Gil Roth11.18.13
ChanRx has posted positive safety and statistically significant efficacy data from a Phase IIb study of vanoxerine (GBR-12909), a drug in development for the treatment of atrial fibrillation. The data were presented at the American Heart Association 2013 Scientific Sessions.
In the randomized, placebo-controlled trial, 104 patients presenting with symptomatic atrial fibrillation or atrial flutter of recent onset were assigned to one of three doses of vanoxerine or placebo. Vanoxerine was found to be well tolerated at all doses. Importantly, no episodes of monomorphic or polymorphic ventricular tachycardia were seen. Ventricular tachycardia is a potentially life-threatening arrhythmia that can lead to sudden death. The majority of currently marketed drugs used for atrial fibrillation have a risk of polymorphic ventricular tachycardia.
Patients participating in the trial were measured for conversion from atrial fibrillation or flutter to normal sinus rhythm. Overall, there was a highly statistically significant dose-dependent increase in the conversion to normal sinus rhythm compared to placebo. The highest oral dose (400 mg) achieved a conversion rate of 76% at eight hours and 84% within the first 24 hours, a rate approaching that of direct current (DC) cardioversion. Patients taking placebo achieved a 25% conversion rate at eight hours and a 38% conversion rate at 24 hours.
In the randomized, placebo-controlled trial, 104 patients presenting with symptomatic atrial fibrillation or atrial flutter of recent onset were assigned to one of three doses of vanoxerine or placebo. Vanoxerine was found to be well tolerated at all doses. Importantly, no episodes of monomorphic or polymorphic ventricular tachycardia were seen. Ventricular tachycardia is a potentially life-threatening arrhythmia that can lead to sudden death. The majority of currently marketed drugs used for atrial fibrillation have a risk of polymorphic ventricular tachycardia.
Patients participating in the trial were measured for conversion from atrial fibrillation or flutter to normal sinus rhythm. Overall, there was a highly statistically significant dose-dependent increase in the conversion to normal sinus rhythm compared to placebo. The highest oral dose (400 mg) achieved a conversion rate of 76% at eight hours and 84% within the first 24 hours, a rate approaching that of direct current (DC) cardioversion. Patients taking placebo achieved a 25% conversion rate at eight hours and a 38% conversion rate at 24 hours.