Cyclosporine minimization and cost reduction in renal transplant recipients receiving a C2-monitored, cyclosporine-based quadruple immunosuppressive regimen.
BACKGROUND
Targeting 2-hr postdose cyclosporine (C2) levels to 1,000 to 1,700 mg/dL during the first 6 months after renal transplantation is recommended for triple immunosuppressive regimens. This trial determines whether lower C2 levels could be targeted safely in de novo kidney transplant recipients under a quadruple regimen compared with a similar cohort monitored with trough (C0) levels.


METHODS
This single-center, sequential, cohort-designed trial included patients who received Thymoglobulin, corticosteroids, an antimetabolite, and cyclosporine monitored by C2 (n=50) or C0 (n=50). Cyclosporine was tapered to maintain the C2 between 1,000 and 1,200 ng/mL months 0 to 3 and between 600 and 1,000 ng/mL thereafter and C0 between 250 and 350 ng/mL months 0 to 3 and between 100 and 250 ng/mL thereafter.


RESULTS
Baseline patient and donor characteristics were similar. There were no differences in graft survival (100% C2 vs. 100% C0), acute rejection (4% C2 vs. 6% C0), allograft function, or adverse events at 6 months. C2 levels were lower than the suggested guidelines throughout the study (33% lower at 1 month and 48% lower at 6 months). Lower cyclosporine doses were achieved in the C2 arm compared with the C0 arm by 1 month and were sustained throughout the trial, which translated into an average cyclosporine cost savings of USD $773 in the C2 arm during the 6-month period (P<0.001).


CONCLUSIONS
With a quadruple immunosuppressive regimen and lower C2 targets than recommended for triple therapy, safe and effective cyclosporine minimization was achieved. Lower cyclosporine doses were achieved in C2-monitored patients compared with C0-monitored patients, translating into lower immunosuppressive costs.
Hardinger
Karen L
KL
Department of Pharmacy, Barnes-Jewish Hospital, Washington University, One Barnes-Jewish Hospital Plaza, St. Louis, MO 63110, USA.
Schnitzler
Mark A
MA
Koch
Matthew J
MJ
Enkvetchakul
Decha
D
Desai
Niraj
N
Jendrisak
Martin
M
Lowell
Jeffrey A
JA
Miller
Brent
B
Shenoy
Surendra
S
Brennan
Daniel C
DC
D000305:Adrenal Cortex Hormones / Q000191:economics / Q000627:therapeutic use; D000328:Adult; D000961:Antilymphocyte Serum / Q000191:economics / Q000627:therapeutic use; D000963:Antimetabolites / Q000191:economics / Q000627:therapeutic use; D015331:Cohort Studies; D003363:Cost Control; D016572:Cyclosporine / Q000008:administration & dosage* / Q000097:blood* / Q000191:economics / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D016527:Drug Costs; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000961:Antilymphocyte Serum; D000963:Antimetabolites; D007166:Immunosuppressive Agents; D016572:Cyclosporine