Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/131907
Citations | ||
Scopus | Web of Science® | Altmetric |
---|---|---|
?
|
?
|
Type: | Journal article |
Title: | Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial |
Author: | Hankey, G.J. Hackett, M.L. Almeida, O.P. Flicker, L. Mead, G.E. Dennis, M.S. Etherton-Beer, C. Ford, A.H. Billot, L. Jan, S. Lung, T. Murray, V. Lundström, E. Anderson, C.S. Herbert, R. Carter, G. Donnan, G.A. Nguyen, H.T. Gommans, J. Yi, Q. et al. |
Citation: | Lancet Neurology, 2020; 19(8):651-660 |
Publisher: | Elsevier |
Issue Date: | 2020 |
ISSN: | 1474-4422 1474-4465 |
Statement of Responsibility: | Graeme J.Hankey, Maree L.Hackett, Osvaldo P.AlmeidaLeon, FlickerGillian E.Mead Martin S.Dennis |
Abstract: | Background Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population. Methods AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2–15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921. Findings Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76–1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [<1%]; p=0·038) at 6 months. Interpretation Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke. Funding National Health and Medical Research Council of Australia. |
Keywords: | AFFINITY Trial Collaboration Humans Fluoxetine Treatment Outcome Follow-Up Studies Double-Blind Method Recovery of Function Adult Aged Middle Aged Female Male Stroke Selective Serotonin Reuptake Inhibitors |
Rights: | © 2020 Elsevier Ltd. All rights reserved. |
DOI: | 10.1016/S1474-4422(20)30207-6 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1059094 |
Published version: | http://dx.doi.org/10.1016/s1474-4422(20)30207-6 |
Appears in Collections: | Aurora harvest 8 Medicine publications |
Files in This Item:
There are no files associated with this item.
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.