PMID- 33730412
OWN - NLM
STAT- MEDLINE
DCOM- 20211222
LR  - 20211222
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 30
IP  - 10
DP  - 2021 Oct
TI  - Risk of interstitial lung disease in patients treated for atrial fibrillation 
      with dronedarone versus other antiarrhythmics.
PG  - 1353-1359
LID - 10.1002/pds.5233 [doi]
AB  - PURPOSE: To compare risks of interstitial lung disease (ILD) between patients 
      treated with dronedarone versus other antiarrhythmics. METHODS: Parallel 
      retrospective cohort studies were conducted in the United States Department of 
      Defense Military Health System database (DoD) and the HealthCore Integrated 
      Research Database (HIRD). Study patients were treated for atrial fibrillation 
      (AF) with dronedarone, amiodarone, sotalol, or flecainide. Propensity score 
      matching was employed to create analysis cohorts balanced on baseline variables 
      considered potential confounders of treatment decisions. The study period of July 
      20, 2008 through September 30, 2014 included a 1-year baseline and minimum 6 
      months of follow-up, for patients with drugs dispensed between July 20, 2009 and 
      March 31, 2014. Suspect ILD outcomes were reviewed by independent adjudicators. 
      Cox proportional hazards regression compared risk of confirmed ILD between 
      dronedarone and each comparator cohort. A sensitivity analysis examined the 
      effect of broadening the outcome definition. RESULTS: A total 72 ILD cases (52 
      DoD; 20 HIRD) were confirmed among 27 892 patients. ILD risk was significantly 
      higher among amiodarone than dronedarone initiators in DoD (HR = 2.5; 95% 
      CI = 1.1-5.3, p = 0.02). No difference was detected in HIRD (HR = 1.0; 95% 
      CI = 0.4-2.4). Corresponding risks in sotalol and flecainide exposure groups did 
      not differ significantly from dronedarone in either database. CONCLUSIONS: ILD 
      risk among AF patients initiated on dronedarone therapy was comparable to or 
      lower than that of amiodarone initiators, and similar to that of new sotalol or 
      flecainide users. This finding suggests that elevated ILD risk associated with 
      amiodarone does not necessarily extend to dronedarone or other antiarrhythmic 
      drugs.
CI  - (c) 2021 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley 
      & Sons Ltd.
FAU - Tave, Arlene
AU  - Tave A
AUID- ORCID: 0000-0001-8379-3816
AD  - PharmaLex US Corp, Fairfax, Virginia, USA.
FAU - Goehring, Earl
AU  - Goehring E
AD  - PharmaLex US Corp, Fairfax, Virginia, USA.
FAU - Desai, Vibha
AU  - Desai V
AD  - HealthCore, Andover, Massachusetts, USA.
FAU - Wu, Chuntao
AU  - Wu C
AD  - Sanofi Pharmaceuticals, Inc., Bridgewater, New Jersey, USA.
FAU - Bohn, Rhonda L
AU  - Bohn RL
AD  - Bohn Epidemiology, Boston, Massachusetts, USA.
FAU - Tamayo, Sally G
AU  - Tamayo SG
AD  - Naval Medical Center, Portsmouth, Virginia, USA.
FAU - Sicignano, Nicholas
AU  - Sicignano N
AD  - Health ResearchTx, Trevose, Pennsylvania, USA.
FAU - Juhaeri, Juhaeri
AU  - Juhaeri J
AD  - Sanofi Pharmaceuticals, Inc., Bridgewater, New Jersey, USA.
FAU - Jones, Judith K
AU  - Jones JK
AD  - PharmaLex US Corp, Fairfax, Virginia, USA.
FAU - Weiss, Sheila R
AU  - Weiss SR
AD  - Avigilan, LLC, Potomac, Maryland, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210504
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Anti-Arrhythmia Agents)
RN  - JQZ1L091Y2 (Dronedarone)
SB  - IM
MH  - Anti-Arrhythmia Agents/adverse effects
MH  - *Atrial Fibrillation/drug therapy/epidemiology
MH  - Dronedarone
MH  - Humans
MH  - *Lung Diseases, Interstitial/chemically induced/epidemiology
MH  - Retrospective Studies
MH  - United States/epidemiology
PMC - PMC8453764
OTO - NOTNLM
OT  - amiodarone
OT  - antiarrhythmia agents
OT  - atrial fibrillation
OT  - dronedarone
OT  - interstitial
OT  - lung diseases
COIS- Ms. Tave, Mr. Goehring, Dr. Desai, Dr. Bohn, Dr. Jones and Dr. Weiss declare that 
      they have no conflicts of interest. Dr. Wu was employed by Sanofi at the time of 
      conducting this study. Dr. Juhaeri is a Sanofi employee. Dr. Tamayo is a retired 
      member of the US military; this work was prepared as part of her official duties. 
      Mr. Sicignano is an employee of Health ResearchTx.
EDAT- 2021/03/18 06:00
MHDA- 2021/12/24 06:00
PMCR- 2021/09/21
CRDT- 2021/03/17 17:53
PHST- 2021/03/13 00:00 [revised]
PHST- 2020/06/10 00:00 [received]
PHST- 2021/03/15 00:00 [accepted]
PHST- 2021/03/18 06:00 [pubmed]
PHST- 2021/12/24 06:00 [medline]
PHST- 2021/03/17 17:53 [entrez]
PHST- 2021/09/21 00:00 [pmc-release]
AID - PDS5233 [pii]
AID - 10.1002/pds.5233 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1353-1359. doi: 10.1002/pds.5233. 
      Epub 2021 May 4.