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Efficacy of low-dose daily versus alternate-day prednisolone in frequently relapsing nephrotic syndrome: an open-label randomized controlled trial
- Source :
- Pediatric Nephrology. May, 2019, Vol. 34 Issue 5, p829, 7 p.
- Publication Year :
- 2019
-
Abstract
- Background While patients with frequently relapsing nephrotic syndrome (FRNS) are initially treated with long-term alternate-day prednisolone, relapses and adverse effects are common. In an open-label randomized controlled trial, we compared the efficacy of therapy with low-dose daily to standard alternate-day prednisolone in reducing relapse rates over 12-month follow-up. Methods Consecutive patients, aged 2-18 years, with FRNS were included. Following therapy of relapse, prednisolone was tapered to 0.75 mg/kg on alternate days. Stratifying for steroid dependence, patients were randomly assigned to prednisolone at 0.2-0.3 mg/kg daily or 0.5-0.7 mg/kg alternate day for 12 months. Relapses were treated with daily prednisolone, followed by return to intervention. Primary outcome was the incidence of relapses. Proportion with therapy failure ([greater than or equal to] 2 relapses in any 6 months or significant steroid toxicity) and sustained remission, cumulative prednisolone intake and adverse events were evaluated. Results Patients receiving daily prednisolone (n = 30) showed significantly fewer relapses than those on alternate-day therapy (n = 31) (0.55 relapses/person-year versus 1.94 relapses/person-year; incidence rate ratio 0.28; 95% CI 0.15, 0.52). Daily therapy was associated with higher rates of sustained remission at 6 months (73.3 versus 48.4%) and 1 year (60 versus 31.6%; log rank p = 0.013), lower rates of treatment failure at 6 months (3.3 versus 32.8%) and 1 year (6.7 versus 57.4%; p < 0.0001), and lower prednisolone use (0.27 ± 0.07 versus 0.39 ± 0.19 mg/kg/day; p = 0.003). Three and two patients need to receive the study intervention to enable sustained remission and prevent treatment failure, respectively. Conclusions In patients with FRNS, daily administration of low-dose prednisolone is more effective than standard-dose alternate day therapy in lowering relapse rates, sustaining remission, and enabling steroid sparing.<br />Author(s): Menka Yadav [sup.1] , Aditi Sinha [sup.1] , Priyanka Khandelwal [sup.1] , Pankaj Hari [sup.1] , Arvind Bagga [sup.1] Author Affiliations: (Aff1) 0000 0004 1767 6103, grid.413618.9, Division of [...]
Details
- Language :
- English
- ISSN :
- 0931041X
- Volume :
- 34
- Issue :
- 5
- Database :
- Gale General OneFile
- Journal :
- Pediatric Nephrology
- Publication Type :
- Academic Journal
- Accession number :
- edsgcl.579406373
- Full Text :
- https://doi.org/10.1007/s00467-018-4071-7