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Tytuł pozycji:

Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration.

Tytuł:
Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration.
Autorzy:
Hankey GJ; Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Perth, Western Australia, Australia (G.J.H., O.P.A., L.F.).; Department of Neurology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia (G.J.H.).
Hackett ML; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (M.L.H., S.J., T.L., C.S.A.).; The University of Central Lancashire, Preston, England (M.L.H.).
Almeida OP; Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Perth, Western Australia, Australia (G.J.H., O.P.A., L.F.).
Flicker L; Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Perth, Western Australia, Australia (G.J.H., O.P.A., L.F.).; Royal Perth Hospital, Perth, Western Australia, Australia (L.F.).
Mead GE; University of Edinburgh, Royal Infirmary, Scotland (G.E.M., M.S.D.).
Dennis MS; University of Edinburgh, Royal Infirmary, Scotland (G.E.M., M.S.D.).
Etherton-Beer C; The University of Western Australia, Perth, Western Australia, Australia (C.E.-B., A.H.F.).
Ford AH; The University of Western Australia, Perth, Western Australia, Australia (C.E.-B., A.H.F.).
Billot L; Statistics Division, The George Institute for Global Health, Sydney, New South Wales, Australia (L.B.).; Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia (L.B., T.L., C.S.A.).
Jan S; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (M.L.H., S.J., T.L., C.S.A.).
Lung T; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (M.L.H., S.J., T.L., C.S.A.).; Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia (L.B., T.L., C.S.A.).
Lundström E; Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden (E.L.).
Sunnerhagen KS; Institute of Neuroscience and Physiology-Clinical Neuroscience, The Sahlgrenska Academy, University of Gothenburg, Sweden (K.S.S.).
Anderson CS; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (M.L.H., S.J., T.L., C.S.A.).; Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia (L.B., T.L., C.S.A.).; Neurology Department, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (C.S.A.).
Thang-Nguyen H; The George Institute for Global Health at Peking University Health Science Center, Beijing, China (C.S.A.).
Gommans J; Department of Neurology, The People's Hospital 115, Ho Chi Minh city, Vietnam (H.T.-N.).
Yi Q; Hawke's Bay Hospital, Hastings, New Zealand (J.G.).
Corporate Authors:
AFFINITY Trial Collaboration
Źródło:
Stroke [Stroke] 2021 Aug; Vol. 52 (8), pp. 2502-2509. Date of Electronic Publication: 2021 May 21.
Typ publikacji:
Journal Article; Randomized Controlled Trial
Język:
English
Imprint Name(s):
Publication: 1998- : Baltimore, Md. : Lippincott Williams & Wilkins
Original Publication: Dallas : American Heart Association
MeSH Terms:
Cognition*
Quality of Life*
Recovery of Function*
Fluoxetine/*therapeutic use
Selective Serotonin Reuptake Inhibitors/*therapeutic use
Stroke/*drug therapy
Accidental Falls/statistics & numerical data ; Affect ; Aged ; Double-Blind Method ; Fatigue/physiopathology ; Female ; Fractures, Bone/epidemiology ; Hemorrhagic Stroke/drug therapy ; Hemorrhagic Stroke/physiopathology ; Hemorrhagic Stroke/psychology ; Humans ; Ischemic Stroke/drug therapy ; Ischemic Stroke/physiopathology ; Ischemic Stroke/psychology ; Male ; Middle Aged ; Recurrence ; Seizures/epidemiology ; Stroke/physiopathology ; Stroke/psychology
Contributed Indexing:
Investigator: V Murray; R Herbert; G Carter; GA Donnan; HT Nguyen; Q Li; S Bompoint; S Barrett; A Claxton; J O'Dea; M Tang; C Williams; S Peterson; C Drummond; UH Hong; LT My Le; TT Bich Ngo; YB Mai; HT Han; NQ Truong; HT Nguyen; HT Ngo; TB Nguyen; OT Kieu Ha; TL Huyen Nguyen; RI Lindley; P New; A Lee; TT Tran; LT Truc Mai Le; TL Vu Kieu; SV Nguyen; TA Diem Nguyen; TN Dang; HT Truc Phan; LT Ngoc Vo; MH Nguyen; HC Dang; HT Tran; LT Cam Dam; TT Kim Ngo; TN Thanh Pham; BN Pham; NT Thanh Dao; HT Bich Nguyen; LT Cam Le; CM Do; HQ Huynh; GK Tran; OT Le; LT Khanh Tran; CD Duong; DV Kieu; N Le; HN Nguyen; BV Le; LT Nguyen; LV Nguyen; TQ Dinh; TV Vo; TN Bui; UT To Hoang; HT Bich Nguyen; HT Thu Nguyen; NT Lam; KK Le; PT Trinh; HQ Huynh; TT Thu Nguyen; HN Lu; TH Pham; SH Nguyen; NH Le; GT Nguyen; BT Doan; SP Pham; DH Luong; HV Mai; TV Tran; PT Do; HT Le; CV Nguyen; PD Nguyen; TD Mai; PV Dao; DT Nguyen; DQ Khuong; TX Vuong; LT Vu; ND Ngo; HH Dang; PT Truong; NT Le; HV Hoang; CQ Do; MT Nguyen; AH Dam; QN Le; NH Nguyen; TV Nguyen; TD Le; HT Hai Dinh; CV Pham; KT Ngoc Thach; LH Nguyen; LT Nguyen; VC Le; PH Tran; TA Nguyen; TV Le; LV Truong; TC Bui; NX Huynh; LV Dinh; AG Pham; TT Huyen Le; VT Nguyen; YH Nguyen; TB Nguyen; H Thai; QT Ngoc Pham; KD Dao; QN Bao Pham; TT Huyen Dang; HH To Dinh; TM Tong; TT Vu; ST Le; TN Tran; PH Tran; NT Nhu Dinh; BT Nguyen; VP Do; AN Nguyen; BT Thanh Nguyen; BT Nguyen; D Blacker; L Bunce; AL Tan; D Ghia; G Edmonds; N O'Loughlin; M Ewing; KA Whittaker; L Deane; Y Gawarikar; B Jones; M Lopez; K Nagesh; E Siracusa; S Davis; A McDonald; J Tsoleridis; R McCoy; D Jackson; G Silver; TR Bates; A Boudville; L Southwell; D Cordato; AJ McDougall; C Cappelen-Smith; Z Calic; S Askar; Q Cheng; R Kumar; R Geraghty; M Duroux; M Ratcliffe; S Shone; C McLennan; R Sahathevan; C Hair; S Levy; B Macdonald; B Nham; L Rigney; D Nathani; S Gopinath; V Patel; A Mamun; B Trewin; C Phua; H Choong; L Tarrant; K Boyle; L Hewitt; M Hourn; A Masterson; K Oakley; K Ruddell; C Sanctuary; K Veitch; C Burdusel; L Lee; G Cheuk; J Christley; T Hartwell; C Davenport; K Hickey; R Robertson; M Carr; S Akbari; H Coyle; M O'Neill; C Redpath; C Roberts; M Tabesh; T Withiel; K Abeysuriya; A Granger; A Abraham; C Chua; DD Nguyen; V Surendran; M Daines; D Shivlal; M Latif; N Mughal; P Morgan; M Krause; M Priglinger; EE Shandiz; S Day; L Kho; M Pollack; J Dunne; H Baines; M Rees; J White; M Hourn; K Veitch; A Withanage; C Sanctuary; C Delcourt; C Carcel; A Malavera; A Kunchok; E Ray; E Pepper; E Duckett; J White; K Veitch; L Hewitt; M Hourn; K Boyle; S Ormond; C Sanctuary; A Moey; T Kleinig; V Maxwell; C Baldwin; W Vallat; D Field; R Markus; K Page; D Wheelwright; S Bolitho; S Faux; F Sangvatanakul; A Brown; S Walker; J Massey; M Pollack; J White; K Veitch; H Hayes; L Hewitt; M Hourn; C Sanctuary; P Katrak; A Winker; A Zagami; A Bailey; S Mccormack; A Murray; M Rollason; C Taylor; F O'Rourke; YM Kuang; H Burnet; Y Liu; Q Cheng; A Wu; S Akbari; H Coyle; M O'Neill; D Ramirez; T Wijeratne; S Celestino; E Low; C Chen; J Bergqvist; A Evans; Q Leung; M Jude; R McQueen; K Mohr; L Kernaghan; P Stockle; BL Tan; S Laubscher; D Schmid; M Spooner; B Lallu; B Pepperell; J Chalissery; K Mahawish; S DeCaigney; P Broughton; K Knight; V Duque; H McNaughton; J Lanford; V Fu; LK Wong
Keywords: clinical trial; fluoxetine; placebo; recovery of function; stroke
Substance Nomenclature:
0 (Serotonin Uptake Inhibitors)
01K63SUP8D (Fluoxetine)
Entry Date(s):
Date Created: 20210521 Date Completed: 20210809 Latest Revision: 20221207
Update Code:
20240104
DOI:
10.1161/STROKEAHA.120.033070
PMID:
34015940
Czasopismo naukowe
Background and Purpose: The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that 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 seizures. After trial medication was ceased at 6 months, survivors were followed to 12 months post-randomization. This preplanned secondary analysis aimed to determine any sustained or delayed effects of fluoxetine at 12 months post-randomization.
Methods: AFFINITY was a randomized, parallel-group, double-blind, placebo-controlled trial in adults (n=1280) with a clinical diagnosis of stroke in the previous 2 to 15 days and persisting neurological deficit who were recruited at 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10) between 2013 and 2019. Participants were randomized to oral fluoxetine 20 mg once daily (n=642) or matching placebo (n=638) for 6 months and followed until 12 months after randomization. The primary outcome was function, measured by the modified Rankin Scale, at 6 months. Secondary outcomes for these analyses included measures of the modified Rankin Scale, mood, cognition, overall health status, fatigue, health-related quality of life, and safety at 12 months.
Results: Adherence to trial medication was for a mean 167 (SD 48) days and similar between randomized groups. At 12 months, the distribution of modified Rankin Scale categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.93 [95% CI, 0.76-1.14]; P =0.46). Compared with placebo, patients allocated fluoxetine had fewer recurrent ischemic strokes (14 [2.18%] versus 29 [4.55%]; P =0.02), and no longer had significantly more falls (27 [4.21%] versus 15 [2.35%]; P =0.08), bone fractures (23 [3.58%] versus 11 [1.72%]; P =0.05), or seizures (11 [1.71%] versus 8 [1.25%]; P =0.64) at 12 months.
Conclusions: Fluoxetine 20 mg daily for 6 months after acute stroke had no delayed or sustained effect on functional outcome, falls, bone fractures, or seizures at 12 months poststroke. The lower rate of recurrent ischemic stroke in the fluoxetine group is most likely a chance finding. Registration: URL: http://www.anzctr.org.au/; Unique identifier: ACTRN12611000774921.

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