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Daily compared with alternate-day levamisole in pediatric nephrotic syndrome: an open-label randomized controlled study
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Daily compared with alternate-day levamisole in pediatric nephrotic syndrome: an open-label randomized controlled study
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Daily compared with alternate-day levamisole in pediatric nephrotic syndrome: an open-label randomized controlled study
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Journal Article
Daily compared with alternate-day levamisole in pediatric nephrotic syndrome: an open-label randomized controlled study
2024
Overview
Background
Levamisole is less expensive and has a better toxicity profile compared to other steroid sparing agents used in nephrotic syndrome. It has a plasma half-life of 2.0 to 5.6 hours, but is conventionally administered on alternate days. We aimed to assess whether daily levamisole is safe and more effective than standard alternate-day therapy in maintaining remission in children with frequently relapsing or steroid-dependent nephrotic syndrome (FR/SDNS).
Methods
An open-label randomized controlled trial was conducted in children with FR/SDNS. Group A received daily while Group B received alternate-day levamisole (2–3 mg/kg/dose) for 12 months. Prednisolone was tapered off by 3 months. Patients were monitored for relapses, further steroid requirement, and adverse effects.
Results
A total of 190 children with FR/SDNS (94 in Group A and 96 in Group B) were analyzed. Sustained remission for 12 months was observed in 36% of Group A and 27% of Group B patients (
p
= 0.18). Numbers completing 12 months in the study were 67% in Group A and 56% in Group B (
p
= 0.13). Time to first relapse, persistent FR/SDNS, and withdrawal due to poor compliance were statistically similar in both groups, while relapse rate and cumulative steroid dosage were significantly lower in Group A compared to Group B (
p
= 0.03 and
p
= 0.02, respectively). The incidence of adverse effects was comparable in both groups, with reversible leucopenia and hepatic transaminitis being the commonest.
Conclusions
Daily levamisole therapy was not superior to alternate-day therapy in maintaining sustained remission over 12 months. Nevertheless, relapse rate and cumulative steroid dosage were significantly lower without increased adverse effects.
Graphical abstract
A higher resolution version of the Graphical abstract is available as Supplementary information
Publisher
Springer Berlin Heidelberg,Springer,Springer Nature B.V
Subject
/ Child
/ Children
/ Dosage
/ Drug Administration Schedule
/ Drugs
/ Female
/ Glucocorticoids - administration & dosage
/ Glucocorticoids - adverse effects
/ Humans
/ Levamisole - administration & dosage
/ Levamisole - adverse effects
/ Male
/ Medicine
/ Nephrotic Syndrome - drug therapy
/ Prednisolone - administration & dosage
/ Prednisolone - adverse effects
/ Prednisolone - therapeutic use
/ Remission Induction - methods
/ Steroids
/ Toxicity
/ Urology
