title: The safety of flecainide treatment of atrial fibrillation: long-term incidence of sudden cardiac death and proarrhythmic events.
abstract: OBJECTIVE
  To assess the safety of long-term treatment with flecainide in patients with atrial fibrillation (AF), particularly with regard to sudden cardiac death (SCD) and proarrhythmic events.
  
  
  METHODS
  Retrospective, observational cohort study.
  
  
  METHODS
  Single-centre study at Örebro University Hospital, Sweden. Subjects.  A total of 112 patients with paroxysmal (51%) or persistent (49%) AF (mean age 60 ± 11 years) were included after identifying all patients with AF who initiated oral flecainide treatment (mean dose 203 ± 43 mg per day) between 1998 and 2006. Standard exclusion/inclusion criteria for flecainide were used, and flecainide treatment was usually combined with an atrioventricular-blocking agent (89%).
  
  
  METHODS
  Death was classified as sudden or nonsudden according to standard definitions. Proarrhythmia was defined as cardiac syncope or life-threatening arrhythmia.
  
  
  RESULTS
  Eight deaths were reported during a mean follow-up of 3.4 ± 2.4 years. Compared to the general population, the standardized mortality ratios were 1.57 (95% confidence interval (CI) 0.68-3.09) for all-cause mortality and 4.16 (95% CI 1.53-9.06) for death from cardiovascular disease. Three deaths were classified as SCDs. Proarrhythmic events occurred in six patients (two each with wide QRS tachycardia, 1 : 1 conducted atrial flutter and syncope during exercise).
  
  
  CONCLUSIONS
  We found an increased incidence of SCD or proarrhythmic events in this real-world study of flecainide used for the treatment of AF. The findings suggest that further investigation into the safety of flecainide for the treatment of patients with AF is warranted.
authors.affiliation: Department of Cardiology, Örebro University Hospital, Örebro, Sweden. henrik.almroth@orebroll.se
authors.forename: H
authors.initials: H
authors.lastname: Almroth
authors.forename: T
authors.initials: T
authors.lastname: Andersson
authors.forename: E
authors.initials: E
authors.lastname: Fengsrud
authors.forename: L
authors.initials: L
authors.lastname: Friberg
authors.forename: P
authors.initials: P
authors.lastname: Linde
authors.forename: M
authors.initials: M
authors.lastname: Rosenqvist
authors.forename: A
authors.initials: A
authors.lastname: Englund
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001145:Arrhythmias, Cardiac / Q000139:chemically induced*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality*; D002317:Cardiovascular Agents / Q000627:therapeutic use; D015331:Cohort Studies; D015897:Comorbidity; D016757:Death, Sudden, Cardiac / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D005424:Flecainide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D012107:Research Design; D012189:Retrospective Studies; D012307:Risk Factors; D013548:Sweden / Q000453:epidemiology
chemical_list: D000889:Anti-Arrhythmia Agents; D002317:Cardiovascular Agents; D005424:Flecainide