Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
In RCT (n=4271), empagliflozin vs usual care did not reduce 28-day mortality (289 [14%] vs. 307 [14%], respectively, died within 28 days; rate ratio 0.96; 95% CI 0.82–1.13]; p=0.64), duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death.
Source:
The Lancet Diabetes & Endocrinology
SPS commentary:
According to a commentary, these data add to previous studies evaluating outcomes of COVID-19 in people with diabetes who, at the time of hospital admission for COVID-19, were given an SGLT2 inhibitor. It notes that in keeping with the results of RECOVERY, in the Association of British Clinical Diabetologists COVID-19 diabetes national audit, the in-hospital case fatality rate of participants prescribed an SGLT2 inhibitor before hospitalisation was not different from that of the total study population. It points out however that meta-analyses of retrospective cohorts of people with type 2 diabetes hospitalised with COVID-19 suggested that the pre-admission use of SGLT2 inhibitor therapy was associated with reduced risk of adverse outcomes, such as admission to ICU, need for mechanical ventilation, or in-hospital death. It acknowledges that reconciling discrepancies between retrospective studies and meta-analyses of cohorts and the two randomised placebo-controlled trials (RECOVERY and DARE-19) might not be straightforward, and the large number of potential confounders of the former and the short duration of SGLT2 inhibitor exposure of the latter should be considered. It concludes that whatever the explanation for such discrepancies, the RECOVERY trial shows there is no specific advantage in adding an SGLT2 inhibitor at the time of admission to hospital of people with COVID-19, although these results are reassuring with respect to their tolerability and safety.