title: Regulatory pathways for development of antiarrhythmic drugs for management of atrial fibrillation/flutter.
abstract: New antiarrhythmic drugs are urgently required for the treatment of atrial fibrillation (AF), an increasingly common sustained cardiac arrhythmia seen predominantly in the elderly population. Pharmaceutical companies are generally interested in this important group of patients and a relatively large number of antiarrhythmic agents are under development for several indications relating to AF, predominantly rhythm and rate management. Because of the significant clinical consequences of the arrhythmia, it has been recognized that controlled trials in patients with AF should assess the effect of therapy in several major outcome domains such as mortality, morbidity, and hospitalization, with an emphasis on stroke and heart failure. As part of a regular series of meetings, the European Society of Cardiology recently met with European regulators and representatives of the pharmaceutical industry to review the current status of medical therapies for AF. Special attention has been paid to the debate on the relevant clinical endpoints in future AF trials and their implications for drug indications. The need for large-scale major cardiovascular outcome and comparator studies for the approval of drugs designed to manage rhythm and/or control the rate has been discussed. The requirements for appropriate ancillary studies, including quality of life and left ventricular function assessment and cost-effectiveness analysis, have been identified. This article reports the discussions that were held.
authors.affiliation: Division of Cardiac and Vascular Sciences, St George's University of London, London, UK. isavelie@sgul.ac.uk
authors.forename: Irina
authors.initials: I
authors.lastname: Savelieva
authors.forename: Paulus
authors.initials: P
authors.lastname: Kirchhof
authors.forename: Nicholas
authors.initials: N
authors.lastname: Danchin
authors.forename: Pieter A
authors.initials: PA
authors.lastname: de Graeff
authors.forename: A John
authors.initials: AJ
authors.lastname: Camm
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000592:standards*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000401:mortality; D001282:Atrial Flutter / Q000188:drug therapy* / Q000401:mortality; D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval / Q000379:methods*; D015195:Drug Design; D005060:Europe; D006801:Humans
chemical_list: D000889:Anti-Arrhythmia Agents