Comparison of Antiarrhythmic Activity and Safety of Russian-Made Drugs Containing Lappaconitine Hydrobromide

Abstract

Aim. To compare the antiarrhythmic activity and safety of two Russian-made drugs, Laporitmin (PharmVILAR) and Allapinin (Pharmcenter VILAR) in premature ventricular contractions (PVCs) in patients without structural heart pathology.Material and methods. The study included 100 subjects divided into 2 groups; the follow-up period was 3 weeks. The drug efficacy was assessed based on the results of ECG monitoring and Holter ECG monitoring (ECG-HM).Results. A comparative analysis of the antiarrhythmic activity and safety of the drugs containing lappaconitine hydrobromide showed a comparably high clinical efficacy and good tolerability of the original drug Allapinin and the generic drug Laporitmin for PVCs. According to the results of ECG monitoring, the number of PVCs significantly decreased from 2 (2-6) to 0 (0-1) in patients of the main group (Laporitmin treatment group) and from 2 (2-7) to 0 (0-2) in patients of the control group (Allapinin treatment group) (p>0.05); according to the ECG-HM data, the number of PVCs significantly decreased by 88.2 Δ% in the main group and by 87.5 Δ% in the control group (p <0.01). There were no statistically significant differences in the primary effectiveness criterion between the main and control groups (F statistic = 1.41; p = 0.23).Conclusion. The comparative analysis of the original drug Allapinin and the generic drug Laporitmin for PVCs in patients without structural heart pathology who had indications for antiarrhythmic therapy did not detect statistically significant differences in the primary criterion of effectiveness. Therapy with either drug showed a comparably high efficacy in reducing the number of PVCs by more than 75∆%, which was established as a criterion for primary effectiveness in the clinical trial protocol. Both drugs were well tolerated.