Graft function, cardiovascular risk factors, and sex hormones in renal transplant recipients on an immunosuppressive regimen of everolimus, reduced dose of cyclosporine, and basiliximab.
A prospective, randomized trial evaluated the combination of everolimus of 1.5 or 3 mg/d with steroids, basiliximab, and low-dose cyclosporine (CsA) adjusted by C2 monitoring in 256 renal transplant recipients. CsA C2 target levels, initially set at 600 ng/mL, were tapered over time posttransplant. The median serum creatinine concentrations were 130 mumol/L in both sirolimus groups (1.5 and 3 mg/d) at 6 months. Biopsy-proven acute rejection (BPAR) occurred in 13.7% and 15.1% of patients in the 1.5 and 3 mg/d groups, respectively. The incidence of BPAR was significantly higher among patients with everolimus trough levels < 3 ng/mL. Posttransplant diabetes mellitus occurred rarely, and blood pressure control appeared favorable; however, serum cholesterol levels were increased by approximately 50%, and serum triglycerides by approximately 100%. Serum testosterone concentrations increased after renal transplantation in both everolimus groups. Concentration-controlled everolimus therapy combined with low-dose CsA provides effective protection against rejection with good renal function and safety profiles.
Krämer
B K
BK
Transplant Centre Regensburg, Regensburg, Germany. bernhard.kraemer@klinik.uni-regensburg.de
Neumayer
H-H
HH
Stahl
R
R
Pietrzyk
M
M
Krüger
B
B
Pfalzer
B
B
Bourbigot
B
B
Campbell
S
S
Whelchel
J
J
Eris
J
J
Vitko
S
S
Budde
K
K
D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000077552:Basiliximab; D001794:Blood Pressure; D002318:Cardiovascular Diseases / Q000453:epidemiology*; D016572:Cyclosporine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D012739:Gonadal Steroid Hormones / Q000097:blood*; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007239:Infections / Q000453:epidemiology; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000276:immunology / Q000502:physiology*; D008297:Male; D011183:Postoperative Complications / Q000145:classification / Q000453:epidemiology*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D012307:Risk Factors; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D012739:Gonadal Steroid Hormones; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D000068338:Everolimus; D020123:Sirolimus