Co-administration of cyclosporine and ketoconazole in idiopathic childhood nephrosis

El-Husseini, Amr; El-Basuony, Fathy; Mahmoud, Ihab; Donia, Ahmed Farouk; Hassan, Nabil; Sayed-Ahmad, Nagy; Sobh, Mohamed

doi:10.1007/s00467-004-1545-6

Cited by 7 publications

(6 citation statements)

References 21 publications

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“…Adverse effects are significant with 4% of children developing hypertension, 9% reduced renal function, 28% gum hypertrophy and 34% hirsutism [26]. A retrospective study has shown that the administration of ketoconazole with cyclosporin as a cyclosporine-sparing agent reduced the number of children with renal impairment, increased the likelihood of withdrawing steroids and reduced the cost of therapy [35]. [36].…”

Section: Cyclosporinmentioning

confidence: 99%

Evidence-based management of steroid-sensitive nephrotic syndrome

2005

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Using data from systematic reviews and randomised controlled trials, the evidence for managing steroid sensitive nephrotic syndrome (SSNS) is reviewed. In the initial episode, increased duration (3-7 months) of prednisone compared with 2 months significantly reduced the risk for relapse at 12-24 months [relative risk (RR) 0.70; 95% confidence intervals (CI) 0.58-0.84] without increase in adverse effects. Six months of prednisone was significantly more effective than 3 months (RR 0.57; 95% CI 0.45-0.71). Higher prednisone doses given for the same duration reduced the risk of relapse (RR 0.59; 95% CI 0.42-0.84) suggesting that both dose and duration of prednisone therapy lead to prolonged remission. In relapsing SSNS prolonged prednisone treatment, daily prednisone during infections, oral or intravenous cyclophosphamide, chlorambucil, levamisole and cyclosporin significantly reduced the risk of relapse. Comparative effects of these options remain uncertain because of the absence of head-to-head trials, but existing trial evidence is strongest for cyclophosphamide and cyclosporin. Further adequately powered multinational trials are required to determine the optimum induction dose and duration of prednisone in the initial episode of SSNS and to determine the relative efficacies of immunosuppressive agents and the efficacy of newer agents, including mycophenolate and tacrolimus, in relapsing SSNS.

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Section: Cyclosporinmentioning

confidence: 99%

Evidence-based management of steroid-sensitive nephrotic syndrome

2005

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“…Patients with steroid-resistant idiopathic nephrotic syndrome (SRINS) often have poor prognosis, and some patients progress to end-stage renal disease (ESRD) [1][2][3].…”

Section: Introductionmentioning

confidence: 99%

Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome

Duan

et al. 2009

Pediatr Nephrol

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Treating children with steroid-resistant nephrotic syndrome (SRNS) has been a clinical challenge for pediatricians. We recruited 24 children (18 boys and six girls) with steroid-resistant idiopathic nephrotic syndrome (SRINS) who were <2 years. All patients were administered prednisone 2 mg/kg per day prior to mycophenolate mofetil (MMF). By the end of the eighth week, MMF was initiated at 25-30 mg/kg daily for 6- 12 months. Prednisone dose was reduced stepwise. Biochemical assays were performed every 2 months. Complete remission was achieved in 15 patients, partial remission in six, and no response to MMF was noted in three. With MMF treatment, the levels of urinary protein and serum cholesterol decreased and that of serum albumin increased in a time-dependant manner. We demonstrated the MMF could reduce proteinuria in SRINS children <2 years. Our study suggests that MMF therapy might be an effective strategy for treating SRINS in children <2 years.

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“…Previous investigators used a daily dose of 50 mg ketoconazole without specifying age or body weight of their pediatric probands. [2122] Ketoconazole was dispensed as tablets or powdered sachets prepared by our pharmacy, and CyA was given as tablets or suspension, as appropriate.…”

Section: Methodsmentioning

confidence: 99%

“…The only larger dataset originates from a single center. [202122] We therefore initiated a pilot study to assess the feasibility and safety of this combination therapy in a pediatric cohort in Southern India.…”

Section: Introductionmentioning

confidence: 99%

Cyclosporine/ketoconazole reduces treatment costs for nephrotic syndrome

Iyengar¹,

Kamath²,

Phadke³

et al. 2013

Indian J Nephrol

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Cyclosporine A (CyA) is an effective agent for the treatment of glucocorticoid-dependent idiopathic nephrotic syndrome (GCDNS), but costs are prohibitive in resource-poor societies. The objectives of this study were to evaluate the efficacy and safety of reducing the dose of CyA by co-administering ketoconazole. A prospective study targeting children 2-18 years of age with GCDNS in remission with CyA monotherapy was conducted. CyA dose was reduced by 50% and ketoconazole was added at 25% of the recommended therapeutic dose, and the drug levels and therapeutic and adverse effects (AE) were monitored. Continued combined therapy after completion of the 4-week trial period was offered. Ten patients (median age 9.5 years, range 3.0-16.0 years) were enrolled in the study. At week 4, the CyA dose was 2.2 ± 0.7 mg/kg/day compared with 5.6 ± 0.9 mg/kg/day at enrolment (P < 0.0001). No AE were noted. All patients continued ketoconazole treatment for at least 3 months. CyA drug cost savings were 61%, and approximately 60% with ketoconazole cost included. The combination of an expensive immunosuppressive drug with a cheap metabolic inhibitor reduced the treatment costs by> 50% without increased adverse events or drug monitoring needs. This intervention demonstrates how access of patients with limited resources to needed drugs can be improved by interference with physiological drug elimination.

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Co-administration of cyclosporine and ketoconazole in idiopathic childhood nephrosis

Cited by 7 publications

References 21 publications

Evidence-based management of steroid-sensitive nephrotic syndrome

Evidence-based management of steroid-sensitive nephrotic syndrome

Mycophenolate mofetil therapy for children with steroid-resistant nephrotic syndrome

Cyclosporine/ketoconazole reduces treatment costs for nephrotic syndrome

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