دورية أكاديمية
Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial
| العنوان: | Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial |
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| المؤلفون: | Hankey, GJ, Hackett, ML, Almeida, OP, Flicker, L, Mead, GE, Dennis, MS, Etherton-Beer, C, Ford, AH, Billot, L, Jan, S, Lung, T, Murray, V, Lundström, E, Anderson, CS, Herbert, R, Carter, G, Donnan, GA, Nguyen, HT, Gommans, J, Yi, Q, Li, Q, Bompoint, S, Barrett, S, Claxton, A, O'Dea, J, Tang, M, Williams, C, Peterson, S, Drummond, C, Hong, UH, Le, LTM, Ngo, TTB, Mai, YB, Han, HT, Truong, NQ, Ngo, HT, Nguyen, TB, Ha, OTK, Nguyen, TLH, Lindley, RI, New, P, Lee, A, Tran, TT, Le, LTTM, Kieu, TLV, Nguyen, SV, Nguyen, TAD, Dang, TN, Phan, HTT, Vo, LTN, Nguyen, MH, Dang, HC, Tran, HT, Dam, LTC, Ngo, TTK, Pham, TNT, Pham, BN, Dao, NTT, Nguyen, HTB, Le, LTC, Do, CM, Huynh, HQ, Tran, GTK, Le, OT, Tran, LTK, Duong, CD, Kieu, DV, Le, N, Nguyen, HN, Le, BV, Nguyen, LT, Nguyen, LV, Dinh, TQ, Vo, TV, Bui, TN, Hoang, UTT, Nguyen, HTT, Lam, NT, Le, KK, Trinh, PT, Nguyen, TTT, Lu, HN, Pham, TH, Nguyen, SH, Le, NH, Nguyen, GT, Doan, BT, Pham, SP, Luong, DH, Mai, HV, Tran, TV, Do, PT, Le, HT, Nguyen, CV, Nguyen, PD, Mai, TD, Dao, PV, Markus, Romesh, Calic, Zeljka, Katrak, Pesho, Faux, Steven, Delcourt, Candice, Carcel, Cheryl, McDougall, Alan, ORourke, Fintan, Cordato, Dennis, Jude, Martin, Zagami, Alessandro, Massey, Jennifer |
| المصدر: | urn:ISSN:1474-4422 ; urn:ISSN:1474-4465 ; The Lancet Neurology, 19, 8, 651-660 |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2020 |
| المجموعة: | UNSW Sydney (The University of New South Wales): UNSWorks |
| مصطلحات موضوعية: | Stroke, Clinical Trials and Supportive Activities, Neurosciences, Biomedical Imaging, Clinical Research, Brain Disorders, 6.1 Pharmaceuticals, 6 Evaluation of treatments and therapeutic interventions, Adult, Aged, Double-Blind Method, Female, Fluoxetine, Follow-Up Studies, Humans, Male, Middle Aged, Recovery of Function, Selective Serotonin Reuptake Inhibitors, Treatment Outcome, AFFINITY Trial Collaboration, anzsrc-for: 1103 Clinical Sciences, anzsrc-for: 1109 Neurosciences |
| الوصف: | 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| اللغة: | unknown |
| العلاقة: | http://hdl.handle.net/1959.4/unsworks_77833Test; https://unsworks.unsw.edu.au/bitstreams/2feb5324-8f14-4674-86e5-c69e054bf651/downloadTest; https://doi.org/10.1016/S1474-4422Test(20)30207-6 |
| DOI: | 10.1016/S1474-4422(20)30207-6 |
| الإتاحة: | https://doi.org/10.1016/S1474-4422Test(20)30207-6 http://hdl.handle.net/1959.4/unsworks_77833Test https://unsworks.unsw.edu.au/bitstreams/2feb5324-8f14-4674-86e5-c69e054bf651/downloadTest |
| حقوق: | open access ; https://purl.org/coar/access_right/c_abf2Test ; CC-BY-NC-ND ; https://creativecommons.org/licenses/by-nc-nd/4.0Test/ ; free_to_read |
| رقم الانضمام: | edsbas.5548D874 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S1474-4422(20)30207-6 |
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