Two-year experience with tacrolimus in renal transplantation after late conversion from cyclosporine therapy. 2009

C O Videla
Department of Nephrology, Dr Gustavo Fricke Hospital, Viña de Mar, Valparaíso, Chile. chvidelao@sodinef.tie.cl.Chile

BACKGROUND Calcineurin inhibitors are associated with chronic allograft nephropathy. Protocols to reverse nephrotoxicity incorporate dosage reduction or withdrawal of these agents. Using ketoconazole as a sparing agent with mean cyclosporine doses of less than 50 mg/d, we have usually observed adverse cosmetic effects. One cohort of patients exhibited severe gingival hyperplasia that required gum resection; some also had hypertricosis. OBJECTIVE To evaluate the effects of conversion from cyclosporine (CsA) to a tacrolimus generic formulation (TAC) in patients with adverse cosmetic effects from CsA. METHODS Twenty-three patients were studied at a mean (SD) of 56 (48) months posttransplantation; serum creatinine concentration was 1.91 (0.68) mg/dL. All had eyebrow and facial hypertricosis, and 10 also had gum hyperplasia. Cyclosporine C0 or C2 levels and CsA dosage had previously been changed simultaneously with ketoconazole. The day after withdrawal of CsA, TAC therapy was started at a dose of 0.065 to 0.030 mg/kg/d. Patients were followed up for 18 months (12.76 [7.57]) with routine laboratory tests. RESULTS Twenty patients without proteinuria demonstrated improved renal function at 1-month follow-up; serum creatinine concentration was 1.76 (0.42) mg/dL vs 1.47 (0.37) mg/dL (P < .02). Levels of tacrolimus were 13.82 (7.95) ng/mL at 15 days and 7.3 (3.5) ng/mL at 2 months after the dosage was decreased to 0.042 mg/kg/d. Gum hypertrophy and hypertrichosis resolved in all patients. One patient died 18 months after conversion of cardiovascular disease and chronic allograft nephropathy. Neither diabetes nor dislipidemia were noted. CONCLUSIONS Generic TAC is a good therapeutic alternative in renal transplant recipients with adverse reactions to CsA.

UI MeSH Term Description Entries
D006965 Hyperplasia An increase in the number of cells in a tissue or organ without tumor formation. It differs from HYPERTROPHY, which is an increase in bulk without an increase in the number of cells. Hyperplasias
D007166 Immunosuppressive Agents Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. Immunosuppressant,Immunosuppressive Agent,Immunosuppressants,Agent, Immunosuppressive,Agents, Immunosuppressive
D007654 Ketoconazole Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients. Nizoral,R-41400,R41,400,R41400,R 41400
D007677 Kidney Function Tests Laboratory tests used to evaluate how well the kidneys are working through examination of blood and urine. Function Test, Kidney,Function Tests, Kidney,Kidney Function Test,Test, Kidney Function,Tests, Kidney Function
D008055 Lipids A generic term for fats and lipoids, the alcohol-ether-soluble constituents of protoplasm, which are insoluble in water. They comprise the fats, fatty oils, essential oils, waxes, phospholipids, glycolipids, sulfolipids, aminolipids, chromolipids (lipochromes), and fatty acids. (Grant & Hackh's Chemical Dictionary, 5th ed) Lipid
D008297 Male Males
D001786 Blood Glucose Glucose in blood. Blood Sugar,Glucose, Blood,Sugar, Blood
D001794 Blood Pressure PRESSURE of the BLOOD on the ARTERIES and other BLOOD VESSELS. Systolic Pressure,Diastolic Pressure,Pulse Pressure,Pressure, Blood,Pressure, Diastolic,Pressure, Pulse,Pressure, Systolic,Pressures, Systolic
D002102 Cadaver A dead body, usually a human body. Corpse,Cadavers,Corpses
D003404 Creatinine Creatinine Sulfate Salt,Krebiozen,Salt, Creatinine Sulfate,Sulfate Salt, Creatinine

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