Lancet Neurology: The Safety and Effectiveness of Fluoxetine on The Prognostic Prognostication of Acute Stroke Function (AFFINITY): a randomized, double-blind, placebo-controlled trial

Fluoxetine is a clinically widely used selective 5-HT reuptake inhibitor that selectively inhibits 5-HT transporter, blocks the reuptake of 5-HT by the synapse prefilm, prolongs and increases the effect of 5-HT, thus producing antidepressant effects.
stroke is an acute cerebrovascular disease that causes damage to brain tissue due to a sudden rupture of blood vessels in the brain or the inament of blood vessels that prevent blood from flowing into the brain.
this paper, the AFFINITY trial was designed to assess whether oral fluoroxitine daily for six months after stroke in different ethnic groups improved functional outcomes.
method: AFFINITY is a randomized, parallel group, double-blind, placebo-controlled trial conducted in 43 hospital stroke units in Australia (n=29), New Zealand (n=4) and Viet Nam (n=10).
Eligible patients were adults (age ≥18 years old), clinically diagnosed as acute stroke within the last 2-15 days, brain imaging tests were consistent with isohemic or hemorrhagic strokes, and persistent neurological deficiencies resulted in an improved Rankin scale (mRS) score of 1 or more.
patients were randomly assigned 1:1, oral fluoxetine capsules 20 mg or matching placebos over a period of 6 months.
the allocation of treatment from patients, caregivers, investigators, and outcome evaluaters.
result is the functional status measured by mrsS at 6 months.
analysis is the ordered logical regression of MRS at 6 months, adjusting the minimum variable.
a preliminary and safety analysis based on the patient's treatment allocation.
: Between 11 January 2013 and 30 June 2019, 1,280 patients were recruited in Australia (n=532), New Zealand (n=42) and Viet Nam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to the placebo group.
duration of experimental treatment was 167 days (SD 48.1).
six months, mRS data were obtained in 624 patients (97%) in the fluoxetine group and 632 (99%) in the placebo group.
similar distributions in the fluoxetine group and the placebo group mRS (adjusted common ratio was 0.94, 95% CI 0.76-1.15; p=0.53).
compared to the placebo group, patients in the fluoxetine group had more falls at 6 months (20 s.3 percent) and 7 s.1 percent ;p s.018), fractures (19 s. 3% and 6 s 1% ;p s 0.014), seizures (10 s 2% s) and 2 s slt;1% s ;p s 0.038).
, fluoxitin can improve mood, but has important side effects, especially fractures.
a meta-analysis of planned individual patient data for AFFINITY, FOCUS, and EFFECTS trials will yield greater accuracy in assessing the effects of fluoroxitine on functional outcomes in important patient subgroups, such as patients with mild paraplegia, severe stroke, and cognitive impairment.
Hankey, Graeme J. et al. Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial. The Lancet Neurology, Volume 19, Issue 8, 651 - 660MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that state "Source: Met Medical" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to reproduce, and any media, website or individual must indicate "Source: Mays Medicine" when authorizing their reprint.
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