Efficacy and safety of extended-release lappaconitine hydrobromide in ventricular premature beats

Purpose. To evaluate the efficacy and safety of extended-release lappaconitine hydrobromide at a minimal dose of 25 mg twice daily in patients with ventricular premature beats (VPBs) without structural heart disease. Materials and methods. This open retrospective prospective study included 50 patients (22 men) aged 35–70 years with frequent VPBs (>500 per day according to 24-hour Holter ECG monitoring). In 39 patients, the analysis was retrospective, while 11 patients were enrolled prospectively. All patients underwent two Holter ECG recordings: before treatment initiation and after 2–3 weeks of therapy with extended-release lappaconitine hydrobromide at a dose of 25 mg twice daily. Quantitative parameters were normalized to 24 hours. Efficacy was assessed by changes in the number of single and paired VPBs, episodes of non-sustained ventricular tachycardia (NSVT), the ectopic burden index, and the proportion of responders according to current clinical guideline criteria. Safety was evaluated by changes in heart rate and P-wave, QRS complex and PQ, QT, QTc intervals duration. Results. The mean number of single VPBs decreased by 78.0% (p < 0.001), and paired VPBs by 94.4% (p < 0.001). Episodes of NSVT were completely eliminated (p < 0.001). Guideline-defined efficacy criteria were achieved in 86.0% of patients for single VPBs, 62.1% for paired VPBs, and 100% for NSVT. The ectopic burden index decreased by 71.2% (p < 0.001). No significant effects on heart rate were observed. A statistically significant but clinically minimal prolongation of PQ and QRS intervals was noted. Conclusion. Extended-release lappaconitine hydrobromide at a minimal dose of 50 mg per day provides a substantial and statistically significant reduction in ventricular ectopic activity in patients without structural heart disease and demonstrates a favorable safety profile when administered twice daily.