06 Dec Fluoxetine (Prozac) Did Not Reduce Risk of Depression After Stroke, But Did Raise Risk of Fractures
MedicalResearch.com Interview with:
Prof. Gillian Mead
Chair of Stroke and Elderly Care Medicine
Prof. Martin Dennis
Chair of Stroke Medicine
Centre for Clinical Brain Sciences
The University of Edinburgh
MedicalResearch.com: What is the background for this study?
Response: We are both practicing stroke physicians as well as clinical trialists. Therefore our interest in this area was triggered by the exciting results of the FLAME trial in 2011. This appeared to indicate that fluoxetine might boost the recovery of stroke patients. Potentially this was very important given the increasing numbers of people having disability due to stroke, and the fact that fluoxetine is inexpensive and could be introduced very easily into clinical practice. We were further encouraged by the large numbers of small RCTs we identified when we carried out a Cochrane systematic review on the topic. These trials provided more evidence of potential benefit but there was evidence that trials of greater quality showed less benefit, and benefits were greater in patients who were depressed. We felt there was a need for more evidence derived from much larger numbers of patients.
MedicalResearch.com: What are the main findings?
Response: Our main findings from the FOCUS trial which recruited 3127 patients in UK hospitals were that fluoxetine did not appear to improve functional outcomes after stroke despite the promising data from small trials in the past.
We confirmed the findings of previous small trials that fluoxetine did reduce the risk of post stroke depression, however we demonstrated for the first time we think in an RCT that fluoxetine increased the risk of post stroke fractures.
MedicalResearch.com: What should readers take away from your report?
Response: Focus is the first of a family of three almost identical trials to report. The Affinity trial in Australasia and Vietnam, and Effects in Sweden will provide additional information on the balance of risks and benefits associated with giving fluoxetine to patients with stroke in 2020. In the mean time we will be carrying out further analyses to better understand the effects on fracture risk and to what extent this could have offset other benefits.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: On the basis of these findings we would not recommend that stroke patients should be given fluoxetine to improve their functional outcomes. One could consider using it to reduce the risk of post stroke depression but this would be at the expense of causing some adverse effects, including fractures.
MedicalResearch.com: Is there anything else you would like to add
Response: This trial would not have been possible without the willingness of patients to participate and thousands of healthcare staff working in the Stroke service in the UK NHS
The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336.
The University of Edinburgh is a charitable body, registered in
Scotland, with registration number SC005336.
Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial
FOCUS Trial Collaboration†
Open AccessPublished:December 05, 2018
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