Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial

SPS commentary:

This is one of two almost identical phase 3 trials in The Lancet Neurology, examining the effects of fluoxetine on disability 6 months after stroke. The EFFECTS study (n=1500) also found functional outcome (modified Rankin Scale) after acute stroke did not improve with fluoxetine 20 mg once daily for 6 months (OR 0·94; 95% CI 0·78-1·13;p=0·42), and though it reduced occurrence of depression, it increased risk of bone fractures and hyponatraemia.

 

A commentary notes these two trials followed the larger Fluoxetine Or Control Under Supervision (FOCUS) trial conducted at 103 sites in the UK (n=3127) and all three trials convincingly show that the use of 20 mg oral fluoxetine prescribed daily and starting 2–15 days after stroke has no effects on the modified Rankin Scale (mRS) compared with placebo. It suggests that before closing the chapter on pharmacological enhancement of recovery after brain injury, it is worth revisiting why fluoxetine was considered a recovery drug in the first place. It adds that AFFINITY and EFFECTS started before FOCUS and it is now not clear what their added value is but in a world of finite resources, these trials illustrate the need for a global agenda for stroke recovery research that allows optimal alignment to address complementary research questions.