The ATHENA study objectives were to show a potential benefit of Multaq(R) on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalisation as compared to placebo. The pre-specified secondary endpoints were death from any cause, cardiovascular death and hospitalisation for cardiovascular reasons. The pre-specified safety endpoint was the incidence of treatment emergent adverse events (time of observation for treatment emergent adverse events) including: all adverse events, serious adverse events, adverse events leading to study drug discontinuation.
The atrial fibrillation or atrial flutter patients studied were either 75 years of age or over (with or without cardiovascular risk factor) or were below 75 years of age with at least one additional cardiovascular risk factor (hypertension, diabetes, previous cerebrovascular event, left atrium size greater than 50 mm or left ventricular ejection fraction lower than 40 percent). Patients suffering from decompensated heart failure were excluded from the study. Patients were randomised to receive Multaq(R) 400 mg BID or placebo, with a maximum follow-up of 30 months.
The countries which enrolled patients included: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czech Republic, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Morocco, New Zealand, Norway, Philippines, Poland, Portugal, Russia, South Africa, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, the UK, the US.
About Multaq(R) (dronedarone)
Dronedarone (brand name Multaq(R)) is an investigational new treatment for patients with atrial fibrillation, which has been discovered and developed by sanofi-aventis for the prevention and treatment of patients with atrial fibrillation or atrial flutter. Dronedarone is a multi-channel blocker that affects calcium, potassium and sodium channels and has anti-adrenergic properties. Dronedarone does not contain the iodine radical and did not show any evidence of thyroid or pulmonary toxicity in clinical trials.
About sanofi-aventis in Cardiology and Thrombosis
Sanofi-aventis' unmatched experience in the treatment of millions of patients suffering from cardiovascular disease (CVD) and thrombosis has uniquely prepared us to take on the growing challenges in these domains. Today, together with academic institutions and healthcare professionals, we are a major contributor in the effort to reduce the public health burden across the broad CVD spectrum and in thrombosis.
Our comprehensive set of innovative therapeutic solutions includes antiplatelet and antithrombotic agents with Plavix(R) and Clexane(R)/Lovenox(R), as well the antihypertensive agent Aprovel(R)/Avapro(R ). By listening and responding to the needs of patients and physicians, we constantly seek to improve the safety and efficacy of our products while developing new therapeutic strategies. Our dedication has already helped lay the foundations of modern cardiovascular treatment. In addition to the first-in-class ticlopidine, we pioneered treatment with amiodarone and heparins, therapies rooted in a deep legacy of research experience spanning decades.
Building on our deep foundations of experience and expertise, we are seeking improved treatment efficacy with new ultra-low-weight heparins (AVE5026), with a new reversible, long-acting anticoagulant, potentially better-suited for venous thromboembolism and atrial fibrillation (biotinylated Idraparinux). Our research into atrial fibrillation continues with ground breaking trials like ATHENA with the clinical development of dronedarone (Multaq(R)). We are simultaneously exploring targeted gene therapy (NV1FGF) with the aim of reducing the risk of amputation in patients with critical ischemia of the lower limbs. As we continue to push the frontiers of cardiovascular and thrombosis therapy, we do so with the conviction that the health of patients is our total commitment and our greatest reward.
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).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Contact: Salah Mahyaoui : +33(0)6-73-68-78-88 / email salah.mahyaoui@sanofi-aventis.com
