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Amiodarone is Superior to Sotalol for Maintaining Sinus Rhythm in Patients with Atrial Fibrillation

May 5, 2005

Los Angeles, CA- Atrial Fibrillation is a common arrhythmia requiring therapy for inducing and maintaining a normal sinus rhythm. The double-blind Sotalol Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T) was done by Bramah N. Singh, M.D., D.Sc. et al from the Department of Veterans Affairs Medical Center to compare the ability of sotalol and amiodarone in restoration of sinus rhythm in atrial fibrillation. The study was published in the May 5, 2005 issue of The New England Journal of Medicine. It was determined that amiodarone and sotalol both restored sinus rhythm in atrial fibrillation and amiodarone was superior for maintaining sinus rhythm in patients with persistent atrial fibrillation. 

In this double-blind, placebo-controlled trial, 665 patients who were receiving anticoagulants and had persistent atrial fibrillation received amiodarone (267 patients), sotalol (261 patients) or placebo (137). The amiodarone regimen was 800 mg per day for the first 14 days, 600 mg per day for the next 14 days and 300 mg per day thereafter. The sotalol regimen was 80 mg twice daily for the first week and 160 mg twice daily thereafter. The patients were monitored from 1 to 4.5 years. The primary end point was the time to recurrence of atrial fibrillation beginning on day 28, determined by means of weekly transtelephonic monitoring.  

Spontaneous conversion to sinus rhythm occurred in 27.1 percent of the amiodarone group, 24.2 percent of sotalol group and 0.8 percent of the placebo group. Direct cardioversion failed in 27.7 percent of the amiodarone group, 26.5 percent of the sotalol group and 32.1 percent of the placebo group. The median time to a recurrence of atrial fibrillation were 487 days in the amiodarone group, 74 days in the sotalol group, and 6 days in the placebo group. Amiodarone was superior to sotalol (P<0.001) and to placebo (P<0.001), and sotalol was superior to placebo (P<0.001). In patients with ischemic heart disease, the median time to recurrence of atrial fibrillation was 569 days with the amiodarone therapy and 428 days with the sotalol therapy (P=0.53). Restoration and maintenance of sinus rhythm significantly improved the quality of life and exercise capacity. There were no significant differences in the adverse effects among the three groups.  

Overall, it was determined that amiodarone and sotalol are equally efficacious in converting atrial fibrillation to sinus rhythm. Amiodarone is superior for maintaining sinus rhythm, but both drugs have a similar efficacy in patients with ischemic heart disease.  

Co-authors: Steven N. Singh, M.D., Domenic J. Reda, PhD., X. Charlene Tang, M.D., PhD., Becky Lopez, R.N., Crystal L. Harris, Pharm D., Ross D. Fletcher, M.D., Satish C. Sharma, M.D., J. Edwin Atwood, M.D., Alan K. Jacobson, M.D., H. Daniel Lewis, Jr., M.D., Dennis W. Raisch, PhD., and Michael D. Ezekowitz , M.B., Ch.B, PhD. 


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