Regulatory pathways for development of antiarrhythmic drugs for management of atrial fibrillation/flutter

Irina Savelieva*, Paulus Kirchhof, Nicholas Danchin, Pieter A. de Graeff, A. John Camm

*Corresponding author for this work

    Research output: Contribution to journalReview articlepeer-review

    8 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)1063-1076
    Number of pages14
    JournalEuropace
    Volume13
    Issue number8
    DOIs
    Publication statusPublished - Aug-2011

    Keywords

    • Antiarrhythmic drugs
    • Atrial fibrillation
    • Atrial fibrillation burden
    • Clinical trial
    • Drug approval
    • Drug development
    • EMA
    • Hospitalization
    • MACE
    • Mortality
    • Outcome
    • Rate control
    • Rhythm control
    • QUALITY-OF-LIFE
    • CATHETER ABLATION
    • RHYTHM CONTROL
    • HEART-FAILURE
    • FOLLOW-UP
    • FLUTTER
    • PREVALENCE
    • TRIAL
    • PROGRESSION
    • CARDIOVERSION

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