Abstract 1122‐000132: Fuoxetine for Recovery After Stroke: A Pooled Analysis of 7165 Patients

Introduction : Stroke is one of the predominant causes of permanent disability, mortality, significant cognitive, physical, and psychosocial morbidity in the world. We conducted this systematic review and meta‐analysis to assess the safety and efficacy of fluoxetine for recovery stroke patients through different time points of follow up. Methods : We searched in PubMed, Cochrane Library, Scopus, and Web of Science databases/ search engines until June 2021. Mean difference (MD) with 95% confidence interval (CI) was applied for continuous data, while risk ratio (RR) with 95% CI was used for dichotomous data. Results : Seventeen randomized clinical trials were identified which assessed the safety and efficacy of fluoxetine compared to placebo for stroke patients. Fluoxetine enhances the National Institutes of Health Stroke Scale (NIHSS) score [MD = ‐0.67, 95 % CI (‐1.19 to ‐0.15), P = 0.01] and the Fugl‐Meyer Motor Scale (FMMS) score [MD = 17.36, 95 % CI (12.12 to 22.61), P <0.00001] at three months follow up. However, the NIHSS score showed no significant difference between the two groups at two weeks [MD = ‐0.32, 95% CI (‐0.72 to 0.07), p = 0.11] or at six months [MD = ‐0.17,95% CI (‐0.47 to 0.14), p = 0.29]. Fluoxetine and placebo‐treated patients had the same overall impact on FMMS scores at one month [MD = 7.77, 95 % CI (‐10.57 to 26.11), P = 0.41]. The fluoxetine arm had a higher risk of broken bone (RR = 2.30, 95% CI [1.59, 3.32], p < 0.001) and hyponatremia (RR = 2.12, 95% CI [1.19, 3.76], p = 0.01) with lower risk of new depression (RR = 0.72, 95% CI [0.61, 0.84], p< 0.001) in comparison to the placebo arm. Conclusions : The efficacy of fluoxetine is likely to take time to emerge, and is expected to be transient. The use of fluoxetine increased the incidence of hyponatremia and bone fractures while decreasing the risk of new‐onset depression.