The review, to be published in the April 23 issue of the Journal of the American College of Cardiology, assessed data on dronedarone submitted during the drug's FDA approval process and determined that dronedarone is 50 percent less effective than amiodarone (Cordarone), a frequently used treatment for atrial fibrillation, a common type of heart rhythm disorder.
Despite initial hopes that dronedarone would cause fewer side effects than amiodarone, the studies submitted to the FDA do not confirm that, the researchers conclude.
"We believe that dronedarone should only be used as a second-line or third-line agent in individuals that are not able to tolerate amiodarone or other first-line agents recommended by the guidelines," says the study's senior author, Dr. Sanjay Kaul, director of the Vascular Physiology and Thrombosis Research Laboratory at the Cedars-Sinai Heart Institute.
Atrial fibrillation and atrial flutter are disruptions of the heart's natural rhythm. Atrial fibrillation occurs when the heart's upper chambers (called atria) quiver, instead of beating properly, and this disruption may allow blood to pool or clot, raising the risk of stroke. Atrial flutter is a type of rapid heartbeat related to atrial fibrillation. Nearly 2.3 million Americans are affected by atrial fibrillation and atrial flutter and these conditions account for nearly 71,000 deaths each year.
Although amiodarone is an effective treatment for atrial fibrillation and atrial flutter, it can cause serious side effects, such as thyroid and lung toxicity. Dronedarone is chemically similar to amiodarone and was specifically designed to avoid amiodarone's side effects. However, the studies submitted to the FDA failed to confirm that dronedarone was significantly safer or more effective than amiodarone, says Kaul. While it's possible that dronedarone might provoke fewer side effects than amiodarone, the studies done so far have been too small and of insufficient duration to confirm this, he says.
Dronedarone has received widespread attention recently due to a controversial lecture sponsored by the drug's maker, Sanofi-Aventis, that touted dronedarone's off-label use. When the drug received a green light from the FDA in 2009, its approval was for reducing the risk of cardiovascular hospitalization in patients with nonpermanent atrial fibrillation or atrial flutter, rather than as a drug indicated for suppression of arrhythmia, says Kaul.
"Dronedarone has, at best, modest effectiveness as an antiarrhythmic agent, and it has not been proven to be any safer than amiodarone," says Kaul. "Amiodarone does have the potential for toxicity that can adversely impact quality of life, but it's also very effective and we can manage side effects or avoid them by lowering the dose. The argument that dronedarone is potentially safer than amiodarone is weakened by the fact that it's also half as effective. However, patient preference is an important consideration in treatment decisions. There are some patients who might consider improved short-term tolerability over reduced efficacy an acceptable tradeoff."
Based on the current studies, physicians should be very cautious about using dronedarone for off-label indications such as ventricular arrhythmia, and should avoid using it in high-risk patients such as those with advanced heart failure or those with recently decompensated heart failure requiring hospitalization or special attention, says Kaul. "Dronedarone has very modest efficacy as an antiarrhythmic agent, and based on the current evidence its use for the treatment of nonpermanent atrial fibrillation or atrial flutter can only be supported as a second- or third-line agent after guideline-recommended first-line agents have failed."
The Cedars-Sinai Heart Institute is internationally recognized for outstanding heart care built on decades of innovation and leading-edge research. From cardiac imaging and advanced diagnostics to surgical repair of complex heart problems to the training of the heart specialists of tomorrow and research that is deepening medical knowledge and practice, the Cedars-Sinai Heart Institute is known around the world for excellence and innovations.
Sally Stewart | Cedars-Sinai News
Study tracks inner workings of the brain with new biosensor
16.08.2018 | Rheinische Friedrich-Wilhelms-Universität Bonn
Foods of the future
15.08.2018 | Georg-August-Universität Göttingen
There are currently great hopes for solid-state batteries. They contain no liquid parts that could leak or catch fire. For this reason, they do not require cooling and are considered to be much safer, more reliable, and longer lasting than traditional lithium-ion batteries. Jülich scientists have now introduced a new concept that allows currents up to ten times greater during charging and discharging than previously described in the literature. The improvement was achieved by a “clever” choice of materials with a focus on consistently good compatibility. All components were made from phosphate compounds, which are well matched both chemically and mechanically.
The low current is considered one of the biggest hurdles in the development of solid-state batteries. It is the reason why the batteries take a relatively long...
New design tool automatically creates nanostructure 3D-print templates for user-given colors
Scientists present work at prestigious SIGGRAPH conference
Most of the objects we see are colored by pigments, but using pigments has disadvantages: such colors can fade, industrial pigments are often toxic, and...
Scientists at the University of California, Los Angeles present new research on a curious cosmic phenomenon known as "whistlers" -- very low frequency packets...
Scientists develop first tool to use machine learning methods to compute flow around interactively designable 3D objects. Tool will be presented at this year’s prestigious SIGGRAPH conference.
When engineers or designers want to test the aerodynamic properties of the newly designed shape of a car, airplane, or other object, they would normally model...
Researchers from TU Graz and their industry partners have unveiled a world first: the prototype of a robot-controlled, high-speed combined charging system (CCS) for electric vehicles that enables series charging of cars in various parking positions.
Global demand for electric vehicles is forecast to rise sharply: by 2025, the number of new vehicle registrations is expected to reach 25 million per year....
17.08.2018 | Event News
08.08.2018 | Event News
27.07.2018 | Event News
21.08.2018 | Ecology, The Environment and Conservation
21.08.2018 | Life Sciences
21.08.2018 | Power and Electrical Engineering