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Impact of dronedarone on patients with atrial fibrillation and diabetes : A sub-analysis of the ATHENA and EURIDIS/ADONIS studies

Handelsman, Yehuda ; Bunch, T. Jared ; Rodbard, Helena W. ; Steinberg, Benjamin A. ; Thind, Munveer ; Bigot, Gregory ; Konigsberg, Lana ; Wieloch, Mattias LU and Kowey, Peter R. (2022) In Journal of Diabetes and its Complications 36(7).
Abstract

Aim: This post hoc analysis evaluated efficacy and safety of dronedarone in atrial fibrillation (AF) and atrial flutter (AFL) patients with/without diabetes. Methods: Patients were categorized according to baseline diabetes status. Time-to-event analyses were performed using Kaplan-Meier method. Hazard-ratios were assessed using Cox models. Results: 945/4628 (dronedarone = 482; placebo = 463) patients in ATHENA and 215/1237 (dronedarone = 148; placebo = 67) patients in EURIDIS/ADONIS studies had diabetes. In ATHENA, there were higher rates of CV hospitalization/death in patients with diabetes (39.5%) than without diabetes (34.7%). Incidence of first CV hospitalization/death was lower in patients with diabetes treated with dronedarone... (More)

Aim: This post hoc analysis evaluated efficacy and safety of dronedarone in atrial fibrillation (AF) and atrial flutter (AFL) patients with/without diabetes. Methods: Patients were categorized according to baseline diabetes status. Time-to-event analyses were performed using Kaplan-Meier method. Hazard-ratios were assessed using Cox models. Results: 945/4628 (dronedarone = 482; placebo = 463) patients in ATHENA and 215/1237 (dronedarone = 148; placebo = 67) patients in EURIDIS/ADONIS studies had diabetes. In ATHENA, there were higher rates of CV hospitalization/death in patients with diabetes (39.5%) than without diabetes (34.7%). Incidence of first CV hospitalization/death was lower in patients with diabetes treated with dronedarone (35.1%) than placebo (44.1%), and time to this event was longer in those treated with dronedarone than placebo (log-rank p = 0.005). Median AF/AFL recurrence time was longer in patients treated with dronedarone than placebo in patients with diabetes (ATHENA: 722 vs 527 days, log-rank p = 0.004; EURIDIS/ADONIS: 100 vs 23 days, log-rank p = 0.15) or without diabetes (ATHENA: 741 vs 492 days, log-rank p < 0.0001; EURIDIS/ADONIS: 120 vs 59 days, log-rank p = 0.0002). Occurrence of any treatment-related adverse events with dronedarone was similar for patients with/without diabetes and was comparable to placebo. Conclusions: Dronedarone reduced incidence of CV hospitalization/death, AF/AFL recurrence and increased time to these events in AF/AFL patients with/without diabetes. Trial registration: Not applicable, as it was a post hoc analysis. This article is based on previously conducted studies (ATHENA: NCT00174785, EURIDIS: NCT00259428, and ADONIS: NCT00259376).

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author
; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Anti-arrhythmic drug, Atrial fibrillation, Atrial flutter, Cardiovascular disease, Diabetes, Dronedarone
in
Journal of Diabetes and its Complications
volume
36
issue
7
article number
108227
publisher
Elsevier
external identifiers
  • pmid:35717354
  • scopus:85132750010
ISSN
1056-8727
DOI
10.1016/j.jdiacomp.2022.108227
language
English
LU publication?
yes
id
b535c37a-7a5e-4385-9191-a979b01fb6a4
date added to LUP
2022-09-26 15:24:15
date last changed
2024-04-18 09:43:20
@article{b535c37a-7a5e-4385-9191-a979b01fb6a4,
  abstract     = {{<p>Aim: This post hoc analysis evaluated efficacy and safety of dronedarone in atrial fibrillation (AF) and atrial flutter (AFL) patients with/without diabetes. Methods: Patients were categorized according to baseline diabetes status. Time-to-event analyses were performed using Kaplan-Meier method. Hazard-ratios were assessed using Cox models. Results: 945/4628 (dronedarone = 482; placebo = 463) patients in ATHENA and 215/1237 (dronedarone = 148; placebo = 67) patients in EURIDIS/ADONIS studies had diabetes. In ATHENA, there were higher rates of CV hospitalization/death in patients with diabetes (39.5%) than without diabetes (34.7%). Incidence of first CV hospitalization/death was lower in patients with diabetes treated with dronedarone (35.1%) than placebo (44.1%), and time to this event was longer in those treated with dronedarone than placebo (log-rank p = 0.005). Median AF/AFL recurrence time was longer in patients treated with dronedarone than placebo in patients with diabetes (ATHENA: 722 vs 527 days, log-rank p = 0.004; EURIDIS/ADONIS: 100 vs 23 days, log-rank p = 0.15) or without diabetes (ATHENA: 741 vs 492 days, log-rank p &lt; 0.0001; EURIDIS/ADONIS: 120 vs 59 days, log-rank p = 0.0002). Occurrence of any treatment-related adverse events with dronedarone was similar for patients with/without diabetes and was comparable to placebo. Conclusions: Dronedarone reduced incidence of CV hospitalization/death, AF/AFL recurrence and increased time to these events in AF/AFL patients with/without diabetes. Trial registration: Not applicable, as it was a post hoc analysis. This article is based on previously conducted studies (ATHENA: NCT00174785, EURIDIS: NCT00259428, and ADONIS: NCT00259376).</p>}},
  author       = {{Handelsman, Yehuda and Bunch, T. Jared and Rodbard, Helena W. and Steinberg, Benjamin A. and Thind, Munveer and Bigot, Gregory and Konigsberg, Lana and Wieloch, Mattias and Kowey, Peter R.}},
  issn         = {{1056-8727}},
  keywords     = {{Anti-arrhythmic drug; Atrial fibrillation; Atrial flutter; Cardiovascular disease; Diabetes; Dronedarone}},
  language     = {{eng}},
  number       = {{7}},
  publisher    = {{Elsevier}},
  series       = {{Journal of Diabetes and its Complications}},
  title        = {{Impact of dronedarone on patients with atrial fibrillation and diabetes : A sub-analysis of the ATHENA and EURIDIS/ADONIS studies}},
  url          = {{http://dx.doi.org/10.1016/j.jdiacomp.2022.108227}},
  doi          = {{10.1016/j.jdiacomp.2022.108227}},
  volume       = {{36}},
  year         = {{2022}},
}