August 4th, 2011

Easy Come, Easy Go? ESC to Review Dronedarone’s Role in AF Guidelines

Less than a year after speeding into the European Society of Cardiology’s atrial fibrillation guidelines with a class 1 recommendation, the role of dronedarone (Multaq, Sanofi) in the treatment of AF will be reconsidered.

“The ESC will produce a focused update of the AF Guidelines when the full results of PALLAS have been published and regulatory authorities have revised the labelling for dronedarone,” the ESC announced today.

Since the publication of the ESC guidelines last September, dronedarone has sparked concerns related to several cases of severe liver injury. Then the PALLAS trial was terminated early due to an increase in cardiovascular events in patients with permanent AF treated with dronedarone.

6 Responses to “Easy Come, Easy Go? ESC to Review Dronedarone’s Role in AF Guidelines”

  1. Lorenz Van der Linden, PharmD says:

    The drug is available but not reimbursed in the Netherlands. It’s neither of these in Belgium and as far as I know, it’s also not used a lot in France. Whether it is prescribed in the UK or in Germany, I couldn’t tell.

    Has anyone here used this new (…) drug already then?

  2. Not available in arabian Gulf region yet !!

  3. Ihsan Ullah, MBBS/MRCPI says:

    we are using this drug for more then a year in our patients with aproved indications in Ireland and we are happy with this drug, It is one of the good drug for both rate reduction and cardioversion, we are following our patients closly and we did not see any complication directly reated to this drug but the most common complaint in our patients are GI upsets and I personally believe the 400mgs bd dose is big dose and we sould consider the reduction of dose here.
    we should reevaluate the dose of Dronadrone.

  4. Lorenz Van der Linden, PharmD says:

    In ATHENA only those patients with paroxysmal or persistent AF were included. They had to be in SR at the time of randomisation or otherwise had to be converted. It’s also not as good as amiodarone in keeping AF patients in SR.

    Why is it a good drug for cardioversion?

  5. Adeniyi Molajo, BSc(Hons), MB ChB(Hons), MD says:

    It is questionable why anyone should want to use a Class III antiarrhythmic drug for permanent atrial fibrillation when there are more effective, established and safer drugs like beta-blockers available for rate control.

    When the aim is rhythm change, I certainly will use the drug. My experience in this regards is good but limited. When use this way I have not seen advance effects in my limited use. My experience at this poiunt can only be considered anedoctal. Perhaps an important cosideration in this as any drug for cardioversion is the risk of systemic embolism even with pharmacological cardioversion; hence the need for the possible indication for concurrent use of an antithrombin.

    Competing interests pertaining specifically to this post, comment, or both:
    No conflict of interest.

  6. David Powell , MD, FACC says:

    The PALLAS study used permanent fib as an entry criteria. The point was not to convert the rhythm. Some people believed that this agent has magical properties with regard to CV outcomes and hospitalization. They were motivated by post hoc subgroup analysis from ATHENA. The hypothesis was torn inside out.
    If one were to still use dronedarone, it would be to maintain sinus rhythm and reduce hospitalizations in patients with PAF in sinus rhythm.

    Competing interests pertaining specifically to this post, comment, or both: