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The Effects Of Fluoxetine On Fracture Risk After Stroke: Further Analyses From The Focus Trial
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience.
University of Edinburgh, Centre for Clinical Brain Sciences, Edinburgh, United Kingdom.
University of Edinburgh, Centre for Clinical Brain Sciences, Edinburgh, United Kingdom.
2019 (English)Conference paper, Poster (with or without abstract) (Other academic)
Abstract [en]

Background and Aims: The FOCUS trial showed that 20mg of fluoxetine daily, for six months, started 2–15 days post stroke had no effect on the modified Rankin scale (mRS), reduced the risk of new depression (Risk difference 3.8%) but increased the risk of bone fractures (Risk difference 1.4%). Further analyses aimed to explore the factors associated with bone fractures.

Methods: Sixty five of the 3127 (2.1%) patients enrolled had a fracture within six months of randomisation. Of these 59 (90.8%) resulted from a fall and 26 (40%) affected the neck of femur. Cox proportional hazards modelling of the risk of fracture showed that only age ≤70yr (Hazard Ratio = 0.51 (95%CI 0.29-0.89; p = 0.017), female sex (HR = 2.13 (1.29-3.51; p = 0.003) and fluoxetine treatment (HR = 2.00 (1.20-3.34; p = 0.008) were independent predictors. Stroke pathology, severity, type of deficit, prior fractures, other medication affecting blood pressure, bone density and balance had no significant effect. Furthermore, removing patients with a fracture from the primary analysis did not significantly alter the effect on mRS (Common odds ratio 0.951 with fractures, 0.961 without).

Results: Only increasing age, female sex and fluoxetine were independent predictors of fracture risk. Most fractures resulted from falls. Although many of the fractures were serious, and are likely to have impaired patients’ function, the increased fracture risk did not explain the lack of observed effect of fluoxetine on mRS.

Conclusions: A future individual patient data meta-analysis including the patients from the ongoing AFFINITY and EFFECTS trials may clarify the mechanism of fractures due to fluoxetine.

Trial registration number: ISRCTN registry, number ISRCTN83290762.

Place, publisher, year, edition, pages
2019. Vol. S1, p. 714-714
Keywords [en]
stroke, fluoxetine, SSRI, fracture
National Category
Neurology
Research subject
Neurology
Identifiers
URN: urn:nbn:se:uu:diva-389566DOI: 10.1177/2396987319845581OAI: oai:DiVA.org:uu-389566DiVA, id: diva2:1337876
Conference
European Stroke Conference ESOC 2019, May 22-24 2019, Milan, italy
Note

FOCUS trial collaboration

Available from: 2019-07-18 Created: 2019-07-18 Last updated: 2019-08-27Bibliographically approved

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Lundström, Erik

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