BACKGROUND: In a prospective, randomized study, we previously proved the safety and financial benefits of the coadministration of ketoconazole (keto) and cyclosporine A (CsA) in patients. We report the 10-year follow-up of these patients and the controls. PATIENTS AND METHODS: In January 1992, 100 living-related kidney transplant recipients were randomized into two groups: Group 1 (51 patients) received 100 mg/day keto, and group 2 (49 patients) did not receive keto (control). Both groups were evaluated regarding graft function, CsA dose and levels, liver function tests, serum calcium and phosphorus, bone mineral density, and histopathologic assessment. RESULTS: Follow-up for 10 years showed that CsA dose reduction was maximum after 1 month (76.5%) and decreased gradually after 10 years (64.6%). Acute rejection was diagnosed in 22% and 27% in the keto and control groups, respectively (P =0.27). In the control group, the acute rejection episodes were more frequent with poorer response to treatment. Chronic allograft nephropathy was statistically significantly less in the keto group. Hepatotoxicity and metabolic complications were similar in both groups. The annual cost saving of CsA was 60% after 1 year and 50% at the end of the study. CONCLUSIONS: We conclude that the long-term use of keto for CsA dose reduction in kidney transplant recipients is safe, tolerable, and cost-sparing and is associated with stable graft function.
RCT Entities:
BACKGROUND: In a prospective, randomized study, we previously proved the safety and financial benefits of the coadministration of ketoconazole (keto) and cyclosporine A (CsA) in patients. We report the 10-year follow-up of these patients and the controls. PATIENTS AND METHODS: In January 1992, 100 living-related kidney transplant recipients were randomized into two groups: Group 1 (51 patients) received 100 mg/day keto, and group 2 (49 patients) did not receive keto (control). Both groups were evaluated regarding graft function, CsA dose and levels, liver function tests, serum calcium and phosphorus, bone mineral density, and histopathologic assessment. RESULTS: Follow-up for 10 years showed that CsA dose reduction was maximum after 1 month (76.5%) and decreased gradually after 10 years (64.6%). Acute rejection was diagnosed in 22% and 27% in the keto and control groups, respectively (P =0.27). In the control group, the acute rejection episodes were more frequent with poorer response to treatment. Chronic allograft nephropathy was statistically significantly less in the keto group. Hepatotoxicity and metabolic complications were similar in both groups. The annual cost saving of CsA was 60% after 1 year and 50% at the end of the study. CONCLUSIONS: We conclude that the long-term use of keto for CsA dose reduction in kidney transplant recipients is safe, tolerable, and cost-sparing and is associated with stable graft function.
Authors: Songmao Zheng; Yasar Tasnif; Mary F Hebert; Connie L Davis; Yoshihisa Shitara; Justina C Calamia; Yvonne S Lin; Danny D Shen; Kenneth E Thummel Journal: Transplantation Date: 2013-03-27 Impact factor: 4.939
Authors: John M Kovarik; Hsun-Lun A Huang; Alan Slade; Nikos Sfikas; Patricia A Chandler Journal: Br J Clin Pharmacol Date: 2009-09 Impact factor: 4.335