13 research outputs found
Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial
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 â„18 years) with a clinical diagnosis of acute stroke in the previous 2â15 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 0·76â1·15; 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
Replication Data and Supplemental Materials for: Alexander B. Downes and Lindsey A. O'Rourke, "You Can't Always Get What You Want: Why Foreign-Imposed Regime Change Seldom Improves Interstate Relations," International Security, Vol. 41, No. 2 (Fall 2016), pp. 43â89.
This file includes the data necessary to replicate the statistical results and most of the robustness tests in Alexander B. Downes and Lindsey A. O'Rourke, "You Can't Always Get What You Want: Why Foreign-Imposed Regime Change Seldom Improves Interstate Relations," International Security, Vol. 41, No. 2 (Fall 2016), pp. 43â89
Adipose tissue fibrosis, hypertrophy, and hyperplasia: Correlations with diabetes in human obesity
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/117485/1/oby21377_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/117485/2/oby21377.pd