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Effects of fluoxetine on outcomes at 12 months after acute stroke: Results from EFFECTS, a randomized controlled trial

Stroke Sep 04, 2021

Lundström E, Isaksson E, Norin NG, et al. - The results showed that after acute stroke, fluoxetine had no effect on functional outcome at 12 months. Compared with placebo, patients allocated fluoxetine scored worse on memory and communication on the Stroke Impact Scale, but this is likely to be due to chance.

  • Between 2014 and 2019, researchers recruited a total of 1,500 patients from 35 centers in Sweden; 750 were allocated fluoxetine and 750 placebo.

  • Modified Rankin Scale data were available in 715 (95%) patients allocated fluoxetine and 712 (95%) placebo at 12 months.

  • In the 2 groups, the distribution of modified Rankin Scale categories was similar (adjusted common odds ratio, 0.92 [95% CI, 0.76–1.10]).

  • It was shown that patients allocated fluoxetine scored worse on memory with a median value of 89 (interquartile range, 75–100) vs 93 (interquartile range, 82–100); P=0.0021 and communication 93 (interquartile range, 82–100) vs 96 (interquartile range, 86–100); P=0.024 domains of the Stroke Impact Scale in comparison with placebo.

  • No other differences were observed in secondary outcomes.

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