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Effects of Fluoxetine on Outcomes at 12 Months after Acute Stroke : Results from EFFECTS, a Randomized Controlled Trial

Lundström, Erik ; Isaksson, Eva ; Greilert Norin, Nina ; Näsman, Per ; Wester, Per ; Mårtensson, Björn ; Norrving, Bo LU ; Wallén, Håkan ; Borg, Jörgen and Hankey, Graeme J. , et al. (2021) In Stroke 52(10). p.3082-3087
Abstract

Background and Purpose: The EFFECTS (Efficacy of Fluoxetine - a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months. The purpose of this predefined secondary analysis was to identify if any effects of fluoxetine were maintained or delayed over 12 months. Methods: EFFECTS was an investigator-led, randomized, placebo-controlled, double-blind, parallel group trial in Sweden that enrolled adult patients with stroke. Patients were randomized to 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months. The primary outcome was... (More)

Background and Purpose: The EFFECTS (Efficacy of Fluoxetine - a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months. The purpose of this predefined secondary analysis was to identify if any effects of fluoxetine were maintained or delayed over 12 months. Methods: EFFECTS was an investigator-led, randomized, placebo-controlled, double-blind, parallel group trial in Sweden that enrolled adult patients with stroke. Patients were randomized to 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months. The primary outcome was functional outcome (modified Rankin Scale), at 6 months. Predefined secondary outcomes for these analyses included the modified Rankin Scale, health status, quality of life, fatigue, mood, and depression at 12 months. Results: One thousand five hundred patients were recruited from 35 centers in Sweden between 2014 and 2019; 750 were allocated fluoxetine and 750 placebo. At 12 months, modified Rankin Scale data were available in 715 (95%) patients allocated fluoxetine and 712 (95%) placebo. The distribution of modified Rankin Scale categories was similar in the 2 groups (adjusted common odds ratio, 0.92 [95% CI, 0.76-1.10]). Patients allocated fluoxetine scored worse on memory with a median value of 89 (interquartile range, 75-100) versus 93 (interquartile range, 82-100); P=0.0021 and communication 93 (interquartile range, 82-100) versus 96 (interquartile range, 86-100); P=0.024 domains of the Stroke Impact Scale compared with placebo. There were no other differences in secondary outcomes. Conclusions: Fluoxetine after acute stroke had no effect on functional outcome at 12 months. Patients allocated fluoxetine scored worse on memory and communication on the Stroke Impact Scale compared with placebo, but this is likely to be due to chance. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02683213.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
antidepressive agents, disability studies, fluoxetine, functional status, randomized controlled trial, serotonin uptake inhibitors, stroke
in
Stroke
volume
52
issue
10
pages
3082 - 3087
publisher
American Heart Association
external identifiers
  • scopus:85116511716
  • pmid:34465201
ISSN
0039-2499
DOI
10.1161/STROKEAHA.121.034705
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2021 Lippincott Williams and Wilkins. All rights reserved.
id
f0757105-be83-4542-9fdf-1c8a1b2527e7
date added to LUP
2021-10-25 13:59:02
date last changed
2022-10-02 19:25:50
@article{f0757105-be83-4542-9fdf-1c8a1b2527e7,
  abstract     = {{<p>Background and Purpose: The EFFECTS (Efficacy of Fluoxetine - a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months. The purpose of this predefined secondary analysis was to identify if any effects of fluoxetine were maintained or delayed over 12 months. Methods: EFFECTS was an investigator-led, randomized, placebo-controlled, double-blind, parallel group trial in Sweden that enrolled adult patients with stroke. Patients were randomized to 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months. The primary outcome was functional outcome (modified Rankin Scale), at 6 months. Predefined secondary outcomes for these analyses included the modified Rankin Scale, health status, quality of life, fatigue, mood, and depression at 12 months. Results: One thousand five hundred patients were recruited from 35 centers in Sweden between 2014 and 2019; 750 were allocated fluoxetine and 750 placebo. At 12 months, modified Rankin Scale data were available in 715 (95%) patients allocated fluoxetine and 712 (95%) placebo. The distribution of modified Rankin Scale categories was similar in the 2 groups (adjusted common odds ratio, 0.92 [95% CI, 0.76-1.10]). Patients allocated fluoxetine scored worse on memory with a median value of 89 (interquartile range, 75-100) versus 93 (interquartile range, 82-100); P=0.0021 and communication 93 (interquartile range, 82-100) versus 96 (interquartile range, 86-100); P=0.024 domains of the Stroke Impact Scale compared with placebo. There were no other differences in secondary outcomes. Conclusions: Fluoxetine after acute stroke had no effect on functional outcome at 12 months. Patients allocated fluoxetine scored worse on memory and communication on the Stroke Impact Scale compared with placebo, but this is likely to be due to chance. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02683213.</p>}},
  author       = {{Lundström, Erik and Isaksson, Eva and Greilert Norin, Nina and Näsman, Per and Wester, Per and Mårtensson, Björn and Norrving, Bo and Wallén, Håkan and Borg, Jörgen and Hankey, Graeme J. and Hackett, Maree L. and Mead, Gillian E. and Dennis, Martin S. and Sunnerhagen, Katharina S.}},
  issn         = {{0039-2499}},
  keywords     = {{antidepressive agents; disability studies; fluoxetine; functional status; randomized controlled trial; serotonin uptake inhibitors; stroke}},
  language     = {{eng}},
  number       = {{10}},
  pages        = {{3082--3087}},
  publisher    = {{American Heart Association}},
  series       = {{Stroke}},
  title        = {{Effects of Fluoxetine on Outcomes at 12 Months after Acute Stroke : Results from EFFECTS, a Randomized Controlled Trial}},
  url          = {{http://dx.doi.org/10.1161/STROKEAHA.121.034705}},
  doi          = {{10.1161/STROKEAHA.121.034705}},
  volume       = {{52}},
  year         = {{2021}},
}