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  • Hankey, Graeme J.Univ Western Australia, Fac Hlth & Med Sci, Med Sch, Room 222,Harry Perkins Inst Med Res QQ Bldg, Perth, WA 6009, Australia.;Sir Charles Gairdner Hosp, Dept Neurol, Perth, WA, Australia. (author)

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

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • Lippincott Williams & Wilkins,2021
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-451559
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-451559URI
  • https://doi.org/10.1161/STROKEAHA.120.033070DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

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  • Hackett, Maree L.Univ New South Wales, George Inst Global Hlth, Fac Med, Sydney, NSW, Australia.;Univ Cent Lancashire, Preston, Lancs, England. (author)
  • Almeida, Osvaldo P.Univ Western Australia, Fac Hlth & Med Sci, Med Sch, Room 222,Harry Perkins Inst Med Res QQ Bldg, Perth, WA 6009, Australia. (author)
  • Flicker, LeonUniv Western Australia, Fac Hlth & Med Sci, Med Sch, Room 222,Harry Perkins Inst Med Res QQ Bldg, Perth, WA 6009, Australia.;Royal Perth Hosp, Perth, WA, Australia. (author)
  • Mead, Gillian E.Univ Edinburgh, Royal Infirm, Edinburgh, Midlothian, Scotland. (author)
  • Dennis, Martin S.Univ Edinburgh, Royal Infirm, Edinburgh, Midlothian, Scotland. (author)
  • Etherton-Beer, ChristopherUniv Western Australia, Perth, WA, Australia. (author)
  • Ford, Andrew H.Univ Western Australia, Perth, WA, Australia. (author)
  • Billot, LaurentGeorge Inst Global Hlth, Stat Div, Sydney, NSW, Australia.;Univ New South Wales, Fac Med, Sydney, NSW, Australia. (author)
  • Jan, StephenUniv New South Wales, George Inst Global Hlth, Fac Med, Sydney, NSW, Australia. (author)
  • Lung, ThomasUniv New South Wales, George Inst Global Hlth, Fac Med, Sydney, NSW, Australia.;Univ New South Wales, Fac Med, Sydney, NSW, Australia. (author)
  • Lundström, Erik,1964-Uppsala universitet,Landtblom: Neurovetenskap(Swepub:uu)erlun676 (author)
  • Sunnerhagen, Katharina S.Univ Gothenburg, Sahlgrenska Acad, Inst Neurosci & Physiol Clin Neurosci, Gothenburg, Sweden. (author)
  • Anderson, Craig S.Univ New South Wales, George Inst Global Hlth, Fac Med, Sydney, NSW, Australia.;Univ New South Wales, Fac Med, Sydney, NSW, Australia.;Royal Prince Alfred Hosp, Neurol Dept, Sydney, NSW, Australia.;Peking Univ, George Inst Global Hlth, Hlth Sci Ctr, Beijing, Peoples R China. (author)
  • Thang-Nguyen, HuyPeoples Hosp 115, Dept Neurol, Ho Chi Minh City, Vietnam. (author)
  • Gommans, JohnHawkes Bay Hosp, Hastings, New Zealand. (author)
  • Yi, QilongCanadian Blood Serv, Toronto, ON, Canada.;Univ Toronto, Toronto, ON, Canada. (author)
  • Univ Western Australia, Fac Hlth & Med Sci, Med Sch, Room 222,Harry Perkins Inst Med Res QQ Bldg, Perth, WA 6009, Australia.;Sir Charles Gairdner Hosp, Dept Neurol, Perth, WA, Australia.Univ New South Wales, George Inst Global Hlth, Fac Med, Sydney, NSW, Australia.;Univ Cent Lancashire, Preston, Lancs, England. (creator_code:org_t)

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  • In:Stroke: Lippincott Williams & Wilkins52:8, s. 2502-25090039-24991524-4628

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