A comparative study of lappaconitine hydrobromide extended release and propafenone in patients with paroxysmal atrial fibrillation

DOI: https://doi.org/10.29296/25877305-2024-01-04
Issue: 
1
Year: 
2024

Professor A. Revishvili(1), Academician of the Russian Academy of Sciences, MD; Professor S. Golitsyn(2), MD; S. Aksentiev(6), Candidate of Medical Sciences;
A. Amiraslanov(1); E. Artyukhina(1), MD; Professor D. Duplyakov(3), MD; E. Zubov(4), Candidate of Medical Sciences; E. Isaeva(5), Candidate of Medical Sciences; A. Loginova(2); T. Malkina(2), Candidate of Medical Sciences; G. Miloserdov(6); A. Rivin(7); S. Teplykh(8); I. Tsygankova(6); Professor Yu. Shvarts(9), MD; Yu. Yuricheva(2), Candidate of Medical Sciences; Professor S. Kanorsky(10), MD; S. Sokolov(2), Candidate of Medical Sciences
1-National Medical Research Center of Surgery named after A.Vishnevsky, Ministry of Health of Russia, Moscow
2-National Medical Research Centre of cardiology named after Academician
E.I. Chazov, Ministry of Health of Russia, Moscow
3-V.P. Polyakov Samara Region Clinical Cardiological Dispensary
4-LLC «Professor's Clinic», Perm
5-Interregional Clinical Diagnostic Center, Kazan
6-Regional Clinical Hospital, Ryazan
7-AntMed LLC, Saint Petersburg
8-LLC «Center for Professional Medicine», Perm
9-Saratov State Medical University named after V.I. Razumovsky
10-Kuban State Medical University, Ministry of Health of Russia, Krasnodar

A new dosage form of lappaconitine hydrobromide has been created – the long-acting drug Allaforte®, which has fewer side effects compared to the traditional dosage form (Allapinin®). Objective. To evaluate the effectiveness, safety and tolerability of Allaforte® therapy in comparison with the drug Rytmonorm® in patients with paroxysmal atrial fibrillation (AF). Material and methods. Patients who met the inclusion criteria and those who did not meet the non-inclusion criteria were randomized into 2 groups: 1st (n=50) – patients received Allaforte® 25 mg 3 times a day with an increase in dose to 50 mg 2 times a day when detected attack of AF; 2nd (n=50) – patients received Rytmonorm® 150 mg 3 times a day with an increase in dose to 300 mg 2 times a day if an attack of AF was detected. Results. The average time from the first dose of the drug to the development of AF paroxysm in the 1st group (Allaforte®) was 98.877±6.022 days, in the 2nd group (Rytmonorm®) – 98.808±5.876 days, the average time from the first dose of the drug to the completion of the study – 105.740±5.032 and 103.732±5.353 days, respectively. The drugs Allaforte® and Rytmonorm® equally improved the quality of life of patients. A comparative analysis in groups according to the severity of adverse events and their cause-and-effect relationship with the drug did not show significant differences. Conclusion. The study drugs showed comparable effectiveness in preventing attacks of AF with similar safety and tolerability.

Keywords: 
cardiology
atrial fibrillation
rhythm control
lappaconitine hydrobromide
propafenone.



References: 
  1. Dong X.J., Wang B.B., Hou F.F. et al. Global burden of atrial fibrillation/atrial flutter and its attributable risk factors from 1990 to 2019. Europace. 2023; 25 (3): 793–803. DOI: 10.1093/europace/euac237
  2. Jahangir A., Lee V., Friedman P.A. et al. Long-term progression and outcomes with aging in patients with lone atrial fibrillation: a 30-year follow-up study. Circulation. 2007; 115 (24): 3050–6. DOI: 10.1161/CIRCULATIONAHA.106.644484
  3. Kirchhof P., Camm A.J., Goette A. et al. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020; 383 (14): 1305–16. DOI: 10.1056/NEJMoa2019422
  4. Schnabel R.B., Marinelli E.A., Arbelo E. et al. Early diagnosis and better rhythm management to improve outcomes in patients with atrial fibrillation: the 8th AFNET/EHRA consensus conference. Europace. 2023; 25 (1): 6–27. DOI: 10.1093/europace/euac062
  5. Saljic A., Heijman J., Dobrev D. Recent Advances in Antiarrhythmic Drug Therapy. Drugs. 2023; 83 (13): 1147–60. DOI: 10.1007/s40265-023-01923-3
  6. Hindricks G., Potpara T., Dagres N. et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021; 42 (5): 373–498. DOI: 10.1093/eurheartj/ehaa612
  7. Tran Q.T., Baek I.H., Han N.Y. et al. The Effect of CYP2D6 Phenotypes on the Pharmacokinetics of Propafenone: A Systematic Review and Meta-Analysis. Pharmaceutics. 2022; 14 (7): 1446. DOI: 10.3390/pharmaceutics14071446
  8. Соколов С.Ф., Беляева М.М., Бакалов С.А. и др. Сравнительная эффективность и безопасность двух лекарственных форм лаппаконитина гидробромида при желудочковой экстрасистолии у больных без органической патологии сердца. Кардиология. 2017; 57 (4): 91–5 [Sokolov S.F., Belyaeva M.M., Bakalov S.A. et al. Comparative efficacy and safety of two medicine forms of lappaconitin hydrobromide in patients with ventricular extrasystole without organic pathology of the heart. Kardiologiia. 2017; 57 (4): 91–5 (in Russ.)]. DOI: 10.18565/cardio.2017.4.5-11
  9. Wynn G.J., Todd D.M., Webber M. et al. The European Heart Rhythm Association symptom classification for atrial fibrillation: validation and improvement through a simple modification. Europace. 2014; 16 (7): 965–72. DOI: 10.1093/europace/eut395
  10. Rillig A., Magnussen C., Ozga A.K. et al. Early Rhythm Control Therapy in Patients With Atrial Fibrillation and Heart Failure. Circulation. 2021; 144 (11): 845–58. DOI: 10.1161/CIRCULATIONAHA.121.056323
  11. Chung S.C., Lai A., Lip G.Y.H. et al. Impact of anti-arrhythmic drugs and catheter ablation on the survival of patients with atrial fibrillation: a population study based on 199 433 new-onset atrial fibrillation patients in the UK. Europace. 2023; 25 (2): 351–9. DOI: 10.1093/europace/euac155
  12. Echt D.S., Liebson P.R., Mitchell L.B. et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991; 324 (12): 781–8. DOI: 10.1056/NEJM199103213241201
  13. Cardiac Arrhythmia Suppression Trial II Investigators. Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med. 1992; 327 (4): 227–33. DOI: 10.1056/NEJM199207233270403
  14. Burnham T.S., May H.T., Bair T.L. et al. Long-term outcomes in patients treated with flecainide for atrial fibrillation with stable coronary artery disease. Am Heart J. 2022; 243: 127–39. DOI: 10.1016/j.ahj.2021.08.013