Study findings indicate that extending initial prednisolone treatment durations in patients with pediatric nephrotic syndrome from 3 to 6 months without increasing the overall dose does not reduce the number of relapses.
On the basis of the cumulative incidence rate of frequently relapsing nephrotic syndrome, which was classified using both strict and broader, more clinically relevant definitions, there was no benefit in giving prednisolone for 6 months.
According to Nynke Teeninga (Erasmus Medical College, Sophia Children's Hospital, Rotterdam, the Netherlands) and colleagues: "This finding challenges the previous assumption that prolonged treatment duration improves clinical outcome."
In this multicenter study reported in the Journal of the American Society of Nephrology, 150 patients with pediatric nephrotic syndrome were randomly assigned to receive prednisolone for 3 months followed by placebo for 3 months or prednisolone for the entire 6 months. The median cumulative medication dose was 3360 mg/m2 in the 3-month group and 3390 mg/m2 in the 6-month group.
Among the 126 children who actually started medication, relapses occurred in 77% of the 62 children who received prednisolone for 3 months and in 80% of the 64 who received it for 6 months, reflecting a nonsignificant difference.
The two groups also had similar rates of frequent relapses, according to international criteria, and there was no significant difference in the eventual initiation of prednisolone maintenance or other immunosuppressive therapy.
Growth rates, bone mineral density, and the incidence of adverse events did not differ significantly between the two groups.
Pediatric nephrotic syndrome is a rare condition, but relapse rates are high. Although current treatment strategies are mostly based on reports by the International Study of Kidney Disease, there is no consensus on how to improve treatments to lower the incidence of relapses. Furthermore, longer treatment regimens often result in corticosteroid toxicity.
In a press release accompanying the article, Teeninga said: "We believe our work offers an important contribution towards more evidence-based treatment of childhood nephrotic syndrome." She added that the focus of future research in pediatric nephrotic syndrome should be preventing relapses through new treatment strategies.
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