https://doi.org/10.55788/f058fac2
The MERCURI-1 trial (EudraCT 2021-003172-13), a single-centre, open-label, randomised, parallel-group, phase 4 pilot study, investigated the potential protective effect of perioperative empagliflozin on renal injury in participants undergoing elective cardiopulmonary bypass-assisted cardiac surgery. Participants with diabetes, a body-mass index <25 kg/m2 eGFR <30 mL/min/1.73 m2, and/or ongoing SGLT2 inhibition were excluded from the trial. Participants were randomised to empagliflozin 10 mg daily (starting 3 days before surgery and ending 2 days after surgery, n=25) or a standard-of-care control (n=30). The primary endpoint was the difference between the renal injury biomarker neutrophil gelatinase-associated lipocalin (NGAL) at post-operative day 2. Dr Lars Snel (Amsterdam University Medical Centre, the Netherlands) presented the results [1].
On post-operative days 1 and 2, NGAL concentrations did not differ between groups. Following surgery, the rates of acute kidney injury were significantly lower with empagliflozin (20%) versus control (66.7%), corresponding to a 47% reduction in kidney injury (95% CI 24–70%; P=0.001). Post-operative glycaemic control was significantly improved with empagliflozin compared with control, with lower peak glucose levels (P=0.007), and fewer participants presenting with hyperglycaemia (P=0.029) and receiving insulin (P=0.023). None of the participants developed hypoglycaemia in either treatment group. As participants fasted before surgery, the administration of an SGLT2 inhibitor could promote the development of ketone bodies. However, ketoacidosis rates did not differ between treatment groups.
“This is the first clinical trial of perioperative SGLT2 inhibitor use as opposed to pre-operative SGLT2 inhibition. Our data suggest that acute SGLT2 inhibition protects from renal injury in participants undergoing cardiac surgery”, highlighted Dr Snel. The results are currently further tested in the larger, double-blind, phase 4 MERCURI-2 trial (NCT05590143) with results expected in 2025.
- Snel L, et al. Empagliflozin limits AKI incidence and severity following cardiac surgery: an open-label phase IV randomized pilot study. Abstract #976, ERA 2024, 23–26 May, Stockholm, Sweden.
Medical writing support was provided by Mihai Surducan, PhD.
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