Poststroke fluoxetine exerts null effect on functional outcome

Use of fluoxetine following stroke confers no benefit for functional outcome after 1 year and may potentially affect memory and communication, according to a secondary analysis of the EFFECTS* study.

EFFECTS included 1,500 stroke survivors (mean age 71 years, 38.3 percent women) who had been randomized to receive 20 mg oral fluoxetine (n=750) or matching placebo (n=750) for 6 months and followed for another 6 months. The current analysis was performed to identify if any effects of fluoxetine were maintained or delayed over 12 months.

Modified Rankin Scale (mRS) data were available for 95 percent of the overall population. There were 4.1 percent of participants who were lost to follow-up, and 4.5 percent died within 12 months.

The distribution of mRS categories, the primary study outcome, was similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.92, 95 percent confidence interval, 0.76–1.10).

In terms of secondary outcomes, patients who received fluoxetine vs placebo had poorer scores on some domains of the Stroke Impact Scale, namely memory (median, 89 [interquartile range, 75–100] vs 93 [interquartile range, 82–100]; p=0.0021) and communication (median, 93 [interquartile range, 82–100] vs 96 [interquartile range, 86–100]; p=0.024).

The finding on memory and communication with fluoxetine is said to be likely due to chance. An ongoing meta-analysis of individual patient data from EFFECT and other trials will present more precise estimates of any effects of fluoxetine. [Trials 2020;21:971]

*Efficacy of Fluoxetine—a Randomised Controlled Trial in Stroke