Building on earlier studies that showed initial promise for beneficial effects of the use of the antidepressant fluoxetine on functional outcomes following a stroke, researchers in Sweden embarked on a more robust exploration of the medication’s potential benefits. In an article published July 2020 in The Lancet Neurology, researchers were disappointed to learn that the drug seems to confer no such benefit after all.
Principal Investigator of the study, Dr. Erik Lundström, affiliated with the Karolinska Institute and researcher at the Department of Clinical Neuroscience, and his team used previous results of small trials that showed initial improvement in functional outcomes in patients who experienced a stroke and who used fluoxetine. Although previous studies demonstrated potential, the results were insufficiently compelling to generate an update to guidelines. The researchers conducted the FOCUS (fluoxetine on functional outcomes after acute stroke) study, which was designed to better understand these effects, and they identified the primary outcome to be the patient’s functional status based on the modified Rankin Scale.
The FOCUS trial was a double-blind, randomized, placebo-controlled multicenter trial of 103 hospitals in the UK. The inclusion criteria required a diagnosis of clinical stroke diagnosis with neurological deficits and enrollment to the study within a range of 2 days poststroke up to the maximum of 15 days after onset and a patient of age 18 years or older. One cohort of 1,564 patients received fluoxetine 20 mg while the remaining 1,563 received placebo for 6 months. Healthcare providers, caregivers, and patients were unaware of the treatment each person was randomized to receive.
The researchers reported that the subjects who received fluoxetine were less likely to develop depression than those who received placebo during that 6-month period. The authors found no significant differences in any other event at 6 or 12 months and concluded that fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. They noted that while there was a decreased incidence of depression, the increase risk of bone fracture does not support routine use of fluoxetine to improve function or to prevent depression in patients who experience a stroke.
According to Dr. Lundström, “Our study shows that fluoxetine does not improve recovery after stroke.” He added, “The number of depressions did indeed decrease, but the risk of bone fractures increased. My advice is to refrain from using fluoxetine as a preventative treatment following stroke.”
The authors note that further studies are needed to confirm whether these findings could be generalizable to various other populations and recommend that a “planned individual patient data meta-analysis” be conducted to provide more precise estimates of all harms and whether there may be subgroups that may still derive benefit from the use of poststroke fluoxetine administration.
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