Translating regulatory advice into practice: Use of dronedarone and older anti-arrhythmics in AF management

A.John Camm, Chris Arden, Anna-Maria Choy, Riyaz A. Kaba, David Keane, Khalid Khan, Ernest Lau, Gregory Y. H. Lip, Francis Murgatroyd, G.Andre Ng, Nicholas Peters, Henry Purcell, Peter Stafford, Neil Sulke, Helen Williams, Helen Williams

    Research output: Contribution to journalArticle

    3 Citations (Scopus)

    Abstract

    There is a lack of clarity around the current use of antiarrhythmic drugs (AADs), highlighted by the recent changes to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) recommendations for dronedarone use, which were in response to the early termination of the Permanent Atrial Fibrillation Outcome Study Using Dronedarone On Top Of Standard Therapy (PALLAS) trial due to increased mortality in the dronedarone arm. A UK- and Ireland-based multi-disciplinary expert group was convened by Sanofi*, the manufacturers of dronedarone, to address the need for guidance in the practical implementation of guidelines for AADs. This position statement provides the group's evidence-based recommendations for the practical use of AADs and dronedarone in particular. Since AADs are not always used in line with recommendations, the guidelines for the use of AADs, and the evidence base supporting them, are reviewed. The current recommendations for dronedarone use are set within this context. On consideration of the evidence, the recommendation for dronedarone use is for the maintenance of sinus rhythm in non-permanent atrial fibrillation (AF) patients, without severe heart failure, or amiodarone-related liver or lung toxicities, and with appropriate anticoagulation. Given that there have been no new AADs available in 25 years to address the need for an effective anti-arrhythmic with reduced side effects, dronedarone has a place in the treatment of non-permanent AF to provide options for clinicians and patients.
    Original languageEnglish
    JournalBritish Journal of Cardiology
    Volume19
    Issue number3
    DOIs
    Publication statusPublished - 2012

    Fingerprint

    Anti-Arrhythmia Agents
    Atrial Fibrillation
    Guidelines
    Amiodarone
    dronedarone
    United States Food and Drug Administration
    Ireland
    Heart Failure
    Maintenance
    Outcome Assessment (Health Care)
    Lung
    Mortality
    Liver
    Therapeutics

    Cite this

    Camm, A.John ; Arden, Chris ; Choy, Anna-Maria ; Kaba, Riyaz A. ; Keane, David ; Khan, Khalid ; Lau, Ernest ; Lip, Gregory Y. H. ; Murgatroyd, Francis ; Ng, G.Andre ; Peters, Nicholas ; Purcell, Henry ; Stafford, Peter ; Sulke, Neil ; Williams, Helen ; Williams, Helen . / Translating regulatory advice into practice : Use of dronedarone and older anti-arrhythmics in AF management. In: British Journal of Cardiology. 2012 ; Vol. 19, No. 3.
    @article{e4d4616da2e84fc9821658ba95ae5548,
    title = "Translating regulatory advice into practice: Use of dronedarone and older anti-arrhythmics in AF management",
    abstract = "There is a lack of clarity around the current use of antiarrhythmic drugs (AADs), highlighted by the recent changes to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) recommendations for dronedarone use, which were in response to the early termination of the Permanent Atrial Fibrillation Outcome Study Using Dronedarone On Top Of Standard Therapy (PALLAS) trial due to increased mortality in the dronedarone arm. A UK- and Ireland-based multi-disciplinary expert group was convened by Sanofi*, the manufacturers of dronedarone, to address the need for guidance in the practical implementation of guidelines for AADs. This position statement provides the group's evidence-based recommendations for the practical use of AADs and dronedarone in particular. Since AADs are not always used in line with recommendations, the guidelines for the use of AADs, and the evidence base supporting them, are reviewed. The current recommendations for dronedarone use are set within this context. On consideration of the evidence, the recommendation for dronedarone use is for the maintenance of sinus rhythm in non-permanent atrial fibrillation (AF) patients, without severe heart failure, or amiodarone-related liver or lung toxicities, and with appropriate anticoagulation. Given that there have been no new AADs available in 25 years to address the need for an effective anti-arrhythmic with reduced side effects, dronedarone has a place in the treatment of non-permanent AF to provide options for clinicians and patients.",
    author = "A.John Camm and Chris Arden and Anna-Maria Choy and Kaba, {Riyaz A.} and David Keane and Khalid Khan and Ernest Lau and Lip, {Gregory Y. H.} and Francis Murgatroyd and G.Andre Ng and Nicholas Peters and Henry Purcell and Peter Stafford and Neil Sulke and Helen Williams and Helen Williams",
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    Camm, AJ, Arden, C, Choy, A-M, Kaba, RA, Keane, D, Khan, K, Lau, E, Lip, GYH, Murgatroyd, F, Ng, GA, Peters, N, Purcell, H, Stafford, P, Sulke, N, Williams, H & Williams, H 2012, 'Translating regulatory advice into practice: Use of dronedarone and older anti-arrhythmics in AF management', British Journal of Cardiology, vol. 19, no. 3. https://doi.org/10.5837/bjc.2012.020

    Translating regulatory advice into practice : Use of dronedarone and older anti-arrhythmics in AF management. / Camm, A.John; Arden, Chris; Choy, Anna-Maria; Kaba, Riyaz A.; Keane, David; Khan, Khalid; Lau, Ernest; Lip, Gregory Y. H.; Murgatroyd, Francis; Ng, G.Andre; Peters, Nicholas; Purcell, Henry; Stafford, Peter; Sulke, Neil; Williams, Helen; Williams, Helen .

    In: British Journal of Cardiology, Vol. 19, No. 3, 2012.

    Research output: Contribution to journalArticle

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    AU - Choy, Anna-Maria

    AU - Kaba, Riyaz A.

    AU - Keane, David

    AU - Khan, Khalid

    AU - Lau, Ernest

    AU - Lip, Gregory Y. H.

    AU - Murgatroyd, Francis

    AU - Ng, G.Andre

    AU - Peters, Nicholas

    AU - Purcell, Henry

    AU - Stafford, Peter

    AU - Sulke, Neil

    AU - Williams, Helen

    AU - Williams, Helen

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