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FDA (Food and Drug Administration) has approved the provision of dronedarone as a therapy for patients with atrial fibrillation or atrial flutter, to reduce the risk of hospitalization due to after-care cardiovascular events.

This decision was made based on recommendations from FDA advisory panel for cardiovascular drugs and kidney (FDA Cardiovascular and Renal Drug Advisory Panel). Dronedarone considered as a safer drug than with Amiodarone, a drug that had been widely used as therapy for patients with atrial fibrillation.

Recommendations are given the FDA panel was made based on research results ATHENA (A Placebo Controlled, Double Blind, Parallel-arm, Trial to Assess the Efficacy of Donedarone 400 mg BID for the Prevention of Cardiovascular Hospitalization or Death from any Cause in Patients with Atrial fibrillation / Atrial Flutter). ATHENA research is led by dr. Stefan H. Hohnloser from JW Goethe University, Frankfurt, Germany, and has been published in the New England Journal of Medicine. ATHENA study results showed that treatment with dronedarone reduce the risk of death from any cause or decreased risk for hospitalization for 24%, when compared with placebo. In addition, a decline in the incidence of stroke in patients with atrial fibrillation, who received standard therapy, and getting dronedarone therapy.



Dronedarone contraindicated for patients with severe heart failure or for patients with heart failure with NYHA 2 or 3, with the dekompensasi hospitalization memerlukkan. Research Andromeda (Antiarrhytmic Trial with Dronedarone in Moderate to Severe Congestive Heart Failure Evaluating Morbidity Decrease) has ever done in quite some time ago showed that dronedarone may increase the risk of death in patients with heart failure are heavy, and ventricular dysfunction.

Further research needs to be done to find out with more certain about the effects of dronedarone on stroke events and more data to be collected about the impact on patients with heart failure.

Conclusion:

FDA (Food and Drug Administration) has approved the provision of dronedarone as a therapy for patients with atrial fibrillation or atrial flutter, to reduce the risk of hospitalization due to after-care cardiovascular events.
Dronedarone considered as a safer drug than with Amiodarone.
ATHENA study results showed that treatment with dronedarone reduce the risk of mortality due to all causes or hospitalization risk reduction of 24% compared to placebo and reduced the risk of stroke events.