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PARIS, July 02, 2009 /PRNewswire-FirstCall/ --Sanofi-aventis announced today that the U. Food and Drug Administration (FDA) has approved Multaq (dronedarone) 400 mg Tablets. The ATHENA and ANDROMEDA trials provided two sets of data supporting the assessment of the product's benefit risk ratio in two significantly different patient populations.001) compared with placebo meeting the primary endpoint. About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. soma fernandez D. soma fernandez Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. The FDA approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients. adipex p consumer information

Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL." The landmark ATHENA trial evaluated the efficacy and safety of Multaq in patients with AF/AFL or a recent history of these conditions (71% of these patients had no heart failure, 29% were in NYHA class I-III with stable heart failure). Initiation of Multaq treatment is contraindicated in patients with severe heart failure (NYHA class IV) or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. About dronedarone (Multaq) Multaq, discovered and developed by sanofi-aventis, is one of the major therapeutic innovations in patients with atrial fibrillation in the last twenty years. Hypokalemia and hypomagnesemia may occur with concomitant administration of potassium-depleting diuretics. soma fernandez A registration dossier of Multaq is also under regulatory review by the European Medicines Agency (EMEA).us/Multaq/Multaq. soma fernandez " The incidence of atrial fibrillation is growing worldwide in relation to aging populations. "Based on clinical studies, Multaq reduces the risk of cardiovascular hospitalizations in patients with atrial fibrillation / atrial flutter, this outcome could change the way we approach the management of the disease. phentermine myrx

Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular ejection fraction [LVEF] <40%. The efficacy and safety of Multaq 400 mg twice daily was evaluated in five controlled studies, ATHENA, ANDROMEDA, EURIDIS, ADONIS, and DAFNE, involving nearly 6,300 patients including more than 3200 patients who received Multaq.027]. Serum creatinine levels increase by about 0. soma fernandez Initiation of Multaq treatment is contraindicated in patients with severe heart failure (NYHA class IV) or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. Multaq should not be coadministered with strong CYP 3A inhibitors or medicinal products that prolong the QT interval. soma fernandez It is emerging as a public health concern and affects about 2.