Data from three similar trials of daily fluoxetine for functional recovery after stroke provide compelling evidence that the agent should not be routinely prescribed after acute stroke, researchers say.

Results of the AFFINITY trial, which included 532 Australians with stroke, 42 patients from New Zealand and 706 from Vietnam, showed no difference in outcomes on the modified Rankin Scale six months post-stroke for patients randomised to 20mg fluoxetine daily compared with those on placebo.

Participants had a mean age of 64 years and 63% were male. All had experienced an acute ischaemic or haemorrhagic stroke in the past 2-15 days, most (87%) were able to talk and were not confused at baseline, 69% could lift both arms off the bed and 44% could walk.

While the distribution of modified Rankin Scale scores was not significantly different between the two arms, there were differences in adverse effects.