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7-Apr-10 9:00 AM  CST  

Dronedarone Doesn’t Fit the Hype, Experts Say 

Dronedarone, hailed as a safer alternative to amiodarone in the treatment of atrial fibrillation, fails to live up to its reputation, according to a new study in the Journal of the American College of Cardiology.

Dronedarone, sold under the name Multaq by Sanofi-Aventis, was marketed with the hopes that its similarity in chemical structure to amiodarone, would make it just as effective as amiodarone but with fewer side effects. A study by experts at the Cedars-Sinai Heart Institute not only found no conclusive evidence that dronedarone had fewer side effects than amiodarone. It also found dronedarone to be 50 percent less effective than amiodarone.  

"Dronedarone has, at best, modest effectiveness as an antiarrhythmic agent, and it has not been proven to be any safer than amiodarone," said Dr. Sanjay Kaul, the director of the Vascular Physiology and Thrombosis Research Laboratory at the Cedars-Sinai Heart Institute and the senior writer of the study.

Atrial fibrillation (AF) is a common form of cardiac arrhythmia where the upper chambers of the heart quiver instead of beating at regular intervals. Chronic AF can result in palpitations, fainting, chest pain and an increased risk of stroke. A common part of treatment for AF is amiodarone, but amiodarone has potentially lethal side effects such as thyroid and lung toxicity. Though it is not approved by the FDA for treatment of AF, amiodarone is frequently prescribed for off-label use in patients due to a lack of effective alternative AF treatments available.    

Dronedarone was developed as an alternative to amiodarone for patients with chronic AF who may currently have a regular heart rhythm or are undergoing medical treatment to return to a regular heart rhythm. According to the FDA’s press release on dronedarone, the drug was approved due to a clinical trial that found it reduced cardiovascular hospitalization related to AF when compared with a placebo. However, the Cedars-Sinai study took the same data that was presented for that trial and found different results.

“The argument that dronedarone is potentially safer than amiodarone is weakened by the fact that it's also half as effective,” Kaul said.

Kaul recommends that dronedarone be used as a second-line or third-line treatment in individuals that are not able to tolerate amiodarone or other first-line agents. In the Cedars-Sinai article on the study, he said doctors should be cautious about prescribing dronedarone for off-label use and that patients should be allowed to weigh the pros and cons of both dronedarone and amiodarone.

“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,” Kaul said. “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.”

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Total Comments: 1
  • angelo on 2-Feb-11 9:29 AM permalink

    I used for 2 years Amiodarone It was very effective gainst AF, but has caused Tyroids and skin problems. I have started since 4 months to take dronedarone and so far it looks ok.

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