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Sanofi Aventis has developed a new drug treatment for atrial fibrillation. Dronedarone is a modified relative of amiodarone, and it worked well in two identical placebo controlled trials. Participants were in sinus rhythm when randomised, and the drug kept them in sinus rhythm significantly longer than placebo in both trialstrials.
It is good to know that the drug works better than nothing, but patients and doctors would also like to know whether it works better and more safely than currently available treatments including amiodarone, says an editorial (p 1039). The safety profile looks reasonable so far, but only large head to head trials with a long follow-up will provide the answers everyone is waiting for.
Sanofi Aventis designed dronedarone to have fewer adverse effects on thyroid function and lung function than amiodarone, but the company is not required to compare the new drug directly with amiodarone or anything else to get a licence. In their placebo controlled trials, patients taking dronedarone were not at increased risk of hypothyroidism or hyperthyroidism, and the authors found no evidence of pulmonary toxicity during the 12 month trial period. Patients with heart failure were excluded from both trials because a previous study suggested that dronedarone might increase their risk of death.