The use of a cyclosporin-ketoconazole combination: making renal transplantation affordable in developing countries.
OBJECTIVE
The costs of immunosuppressive drugs in renal transplant recipients remains prohibitively high. Ketoconazole (KZ) has, in limited studies, been shown to significantly reduce the dose of cyclosporin (CyA) after renal transplantation. We report our long-term experience with the use of KZ in a large group of renal transplant recipients. Although this study was not a formal health economic assessment, we undertook a cost-saving analysis of the CyA-KZ combination usage.


METHODS
The 170 patients (174 transplants) undergoing renal transplantation between 1991 and 1997 included in the study received CyA (10 mg/kg/day), prednisone (30 mg/day) and azathioprine (100 mg/day) in the immediate perioperative period. At 1 month post-transplantation, KZ (100 mg twice daily) was added and the CyA dose reduced to 25% and the prednisone dose to 50%. The CyA dose was adjusted to maintain trough levels of 150-200 ng/ml.


RESULTS
There was an 85% reduction in the dose of CyA. The average costs were 10.61 pounds sterling for CyA alone compared with pound 2.26 (pounds sterling) for the CyA-KZ combination, which represents an average savings of 8.35 pounds sterling (79%) per patient per day. The estimated savings during the study period was 999,930 pounds sterling. The patient and graft survival for patients receiving KZ was similar to patients on the South African Dialysis and Transplant Registry. Graft survival was significantly worse in black patients.


CONCLUSIONS
The use of KZ with CyA in renal transplant recipients with stable allograft function results in a significant reduction in the dose of CyA and a significant cost savings, without compromising patient or graft survival. The regimen may be useful in countries with limited resources.
Gerntholtz
T
T
Department of Medicine, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.
Pascoe
M D
MD
Botha
J F
JF
Halkett
J
J
Kahn
D
D
D000293:Adolescent; D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use*; D003906:Developing Countries / Q000191:economics*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006085:Graft Survival / Q000187:drug effects / Q000502:physiology; D006801:Humans; D007654:Ketoconazole / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000191:economics* / Q000208:ethnology / Q000401:mortality; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D013019:South Africa; D016019:Survival Analysis; D013997:Time Factors; D000637:Transaminases / Q000097:blood
D004338:Drug Combinations; D016572:Cyclosporine; D000637:Transaminases; D007654:Ketoconazole