Low-dose versus conventional-dose prednisolone for nephrotic syndrome relapses: a randomized controlled non-inferiority trial
| Autor: | Manish Kumar, Seenam Sheikh, Kirtisudha Mishra |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Nephrology
medicine.medical_specialty Nephrotic Syndrome Subsequent Relapse medicine.drug_class Prednisolone 030232 urology & nephrology 030204 cardiovascular system & hematology Gastroenterology 03 medical and health sciences 0302 clinical medicine Recurrence Internal medicine Humans Medicine Child business.industry Low dose Infant medicine.disease Log-rank test Treatment Outcome Child Preschool Chronic Disease Pediatrics Perinatology and Child Health Non inferiority trial Corticosteroid Steroids business Nephrotic syndrome medicine.drug |
| Zdroj: | Pediatric Nephrology. 36:3143-3150 |
| ISSN: | 1432-198X 0931-041X |
| DOI: | 10.1007/s00467-021-05048-1 |
| Popis: | Reduction of steroid exposure in relapses of steroid-sensitive nephrotic syndrome (SSNS) is under-researched. In this randomized controlled non-inferiority trial, 1–12-year-old children with relapse of SSNS were randomized to receive prednisolone 1 mg/kg/day (low dose) or 2 mg/kg/day (standard dose) until disease remission or day 15, whichever was earlier. Therapy was switched to 2 mg/kg/day in children in low-dose group not in remission by day 15. Primary outcome was days to remission, and secondary outcome being pattern of subsequent relapse(s) over 1 year. Estimating time to remission of 8 ± 2.5 days with standard-dose therapy, non-inferiority margin of 2 days, 90% power, and α-0.05, 60 patients were randomized. Of the 60 children (30 in each group) enrolled, 4 (one in low-dose group) failed remission by day 15. Time to remission was comparable between low-dose and standard-dose groups [9.0 ± 2.2 vs. 8.6 ± 2.2 days; mean difference (95% CI) 0.4 (− 0.79 to 1.59) days; p = 0.49], thus establishing non-inferiority of low dose. Median time to subsequent relapse was 86 (IQR 74.8, 97.2) and 150 (IQR 59.0, 240.9) days, in low- versus standard-dose groups, respectively (log rank p = 0.39). In follow-up, proportion of children having relapses, frequency of relapses, proportion with frequent relapse/steroid dependent (FR/SD), and cumulative corticosteroid dose taken were comparable between groups. This study shows that time to achieve remission after treatment of a relapse with low-dose prednisolone is non-inferior to that after treatment with conventional dose in children with SSNS. The proportion of children achieving remission, further course, and pattern of relapses was comparable between both groups. |
| Databáze: | OpenAIRE |
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