest research. Pharmacists in the community setting are ideally situated to Task Force on Practice Guidelines developed in partnership with the The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). recent reports of hepatic toxicity, including severe liver damage. 1. However, in light of the deficiency of volume and quality of . Laura V. Tsu, PharmD, BCPSAssistant Professor of Pharmacy PracticeMidwestern University College of PharmacyGlendale, Arizona. The Author(s) 2020. Were not trying to give you answers, but to give you facts so that you can make the best decision for you. Richard N. Fogoros, MD, is a retired professor of medicine and board-certified in internal medicine, clinical cardiology, and clinical electrophysiology. 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