The site is secure. Patients who had been receiving effective anticoagulation treatment or who required a change of amiodarone treatment for any reason (excluding those with major amiodarone-related toxicity, ie, interstitial lung disease, thyroid, or hepatotoxicity) were also eligible for inclusion in the Long-term study. Due to slow enrollment, the study was stopped by the sponsor prior to reaching the planned sample size. Unauthorized use of these marks is strictly prohibited. An official website of the United States government. Recommended studies: 2 studies . The ARTEMIS AF Loading study involved administration of dronedarone to patients who had persistent AF requiring conversion at 3 different intervals after administration of a loading dose of amiodarone. 2010;31(19):23692429. doi:10.1007/s00228-012-1377-4 Dronedarone and amiodarone have similar electrophysiological profiles; however, little is known about the optimal timing of switching, given the long half-life of amiodarone. The simulated data indicated that up to a 3% carryover of AUC into the second period of a bioequivalence study had no effect on the power of the 90% CI for AUC and C(max). The higher amiodarone concentrations observed before any dronedarone intake might be due to unbalanced patient randomization regarding a specific patients covariates between the different groups, causing higher amiodarone steady-state exposures in the 2-week washout patients. The primary objectives were, for the Loading study, to evaluate recurrence of AF 60 days; and for the Long-term study, to profile the pharmacokinetics of dronedarone and its metabolite according to different timings of dronedarone initiation. Patients who did not experience AF recurrence were censored at day 61 or at the end of the study if this date was prior to day 60; patients who discontinued prematurely were censored at the day of discontinuation. Methods: The ARTEMIS atrial fibrillation (AF) Loading and Long-term studies evaluated switching patients with paroxysmal/persistent AF from amiodarone to dronedarone. Type of study: Fasting Design: Single-dose, two-way crossover in-vivo Strength: 200 mg Subjects: Healthy males and nonpregnant females, general population. 2007 Nov;29(8):575-86. doi: 10.1080/10641960701744111. The .gov means its official. The vertical error bars describe the variation in dronedarone concentrations. FOIA Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. Editorial and administration support was provided by Prime, Knutsford, UK. Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088. The primary objective of the Long-term study was to explore the PK profile of dronedarone and its metabolite SR35021 according to different timings of dronedarone initiation. Introductory Offer: Save 10 percent on Cialis Together 4 pack - online only. A patient who misses a dose should NOT double the next dose. is a consultant for and/or has worked on speakers bureaus for Menarini and MSD; and has received honoraria from Menarini, BMS, and Pfizer. The products discussed herein may have different product labeling in different countries. Overall 15, 14, and 9 patients (22.5, 34.3, and 35.0 patient-months) experienced an AE in the immediate-switch group (group A), 2-week washout group (group B), and 4-week washout group (group C), respectively (Table 5). J.T. All of them had heart disease and were first seen with high-grade ventricular arrhythmias (Lown class 4a and 4b) at enrollment. difficulty falling asleep or staying asleep. At 2-3 hours after each subsequent dose of Tikosyn, determine the QTc or QT (if heart rate is less than 60 beats per minute) (for in-hospital doses 2-5). This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (, Supplemental Material, Multaq_ARTEMIS_ms_Appendix_18Mar20 - Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies, GUID:17A48080-2ABD-4543-922C-A2B9EB7816B3, atrial fibrillation, antiarrhythmic drug therapy, amiodarone, dronedarone, {"type":"clinical-trial","attrs":{"text":"NCT01199081","term_id":"NCT01199081"}}, {"type":"clinical-trial","attrs":{"text":"NCT01140581","term_id":"NCT01140581"}}. The trial was terminated early due to poor recruitment and so our findings are limited by low numbers. Baseline Demographics and Cardiovascular Parameters in the Long-term Study (Randomized Population). European Heart Rhythm Association, European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GYH, et al. official website and that any information you provide is encrypted However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving amiodarone. It is critically important that if at any time this lower dose is increased, the patient needs to be rehospitalized for three days. Overall, changes were similar across the 3 treatment groups. Patients were randomized based on the timing of the switch: immediate, after a 2-week, or after a 4-week washout of amiodarone. The Loading study was conducted from September 2010 to October 2011, while the Long-term study was conducted from October 2010 to April 2012. ARTEMIS Long-Term Study. bElectrical cardioversion is allowed (after 7 days of amiodarone in loading study) up to day 1 inclusive. Patients to be discharged on TIKOSYN therapy from an inpatient setting as described above must have an adequate supply of TIKOSYN, at the patient's individualized dose, to allow uninterrupted dosing until the patient can fill a TIKOSYN prescription. For each patient, individual PK parameter estimates were made from the obtained population parameters. For the 3 patients with complete washout-phase data, the amiodarone t 1/2 values were 9.3, 6.9, and 11.4 days (Figure 6, right). Step 7. The drug prevents the recurrence of life-threatening ventricular arrhythmias and. Careers. A Cox proportional hazard model was used to calculate hazard ratios (HRs), with 2-sided 97.5% CIs. Amiodarone hydrochloride tablets can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. If heart rate is less than 60 beats per minute, QT interval should be used. Bethesda, MD 20894, Web Policies Treatment-emergent AEs leading to permanent dronedarone discontinuation included arrhythmia, cardiac failure, burning sensation, diplopia, vision blurred, and syncope in group A and abdominal pain upper, nausea, tinnitus, pruritus, hypersensitivity, asthenia, and erythema in group B. Careers, Unable to load your collection due to an error. The .gov means its official. Enrollment Summary by Country and SiteRandomized Population. Patients were randomized based on the timing of the switch: immediate, after a 2-week, or after a 4-week washout of amiodarone. Please enable it to take advantage of the complete set of features! and transmitted securely. A, First recurrence of AF 60 days after randomization in the Loading study (ITT population), and (B) First recurrence of AF 60 days after randomization in the Long-term study (ITT population). In order to provide you with relevant and meaningful content we need to know more about you. Prescribing amiodarone: an evidence-based review of clinical indications, Trends in antiarrhythmic drug use after marketing authorization of dronedarone: comparison between Emilia Romagna (Italy) and Sweden, 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, A Linux cluster for population pharmacokinetic analyses. For the safety analysis, an AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment, irrespective of any presumed relationship with the drug. The Bayesian analysis was performed with the NONMEM computer program (version 7.2) running on a LINUX cluster of multiprocessor computers.7 A previously developed population pharmacokinetics (PopPK) model was applied to the data set, using its population parameter estimates as prior estimates for the assessment of individual parameters and concentration predictions for the patients from the ARTEMIS AF study. doi:10.1001/jama.298.11.1312 and L.N.-B. Superficially, such observations could suggest a possible drugdrug interaction between dronedarone and amiodarone. As such, any decisions regarding switching between 1 drug and another should be made by the treating physician and taken on a case-by-case basis, considering the individual patients characteristics. These medications, although effective, require extensive monitoring and patient education. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). In the loading study, following a change in label recommendations after study start (regarding contraindications to dronedarone in the EU with regard to heart failure after the PALbociclib CoLlaborative Adjuvant Study [PALLAS]), patients with a history of and/or current clinically overt heart failure (congestive heart failure [CHF]), left ventricular systolic dysfunction, or unstable hemodynamic conditions were excluded from the study; however, some patients with CHF or left ventricular ejection fraction <40% were already enrolled prior to this change and were included. is a consultant for and/or has worked on speakers bureaus for Menarini and MSD; and has received honoraria from Menarini, BMS, and Pfizer. In clinical trials (see CLINICAL STUDIES), the highest dose of 500 mcg BID of TIKOSYN as modified by the dosing algorithm led to greater effectiveness than lower doses of 125 or 250 mcg BID as modified by the dosing algorithm. Rhim SY, Park JH, Park YS, Lee MH, Kim DS, Shaw LM, Yang SC, Kang JS. Hohnloser SH, Crijns HJ, van Eickels M, et al. Archivio Istituzionale della Ricerca Unimi, European Heart Rhythm Association, European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GYH, et al. Careers. Compared with the 4-week washout group (group C), there was a nonsignificant increase in AF recurrence of 6.3% in the immediate group (group A; P = .93). Kim SD, Kang W, Lee HW, Park DJ, Ahn JH, Kim MJ, Kim EY, Kim SW, Nam HS, Na HJ, Yoon YR. Clin Ther. Additional exclusion criteria in the Long-term study included unstable angina pectoris (<7 days), myocardial infarction (<6 weeks), and a history of thyroid dysfunction. Comparative crossover, randomized, open-label bioequivalence study on the bioequivalence of two formulations of thioctic acid in healthy volunteers. Patients were randomized into 3 parallel groups (A, B, and C) according to the timing of dronedarone initiation after the loading dose or following discontinuation of long-term amiodarone treatment (6 months). When no new prescription was dispensed during the washout period, the cumulative dose was set to 0 after the washout period and started again from 0 when a new episode started. sharing sensitive information, make sure youre on a federal In ARTEMIS AF Loading, 176 were randomized (planned 768) after a 28 2 days load of oral amiodarone. Pulmonary toxicity has been fatal about 10% of the time. Abbreviations: AF, atrial fibrillation; BMI, body mass index; CHF, congestive heart failure; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; WO, washout. Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion. In these 2 international, prospective, multicenter, open-label, randomized, controlled trials, patients with either persistent AF requiring conversion to normal sinus rhythm (Loading study) or paroxysmal or persistent AF (long-term study) were enrolled. Abbreviations: AUC, area under the curve; C Accessibility A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. Switching between antiarrhythmic drugs is timed to minimize arrhythmia recurrence and adverse reactions. Group A patients were switched to dronedarone 400 mg twice daily for 8 weeks immediately after randomization, group B patients were switched to dronedarone 400 mg twice daily for 6 weeks following a 2-week amiodarone washout period, and group C patients were switched to dronedarone 400 mg twice daily for 4 weeks following a 4-week amiodarone washout period (Figure 1). Touboul P, Brugada J, Capucci A, Harry Crijns JGM, Nils E, Stefan HH. For amiodarone, second period pre-dose drug concentrations equal to as much as 50% of the observed period 2 C(max . An official website of the United States government. Patients should continue to be monitored in this way for a minimum of three days. J.-Y.L.H. The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. Finally, there was a strong trend toward an increase in dose-normalized C avg with age ( P =0.06, Figure 6 , left), suggesting a decrease in clearance of the drug from the plasma with age. Long-term usage of amiodarone can cause pulmonary toxicity or severe damage to the lungs, resulting in dry cough, shortness of breath, and chest pain. cWith at least the last 2 months at a regimen of 200 mg/d. Write a review. The mechanism of action is blockade of the cardiac ion Two randomized, parallel, double-blind, placebo-controlled, dose-response trials evaluated the TIKOSYN 125 mcg (0.125 mg) capsules are supplied as No. A rare, but more severe, side effect of amiodarone is optic . Federal government websites often end in .gov or .mil. Mechanism of Action Adenosine is a potent vasodilator in most vascular beds, except in renal afferent arterioles and hepatic veins where it produces vasoconstriction. Type of study: Fed Design: Single-dose, two-way crossover . Abstention from excess physical activity and regular control of blood headache. Proceed to Step 2 if the QTc or QT is 440 msec. D.L.B has participated in advisory boards for Cardax, Cereno Scientific, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, PLx Pharma, and Regado Biosciences; is a member of the Board of Directors of Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; is Chair of the American Heart Association Quality Oversight Committee; is on the data monitoring committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), and Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Todays Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME steering committees); has other relationships with Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); has received research funding from Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwalds Heart Disease); is a site co-investigator for Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), and Svelte; is a trustee for American College of Cardiology; and has performed unfunded research for FlowCo, Merck, Novo Nordisk, and Takeda. 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