- Design
- Randomised, open-label, proof-of-concept study
- Population
- 21 adults with type 2 diabetes, decompensated cirrhosis and refractory ascites
- Primary outcome
- Change in fractional excretion of sodium over 10 days
- Effect
- FENa +0.44 points (95% CI 0.05 to 0.83); paracentesis −0.70 L/day (−1.17 to −0.23)
This open-label, randomised proof-of-concept study enrolled 21 adults with type 2 diabetes, decompensated cirrhosis and refractory ascites, assigning empagliflozin 10 mg daily plus standard care or standard care alone for 10 days.
Empagliflozin raised fractional sodium excretion by 0.44 percentage points (95% CI 0.05 to 0.83), urinary sodium by 92 mmol a day (47 to 137) and urine volume by 822 mL a day. Mean daily paracentesis volume was 0.6 L with empagliflozin against 1.3 L with standard care (difference −0.70 L/day, −1.17 to −0.23). No serious adverse events occurred.
Refractory ascites has few options short of repeated paracentesis or TIPS. A drug that increases natriuresis would be welcome, but these are 10-day physiological measures in 21 patients. Risks in decompensated cirrhosis, including volume depletion, kidney injury and ketoacidosis, need a proper trial before this enters practice.
- Do not start an SGLT2 inhibitor for refractory ascites outside a trial on this evidence.
- In patients with cirrhosis already on an SGLT2 inhibitor for diabetes, monitor sodium, creatinine and volume status closely.
- Watch for euglycaemic ketoacidosis when oral intake is poor.
- Look for larger, blinded trials before changing ascites management.
Why it matters
It suggests a familiar diabetes drug might reduce the burden of repeated paracentesis.
Don't overread it
A 21-patient, 10-day, open-label pilot measuring physiology; it does not show clinical benefit or safety.
The statistics, in plain English
The intervals exclude no effect for all the main measures, but with 10 and 11 patients per group they are wide, and open-label designs can influence paracentesis decisions.
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