Everolimus with reduced-dose cyclosporine versus full-dose cyclosporine and mycophenolate in de novo renal transplant patients: a 2-year single-center experience.
BACKGROUND
Although calcineurin inhibitors (CNIs) has improved short-term graft survival, long-term function remains a challenge. CNIs have been implicated in the development of chronic allograft failure. Low-dose cyclosporine with everolimus may mitigate CNI nephrotoxicity and prolong graft survival. We compared the efficacy and safety of de novo everolimus with low-dose cyclosporine and prednisone versus cyclosporine, mycophenolate, and prednisone among kidney transplant patients up to 24 months after transplantation.


METHODS
Kidney transplant patients given low-dose cyclosporine, everolimus, and prednisone were compared with patients given cyclosporine, mycophenolate, and prednisone from December 2006 to December 2008. All had living donors, panel reactive antibody <15%, and follow-up for 2 years after transplantation. Continuous variables using mean and standard deviation, t test and test for proportions were used to determine significant differences between the baseline characteristics of the 2 treatment groups. Generalized linear regression and logistic regression were used to measure the effect of treatment on outcomes.


RESULTS
Demographic characteristics were similar in both groups except for age, length of time awaiting kidney transplantation, type of renal replacement therapy, follow-up time, sex distribution, and number of HLA mismatches. These independent variables were used in the generalized linear regression model. There was no significant difference between the everolimus and mycophenolate groups up to 2 years in mean serum creatinine (1.2 mg/dL vs 1.4 mg/dL-, respectively P ≥ .05), acute rejection (12 months: 20% vs 31%; 24 months: 31% vs 40%; P ≥ .05), patient survival (98%), and graft survival (100%). Likewise, there were no significant differences in surgical, infectious, metabolic, and gastrointestinal side effects between the 2 groups.


CONCLUSIONS
Everolimus with low-dose cyclosporine and prednisone in de novo kidney transplant recipients was similar in efficacy and safety to cyclosporine, mycophenolate, and prednisone. Longer follow-up is needed to see whether everolimus with low-dose cyclosporine will result in improved kidney function.
Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.
S M
SM
Santos
C M
CM
Carlos
C B
CB
Cabanayan-Casasola
R A
RA
Danguilan
D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D016030:Kidney Transplantation / Q000276:immunology; D016014:Linear Models; D019520:Living Donors; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D010679:Philippines; D012189:Retrospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000068338:Everolimus; D009173:Mycophenolic Acid; D020123:Sirolimus