New Drug Update 2009-2010 - LAFP
New Drug Update 2009-2010 - LAFP
New Drug Update 2009-2010 - LAFP
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CYP2C9, CYP2C19, and CYP1A2. we need more information on the potential for clinically significant<br />
drug-drug interactions<br />
Piccini and colleagues (JACC <strong>2009</strong> 54:1089–95) conducted a systematic overview of all randomized,<br />
controlled trials evaluating dronedarone or amiodarone for the prevention of atrial fibrillation (AF) to<br />
determine relative efficacy and safety profiles, as there are limited direct comparison trials. A model<br />
incorporating all trial evidence found amiodarone to be superior to dronedarone (odds ratio [OR]: 0.49) for<br />
the prevention of recurrent AF; however, there was a trend toward higher all-cause mortality (OR: 1.61)<br />
and higher overall adverse events requiring drug discontinuation with amiodarone (OR: 1.81). For every<br />
1,000 patients treated with dronedarone instead of amiodarone, the authors estimate 228 more<br />
recurrences of AF in exchange for 9.6 fewer deaths and 62 fewer adverse events requiring<br />
discontinuation of the drug.<br />
An ongoing randomized trial is comparing dronedarone and amiodarone for the prevention of AF<br />
recurrences, the trial is called DIONYSUS<br />
Paris, France – December 23, 2008 – Sanofi-aventis today reported the results of the DIONYSOS trial,<br />
evaluating the efficacy and safety of dronedarone versus amiodarone for the maintenance of sinus<br />
rhythm in 504 patients with persistent Atrial Fibrillation (AF) for a short treatment duration (mean follow up<br />
of 7 months).<br />
Unsurprisingly, dronedarone showed a decrease of safety events vs. amiodarone but more occurrences<br />
of the composite primary endpoint (AF recurrence or premature drug discontinuation for intolerance or<br />
lack of efficacy). There were 184 patients (73.9%) who reached the primary endpoint in the dronedarone<br />
arm as compared to 141 (55.3%) in the amiodarone arm (p