FDA Approves Heart Drug After New Trials

The FDA has approved the antiarrhythmic dronedarone (Multaq) for treatment of atrial fibrillation and atrial flutter, the drug's developer announced today.

Dronedarone is the first drug approved in the U.S. that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with those conditions.

Calling the drug's approval "exciting," Stuart Connolly, MD, of McMaster University in Hamilton, Ontario, and a principal investigator in the ATHENA trial of dronedarone, suggested that the drug's reduction in hospitalizations "could change the way we approach the management of [atrial fibrillation and flutter]."

The FDA rejected the drug in 2005 following cancellation of the ANDROMEDA trial after enrollment of only 627 of 1,000 planned patients because of "worsening heart failure in the dronedarone group [n=25 versus 12 (placebo), P=0.027]," said a sanofi-aventis press release.

But the ATHENA trial, reported in the Feb. 12, 2009, issue of the New England Journal of Medicine, found a 25% reduced risk of the primary outcome of hospitalization for cardiovascular events or death (P<0.001)>

In ATHENA, 71% of at-risk patients had no heart failure, while 29% were in NYHA class I-III with stable heart failure, and 24% had a reduction in cardiovascular hospitalizations or death from any cause. Because of the ANDROMEDA findings, however, dronedarone is contraindicated, in patients with class IV heart failure or class II-III with recent decompensation needing treatment, said a sanofi-aventis press release.

Dronedarone is available in a 400 mg tablet that should be taken twice daily at morning and evening meals. Common adverse reactions include diarrhea, nausea, vomiting, abdominal pain, weakness, and rash.

Source : www.medpagetoday.com