Multaq® Approved in the European Union for patients with atrial fibrillation
The marketing authorisation of Multaq® was based on the review of four placebo controlled studies in patients with atrial fibrillation (AF) or atrial flutter (AFL) called EURIDIS, ADONIS, ERATO and ATHENA; the DIONYSOS trial, a comparative trial vs amiodarone; and the ANDROMEDA trial, a placebo controlled study in heart failure patients with a recent hospitalization for decompensated systolic heart failure. The landmark ATHENA trial was the largest anti-arrhythmic drug trial ever conducted in patients with AF/AFL, involving 4,628 patients with a follow-up of 30 months. In this trial, dronedarone, on top of standard therapy, significantly reduced cardiovascular hospitalization or death by 24 percent when compared to placebo, meeting the study’s primary endpoint. This reduction was generally consistent across study subgroups based on baseline characteristics or medications. The most common adverse reactions were diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and skin rash. Dronedarone has a convenient fixed dose regimen of twice daily 400 mg tablets to be taken with morning and evening meals. Treatment with dronedarone does not require a loading dose and can be initiated in an outpatient setting with minimal monitoring The EURIDIS-ADONIS, ANDROMEDA and ATHENA trials were published in the New England Journal of Medicine (NEJM) respectively in 2007, 2008 and 2009. About atrial fibrillation
The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern, affects about 4.5 million people in Europe and represents one-third of hospitalizations for arrhythmia in the European Union (1). Atrial fibrillation leads to potential life-threatening complications. AF increases the risk of stroke up to five-fold (2), worsens the prognosis of patients with cardiovascular risk factors (3), and doubles the risk of mortality (4) with significant burden on patients, health care providers and payers. Seventy percent of AF management costs are driven by hospital care and interventional procedure in the European Union (5). About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). 1. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001; 285:2370–5.
2. Lloyd-Jones et al. Lifetime Risk for Development of Atrial Fibrillation: The Framingham Heart Study. Circulation. 2004; 110:1042-1046.
3. Fuster V et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation. European Heart Journal (2006) 27, 1979-2030.
4. Benjamin EJ, Wolf PA, D’Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation 1998 Sep 8; 98(10):946-52.
5. Ringborg et all, Europace 2008 10; 400-411.