Efficacy of low-dose daily versus alternate-day prednisolone in frequently relapsing nephrotic syndrome: an open-label randomized controlled trial

摘要

BackgroundWhile 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.MethodsConsecutive patients, aged 2-18years, with FRNS were included. Following therapy of relapse, prednisolone was tapered to 0.75mg/kg on alternate days. Stratifying for steroid dependence, patients were randomly assigned to prednisolone at 0.2-0.3mg/kg daily or 0.5-0.7mg/kg alternate day for 12months. Relapses were treated with daily prednisolone, followed by return to intervention. Primary outcome was the incidence of relapses. Proportion with therapy failure (2 relapses in any 6months or significant steroid toxicity) and sustained remission, cumulative prednisolone intake and adverse events were evaluated.ResultsPatients 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 6months (73.3 versus 48.4%) and 1year (60 versus 31.6%; log rank p=0.013), lower rates of treatment failure at 6months (3.3 versus 32.8%) and 1year (6.7 versus 57.4%; p<0.0001), and lower prednisolone use (0.270.07 versus 0.39 +/- 0.19mg/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 p id=Par4 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.