ESPN 53rd Annual Meeting

ESPN 2021


 
A randomized control trial comparing safety and efficacy of single dose versus divided daily dose prednisolone in first episode of childhood nephrotic syndrome
Taniya Khan 1 Surupa Basu 1 Shakil Akhtar 1 Subhankar Sarkar 1 Rajiv Sinha 1

1- INSTITUTE OF CHILD HEALTH
 
Abstract:

 

Objectives: Corticosteroid is the standard therapy for first episode nephrotic syndrome (FENS). Daily divided dose (DD) prednisolone is still commonly prescribed despite early morning single dose (SD) hypothetically having less hypothalamic-pituitary-adrenal axis (HPA) suppression and better medication adherence. Controlled study confirming these hypotheses are scarce. We conducted a randomized controlled trial with the primary objective to compare HPA axis suppression between SD and DD steroid at completion of 6 weeks of daily steroid before reduction. Secondary objective included comparing side effects, time to remission, time to first relapse, and frequency of relapse

Methods: Children with FENS were randomized to receive prednisolone 2 mg/kg per day, either as SD (n=26) or in two DD (n=27) for 6 weeks, followed by single alternative daily dose of 1.5 mg/kg for 6 weeks. After completion of 6 + 6 weeks of steroid therapy follow up continued for 6 months. HPA axis was assessed by short synacthen test (SST) on completion of 6 weeks of daily steroid. 

Results: In both groups all patients were steroid responsive without differences in time to remission [SD: 9 days (IQR 8-12.5) and DD: 10 days (IQR 7.5-12)], relapse rates [SD: 35%, n=9 / DD: 37%, n=10], adverse event or medication adherence. In SD group 20% (n=5) passed SST vs 0% in DD group (p =0.01). Time to first relapse was longer in SD (115; IQR 40.5 to 126) than in DD (60; IQR 32 to 68) but did not reach statistical significance.

Conclusion: Our finding suggests that SD is equally effective as DD prednisolone in FENS with less HPA axis suppression. Further studies are required to assess role of HPA axis suppression on relapse of nephrotic syndrome.