Cyclosporine and low-dose ketoconazole in renal transplant recipients: a single-center experience.

BACKGROUND

The high cost of cyclosporine A (CsA) is an impediment for low-income patients. Previous studies have used ketoconazole at doses between 200 and 400 mg/day to lower CsA consumption.

METHODS

Ketoconazole and CsA were administered prospectively to renal transplant patients. Patients treated historically with CsA were used as a reference group. At different intervals posttransplant, clinical and laboratory data were recorded.

RESULTS

The reference group (n=14) was treated with CsA from 1992 to 1997 and the CsA plus ketoconazole group (n=17) from 1998 to 2002. Follow-up was 76+/-22 and 29+/-14 months, respectively. CsA doses throughout the study were 4.0+/-1.3 and 1.6+/-0.6 mg/kg/day (a 60% reduction, P =0.00). Trough levels of CsA were 194+/-87 and 193+/-69 ng/mL, respectively. The ketoconazole dose was 54+/-17 mg/day. The monthly cost of CsA was reduced by 60%, including the cost of ketoconazole.

CONCLUSIONS

CsA with ketoconazole resulted in a substantial dose and cost reduction that proved safe and effective.