New Drug Update 2009-2010 - LAFP

CYP2C9, CYP2C19, and CYP1A2. we need more information on the potential for clinically significant
drug-drug interactions
Piccini and colleagues (JACC 2009 54:1089–95) conducted a systematic overview of all randomized,
controlled trials evaluating dronedarone or amiodarone for the prevention of atrial fibrillation (AF) to
determine relative efficacy and safety profiles, as there are limited direct comparison trials. A model
incorporating all trial evidence found amiodarone to be superior to dronedarone (odds ratio [OR]: 0.49) for
the prevention of recurrent AF; however, there was a trend toward higher all-cause mortality (OR: 1.61)
and higher overall adverse events requiring drug discontinuation with amiodarone (OR: 1.81). For every
1,000 patients treated with dronedarone instead of amiodarone, the authors estimate 228 more
recurrences of AF in exchange for 9.6 fewer deaths and 62 fewer adverse events requiring
discontinuation of the drug.
An ongoing randomized trial is comparing dronedarone and amiodarone for the prevention of AF
recurrences, the trial is called DIONYSUS
Paris, France – December 23, 2008 – Sanofi-aventis today reported the results of the DIONYSOS trial,
evaluating the efficacy and safety of dronedarone versus amiodarone for the maintenance of sinus
rhythm in 504 patients with persistent Atrial Fibrillation (AF) for a short treatment duration (mean follow up
of 7 months).
Unsurprisingly, dronedarone showed a decrease of safety events vs. amiodarone but more occurrences
of the composite primary endpoint (AF recurrence or premature drug discontinuation for intolerance or
lack of efficacy). There were 184 patients (73.9%) who reached the primary endpoint in the dronedarone
arm as compared to 141 (55.3%) in the amiodarone arm (p