RYTHMOL clinical studies
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Clinical Studies
In 2 randomized, crossover, placebo-controlled, double-blind trials of 60 to 90 days’ duration in subjects with paroxysmal supraventricular arrhythmias (paroxysmal atrial fibrillation/flutter [PAF], or paroxysmal supraventricular tachycardia [PSVT]), propafenone reduced the rate of both arrhythmias, as shown in Table 3.
 |
The patient population in the above trials was 50% male with a mean age of 57.3 years. Fifty percent of the subjects had a diagnosis of PAF and 50% had PSVT. Eighty percent of the subjects received 600 mg/day propafenone. No subject died in the above 2 trials.
In US long-term safety trials, 474 subjects (mean age: 57.4 + 14.5 years) with supraventricular arrhythmias [195 with PAF, 274 with PSVT and 5 with both PAF and PSVT] were treated up to 5 years (mean: 14.4 months) with propafenone. Fourteen of the subjects died. When this mortality rate was compared with the rate in a similar patient population (n = 194 subjects; mean age: 43.0 + 16.8 years) studied in an arrhythmia clinic, there was no age-adjusted difference in mortality. This comparison was not, however, a randomized trial and the 95% confidence interval around the comparison was large, such that neither a significant adverse or favorable effect could be ruled out.