concurrent CYP3A4 inhibitors, such as ketoconazole, voriconazole, https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure (20 March 2019). Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Conclusion: Le Heuzey JY, De Ferrari GM, Radzik D, et al. Currently, commonly used drugs for the maintenance of sinus rhythm include amiodarone, dronedarone, propafenone, sotalol, and flecainide. Valembois L, Audureau E, Takeda A, Jarzebowski W, Belmin J, Lafuente-Lafuente C. Cochrane Database Syst Rev. Digoxin and warfarin New York, NY: Pfizer Inc; February 2011. 2017;7(10):e016627. apixaban, is recommended.2. warfarin, and hydroxymethyl glutaryl coenzyme A reductase inhibitors Hannah Wilson and others, 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, European Heart Journal - Cardiovascular Pharmacotherapy, Volume 7, Issue 5, September 2021, Pages 363372, https://doi.org/10.1093/ehjcvp/pvaa018. flecainide may also. Although rhythm control with antiarrhythmic therapy does not confer a Similarly, RCTs investigating flecainide provide further reassurance in the context of pro-arrhythmic activity and subsequent safety of dosage (100mg b.i.d. In the latest afib guidelines, all of the guidelines committees placed dronedarone higher, and in most cases as a first-line treatment for afib where applicable. 1, 2, 3, and 6 monthsincreased symptom permitting, 1, 3, 6, and 12 monthsincreased symptom permitting, Denote persistent AF cohort; mean 26-month duration, Daily ECG, telemetry and Holter monitor when AF observed, Denote persistent AF cohort, defined as; AF > 72 h; 3368 days of range, Days 1, 5, 1028, 40 and Months 3, 6, 9, and 12, Continuous 4 days, Days 7, 14, 30, and 90 then 3 monthly for 6 months, 21% dronedarone group had significant LV hypertrophy, Average 2.8 reviews per patient over a mean 301 days, Telemetry monitoring and transmission of symptoms, Days 58, 14, 30, 60, 90, 120, 150, and 180, increased if symptoms, Chronic AF 24 h and median duration 1.6 years, NYHA Class I and II; 64% underlying heart disease, Copyright 2023 European Society of Cardiology. Attempt to get rid of the atrial fibrillation altogether and restore and maintain normal heart rhythm. years.1 Common heart conditions that can lead to or Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. 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. FOIA Answer: Multaq (or dronedarone) is a modified version of amiodarone without iodine, which provides the advantage for lower side effect profile (such as thyroid and lung toxicity) than amiodarone. Dronedarone will increase serum One study was included for this comparison32 and Figure4 outlines the results of the analysis. level between 0.2 and 1.0 mcg/mL. The antiarrhythmics most commonly used Two RCTs compare flecainide to placebo, when a 16% decreased risk of AF recurrence at 612months was indicated; however, these results were not statistically significant (RR 0.84, 95% CI 0.661.07; P=0.16). 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. Discontinuation of flecainide treated subjects was reported in one study, when 9% (n=5/58)31 of the cohort experienced nausea, headache, sinus arrest, rate-related left bundle branch block (LBBB) or symptomatic premature ventricular contractions (PVCs). Keywords: atrial fibrillation: the DIONYSOS study. atria, commonly after structural heart damage. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (, Comparison between ticagrelor and clopidogrel in myocardial infarction patients with high bleeding risk- A report from the SWEDEHEART registry, Focus on prevention in diabetes mellitus and lipid disorder, A gene risk score using missense variants in SLCO1B1 is associated with earlier onset statin intolerance, Risk of serious hypoglycemia in patients with atrial fibrillation and diabetes concurrently taking antidiabetic drugs and oral anticoagulants: A nationwide cohort study, Heart failure pharmacological treatments and outcomes in heart failure with mildly reduced ejection fraction, About European Heart Journal - Cardiovascular Pharmacotherapy, About the ESC Working Group on Cardiovascular Pharmacotherapy, Results for outcome: atrial fibrillation recurrence, https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure, https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model, Receive exclusive offers and updates from Oxford Academic, The evolving landscape of oral anti-arrhythmic prescriptions for atrial fibrillation in England: 19982014, Dronedarone vs. placebo in patients with atrial fibrillation or atrial flutter across a range of renal function: a, Photoinduced skin reactions of cardiovascular drugsa systematic review. QTc interval prolongation 500 ms was reported by Le Heuzey et al.33 and Said et al.,37 occurring in 11% (n=27/249) (P=0.0033) and 2.6% (n=5/191) of the cohorts, respectively, with no subsequent torsades-de-pointes. Meta-analysis was undertaken using a pooled RR and 95% confidence interval (CI) employing a weighted random effects model. maintenance of normal sinus rhythm in patients with atrial fibrillation. Furthermore, researching the efficacy of flecainide and dronedarone could redefine the balance towards a rhythm control strategy in persistent AF patients. of TDP within the first few days of initiation. Immordino et al. Dronedarone for the treatment of atrial fibrillation and atrial flutter. The comparison of sinus rhythm maintenance between flecainide and dronedarone, 612 months following cardioversion. medications in the prevention of atrial fibrillation events. 2015 Mar 28;(3):CD005049. Soriano et al.39 reported 15.38% (n=8/52) vs. 16.9% (n=12/71) side effects regarding dronedarone and flecainide, respectively, ultimately revealing dronedarone showed a safety profile comparable to flecainide (HR 0.68, 95% CI 0.182.53; P=0.566). BMJ Open. Despite this, only three studies compared drug to placebo,31,32,35 two of which were deemed valid following quality assessment.32,35 In this case, at 6months, a 28% reduced risk of AF recurrence was identified for dronedarone (RR 0.72, 95% CI 0.580.90; P=0.004)32 and a 14% reduced risk of AF was revealed for flecainide (RR 0.86; 95% CI 0.651.14; P=0.28).35 Unequal assignment of candidates to placebo and intervention (n=81 vs. n=263), may have underestimated the statistical conclusion in this respect.35 Two retrospective trials compare flecainide to dronedarone,38,39 in which case flecainide reduced the risk of AF recurrence by 6% [RR 0.94 (95% CI 0.711.24 P=0.66)], however lack of statistical significance and quality renders these outcomes invalid. Antiarrhythmic; Atrial fibrillation; Cardioversion; Dronedarone; Flecainide. factors are considered to be at low risk for thromboembolic events and sodium channel blockers; class II, beta-blockers; class III, potassium NICE Clinical Guideline 1.6.13. position to provide guidance on these medications to patients and 8. 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. Two studies were included for this comparison31,35 and Figure5 outlines the results of the meta-analysis. Secondary outcomes studied were side effects of the AADs, including ventricular rate-control and pro-arrhythmic incidents. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. versus rhythm control in 4,060 patients at high risk for stroke or loading dose (oral or IV) before the dose is decreased to the lowest 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. It is administered orally strictly at 400 mg twice daily. Lafuente-Lafuente C, Longas-Tejero MA, Bergmann JF, Belmin J. Kozlowski D, Budrejko S, Lip GY, Mikhailidis DP, Rysz J, Raczak G, Banach M. Rosa GM, Bianco D, Parodi A, Valbusa A, Zawaideh C, Bizzarri N, Ferrero S, Brunelli C. National Institute for Health and Care Excellence. activity that may be beneficial in the management of atrial these adverse effects occur with doses exceeding 400 mg per day, which Dronedarone for Atrial Fibrillation: Have We Expanded The Armamentarium? Does the new drug pose fewer risks or more tolerable risks than other old or new medicines? 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. can result in hypotension, tachycardia, syncope, and chest pain. Finally, so that you know where we are coming from, remember that the afib community is our number one priority. A database search using EMBASE, CENTRAL, CINAHL, and MEDLINE was executed from inception until March 2019, utilizing the following keywords in various combinations: atrial fibrillation AND cardioversion AND dronedarone AND flecainide (Figure1). The studies involved a total of 1349 persistent AF candidates, with a follow-up 612months. Ratings & Reviews Flecainide has an average rating of 7.3 out of 10 from a total of 168 ratings on Drugs.com. This site needs JavaScript to work properly. In their commentary in the same April 2010 issue of the Journal of the American College of Cardiology, Antiarrhythmic Drugs: Safety First, they stated that ATHENA is the first large trial to provide safety data in a moderate risk population that comprises a large part of the relevant patients for rhythm control therapy.. Clipboard, Search History, and several other advanced features are temporarily unavailable. As can be seen, in the dronedarone group 65% (n=35/54) had AF recurrence, conversely, in the placebo group, 90% (n=43/48) had AF recurrence. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. ED is often a symptom of another health problem or health-related factor. used only to maintain normal sinus rhythm. Task Force on Practice Guidelines developed in partnership with the This high prevalence is likely due to a combination of 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. Thind M, Crijns HJ, Naccarelli GV, Reiffel JA, Corp Dit Genti V, Wieloch M, Koren A, Kowey PR. cardioversion and maintenance of normal sinus rhythm.1,14 It In the flecainide group, 55% (n=6/11) had AF recurrence, conversely, in the comparison group (amiodarone/soltalol), 72% (n=43/60) had AF recurrence. World J Cardiol. doi: 10.1002/14651858.CD005049.pub5. atrial fibrillation patients, especially those who remain symptomatic However, in light of the deficiency of volume and quality of . (AFFIRM) was a landmark randomized, multicenter trial of rate control Six antiarrhythmic drugs are often used to treat atrial fibrillation: propafenone (Rhythmol), flecainide (Tambocor), sotalol (Betapace), dofetilide (Tikosyn), amiodarone (Cordarone), and dronedarone (Multaq). Dronedarone appears to share its pharmacological actions, but lacks the iodine component that is largely responsible for the multiple organ toxicities of the latter.] channel blocker, beta-blocker).1,9 Amiodarone and dofetilide Multaq may also be used for purposes not listed in this medication guide. The Randomized Double blind trIal to evaluate the efficacy and safety of . fibrillation.1,8 Typical dosing for the immediate-release The Author(s) 2020. Retrospective studies and subsequent uncontrolled design measures34,38,39 resulted in a high level of bias throughout these domains. 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). potentially serious effects could ensue without involvement by the Where appropriate, data were analysed using the RevMan software (version 5.3).29 To enable comparison of the two AADs, subgroups were created to compare the two drug categories separately within randomized controlled trials (RCTs). atria to beat irregularly and out of coordination with the ventricles. Risk factors included in CHADS2 are HF, hypertension, age greater than 75 years, diabetes, and previous history of stroke or TIA. However, in actual practice, this approach often turns out to be less effective and less safe than the rate control approach. American College of Cardiology Foundation/American Heart Association Dronedarone 400mg twice daily (b.i.d.) Sotalol is a modestly Flecainide has an average rating of 13. You JJ, Singer DE, Howard PA, et al. 2011 ACCF/AHA/HRS focused Clipboard, Search History, and several other advanced features are temporarily unavailable. A retrospective study was included for this comparison34 and Figure6 outlines the results of the analysis. ** The Controlled Substances Act (CSA) schedule information displayed applies to substances regulated under federal law. Read our, Rhythm-Control Treatment for Atrial Fibrillation, How to Identify Atrial Fibrillation (AFib), Medications Used to Treat Cardiac Arrhythmias, Understanding the Atrial Fibrillation Classification System, Early Rhythm-Control Therapy May Improve Outcomes for AFib, Study Finds. Fuster V, Rydn LE, Cannom DS, et al. nausea, diarrhea, QT prolongation, and HF exacerbation. Dronedarone is a new antiarrhythmic drug on the market, which went on the market in 2009. Incompletion of dronedarone pharmacotherapy over the study period was observed in Touboul et al.32, Le Heuzey et al.,33 and Said et al.,37 the drug was discontinued by 3.9% (n=3/76), 10.4% (n=26/249) and 22% (n=42/191) (95% CI 1727%) of the cohort respectively, as a result of side effects. Data were analysed using risk ratio (RR) or hazard ratio (HR). factors, including the increased incidence of chronic heart disease and See also: Multaq side effects in more detail. See the full pregnancy warnings document. Another Touboul P, Brugada J, Capucci A, Crihns H, Edvardsson N, Hohnloser SH. Before American College of Cardiology Foundation/American Heart Association Heterogeneity among studies was tested and P-values were expressed to reflect statistical significance. The high risk of bias within the research was predominately driven by confounding factors, intervention and construct validity. (94%), (F) 50100mg b.i.d. Circulation. Singh also expressed skepticism about the drugs role in managing atrial fibrillation due to questions regarding its short-term and long-term safety in at-risk patients. This refers to the ANDROMEDA trial (Antiarrhythmic Trial With Dronedarone in Moderate-to-Severe Congestive Heart Failure Evaluating Morbidity Decrease), which was stopped early due to deaths in this high-risk population. 68% of reviewers reported a positive effect, while 20% reported a negative effect. There is a requirement for further research evidence, in light of the study limitations and certainty of the findings of this review. The SR maintenance was numerically but not statistically significant in the flecainide group. Accessibility Lafuente-Lafuente C, Valembois L, Bergmann JF, Belmin J. Cochrane Database Syst Rev. Forest plot: risk of AF recurrence, flecainide vs. dronedarone. Letters to the Editor: Dronedarone for Atrial Fibrillation: Have We Expanded the Antiarrhythmic Armamentarium? Patient education Search criteria and flow diagram of the literature search process. National Library of Medicine Kirchhof et al.35 initially administered 100mg b.i.d. Fogoros, RN. Results for the meta-analysis are presented using a forest plot. effects were seen in the rhythm-control group.3. Dronedarone and flecainide displayed similar efficacy in maintaining SR in patients following electrocardioversion for persistent AF. 200 to 300 mg for atrial fibrillation conversion. beats per minute. It was observed that 35% of the flecainide group had an increased beta-blocker utilization when compared with dronedarone (P=0.032). 1 Stiles S. FDA advisory panel recommends dronedarone approval for atrial fib Heartwire.com. government site. In total, in the intervention groups, 26% (n=352/1349) of the participants within five studies received flecainide and 35% (n=477/1349) received dronedarone within six studies. During the follow-up, there were 36 AF recurrences and 20 safety events. To compare flecainide and dronedarone for sinus rhythm (SR) maintenance following electrocardioversion of persistent atrial fibrillation (AF), in patients with minimal or no structural heart disease. The median age of patients with atrial Unable to load your collection due to an error, Unable to load your delegates due to an error. serious complication of atrial fibrillation is the higher risk of one of the new anticoagulants, such as dabigatran, rivaroxaban, or Singh indicated that the ATHENA trial (A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation / Atrial Flutter) was a subsequent trial to define a population for which dronedarone may be safely used., However, Dr. Christian Torp-Pedersen, a member of the steering committee of the ANDROMEDA and ATHENA trials, and his coauthors argued that the ATHENA trial demonstrates Multaqs safety. Nine articles met the inclusion criteria [five randomized controlled trials (RCTs) and four cohort studies], encompassing 1349 persistent AF candidates. Betapace (sotalol) product information. Is the new drug likely to have negative interactions with any medications the patient is already taking? adverse effects, and monitoring parameters listed above, there are many J Gen Intern Med. 1975;1:115-138. Erectile dysfunction (ED) is often a symptom . to fibrillate, and pharmacotherapy (commonly, beta-blockers, Patients treated with dronedarone after atrial fibrillation ablation were matched 1:1 to patients treated with sotalol between January 1, 2013 and March 31, 2018. Flecainide (Tambocor): Flecainide is a potent sodium channel blocker that may be used in atrial fibrillation patients without structural heart disease.1,7 Saksena S, Slee A, Waldo AL, Freemantle N, Reynolds M, Rosenberg Y, Rathod S, Grant S, Thomas E, Wyse DG. Two retrospective studies were included for this comparison,38,39 and Figure7 outlines the results of the meta-analysis of this study. You can find out more about our use, change your default settings, and withdraw your consent at any time with effect for the future by visiting Cookies Settings, which can also be found in the footer of the site. J Am Coll Cardiol. Said SM, Esperer HD, Kluba K, Genz C, Wiedemann AK, Boenigk H, Herold J, Schmeisser A, Braun-Dullaeus RC. beta-blocking activity, whereas the oral formulation has more potassium To view a report comparing 3 (or more) medications, please sign in or create an account. Would the new drug be a sufficiently better choice for this patientconsidering his or her overall health, other medications, other conditions, and other factorsto merit changing from current treatment. Chun et al.36 was assigned high risk, in light of the open-label design and subsequent confounding factors, as a 19% increase of beta-blockers (P=0.042) were observed within the comparison group.36. based on CrCl. Disclaimer. Antiarrhythmic drugs work by changing the electrical properties of cardiac tissue. death. demonstrated a benefit in clinical outcomes versus rate control. Mild elevation of extracellular potassium greatly potentiates the effect of sodium channel block to cardiovert atrial fibrillation: The Lankenau approach. These quantitative results suggest there is heterogeneity (I2 = 86%). Please enable it to take advantage of the complete set of features! dizziness, tremor, and HF exacerbation. should include drug interactions, adverse effects, and recommendations MeSH Epub 2020 Mar 5. 1. life; most patients experience some degree of palpitation, dizziness, The dose should be reduced in patients with hepatic or renal For atrial fibrillation maintenance, flecainide is generally dosed at Prescribed for Atrial Fibrillation, Atrial Flutter. despite adequate rate control.4 Antiarrhythmic agents are An RCT comparing flecainide to dronedarone, would most effectively determine a first-line drug choice within this patient cohort. atrial fibrillation: antithrombotic therapy and prevention of The final word comes from the three afib guidelines committees, none of whom seemed to have agreed with Singh that dronedarone should be second- or third-line treatment for afib. Get the full list here. Modestly flecainide has an average rating of 7.3 out of coordination with ventricles... 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