Dennis M, et al. - Experts sought to provide a precise estimate of the effects of fluoxetine on functional outcomes after stroke. Seemingly, fluoxetine 20 mg given daily for 6 months after acute stroke does not improve functional outcomes. However, the occurrence of depression was reduced with the treatment, it increased the frequency of bone fractures. The routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function was not supported in the findings.

Methods

• Experts conducted FOCUS a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK.
• Eligiblity of the patients depended on the age of patients if it was 18 years or older, if they had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits.
• They randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm to the patients.
• Functional status, measured with the modified Rankin Scale (mRS), at 6 months was the primary outcome.
• They masked the patients, carers, health-care staff, and the trial team to treatment allocation.
• They assessed the functional status at 6 months and 12 months after randomisation.
• They evaluated the patients according to their treatment allocation.

Results

• As per data, 3,127 patients were recruited between Sept 10, 2012, and March 31, 2017.
• They allocated fluoxetine to 1,564 patients and 1,563 allocated placebo.
• Findings suggested avalibility of mRS data at 6 months for 1553 (99·3%) patients in each treatment group.
• Results demonstrated the distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439).
• They noted less likleness of the patients allocated fluoxetine than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; =0·0070).
• At 6 or 12 months, there were no significant differences in any other event.