Landmark ATHENA Study Findings With Multaq(R) (dronedarone) Shows 24% Reduction In Cardiovascular Hospitalization or Death in Patients With Atrial Fi...(f hospitalization and mortalityand affec...),Health

Date:5/15/2008

f hospitalization and mortality and affects about 2.5 million people in the United States, as well as 4.5 million people in the European Union and is emerging as a growing public health concern because of the aging of the population. Patients suffering from atrial fibrillation have twice the risk of death, an increased risk of stroke and cardiovascular complications, including congestive heart failure. Furthermore atrial fibrillation considerably impairs patients' lives, mainly because of their inability to perform normal daily activities due to complaints of palpitations, chest pain, dyspnoea, fatigue or light-headedness, without consideration of the cumbersome and sometime serious constraints imposed by current therapies of atrial fibrillation.

"In atrial fibrillation where treatment morbidity-mortality benefit still needed to be demonstrated, ATHENA is a unique trial using clinically relevant outcomes such as cardiovascular hospitalization or death as the primary endpoint. In this regard, the trial has clearly achieved these safety and efficacy endpoints," said Dr Stefan H. Hohnloser, J.W. from the Goethe University, Division of Clinical Electrophysiology, Frankfurt, Germany, who served as co-principal investigator of the ATHENA study. "As a consequence, dronedarone is the first potential treatment for atrial fibrillation, which was demonstrated in the ATHENA trial to reduce cardiovascular hospitalization or mortality in patients with AF," he added.

The most frequently reported adverse events of Multaq(R) vs. placebo induced gastro-intestinal effect (26% vs. 22%), skin disorder (10% vs. 8%, mainly rash) and increased blood creatinine (4.7% vs. 1%). The mechanism of blood creatinine increase (inhibition of creatinine secretion at the renal tubular level) was well defined, in a separate study of healthy volunteers. Multaq(R) showed a rate of pro-arrhythmia similar to placebo and no excess of hospitalizations for congestive heart failure. There was a s
'/>"/>

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

9 GOOD

Page: 1 2 3 4 5 6 7
Related medicine technology :

1. TYKERB(R) (Lapatinib) to be Investigated in Landmark Early Breast Cancer Trial
2. Landmark ONTARGET(TM) Trial Demonstrates Micardis(R) is Equally Effective as Ramipril, with Fewer Discontinuations, in a Broad High-Risk Cardiovascular Population
3. JACC Identifies DEFER with 5-year Outcomes as Landmark Trial
4. Hospital Launches Landmark Emergency Medicine Project
5. Long-Term Data from a Landmark Phase III Trial Show Survival Benefit at Three- and Four-Years in Patients with Glioblastoma multiforme
6. Viatronix V3D-Colon Utilized in Another Landmark Study
7. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
8. Quigley Announces Successful Poultry Study of Chickens With Infectious Bronchitis; Plans to Approach the Poultry Industry for Potential Commercialization
9. NicOx Announces Initiation of First Phase 1 Study of Investigational Nitric Oxide-Donating Agent in Hypertensive Patients by Merck & Co., Inc.
10. Ceremeds OSTENE(R) Improves Bone Fusion and Healing After Surgery, New Study Shows
11. St. Jude Study Shows How T Cells Machinery Dials Down Autoimmunity