Conversion to tacrolimus extended-release formulation: short-term clinical results.
OBJECTIVE
To determine the short-term clinical results of conversion of treatment from tacrolimus twice daily (BID TAC) to the extended-release formulation (OD TAC), milligram for milligram, and whether such conversion is safe in stable kidney transplant recipients.


METHODS
The study included 38 kidney transplant recipients (median [SD] age, 54.3 [14.4] years) with stable renal function (mean [SD] serum creatinine concentration 1.29 [0.38] mg/dL). Posttransplantation follow-up was 3.4 (3.1) years (range, 4-168 months). All patients had been receiving BID TAC (2.45 [1.52] mg/d) when treatment was converted to OD TAC, milligram for milligram. Follow-up including clinical evaluation and laboratory tests was at 7, 21, and 90 days postconversion.


RESULTS
No significant differences were observed during follow-up in serum creatinine concentration, blood glucose level, hemoglobin level, or proteinuria. There were no episodes of acute rejection. No de novo posttransplantation diabetes mellitus was diagnosed; patients with diabetes required similar dosage of hypoglycemia treatment. Arterial pressure remained stable without changes in antihypertension treatment. Tacrolimus doses were not modified (2.45 [1.52] mg/d at baseline vs 2.45 [1.67] mg/d at 3 months postconversion; however, tacrolimus concentration decreased significantly (7.6 [1.8] ng/mL at baseline vs 6.42 [1.13] ng/mL at 3 months postconversion. Reduction in tacrolimus concentration was more remarkable in patients receiving a dose of less than 0.025 mg/kg/d.


CONCLUSIONS
Conversion from BID TAC to OD TAC, milligram for milligram, is clinically safe; however, monitoring of tacrolimus concentration in patients receiving low dosage is mandatory to prevent subtherapeutic levels.
Gallego-Valcarce
E
E
Nephrology Department, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
Ortega-Cerrato
A
A
Llamas-Fuentes
F
F
Martinez-Fernandez
G
G
Perez-Martinez
J
J
Gomez-Roldan
C
C
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure; D003404:Creatinine / Q000097:blood; D003692:Delayed-Action Preparations; D048909:Diabetes Complications; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D006973:Hypertension / Q000150:complications; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology* / Q000502:physiology; D008875:Middle Aged; D016559:Tacrolimus / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*
D000305:Adrenal Cortex Hormones; D001786:Blood Glucose; D003692:Delayed-Action Preparations; D006454:Hemoglobins; D007166:Immunosuppressive Agents; D003404:Creatinine; D016559:Tacrolimus