Drs. Ken Ellenbogen and Sanjay Kaul discuss Comparative Efficacy of Amiodarone vs Dronedarone.
Good afternoon this is dr. kenneth ellen bogan and i’m have the privileged today to talk with dr. sanjay call dr. call is a director of the cardiovascular disease training program at cedars-sinai he is a professor of medicine at the ucla school of medicine and at cedars-sinai and today we’re here today to talk to dr. call and to learn from him about a very important
Paper that he published in the journal of the american college of cardiology this paper was a meta-analysis of dronedarone comparing it to amiodarone and in this paper dr. car looked at the clinical outcomes of patients treated with dronedarone versus amiodarone in terms of the benefits and risks of these two medications dr. call can you tell us a little bit
About the methods you used to analyze this question thank you good morning dr. ellen bogan thank you for inviting me ah first of all we looked at two different endpoints we looked at the anti-arrhythmic efficacy of janitorial compared to placebo and their been above less than half a dozen trials that have looked at this and what we found was that dronedarone was
Twice as effective as placebo in maintaining and sinus rhythm in patients with non permanent atrial flutter or atrial fibrillation and we also analyzed at that time the study was not published but had been presented at several meetings including at the fda advisory panel a study that directly compared renee tyrone versus immune iran called dionysus and the major
Primary results in the dinosaurs where they at donator and was half as effective as amiodarone in suppressing recurrence of atrial flutter and near total fibrillation so that’s that was the one part of our study we also analyzed as outcome trials with dronedarone and there being two major outcome trials the first one was called andromeda we’re trained in iran was
Evaluated in high-risk patient populations including patients with congestive heart failure and that study was prematurely terminated because of a observation of increased mortality and the second trial that we evaluated was the penis study upon which dronedarone was approved by the fda for prevention of cardiovascular hospitalization in patients with current or
History of atrial fibrillation or atrial flutter and so the athena study was a positive study and a primary endpoint of all-cause mortality and cardiovascular hospitalization was significantly reduced with donator or therapy now what about the toxicity of these two agents you’ve talked a little bit about efficacy how do they compare both in the short term and
The long term well there’s only been one small study the diana study and with very short follow-up that directly evaluated safety along with efficacy of turnaround versus commuter oh and draenei turin was given in 400 milligrams twice daily dose versus amiodarone in 200 milligrams daily dose after a month of loading dose with 600 milligrams and in that study are
The the safety profiles see appeared to be better with janitorial about twenty percent better than any other role but it was not statistically significant and it is conceivable that if they had enrolled a larger number of patients and followed the patients for a longer period time the differences would have been statistically significant and the safety profile
Advantage of tornado road was primarily related to thyroid dysfunction mostly hypothyroid disorder and also some neurologic and the ecg signs of prolonged qt and bradycardia so they’re so in the dinosaur study journee turin was half as effective as a mural but appeared to have a superior safety pro profile so for clinician how does this come together and what and
There are a couple considerations one is many people have afib you’re tweeting for 5 years 10 years 15 years how would you put all this together in terms of what we know about these two agents and their relative efficacy and toxicity just sort of an overview maybe summarizing the important take-home points for the clinician you know in my opinion given the modest
Antiarrhythmic efficacy of janet our own relative to the gold standard which is amiodarone and lack of a clear-cut safety advantage that has been not demonstrated in the recurrent of trials and the huge cost disadvantage remember a muter own is generic whereas donator own costs nearly nine bucks a day it’s hard to make a case for using donator own as first-line
Therapy of course as a clinician each decision has to be individualized and patient preferences and clinical judgments certainly play important role in clinical decision making and i can see there are some patients who may actually accept it improved short-term tolerability or reduced efficacy as an acceptable trade-off and then those would be the patients where
I can envision dronedarone to be initiated in these types of patients but typically what i would say is that if patients are respond to guideline recommended first-line therapies the class 1 agents such as profit professional on a subtle all of like a night in in the appropriate patients and but they have some tolerability issues agents or then i would certainly
Consider the use of judah touro particularly a second line or a third line but i would not use dronedarone as first-line in these patients and i certainly wouldn’t use donator on in high-risk patients such as those with class for heart failure or patients with decompensated class 3 heart failure well i want to thank you very much for your overview of your paper
It was very useful and very thoughtful thank you very much
Transcribed from video
News Archive | Comparative Efficacy of Amiodarone vs Dronedarone By American College of Cardiology Video Archive 2