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

Abstract

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.