Lappaconitine hydrobromide and its sustained-release form in case of ventricular premature beats in patients without organic heart diseases: efficiency and safety

• Sokolov S.F.
• Belyaeva M.M.
• Bakalov S.A.
• Golitsyn S.P.

Abstract

Antiarrhythmic properties of lappaconitine hydrobromide (LAHB) determine wide possibilities in therapy of various heart rhythm disturbances, when prescribed to patients without pronounced organic heart diseases in order to prevent repeated arrhythmic episodes.

The aim of the study was to find ways to eliminate LAHB adverse side effects by using its tablet dosage form (Allaforte®) with active agent sustained release.

Material and methods. The double-blind randomized cross-over comparison of the three LAHB dosage forms was made: Allapinin® in tablets of 25 mg (ALP), Allaforte® in tablets of 25 mg (ALF-25) and 50 mg (ALF-50). Out of 41 patients who underwent presumptive treatment with ALP, antiarrhythmic effect was achieved in 31 patients (75.6%). Thus, data from 32 patients were included in study.

A randomized, double-blind, cross-over drugs comparison foreseed sequential administration to each patient of a 7-day course of treatment with each of investigational drugs. Drugs effect evaluation was carried out on the last day of each treatment course, use patient survey, 12-lead ECG and 24-hour Holter ECG monitoring for control methods.

Results. In the course of the treatment with ALF-25 and ALF-50, extracardiac adverse effects manifest themselves with lower frequency and much lesser extent in comparison with those on the background of ALP treatment.

Conclusion. Subjective Allaforte® tolerance is significantly higher in comparison with LAHB standard dosage form due to decrease in frequency and severity of side effects. Allaforte® retains no less antiarrhythmic activity and does not increase negative effect on cardiac conduction system compared with LAHB standard dosage form.

Keywords:lappaconitine hydrobromide, Allaforte®, adverse effects, arrhythmia, treatment

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