title: [The Study of Evidence Base for the Use of Lappaconitine Hydrobromide in Patients With Atrial Fibrillation].
abstract: Lappaconitine Hydrobromide (LH, allapinin) has been included by authors of National Guidelines on Diagnosis and Treatment of Atrial Fibrillation (AF), 2012 in the number of medications recommended for use in patients with AF for rhythm control. Moreover, LH is also included into the List of Vital and Essential Medicinal Drugs (VEMD) 2015. However, LH is not mentioned in corresponding guidelines of the European Society of Cardiology (ESC). Aim of the present review was to explore evidence base underlining use of LH in the context of AF and to understand reason for LH-related discrepancy between European and domestic guidelines.
  
  
  RESULTS
  Literature search has indicated that efficacy of LH was assessed only in small open studies. None of prospective trials included more than 100 patients. For more than 25 years of presence on the market slightly more than 400 patients were administered LH in clinical studies. In the only trial, designated as randomized number of participants (only men younger than 60 years) was small and the comparator was quinidine that presently is not used for maintenance of sinus rhythm in AF. Another study referenced in domestic guidelines on management of AF was observational and not intended for comparison of antiarrhythmic activity of drugs.
  
  
  CONCLUSIONS
  Design of studies reviewed as well as their results provide insufficient evidence supporting the use of LH for maintenance of sinus rhythm in routine management of AF. At present inclusion of LH in guidelines on AF management and in the List of VEMD appears unjustified.
authors.affiliation: Research Institute for Physicochemical Medicine, Moscow, Russia.
authors.forename: A D
authors.initials: AD
authors.lastname: Erlikh
mesh_terms: D000157:Aconitine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D055317:Evidence-Based Practice; D006801:Humans; D008297:Male; D011446:Prospective Studies
chemical_list: D000889:Anti-Arrhythmia Agents; C051402:allapinin; D000157:Aconitine