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Copyright © 2005 by American Society of Health-System Pharmacists
Reports |
Cyclosporine-sparing effects of daclizumab in renal allograft recipients
GORDON R. INGLE, PHARM.D., BCPS, is transplant specialist, Department of Pharmacy, St. Vincent Medical Center, Los Angeles, CA, and Assistant Clinical Professor, School of Pharmacy, University of Southern Nevada, Henderson. ASHA MOUDGIL, M.D., is Associate Professor of Pediatrics, Department of Nephrology, Children’s National Medical Center, Washington, DC. ASHLEY VO, PHARM.D., is Transplant Pharmacist and STANLEY C. JORDAN, M.D., is Medical Director, Renal Transplantation and Transplant Immunology, Department of Renal Transplantation and Transplant Immunology, Cedars-Sinai Health System.
Address correspondence to Dr. Ingle at the Department of Pharmacy, St. Vincent Medical Center, 2131 West 3rd Street, Los Angeles, CA 90057 (gordoningle{at}dochs.org).
Methods. Patients receiving their first renal transplant received daclizumab 1 mg/kg every 14 days for a total of five doses, mycophenolate mofetil 1 g twice daily, corticosteroids per the institution’s routine protocol, and half of the institution’s usual cyclosporine dosage. Trough cyclosporine concentrations targeted were half the customary goals, or 150–200 ng/mL for the first six months and 125–175 ng/mL for months 7–12. A retrospective control group included 15 matched patients who had received full-dose cyclosporine, mycophenolate mofetil, and corticosteroids without daclizumab induction therapy.
Results. Thirty patients were studied (15 in each group). At baseline, the control group had a significantly lower panel reactive antibody level (0.13%) than the treatment group (5.2%) (p = 0.01). Mean cyclosporine concentrations at 1, 6, and 12 months were significantly lower in the treatment group (p < 0.0001). No patient in either group had an acute rejection episode. All control patients had cyclosporine-associated adverse effects, compared with seven treatment-group patients (p = 0.0022). The treatment group had 19 infections, versus 29 in the control group (p = 0.39). Three study-group patients and eight control patients required a fine-needle aspiration or biopsy (p = 0.13).
Conclusion. Among kidney transplant patients at low risk of acute rejection, those treated with daclizumab and low-dose cyclosporine had an identical rate of acute rejection (none) and fewer cyclosporine-associated adverse effects compared with patients in a retrospective control group who received full-dose cyclosporine without daclizumab.
Index terms: Blood levels; Combined therapy; Cyclosporine; Daclizumab; Dosage; Graft rejection; Immunosuppressive agents; Mycophenolate mofetil; Steroids, cortico-; Toxicity; Transplantation
Purpose. The safety and efficacy of reduced-dose cyclosporine in renal transplantation were studied.
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