title: Acute renal failure in patients treated with dronedarone or amiodarone: a large population-based cohort study in Italy.
abstract: OBJECTIVE
  Causes of ARF are numerous including drugs. In 2012, spontaneous reporting showed a possible association between dronedarone and ARF. To further investigate such association, a retrospective cohort study on health-service claim databases was performed taking amiodarone as comparison.
  
  
  METHODS
  All patients receiving new prescription of amiodarone or dronedarone between September 2010 and December 2012 were selected. Cox regression models to estimate the hazard ratios (HRs), with 95 % confidence intervals (CIs), for dronedarone versus amiodarone were performed. HRs were calculated: (i) for the entire cohort; (ii) for matched cohorts using propensity score; (iii) and high-dimensional propensity score.
  
  
  RESULTS
  New users without previous episodes of ARF were 56,739 and 1761 on dronedarone and 54,978 on amiodarone. After 1:1 matching for propensity score, new users with dronedarone and amiodarone were 1467 and 1467, respectively. The cumulative incidence rate of ARF was 1.6 % (95 % CI 0.7-3.6 %) among dronedarone group and 2.3 % (1.0-5.1 %) among amiodarone group (p from log rank test = 0.4884). The unadjusted HR of ARF was 0.34 (0.18-0.64) in dronedarone new users compared to amiodarone; in propensity score matched cohort, it was 0.75 (0.26-2.16), and in high-dimensional propensity score, it was 0.83 (0.25-2.73).
  
  
  CONCLUSIONS
  This large community-based study did not confirm the signal of an increased nephrotoxicity from dronedarone compared to amiodarone. Nevertheless, given the increasing number of reports collected from pharmacovigilance databases worldwide on this association, it is advisable for clinicians and patients to be aware of the possible kidney damage due to dronedarone in order to improve clinical outcomes with early intervention.
authors.affiliation: Pharmacovigilance Regional Centre of Lombardy, Via Taramelli 26, 20124, Milan, Italy.
authors.forename: Valentino
authors.initials: V
authors.lastname: Conti
authors.forename: Chiara
authors.initials: C
authors.lastname: Biagi
authors.forename: Mauro
authors.initials: M
authors.lastname: Melis
authors.forename: Ida
authors.initials: I
authors.lastname: Fortino
authors.forename: Monia
authors.initials: M
authors.lastname: Donati
authors.forename: Alberto
authors.initials: A
authors.lastname: Vaccheri
authors.forename: Mauro
authors.initials: M
authors.lastname: Venegoni
authors.forename: Domenico
authors.initials: D
authors.lastname: Motola
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced*; D000368:Aged; D000638:Amiodarone / Q000009:adverse effects* / Q000031:analogs & derivatives*; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects; D016208:Databases, Factual; D000077764:Dronedarone; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D016016:Proportional Hazards Models; D012189:Retrospective Studies
chemical_list: D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone