Background: Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia, predominantly affecting elderly patients. There is a continued need for new antiarrhythmic drugs to treat the ever-increasing number of patients with this arrhythmia. Dronedarone is a new antiarrhythmic compound currently being developed for treatment of AF.
Methods: 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) is the largest single antiarrhythmic drug trial ever conducted. More than 4,600 patients with a history of AF or atrial flutter (AFL) have been randomized to receive dronedarone 400 mg bid or matching placebo. The primary study endpoint is time to first cardiovascular hospitalization or death from any cause. The study has completed patient enrollment in December 2006 and is expected to end follow-up 1 year later.
Conclusion: ATHENA will be the largest efficacy and safety trial of dronedarone, a multichannel blocker compound with properties from class I, II, III, and IV antiarrhythmic drugs developed to treat patients with AF.
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Bioavailability of dronedarone tablets administered with or without food in healthy participants.
Am Heart J Plus
September 2024
Department of Medicine, Columbia University, and Attending Physician Emeritus, New York Presbyterian Hospital, New York, NY, USA.
Study Objective: There is inadequate awareness of the effect of food on the bioavailability of dronedarone. We report results from two phase 1 studies assessing the effect of food on dronedarone's bioavailability.
Design Setting And Participants: Study 1; single-center, open-label, randomized study in healthy adults (males and females).
Efficacy of Shensong Yangxin capsule combined with dronedarone in paroxysmal atrial fibrillation after ablation.
Medicine (Baltimore)
April 2024
Sichuan Mianyang 404 Hospital, Mianyang, China.
Objective: To investigate whether postoperative administration of Shensong Yangxin capsules (SSYX) and dronedarone for atrial fibrillation (AF) can reduce the recurrence of paroxysmal AF after radiofrequency ablation, thus providing a more optimal choice of antiarrhythmic medication during the blank period.
Methods: We included 120 patients with paroxysmal AF who underwent radiofrequency ablation at our hospital between July 2020 and July 2022. They underwent routine circumferential pulmonary vein ablation and, subsequently, left and right atrial pressure monitoring to assess sinoatrial node recovery time under burst 400/300 ms stimulation.
Development and verification of a physiologically based pharmacokinetic model of dronedarone and its active metabolite N-desbutyldronedarone: Application to prospective simulation of complex drug-drug interaction with rivaroxaban.
Br J Clin Pharmacol
June 2023
Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore.
Aims: Despite potential enzyme- and transporter-mediated drug-drug interactions (DDIs) between dronedarone and rivaroxaban in atrial fibrillation (AF) patients, pharmacokinetic/pharmacodynamic data remain limited to guide clinical practice. We aimed to develop, verify and validate a physiologically based pharmacokinetic (PBPK) model of dronedarone and its major metabolite, N-desbutyldronedarone (NDBD), to prospectively interrogate this clinically relevant DDI in healthy and mild renal impairment populations.
Methods: The middle-out development of our PBPK model combined literature-derived or in-house in vitro data, predicted in silico data and in vivo clinical data.
Effect of Dronedarone in the Treatment of Atrial Fibrillation in the Asian Population: Post Hoc Analysis of the ATHENA Trial.
Clin Ther
September 2022
Emergency and Critical Care Center, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing.
Purpose: Limited data are available on the impact of dronedarone treatment in Asian patients with atrial fibrillation (AF) or atrial flutter (AFL). This post hoc analysis evaluated the efficacy and safety of dronedarone compared with placebo in populations from Asian and non-Asian regions randomized in the ATHENA trial (A Placebo-Controlled, Double-blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg BID for the Prevention of CV Hospitalization or Death From Any Cause in Patients With AF/AFL).
Methods: Time to first hospitalization for cardiovascular events or death from any cause (primary outcome) and time to first AF/AFL event recurrence (secondary outcome) were analyzed by Kaplan-Meier curves and Cox proportional hazards regression.
Dronedarone for the treatment of atrial fibrillation with concomitant heart failure with preserved and mildly reduced ejection fraction: a post-hoc analysis of the ATHENA trial.
Eur J Heart Fail
June 2022
Division of Clinical Electrophysiology, Department of Cardiology, J. W. Goethe University, Frankfurt, Germany.
Aims: Limited therapeutic options are available for the management of atrial fibrillation/flutter (AF/AFL) with concomitant heart failure (HF) with preserved (HFpEF) and mildly reduced ejection fraction (HFmrEF). Dronedarone reduces the risk of cardiovascular events in patients with AF, but sparse data are available examining its role in patients with AF complicated by HFpEF and HFmrEF.
Methods And Results: ATHENA was an international, multicentre trial that randomized 4628 patients with paroxysmal or persistent AF/AFL and cardiovascular risk factors to dronedarone 400 mg twice daily versus placebo.
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