title: A randomized trial of steroid avoidance in renal transplant patients treated with everolimus and cyclosporine.
abstract: In this randomized trial renal transplant recipients were treated with basiliximab, everolimus 3 mg/day, low-dose CsA. At transplantation, patients were randomized to stop steroids at the seventh day (group A) or to continue oral steroids in low doses (group B). Of the 113 patients enrolled, 65 were randomized to group A and 68 to group B. All patients were followed for 2 years. During the study 28 (43%) group A patients required reintroduced corticosteroids. One patient died, in group B. The Graft survival rate was 97% in group A and 90% in group B. There were more biopsy-proven rejections in group A (32% vs 16%; P = .044). The mean creatinine clearance was 54 +/- 21 mL/min in group A vs 56 +/- 22 mL/min in group B. Mean levels of serum cholesterol tended to be lower in group A, but the difference was of borderline significance (191 +/- 91 vs 251 +/- 188 mg/dL; P = .07). Vascular thrombosis (0 vs 5) and pneumonia requiring hospitalization (2 vs 7) tended to be more frequent in group B. Only three cases of CMV infection (1 vs 2) occurred. An immunosuppressive therapy with everolimus and low-dose CsA allows one to obtain excellent renal graft survival and stable graft function at 2 years. Early interruption of steroids in patients treated with this regimen may increase the risk of acute rejection, but neither affects graft survival nor graft function, while possibly reducing the risk of hyperlipemia and vascular thrombosis. About 60% of patients given everolimus and low-dose CsA can definitively stop steroids after 1 week.
authors.affiliation: Department of Renal Transplant, University of Milano, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Montagnino
authors.forename: S
authors.initials: S
authors.lastname: Sandrini
authors.forename: C
authors.initials: C
authors.lastname: Casciani
authors.forename: F P
authors.initials: FP
authors.lastname: Schena
authors.forename: M
authors.initials: M
authors.lastname: Carmellini
authors.forename: G
authors.initials: G
authors.lastname: Civati
authors.forename: P
authors.initials: P
authors.lastname: Rigotti
authors.forename: M
authors.initials: M
authors.lastname: Cossu
authors.forename: P
authors.initials: P
authors.lastname: Altieri
authors.forename: M
authors.initials: M
authors.lastname: Salvadori
authors.forename: S
authors.initials: S
authors.lastname: Federico
authors.forename: S
authors.initials: S
authors.lastname: Stefoni
authors.forename: V
authors.initials: V
authors.lastname: Cambi
authors.forename: A
authors.initials: A
authors.lastname: Albertazzi
authors.forename: U
authors.initials: U
authors.lastname: Buoncristiani
authors.forename: P
authors.initials: P
authors.lastname: Berloco
authors.forename: G
authors.initials: G
authors.lastname: Segoloni
authors.forename: L
authors.initials: L
authors.lastname: Boschiero
authors.forename: V
authors.initials: V
authors.lastname: Sparacino
authors.forename: D
authors.initials: D
authors.lastname: Donati
authors.forename: E
authors.initials: E
authors.lastname: Turello
authors.forename: A
authors.initials: A
authors.lastname: Dal Canton
authors.forename: C
authors.initials: C
authors.lastname: Ponticelli
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000627:therapeutic use*; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006680:HLA Antigens / Q000276:immunology; D006650:Histocompatibility Testing; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000305:Adrenal Cortex Hormones; D006680:HLA Antigens; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000068338:Everolimus; D020123:Sirolimus