March 25, 2008 - Investigational agent KYNAPID (vernakalant hydrochloride) Injection converted short-duration atrial fibrillation (AF) to sinus rhythm in 51 percent of the patients in a Phase III study launched by Astellas Pharma US and Cardiome Pharma Corp., reported Circulation, the official journal of the American Heart Association.
In the study, known as the Atrial arrhythmia Conversion Trial (ACT I), the primary efficacy analysis showed that 75 of the 145 (51.7 percent) KYNAPID patients in the short-duration AF group (three hours to seven days) converted to sinus rhythm within 90 minutes compared with three of the 75 (4 percent) placebo patients.
Patients with AF lasting three to 48 hours who received KYNAPID demonstrated the highest conversion rate (62.1 percent) compared with 4.9 percent with placebo. The median time to conversion to sinus rhythm for the 75 patients receiving KYNAPID who converted was 11 minutes. Only one of the 75 KYNAPID-treated patients who converted to sinus rhythm relapsed to AF at 24 hours.
"Due to the importance of treating AF quickly, we're pleased that KYNAPID displayed such a rapid conversion of AF to sinus rhythm," said Edward Pritchett, M.D., consulting professor of Medicine, Divisions of cardiology and Clinical Pharmacology, Duke University Medical Center and consultant for Astellas Pharma US.
The Phase III study, referred to as ACT I, was a prospective, randomized, double-blind, placebo-controlled trial of hemodynamically stable patients with symptomatic AF or nontypical atrial flutter, conducted at 44 sites in Canada, the U.S. and Scandinavia. The study assessed the safety and efficacy of KYNAPID for the conversion of AF. Results of the study showed KYNAPID demonstrated rapid conversion of short-duration AF and was well tolerated.
For more information: www.astellas.com/us and www.cardiome.com