Efficacy and safety of deflazacort in children with an initial episode of idiopathic nephrotic syndrome - a randomized controlled trial
DOI:
https://doi.org/10.18203/2349-3291.ijcp20251857Keywords:
Idiopathic nephrotic syndrome, Deflazacort, Prednisolone, ChildrenAbstract
Background: Idiopathic nephrotic syndrome (INS) is the most common glomerular disease in children. Prednisolone has been the standard first-line therapy, but deflazacort, a synthetic corticosteroid, has shown promise with potentially fewer side effects. This study aimed to compare the efficacy and safety of deflazacort versus prednisolone in children with an initial episode of INS.
Methods: This randomized controlled trial was conducted in the Department of Pediatric Nephrology, National Institute of Kidney Diseases and Urology (NIKDU), Dhaka, Bangladesh, from June 2019 to January 2021. In this study, we included 83 children, aged 2 to 12 years, who had Idiopathic nephrotic syndrome and visited the outdoor department and were admitted to the pediatric nephrology department of NIKDU. Patients were divided into two treatment groups – group A patients were prescribed prednisolone, and group B patients were prescribed deflazacort.
Results: The mean age was significantly higher in the deflazacort group (4.97±2.11 years) compared to the prednisolone group (3.87±1.23 years), with a statistically significant p value of 0.007. The mean time to induce remission was significantly shorter in the deflazacort group (7.87±3.33 days) compared to the prednisolone group (9.82±3.43 days; p=0.02). Although relapse rates were higher in the prednisolone group at 3 and 6 months, the differences were not statistically significant. Complications like moon face and buffalo hump occurred more frequently in the prednisolone group, but without statistical significance. No significant differences were observed in growth parameters, blood pressure, cholesterol, or random blood sugar (RBS) levels between the two groups during follow-up.
Conclusions: This study showed that deflazacort induced remission in a shorter time compared to prednisolone in children with an initial episode of INS. While both treatments were similarly effective in achieving remission, the deflazacort group experienced fewer relapses and a lower incidence of side effects during the follow-up period.
Metrics
References
Indian Pediatric Nephrology Group, Indian Academy of Pediatrics. Consensus statement on management of steroid sensitive nephrotic syndrome. Indian Pediatr. 2001;38(9):975.
Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003;362:629-39. DOI: https://doi.org/10.1016/S0140-6736(03)14184-0
Sharples PM, Poulton J. Steroid responsive nephrotic syndrome is more common in Asian. Arch Dis Child. 1985;60:1014-7. DOI: https://doi.org/10.1136/adc.60.11.1014
Sinha A, Yadav R, Krishna N. Disease course of steroid sensitive nephrotic syndrome. Indian Pediatr. 2012;49:881-7. DOI: https://doi.org/10.1007/s13312-012-0220-4
Bagga A, Srivastava RN. Nephrotic syndrome. In: Bagga A, Srivastava RN, editors. Pediatric Nephrology. 6th ed. New Delhi: Replika Press Pvt. Ltd. 2016;191-200. DOI: https://doi.org/10.5005/jp/books/12792_12
Thorn GW, Forsham PH, Frawley TF, Hill SR Jr, Roche M, Staehelin D, et al. The clinical usefulness of ACTH and cortisone. N Engl J Med. 1950;242(22):865-72. DOI: https://doi.org/10.1056/NEJM195006012422205
Arneil GC, Wilson HEC. Cortisone treatment of nephrosis. Arch Dis Child. 1952;27(134):322. DOI: https://doi.org/10.1136/adc.27.134.322
Report of International Study of Kidney Disease in Children, Barnett HL, Edelmann CM. Minimal change nephrotic syndrome in children: deaths during the first 5 to 15 years’ observation. Pediatrics. 1984;73(4):497-501. DOI: https://doi.org/10.1542/peds.73.4.497
Primary nephrotic syndrome in children: clinical significance of histopathologic variants of minimal change and of diffuse mesangial hypercellularity. A Report of the International Study of Kidney Disease in Children. Kidney Int. 1981;20(6):765-71. DOI: https://doi.org/10.1038/ki.1981.209
Hodson EM, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2007;(4):CD001533. DOI: https://doi.org/10.1002/14651858.CD001533.pub4
Czock D, Keller F, Rasche FM, Häussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. DOI: https://doi.org/10.2165/00003088-200544010-00003
Jat KR, Khairwa A. Deflazacort in comparison to other steroids for nephrotic syndrome. Indian J Nephrol. 2012;22:239-45. DOI: https://doi.org/10.4103/0971-4065.101238
Joshi N, Rajeswari K. Deflazacort. Postgrad Med Sci. 2009;55:296-300. DOI: https://doi.org/10.4103/0022-3859.58942
Penaloza J, Sojo ET, Calette MG, Mendilaharzu F. Evaluation of deflazacort: a new steroid in the initial therapy of children with idiopathic nephrotic syndrome. Med J Infant. 1994;21:185-9.
Lee CY, Chung HK, Park JS. The effect of Calcort (deflazacort) in connective tissue diseases and nephrotic syndrome in childhood. Med J Korea. 1995;38:88-93.
Broyer M, Terzi F, Lehnert A, Gagnadoux F, Guest G, Niaudet P. A controlled study of deflazacort in the treatment of idiopathic nephrotic syndrome. Pediatr Nephrol. 1997;11:418-22. DOI: https://doi.org/10.1007/s004670050308
Kurt L, Jean PA, Fritz FH, Philippe J. Effects of deflazacort versus prednisone on bone mass, body composition and lipid profile: a randomized double-blind study in kidney transplant patients. J Clin Endocrinol Metab. 2008;83:3795-9. DOI: https://doi.org/10.1210/jc.83.11.3795
Elli A, Edward J, Tozar P, Simpson D. A randomized trial of deflazacort versus methylprednisolone. Lancet. 1993;55:209-12. DOI: https://doi.org/10.1097/00007890-199301000-00041
Ravish S, Saddhavana P, Neeraj D. Deflazacort versus prednisolone: randomized controlled trial in treatment of children with idiopathic nephrotic syndrome. Iran J Pediatr. 2015;25:510-20. DOI: https://doi.org/10.5812/ijp.510
Nayak S, Achariya B. Deflazacort vs other glucocorticoid: a comparison. Indian J Dermatol. 2008;53(4):167-70. DOI: https://doi.org/10.4103/0019-5154.44786
Catarina N, Ana CC, Carmen F, Clara G, Antonia JC. Idiopathic nephrotic syndrome – deflazacort, an alternative? Port J Nephrol. 2015;29:59-63.
Visal R, Singh P, Mahajan A. Comparative adverse drug profile of deflazacort vs conventional corticosteroids in spontaneous reporting system of pharmacovigilance. J K Sci. 2014;16:16-20.
Luca P. Deflazacort: therapeutic index, relative potency and equivalent doses versus other corticosteroids. BMC Pharmacol Toxicol. 2016;28:3-9.