- Design
- Randomised, open-label, proof-of-concept trial, 10 days
- Population
- 21 adults with type 2 diabetes, decompensated cirrhosis and refractory ascites
- Primary outcome
- Change in fractional excretion of sodium
- Effect
- +0.44 percentage points (95% CI 0.05-0.83); paracentesis 0.6 vs 1.3 L/day
Twenty-one adults with type 2 diabetes, decompensated cirrhosis and refractory ascites were randomised, open label, to empagliflozin 10 mg daily plus standard care or standard care alone for ten days.
Fractional sodium excretion rose by 0.44 percentage points more with empagliflozin (95% CI 0.05 to 0.83). Urinary sodium increased by about 92 mmol a day and urine volume by about 820 mL a day compared with control. Mean paracentesis volume was 0.6 L a day with empagliflozin and 1.3 L a day without, a difference of 0.70 L (0.23 to 1.17). No serious adverse events were reported.
This is a physiological signal from a very small, unblinded, ten-day study. It does not show safety over weeks in decompensated cirrhosis, where volume depletion, kidney injury and ketoacidosis are real concerns. It is a reason for a proper trial, not for prescribing outside one.
- Do not start an SGLT2 inhibitor for ascites on the strength of this pilot; it is research-stage.
- In a patient with cirrhosis already on an SGLT2 inhibitor, watch sodium, creatinine and volume status closely.
- Hold SGLT2 inhibitors during acute illness, poor intake or before large-volume paracentesis if the patient is unwell.
- Refer patients with refractory ascites to hepatology rather than adjusting diuretics alone.
Why it matters
It suggests a drug many of these patients already qualify for could help their ascites, which is worth testing properly.
Don't overread it
Ten days, 21 patients and no blinding cannot establish safety or benefit in decompensated cirrhosis.
The statistics, in plain English
The confidence interval for fractional sodium excretion (0.05 to 0.83) only just clears zero, which is what you expect from 21 patients: the direction is probably real but the size is uncertain. Paracentesis volume is a softer outcome in an open-label study, because clinicians knew who was taking the drug.
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