ATHENA Clinical Results with Dronedarone (Multaq(R)) Highlighted at the World Cardiolog...(rease in therisk of cardiovascular death...),Health

Date:5/22/2008

rease in the risk of cardiovascular death by 30% (p=0.03) on top of standard therapy, including rate control and antithrombotic drugs, in patients with atrial fibrillation or atrial flutter. Multaq(R) also significantly decreased the risk of arrhythmic death by 45% (p=0.01) and there were numerically fewer deaths (16%) from any cause in the dronedarone group compared to placebo (p=0.17). First cardiovascular hospitalization was reduced by 25% (p=0.000000009) in the dronedarone group. 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 atri
'/>"/>

SOURCE sanofi-aventis Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6
Related medicine technology :

1. ATHENA Clinical Results for Dronedarone (Multaq(R)) Highlighted at the World Cardiology Congress
2. Landmark ATHENA Study Findings With Multaq(R) (dronedarone) Shows 24% Reduction In Cardiovascular Hospitalization or Death in Patients With Atrial Fibrillation
3. Treprostinil Data Presented at American Thoracic Society Conference Demonstrates Significant Clinical Progress in All Four Routes of Administration
4. Alba Therapeutics Announces the Presentation of Results of a Phase IIa Clinical Trial for Larazotide Acetate for the Treatment of Celiac Disease at the Digestive Disease Week Conference
5. Sunesis Pharmaceuticals Initiates Phase 2 Clinical Trial of Voreloxin (SNS-595) in Acute Myeloid Leukemia
6. Jennerex Publishes Promising Results from Cancer Clinical Trial of JX-594 in Lancet Oncology
7. Genta Clinical Programs Featured in Multiple Abstracts at the Annual Meeting of the American Society of Clinical Oncology
8. Dendreon Presents Preclinical Data Demonstrating Activity of Trp-p8 agonist, D-3263, in Benign Prostatic Hyperplasia
9. Uroplasty Highlights Clinical Results From a Study of the Urgent(R) PC Neuromodulation System
10. Cryoablation Is Focus of 17 Clinical Studies at American Urological Association Annual Meeting
11. Multi-Center Patient Registry Supports Safety and Clinical Utility of Boston Scientifics SpyGlass(R) Direct Visualization System