Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Efficacy and safety of dronedarone versus placebo in patients with atrial fibrillation stratified according to renal function : Post hoc analyses of the EURIDIS-ADONIS trials

Thind, Munveer ; Zareba, Wojciech ; Atar, Dan ; Crijns, Harry J.G.M. ; Zhu, Jun ; Pak, Hui Nam ; Reiffel, James ; Ludwigs, Ulf ; Wieloch, Mattias LU and Stewart, John , et al. (2022) In Clinical Cardiology 45(1). p.101-109
Abstract

Background: The use of antiarrhythmic drugs (AADs) in patients with chronic kidney disease (CKD) is complex because impaired renal clearance can cause increased drug levels, and risk of intolerance or adverse events. Due to the propensity for CKD to occur alongside atrial fibrillation/atrial flutter (AF/AFL), it is essential that AAD safety and efficacy are assessed for patients with CKD. Hypothesis: Dronedarone, an approved AAD, may present a suitable therapeutic option for patients with AF/AFL and concomitant CKD. Methods: EURIDIS-ADONIS (EURIDIS, NCT00259428; ADONIS, NCT00259376) were identically designed, multicenter, double-blind, parallel-group trials investigating AF/AFL control with dronedarone 400 mg twice daily versus placebo... (More)

Background: The use of antiarrhythmic drugs (AADs) in patients with chronic kidney disease (CKD) is complex because impaired renal clearance can cause increased drug levels, and risk of intolerance or adverse events. Due to the propensity for CKD to occur alongside atrial fibrillation/atrial flutter (AF/AFL), it is essential that AAD safety and efficacy are assessed for patients with CKD. Hypothesis: Dronedarone, an approved AAD, may present a suitable therapeutic option for patients with AF/AFL and concomitant CKD. Methods: EURIDIS-ADONIS (EURIDIS, NCT00259428; ADONIS, NCT00259376) were identically designed, multicenter, double-blind, parallel-group trials investigating AF/AFL control with dronedarone 400 mg twice daily versus placebo (randomized 2:1). In this post hoc analysis, the primary endpoint was time to first AF/AFL. Patients were stratified according to renal function using the CKD-Epidemiology Collaboration equation and divided into estimated glomerular filtration rate (eGFR) subgroups of 30–44, 45–59, 60–89, and ≥90 ml/min. Time-to-events between treatment groups were compared using log-rank testing and Cox regression. Results: At baseline, most (86%) patients demonstrated a mild or mild-to-moderate eGFR decrease. Median time to first AF/AFL recurrence was significantly longer with dronedarone versus placebo for all eGFR subgroups except the 30 to 44 ml/min group, where the trend was similar but statistical power may have been limited by the small population. eGFR stratification had no significant effect on serious adverse events, deaths, or treatment discontinuations. Conclusions: This analysis suggests that dronedarone could be an effective therapeutic option for AF with an acceptable safety profile in patients with impaired renal function.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Clinical Cardiology
volume
45
issue
1
pages
9 pages
publisher
Wiley-Blackwell
external identifiers
  • pmid:35019175
  • scopus:85122798908
ISSN
0160-9289
DOI
10.1002/clc.23765
language
English
LU publication?
yes
id
aacd8272-e0d2-437f-8708-b93327459ab6
date added to LUP
2022-02-21 16:06:01
date last changed
2024-06-13 11:04:08
@article{aacd8272-e0d2-437f-8708-b93327459ab6,
  abstract     = {{<p>Background: The use of antiarrhythmic drugs (AADs) in patients with chronic kidney disease (CKD) is complex because impaired renal clearance can cause increased drug levels, and risk of intolerance or adverse events. Due to the propensity for CKD to occur alongside atrial fibrillation/atrial flutter (AF/AFL), it is essential that AAD safety and efficacy are assessed for patients with CKD. Hypothesis: Dronedarone, an approved AAD, may present a suitable therapeutic option for patients with AF/AFL and concomitant CKD. Methods: EURIDIS-ADONIS (EURIDIS, NCT00259428; ADONIS, NCT00259376) were identically designed, multicenter, double-blind, parallel-group trials investigating AF/AFL control with dronedarone 400 mg twice daily versus placebo (randomized 2:1). In this post hoc analysis, the primary endpoint was time to first AF/AFL. Patients were stratified according to renal function using the CKD-Epidemiology Collaboration equation and divided into estimated glomerular filtration rate (eGFR) subgroups of 30–44, 45–59, 60–89, and ≥90 ml/min. Time-to-events between treatment groups were compared using log-rank testing and Cox regression. Results: At baseline, most (86%) patients demonstrated a mild or mild-to-moderate eGFR decrease. Median time to first AF/AFL recurrence was significantly longer with dronedarone versus placebo for all eGFR subgroups except the 30 to 44 ml/min group, where the trend was similar but statistical power may have been limited by the small population. eGFR stratification had no significant effect on serious adverse events, deaths, or treatment discontinuations. Conclusions: This analysis suggests that dronedarone could be an effective therapeutic option for AF with an acceptable safety profile in patients with impaired renal function.</p>}},
  author       = {{Thind, Munveer and Zareba, Wojciech and Atar, Dan and Crijns, Harry J.G.M. and Zhu, Jun and Pak, Hui Nam and Reiffel, James and Ludwigs, Ulf and Wieloch, Mattias and Stewart, John and Kowey, Peter}},
  issn         = {{0160-9289}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{101--109}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Clinical Cardiology}},
  title        = {{Efficacy and safety of dronedarone versus placebo in patients with atrial fibrillation stratified according to renal function : Post hoc analyses of the EURIDIS-ADONIS trials}},
  url          = {{http://dx.doi.org/10.1002/clc.23765}},
  doi          = {{10.1002/clc.23765}},
  volume       = {{45}},
  year         = {{2022}},
}