Atrial Fibrillation Death Rate Reduced by
Experimental Drug Multaq (Dronedarone)
FDA has drug in priority review; approves first
ablation catheters for the treatment of atrial fibrillation, which
affects mainly senior citizens over age 65
Feb. 17, 2009 Deaths and hospitalizations for
patients with atrial fibrillation, which are climbing with the
increasing number of seniors, can be reduced by a new, still unlicensed,
anti-arrhythmic drug named dronedarone, according to a report in the
New England Journal of Medicine reporting on the ATHENA trial. To be
marketed as Multaq by Sanofi-aventis, the drug was granted a priority
review status by the FDA in July of 2008.
The FDA priority review is granted to applications
in which a new indication or new drug product, if approved, has the
potential to present a safe and effective therapy where no satisfactory
alternative exists compared to currently available therapies or marketed
products.
The ATHENA trial was performed at more than 550
centers in 37 countries.
The trial, with a mean follow-up of 21 months,
randomized 4628 patients with atrial fibrillation and at least one other
cardiovascular risk factor to either dronedarone or placebo.
Results found 24% fewer deaths or hospitalizations
(the primary composite endpoint) in the treatment group than in the
group receiving a placebo.
The ACC/AHA/ESC guidelines for the management of
patients with atrial fibrillation have described dronedarone as a
derivative of amiodarone (a well established and recommended treatment
for atrial fibrillation) under development as an ion-channel blocking
drug.
Speaking on behalf of the European Society of
Cardiology, Professor Christophe Leclercq from the CHU in Rennes,
France, said: The ATHENA trial shows that dronedarone, a new
anti-arryhtmic drug similar to amiodarone but with different effects on
individual ion channels, reduced the risk of death or hospitalization
for cardiovascular reasons by 36% when compared with placebo.
This was in patients without severe heart failure
(NYHA class IV) but with paroxysmal or persistent atrial fibrillation or
flutter with additional risk factor for death.
The study found no difference in overall mortality
between the two groups but cardiovascular death was significantly
reduced with dronedarone by 29%. There was no difference in
thyroid-related effects between the two groups. The EURIDIS and ADONIS
trials have already shown that dronedarone significantly reduced the
recurrence of arrythmias in patients with paroxysmal or persistent
atrial fibrillation.
Dronedarone may thus play a role in the management
of atrial arrhythmias in patients with paroxysmal or persistent atrial
tachycardias without severe heart failure.
Atrial fibrillation is a major cause of
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 due to an aging
population.
FDA Approves First Ablation Catheters for the
Treatment of Atrial Fibrillation
The FDA on February 6 approved the first ablation
catheters for the treatment of atrial fibrillation (uncoordinated
contractions of the upper heart chambers), one of the most common types
of arrhythmias - or abnormal heart rhythms - affecting more than two
million Americans.
The devices approved today, the NaviStar ThermoCool
saline irrigated radio-frequency ablation catheter and the EZ Steer
ThermoCool Nav, can be used to create small, strategically placed scars
in heart tissue to block irregular electrical waves that cause atrial
fibrillation. The FDA previously approved other ablation catheters to
treat arrhythmias such as atrial flutter and ventricular
tachyarrhythmia, but not atrial fibrillation.
Atrial fibrillation is usually treated with drugs,
and in certain severe cases, with open heart surgery. Catheter ablation
should be used only after drug treatment has failed to adequately
control the symptoms of the condition.
This approval provides physicians with another
option for treating this common and potentially debilitating condition,
said Daniel G. Schultz, M.D., director of the FDAs Center for Devices
and Radiological Health.
While atrial fibrillation is a major risk factor
related to stroke, there is no conclusive evidence that links the
treatment of symptoms by ablation to a reduction in stroke. Therefore,
the FDA agrees with the American College of Cardiology, the American
Heart Association and the European Society of Cardiology, which
recommend that patients at risk for stroke continue to take
blood-thinning medications after ablation procedures for atrial
fibrillation.
The FDA based this approval on a clinical study of
167 patients at 19 medical centers in the United States, Brazil, Canada,
the Czech Republic, and Italy. Data from the study showed the devices to
be effective in eliminating symptomatic recurrence of atrial
fibrillation episodes for one year in approximately 63 percent of
treated patients versus 17 percent of the patients in the control
group.
The catheters were the focus of an FDA Circulatory System Devices
advisory panel on Nov. 20, 2008, when they received the panels
unanimous recommendation for approval.
As a condition of approval, manufacturer BioSense
Webster must establish a physician training program and conduct
postmarket studies to collect data on these devices long-term safety
and effectiveness (including incidence of stroke, mortality, cardiac
arrest, major bleeding, and pulmonary vein stenosis), and the effect of
physicians experience in operating the device on procedural safety.
Both catheters are manufactured by BioSense Webster of Diamond Bar,
Calif.
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.
Background Information
About Multaq (dronedarone) by Sanofi-Afentis
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
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).
Source: Hohnloser SH, Crijns HJGM, van Eickels M,
et al. Effect of dronedarone on cardiovascular events in atrial
fibrillation. N Engl J Med 2009; 360: 668-678.
>> ACC/AHA/ESC 2006 guidelines for the management of patients with
atrial fibrillation can be found here.
Keep up with the latest news for senior citizens, baby
boomers
Feb. 17, 2009 Deaths and hospitalizations for
patients with atrial fibrillation, which are climbing with the
increasing number of seniors, can be reduced by a new, still unlicensed,
anti-arrhythmic drug named dronedarone, according to a report in the
New England Journal of Medicine reporting on the ATHENA trial. To be
marketed as Multaq by Sanofi-aventis, the drug was granted a priority
review status by the FDA in July of 2008.