SummaryBackgroundResults of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.MethodsFOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were 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. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.FindingsBetween Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. 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). Patients allocated fluoxetine were less likely 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]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.InterpretationFluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.FundingUK Stroke Association and NIHR Health Technology Assessment Programme.

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Introduction COVID‐19 has triggered a global pandemic and is an emerging situation. Diabetes has been associated with significant mortality in SARS and MERS‐COV infections. Patients with diabetes are at risk of COVID‐19 triggering diabetic emergencies due to known and unknown mechanisms. There is little evidence overviewing the clinical course of COVID‐19 patients who either present or have diabetic emergencies during their disease course. Methods We conducted a retrospective case analysis of all patients admitted to our hospital during the COVID‐19 pandemic. The inclusion criteria were all patients receiving treatment for COVID‐19 and either presenting with a diabetic emergency on admission or developing an emergency during their admission. Data collected for the study were all routinely collected data as part of the admission. We compared these data to nine patients with no COVID‐19. Results Thirty patients received treatment for a diabetic emergency, of which 21 also received treatment for COVID‐19. Significant differences were found between pH and bicarbonate on admission between RT‐PCR‐positive and both RT‐PCR‐negative and non‐COVID‐19 patients. Other results approaching significance include ALP and eGFR. Discussion Patients suffering from COVID‐19 and diabetes concurrently can suffer from profound metabolic disturbance, with a significant difference in inpatient mortality. However further, prospective detailed investigation into biochemical processes is needed to fully elucidate underlying mechanisms that affect these patients' outcomes.

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