| Most common adverse reactions are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and cutaneous rash.
For full prescribing information, please visit http://products. |
This unstable population corresponds to the population of the ANDROMEDA trial in which patients receiving dronedarone had a greater than 2-fold increase in mortality compared to placebo. Such patients should not be given dronedarone. |
Multaq should not be given to patients who are or may become pregnant (Category X) or nursing. Atrial fibrillation is a complex disease that increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality.
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| "Sanofi-aventis’ commitment to research and development in this area is rewarded today, and we hope it will benefit many patients suffering from this disease. In contrast, in ATHENA, all patients had a history of AF/AFL, and 71% of patients had no heart failure, 25% were NYHA class I or II, and only 4% were class III. |
The FDA approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients.5 million people in the United States and 4. |
In patients with new or worsening heart failure, the suspension or discontinuation of Multaq should be considered.us/Multaq/Multaq. |
| This trial showed that Multaq (dronedarone) 400 mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% (p<0.
In patients with new or worsening heart failure, the suspension or discontinuation of Multaq should be considered. |
Viehbacher, Chief Executive Officer of sanofi-aventis.
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. |
A registration dossier of Multaq is also under regulatory review by the European Medicines Agency (EMEA).
The ANDROMEDA and ATHENA trials were published in the New England Journal of Medicine (NEJM) respectively in 2008 and 2009. |
| 5 million people in the European Union. |
Food and Drug Administration (FDA) has approved Multaq (dronedarone) 400 mg Tablets. Sanofi-aventis is listed in Paris and in New York . |
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About Atrial Fibrillation/Atrial Flutter
Atrial fibrillation is the leading cause of hospitalization for arrhythmia in the U. Sanofi-aventis is listed in Paris and in New York . |
| In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA study), patients given dronedarone had a greater than two-fold increase in mortality. |
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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). |
The patients enrolled in ANDROMEDA had relatively severe heart failure and had been hospitalized, or referred to a specialty heart failure clinic for worsening symptoms.pdf
About Atrial Fibrillation/Atrial Flutter
Atrial fibrillation is the leading cause of hospitalization for arrhythmia in the U. |
| This trial showed that Multaq (dronedarone) 400 mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% (p<0.
The ANDROMEDA study, was terminated prematurely after enrolment of 627 of 1000 planned patients with congestive heart failure, in relation to excess mortality due to worsening heart failure in the dronedarone group [n=25 versus 12 (placebo), p=0. |
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.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. |
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.
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