Randomized controlled trial on efficacy and safety of torsemide versus furosemide in patients with nephrotic syndrome.

BACKGROUND

Torsemide is preferred to furosemide in adults with heart failure for its higher bioavailability and longer half-life. Evidence of benefit in children is limited to uncontrolled studies.

METHODS

This single-center, open-label, randomized controlled trial compared the superiority of oral therapy with torsemide administered at a dose of 0.25-0.5 mg/kg twice daily, to furosemide 1-1.5 mg/kg twice daily for 48-h, in inducing diuresis in patients, 3-18 years-old, with nephrotic syndrome and moderate to severe edema without hypovolemia (CTRI/2023/10/058799). Secondary outcomes included proportions of patients with adequate and inadequate diuresis, treatment failure, treatment-emergent adverse events or serious adverse events (TEAE, SAE), percentage weight loss, natriuresis and free water clearance.

RESULTS

Of 173 patients screened, 25 patients each, with no significant baseline differences, were randomized to receive torsemide or furosemide. Nine patients in each group received 4 doses per protocol; others received fewer doses due to treatment failure or TEAE. On intention-to-treat analyses, patients in the torsemide and furosemide groups had similar urine output over 48-h (mean difference, MD 0.42; 95% CI -0.39,1.23 ml/kg/hr) and comparable proportions of patients had adequate diuresis (MD 20%; -3.7, 43.7%), inadequate diuresis (MD 16%; -41, 9.5%), treatment failure (MD -4%; -17.1, 9.1%), and TEAE or SAE. There were no differences in weight loss (MD 0.82; -2.2, 3.8%), natriuresis (MD -2.9; -74.4, 68.5 mEq/day) and free water clearance (MD 150.1; -266.1, 567.2 ml/day). Per-protocol analyses confirmed no intergroup differences.

CONCLUSIONS

Torsemide is not superior to furosemide in inducing diuresis in children with nephrotic syndrome with moderate to severe edema.