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Effect of Dronedarone in the Treatment of Atrial Fibrillation in the Asian Population : Post Hoc Analysis of the ATHENA Trial

Ma, Changsheng ; Lin, Jiunn Lee ; Bai, Rong ; Sun, Yihong ; Nam, Gi Byoung ; Stewart, John ; Wieloch, Mattias LU and Zhu, Jun (2022) In Clinical Therapeutics 44(9). p.1203-1213
Abstract

Purpose: Limited data are available on the impact of dronedarone treatment in Asian patients with atrial fibrillation (AF) or atrial flutter (AFL). This post hoc analysis evaluated the efficacy and safety of dronedarone compared with placebo in populations from Asian and non-Asian regions randomized in the ATHENA trial (A Placebo-Controlled, Double-blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg BID for the Prevention of CV Hospitalization or Death From Any Cause in Patients With AF/AFL). Methods: Time to first hospitalization for cardiovascular events or death from any cause (primary outcome) and time to first AF/AFL event recurrence (secondary outcome) were analyzed by Kaplan-Meier curves and Cox proportional... (More)

Purpose: Limited data are available on the impact of dronedarone treatment in Asian patients with atrial fibrillation (AF) or atrial flutter (AFL). This post hoc analysis evaluated the efficacy and safety of dronedarone compared with placebo in populations from Asian and non-Asian regions randomized in the ATHENA trial (A Placebo-Controlled, Double-blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg BID for the Prevention of CV Hospitalization or Death From Any Cause in Patients With AF/AFL). Methods: Time to first hospitalization for cardiovascular events or death from any cause (primary outcome) and time to first AF/AFL event recurrence (secondary outcome) were analyzed by Kaplan-Meier curves and Cox proportional hazards regression. Findings: The risk of experiencing the primary composite outcome was significantly lower in the dronedarone-treated patients in both the Asian (hazard ratio = 0.541; 95% CI, 0.320–0.914]) and non-Asian (hazard ratio = 0.768; 95% CI, 0.696–0.848) populations than in the placebo-treated patients. The median time to the first AF/AFL event recurrence was longer in the dronedarone-treated population than in the placebo-treated populations: 183 vs 92 days (P = 0.165) in the Asian population and 534 vs 196 days (P < 0.001) in the non-Asian population. Treatment-emergent adverse events in Asian (81.2% vs 78.4%) and non-Asian (71.4% vs 68.7%) populations and serious treatment-emergent adverse events in Asian (14.3% vs 15.7%) and non-Asian (20.3% vs 21.5%) patients were comparable in patients taking dronedarone compared with those taking placebo. Implication: Efficacy and tolerability of dronedarone were consistent in the Asian population compared with the non-Asian population in the ATHENA trial. These finding may aid Asian health care professionals to select the appropriate first-line treatment for Asian patients with AF/AFL.

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author
; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Anti-arrhythmic drug, Asia, atrial fibrillation, cardiovascular disease, dronedarone
in
Clinical Therapeutics
volume
44
issue
9
pages
1203 - 1213
publisher
Excerpta Medica
external identifiers
  • pmid:35927094
  • scopus:85135353695
ISSN
0149-2918
DOI
10.1016/j.clinthera.2022.07.005
language
English
LU publication?
yes
id
91d81d80-849a-42eb-bbcf-d243735c8b54
date added to LUP
2022-10-07 14:10:32
date last changed
2024-05-30 19:08:55
@article{91d81d80-849a-42eb-bbcf-d243735c8b54,
  abstract     = {{<p>Purpose: Limited data are available on the impact of dronedarone treatment in Asian patients with atrial fibrillation (AF) or atrial flutter (AFL). This post hoc analysis evaluated the efficacy and safety of dronedarone compared with placebo in populations from Asian and non-Asian regions randomized in the ATHENA trial (A Placebo-Controlled, Double-blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg BID for the Prevention of CV Hospitalization or Death From Any Cause in Patients With AF/AFL). Methods: Time to first hospitalization for cardiovascular events or death from any cause (primary outcome) and time to first AF/AFL event recurrence (secondary outcome) were analyzed by Kaplan-Meier curves and Cox proportional hazards regression. Findings: The risk of experiencing the primary composite outcome was significantly lower in the dronedarone-treated patients in both the Asian (hazard ratio = 0.541; 95% CI, 0.320–0.914]) and non-Asian (hazard ratio = 0.768; 95% CI, 0.696–0.848) populations than in the placebo-treated patients. The median time to the first AF/AFL event recurrence was longer in the dronedarone-treated population than in the placebo-treated populations: 183 vs 92 days (P = 0.165) in the Asian population and 534 vs 196 days (P &lt; 0.001) in the non-Asian population. Treatment-emergent adverse events in Asian (81.2% vs 78.4%) and non-Asian (71.4% vs 68.7%) populations and serious treatment-emergent adverse events in Asian (14.3% vs 15.7%) and non-Asian (20.3% vs 21.5%) patients were comparable in patients taking dronedarone compared with those taking placebo. Implication: Efficacy and tolerability of dronedarone were consistent in the Asian population compared with the non-Asian population in the ATHENA trial. These finding may aid Asian health care professionals to select the appropriate first-line treatment for Asian patients with AF/AFL.</p>}},
  author       = {{Ma, Changsheng and Lin, Jiunn Lee and Bai, Rong and Sun, Yihong and Nam, Gi Byoung and Stewart, John and Wieloch, Mattias and Zhu, Jun}},
  issn         = {{0149-2918}},
  keywords     = {{Anti-arrhythmic drug; Asia; atrial fibrillation; cardiovascular disease; dronedarone}},
  language     = {{eng}},
  number       = {{9}},
  pages        = {{1203--1213}},
  publisher    = {{Excerpta Medica}},
  series       = {{Clinical Therapeutics}},
  title        = {{Effect of Dronedarone in the Treatment of Atrial Fibrillation in the Asian Population : Post Hoc Analysis of the ATHENA Trial}},
  url          = {{http://dx.doi.org/10.1016/j.clinthera.2022.07.005}},
  doi          = {{10.1016/j.clinthera.2022.07.005}},
  volume       = {{44}},
  year         = {{2022}},
}