title: The dronedarone shared-care clinical model and database: a coordinated paradigm to optimize management of evolving clinical recommendations.
abstract: BACKGROUND
  Dronedarone, a non-iodinated derivative of amiodarone, has been approved for use as a second-line agent for atrial fibrillation (AF). Following reports of possible liver injury during routine post-license monitoring, the European Medicines Agency (EMA) recommended regular liver function test (LFT) monitoring. Despite this recommendation, an audit of patients in our multi-center region who were prescribed dronedarone found that on-going LFT monitoring was inconsistent or absent, leading to potential safety concerns. Thus, we assessed whether the setting up of a clinical database of all patients prescribed dronedarone and a dedicated monitoring clinic would improve coordination of follow-up between primary and secondary care, and the implementation of monitoring guidelines.
  
  
  METHODS
  Baseline demographics, pre-treatment and follow-up renal function and LFTs, baseline left ventricular ejection fraction (LVEF), and cardiac rhythm analysis were recorded according to evolving EMA guidelines. Significant transaminitis was defined as alanine aminotransferase (ALT) >3× upper limit of normal.
  
  
  RESULTS
  During the study period, 107 patients currently taking dronedarone were identified. Once enrolled in the clinic, prospective serial LFT data were obtained in all patients. Of the 107 patients, 6 had elevated baseline ALT, of whom 1 had a further small ALT rise after commencing dronedarone (from 41 to 79 U/L by 9 months). Of the 101 patients with normal baseline ALT, 6 developed a small ALT rise (mean rise 25 U/L, range 11-36 U/L), but none developed significant transaminitis. After new heart failure guidance was issued 6/107 (7%) patients with baseline LVEF < 35% required therapy discontinuation.
  
  
  CONCLUSIONS
  Drugs with complex prescribing monitoring requirements are often managed via a shared-care method. Commencement of a dedicated dronedarone clinic optimized consistency of LFT monitoring and facilitated rapid implementation of further EMA guidance. In typical clinical practice, the need to stop dronedarone therapy is more frequently due to reduced LVEF or persistent/permanent AF than development of elevated LFTs.
authors.affiliation: Craigavon Cardiac Centre, Craigavon Hospital, Craigavon BT63 5QQ, Northern Ireland, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Connolly
authors.forename: Ian B A
authors.initials: IB
authors.lastname: Menown
authors.forename: Siobhan
authors.initials: S
authors.lastname: Hussey
authors.forename: Nikki
authors.initials: N
authors.lastname: Cinnamond
authors.forename: Laila
authors.initials: L
authors.lastname: Damani
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000638:Amiodarone / Q000009:adverse effects / Q000031:analogs & derivatives*; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis* / Q000209:etiology; D000077764:Dronedarone; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009660:Northern Ireland; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012042:Registries
chemical_list: D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone