AFFINITY: Fluoxetine still of no benefit in acute stroke survivors after 12 months

Daily use of fluoxetine for 6 months following acute stroke does not appear to have any delayed or sustained effect on functional outcomes, falls, bone fracture, or seizures at 1 year, according to a secondary analysis of the AFFINITY* trial.

AFFINITY previously showed that using oral fluoxetine 20 mg daily for 6 months after acute stroke fell short of improving functional outcome and even increased the risk of falls, bone fractures, and seizures. In the present analysis, the survivors were followed for 12 months after randomization.

The population comprised 1,280 adults with stroke, diagnosed in the previous 2–15 days, and persisting neurological deficit. These patients had been recruited at hospital stroke units in Australia (n=29), New Zealand (n=4), and Vietnam (n=10). Participants were treated with oral fluoxetine 20 mg once daily (n=642) or matching placebo (n=638).

In terms of adherence to fluoxetine, patients took their medication for a mean 167 days. Adherence did not differ compared to the placebo group. Likewise, there was no difference observed in function at 12 months, with the distribution of modified Rankin Scale categories being similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.93, 95 percent confidence interval, 0.76–1.14; p=0.46).

Relative to placebo, fluoxetine was associated with fewer recurrent ischaemic strokes (2.18 percent vs 4.55 percent; p=0.02). Furthermore, while the frequency of other outcomes was still higher with the study drug, the difference versus placebo was no longer significant (falls: 4.21 percent vs 2.35 percent; p=0.08), bone fractures (3.58 percent vs 1.72 percent; p=0.05), or seizures (1.71 percent vs 1.25 percent; p=0.64) at 12 months.

That fluoxetine use led to a lower rate of recurrent ischaemic stroke is said to be most likely a chance finding.

*Assessment of Fluoxetine in Stroke Recovery