Prolonged versus standard prednisolone therapy for initial episode of nephrotic syndrome

We have examined, in a prospective randomized controlled trial, the effect of 8- and 16-week initial steroid treatment on the course of idiopathic nep hrotic syndrome (INS). Patients with a first episode of INS were randomized to receive standard 8-week prednisolone (2 mg/kg daily for 4 weeks, then 1 .5 mg/kg on alternate days for 4 weeks) or prolonged 16-week prednisolone t reatment (2 and 1.5 mg/kg daily each for 4 weeks, then 1.5 and 1 mg/kg on a lternate days each for 4 weeks). Relapses were treated with prednisolone, 2 mg/kg daily for 2 weeks, then 1.5 mg/kg on alternate days for 4 weeks. Of 45 patients, 23 received standard therapy and 22 prolonged therapy. The mea n duration of follow-up was 29.2 and 27.3 months in the standard and prolon ged treatment groups, respectively. The time to first relapse was longer in the prolonged treatment (mean 222.2 days, median 120.0 days) than the stan dard group (mean 134.3 days, median 96.5 days). The percentage of patients with no relapse at 6 and 12 months after prednisolone withdrawal was 40.9% and 27.3% in the prolonged treatment and 21.7% and 8.7% in the standard gro ups, respectively. The inability to show statistically significant differen ces be tween the two groups was probably related to the small number of pat ients studied. Prolonged therapy did not affect the subsequent relapse rate s and proportion of patients with frequent relapses and steroid dependence. The mean dose of prednisolone received, for the initial episode and relaps es during the next year, was higher and associated with significant steroid toxicity in the prolonged treatment group. Our findings suggest that 16-we ek prednisolone treatment for the initial episode of INS may delay occurren ce of the first relapse, but results in significant side effects. Prolongat ion of initial therapy may be useful in developing countries where frequent infections often induce early relapses.