Comparative Effectiveness of Aksaritmin and Propafenone in the Prevention of Atrial Fibrillation

Abstract

Background: The purpose of this study was to evaluate the efficacy of Aksaritmin (Aks) in comparison with Propafenone (Pr) for the prevention of atrial fibrillation (AF) in patients with none or minimal signs of structural heart disease. Methods and Results: The study included 60 patients aged 18-70 years (mean age of 58.1±7.7 years) with paroxysmal (frequency of more than 2 paroxysms/3 months episodes of AF) or persistent AF with no or minimal signs of structural heart disease. The patients were divided into two groups: Group 1 included 30 patients taking Aks, and Group 2 included 30 patients taking Pr. According to the study protocol, the starting dose of Aks was 75 mg/day, with a possible dose increasing to 112.5 mg/day. The starting dose of Pr was 45 0mg/day, with a possible dose increase to 600 mg/day. In Group 1, preventive efficacy of Aks was observed in 29(96.7%), 26(86.7%), and 24(80%) patients by 1-, 3- and 6-month follow-up, respectively. Of these, 26(86.7%), 22(73.9%), and 16(53.3%) patients showed absolute preventive efficacy of the drug. In Group 2, preventive efficacy of Pr was observed in 28(93.3%), 26(86.7%), and 23(76,7%) patients at 1-, 3- and 6-month follow-up, respectively. Of these, 25(83.3%), 21(70%), and 14(46.7%) patients showed absolute AAE of the Pr. The initial recurrence rate of AF was 4.5±1.4 and 4.2±1.3 in Groups 1 and 2, respectively (P=0.3933 between groups); but after 3 and 6 months of therapy, the recurrence rate decreased to 0.7±1.1 (P<0.0001) and 0.8±1.3 (P<0.0001), and 0.8±1.0 (P<0.0001) and 1.1±1.0 (P<0.0001), respectively, which was statistically significant in both groups. Conclusion: The preventive efficacy of Aks (including in combination with BB) at a dose of 75-112.5mg/day in recurrent forms of AF is comparable to the "reference" drug Pr at a dose of 450-600mg/day.