The effects of empagliflozin on diuresis and natriuresis in patients with type 2 diabetes mellitus and liver cirrhosis.

BACKGROUND

We investigated the short-term diuretic and natriuretic effect of empagliflozin, a sodium-glucose linked transporter 2 inhibitor, in patients with cirrhosis and type 2 diabetes mellitus (T2DM).

METHODS

This was a prospective, single-arm study including 30 patients with T2DM and cirrhosis (Child-Pugh class A/B). Participants received empagliflozin 10 mg for 15 days while continuing their standard treatment. Clinical and biochemical parameters, and urinary samples, using 24-h urine collection, were recorded before and after treatment. Twenty-seven patients continued empagliflozin for 6 months and were assessed for glycemic control and renal function.

RESULTS

Empagliflozin increased median daily urine volume by 475 mL (P=0.010) and fractional sodium excretion (FENa) by 16% at day 15 (P=0.030), but the 8 mmol/L increase in 24-h sodium excretion was not significant. Empagliflozin also reduced body weight (-0.8 kg, P<0.001) and systolic blood pressure (-4 mmHg, P=0.029). Glycemic control remained unremarkable at day 15, but improved at 6 months (baseline vs. 6 months: fasting glucose 146 vs. 116 mg/dL, P=0.016; glycosylated hemoglobin 6.2% vs. 6%, P=0.011). Compared to baseline (89.1±20.6 mL/min/1.73m2, estimated glomerular filtration rate declined numerically but not statistically significantly at day 15 (85.2±21.8, P=0.056 and at 6 months (82.8±23.7, P=0.035. No serious adverse events were noticed.

CONCLUSIONS

Up to 6 months' empagliflozin administration in patients with cirrhosis and T2DM seems safe and increases urine output and FENa, but its impact on renal function requires further investigation. Larger randomized controlled trials are needed to confirm its long-term efficacy and safety in this setting.