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Extending initial prednisolone treatment in a randomized control trial from 3 to 6 months did not significantly influence the course of illness in children with steroid-sensitive nephrotic syndrome
- Source :
- Kidney International. 87:217-224
- Publication Year :
- 2015
- Publisher :
- Elsevier BV, 2015.
-
Abstract
- While studies show that prolonged initial prednisone therapy reduces the frequency of relapses in nephrotic syndrome, they lack power and have risk of bias. In order to examine the effect of prolonged therapy on frequency of relapses, we conducted a blinded, 1:1 randomized, placebo-controlled trial in 5 academic hospitals in India on 181 patients, 1-12 years old, with a first episode of steroid-sensitive nephrotic syndrome. Following 12 weeks of standard therapy, in random order, 92 patients received tapering prednisolone while 89 received matching-placebo on alternate days for the next 12 weeks. On intention-to-treat analyses, primary outcome of number of relapses at 1 year was 1.26 in the 6-month group and 1.54 in the 3-month group (difference -0.28; 95% confidence interval (CI) -0.75, 0.19). Relative relapse rate for 6- vs. 3-month therapy, adjusted for gender, age, and time to initial remission, was 0.70 (95% CI 0.47-1.10). Similar proportions of patients had sustained remission, frequent relapses, and adverse effects due to steroids. Adjusted hazard ratios for first relapse and frequent relapses with prolonged therapy were 0.57 (95% CI, 0.36-1.07) and 1.01 (95% CI, 0.61-1.67), respectively. Thus, extending initial prednisolone treatment from 3 to 6 months does not influence the course of illness in children with nephrotic syndrome. These findings have implications for guiding the duration of therapy of nephrotic syndrome.
- Subjects :
- Male
Pediatrics
medicine.medical_specialty
Nephrotic Syndrome
Time Factors
Prednisolone
law.invention
Double-Blind Method
Randomized controlled trial
Recurrence
law
Prednisone
medicine
Humans
Prospective Studies
Child
Prospective cohort study
Adverse effect
Glucocorticoids
First episode
business.industry
Hazard ratio
Infant
medicine.disease
Surgery
Treatment Outcome
Nephrology
Child, Preschool
Female
business
Nephrotic syndrome
medicine.drug
Subjects
Details
- ISSN :
- 00852538
- Volume :
- 87
- Database :
- OpenAIRE
- Journal :
- Kidney International
- Accession number :
- edsair.doi.dedup.....57793dd9efafb892e62e64bc172c6085