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Concomitant administration of cyclosporine and ketoconazole in idiopathic nephrotic syndrome
Amr El-Husseini1, Fathy El-Basuony, Ahmed Donia
1Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Insights
Adding ketoconazole to cyclosporine (CsA) therapy in nephrotic patients significantly lowers CsA doses and costs. This combination also improves treatment response and reduces the frequency of kidney impairment, offering a cost-effective solution.
Area of Science:
- Nephrology
- Pharmacology
- Immunosuppression
Background:
- Cyclosporine (CsA) is a costly immunosuppressant.
- Ketoconazole is explored to reduce CsA dosage and cost.
- Prior studies focused on transplants; this is the first in nephrotic syndrome.
Purpose of the Study:
- To evaluate the efficacy and safety of co-administering ketoconazole with CsA in nephrotic patients.
- To assess the impact on CsA dosage, treatment costs, and patient outcomes.
Main Methods:
- Retrospective study of 207 nephrotic patients (steroid-resistant/dependent/relapsing).
- 153 patients received CsA with 50mg daily ketoconazole (reduced CsA dose).
- 54 patients received CsA alone; majority were pediatric patients.
Main Results:
- Ketoconazole reduced CsA doses by 37% (1 month) and 47% (1 year), yielding 37% cost savings.
- No significant differences in baseline characteristics or hepatic function between groups.
- Improved CsA therapy response, successful steroid withdrawal, and decreased renal impairment frequency.
Conclusions:
- Ketoconazole co-administration with CsA is effective in idiopathic nephrotic patients.
- This combination significantly reduces CsA costs and enhances treatment efficacy.
- The approach may improve patient outcomes and reduce healthcare expenses.
Background:
The deliberate use of ketoconazole to reduce the need for cyclosporine (CsA) is not new, but it is particularly relevant because of the high cost of CsA. Many studies have documented this benefit in renal and cardiac transplants, but this co-administration has not been reported in patients with nephrotic syndrome.
Methods:
This retrospective study included 207 nephrotic patients who were steroid resistant, dependent or frequent relapsers and received CsA therapy. Among these patients 153 received daily ketoconazole therapy in a dose of 50 mg with concomitant decrease of one-third of the CsA dose while 54 patients received CsA alone. The majority of our cases were children (179 were below 18 years) and male to female ratio was 1.7:1.
Results:
The great majority of the study population received the drugs for 1-2 years. Patients who received CsA and ketoconazole were comparable with those who received CsA alone regarding age, sex, duration of renal disease, renal pathology, severity of nephrotic syndrome, renal function, hepatic function and steroid response. Co-administration of ketoconazole significantly reduced mean doses of CsA by 37% after 1 month and 47% at 1 year with overall net cost savings of 37%. Hepatic functions remained within the normal range in both groups. Additionally, co-administration of ketoconazole significantly improved the response to CsA therapy, successful steroid withdrawal and decreased the frequency of renal impairment.
Conclusions:
Co-administration of keto with CsA in idiopathic nephrotic patients significantly reduces CsA costs and may improve its response.
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