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| |  WCN: Dosage Affects Outcome in First Episode of Steroid-Responsive Nephrotic Syndrome By Paula Moyer BERLIN, GERMANY -- June 10, 2003 -- An adequate steroid dosage is as important as duration of treatment in ensuring a good outcome with a child's first episode of steroid-responsive nephrotic syndrome, according to a randomised, controlled trial. "Most children with nephrotic syndrome respond to corticosteroids, but 70% have relapses," said Carmine Pecoraro, MD, chief of nephrology and dialysis at Santobono Children's Hospital, in Naples, Italy. "Earlier research had emphasised the length of treatment, but our findings show that a sufficiently high dose is also important." Dr. Pecoraro presented the findings of a comparative study here June 9th at the World Congress of Nephrology. They evaluated the benefits and toxicity of 3 corticosteroid regimens in patients' first episode of steroid-responsive nephrotic syndrome. To determine the relative importance of treatment duration and dose in preventing relapse, they randomised 30 patients to 1 of 3 groups: a high-dose group, a long-term group, or a control group receiving standard therapy. The high-dose group received 2 mg/kg/day of prednisone for 6 weeks followed by prednisone at the same dose every other day for 6 weeks. Afterward, the dose was decreased every 2 weeks by 0.25 mg, so that the total duration of therapy was 26 weeks, or 6 months. The long-term treatment group received 20 mg/kg/day of intravenous pulse methylprednisolone for 3 days. Starting on the fourth day, these patients were switched to 1 mg/kg/day of prednisone for 6 weeks. They then were on the same dose of prednisone for 6 weeks with the dose decreased by 0.25 mg every 2 weeks, with a total duration of therapy also consisting of 26 weeks, or 6 months. The group on standard treatment received the therapy recommended by the European Society for Paediatric Nephrology, which consists of 2 mg/kg/day of prednisone for 4 weeks followed by prednisone at the same dose for 4 weeks, with the dose decreased by 0.25 mg every week. For this group, the total duration of therapy was 12 weeks, or 3 months. Dr. Pecoraro and his co-investigators measured the outcome of treatment by assessing the number of children with and without relapse at 12 months. The groups were similar in mean age, sex ratio, values of proteinuria, and other clinical and biochemical parameters of nephrotic syndrome. Patients in the high-dose group achieved remission after an average of 4.6 days of treatment. The long-term treatment group's time to remission was an average of 4.1 days. The control group achieved remission in an average of 6.4 days. Relapses occurred in 30% of patients in the high-dose group after an average of 7.3 months. In the long-term treatment group, 70% of patients relapsed at a mean of 4.1 months. In the control group, 60% of patients relapsed after an average of 3.0 months. The investigators documented no significant difference in toxicity among the groups. "Our findings show that reducing the relapse risk in children with steroid-responsive nephrotic syndrome is linked to an increase in both the duration and the dose of prednisone when treating their first episode," Dr. Pecoraro said.
[Study title: Therapy Of First Episode Of Steroid Responsive Nephrotic Syndrome: A Randomised Controlled Trial. Abstract M199]
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