Rationale and Design of ATHENA
Rationale and Design of ATHENA
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.
In the face of a burgeoning older population, the prevalence of atrial fibrillation (AF) is rapidly increasing. AF is associated with increased morbidity and mortality, particularly in patients with structural heart disease impairing systolic or diastolic LV function. In Western societies, AF has grown as a major contributing cause of hospitalization and thus, socioeconomic burden. Accordingly, attempts to restore and maintain sinus rhythm (SR) in patients with AF are currently the preferred treatment modalities in most institutions, despite the results of studies showing similar mortality figures for patients undergoing rhythm or rate control. Given the epidemic character of the rhythm disorder, nonpharmacological therapy (particularly catheter ablation) is only feasible in selected patient populations, such as younger patients with symptomatic AF but no or only minor structural heart disease. For the great majority of elderly or old patients in whom more or less advanced heart disease constitutes the background of the arrhythmia, pharmacological treatment will remain the mainstay of therapy.
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.
In the face of a burgeoning older population, the prevalence of atrial fibrillation (AF) is rapidly increasing. AF is associated with increased morbidity and mortality, particularly in patients with structural heart disease impairing systolic or diastolic LV function. In Western societies, AF has grown as a major contributing cause of hospitalization and thus, socioeconomic burden. Accordingly, attempts to restore and maintain sinus rhythm (SR) in patients with AF are currently the preferred treatment modalities in most institutions, despite the results of studies showing similar mortality figures for patients undergoing rhythm or rate control. Given the epidemic character of the rhythm disorder, nonpharmacological therapy (particularly catheter ablation) is only feasible in selected patient populations, such as younger patients with symptomatic AF but no or only minor structural heart disease. For the great majority of elderly or old patients in whom more or less advanced heart disease constitutes the background of the arrhythmia, pharmacological treatment will remain the mainstay of therapy.
Source...