title: Controlled randomized study comparing the cardiovascular profile of everolimus with tacrolimus in renal transplantation.
abstract: Left ventricular hypertrophy (LVH) regression after kidney transplantation may be influenced by immunosuppression. In a 24-month open-label, multicenter, phase-IV study, 71 kidney allograft recipients without previous acute rejection, showing eGFR >40 ml/min and proteinuria <500 mg/day and between 6 months and 3 years post-transplantation, were randomized to receive everolimus (EVR) + mycophenolic acid (MPA) or were maintained on tacrolimus (TAC) + MPA. The aim was to assess whether the conversion to EVR could reduce left ventricular mass index (LVMi) at month-24. LVMi at month-24 decreased without differences between groups (TAC: 54.0 vs. 48.2 g/m2.7; EVR: 53.4 vs. 49.4 g/m2.7). The LVH prevalence at baseline and month-24 was 59.4% and 40.6% in TAC group and 57.1% and 50.0% in EVR group. EVR conversion was associated with nearly disappearance of concentric LVH and concentric remodeling pattern. The procollagen type I N-terminal propeptide at month-24 showed greater reduction in EVR group (51.6 vs. 58.2 mg/l; P = 0.004). Conversion from TAC to EVR was associated with a significant improvement of eGFR (P = 0.0315, ancova). Adverse events were similar between groups without rejection episode or graft loss. Conversion from TAC to EVR did not further reduce LVMi after 24 months, although its effect on concentric LVH deserves further investigation (NCT01169701).
authors.affiliation: Nephrology Department, IDIBELL, Hospital de Bellvitge, Barcelona, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Cruzado
authors.affiliation: Nephrology Department, Hospital del Mar, Barcelona, Spain.
authors.forename: Julio
authors.initials: J
authors.lastname: Pascual
authors.affiliation: Nephrology Department, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Sánchez-Fructuoso
authors.affiliation: Nephrology Department, Hospital Vall Hebron, Barcelona, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Serón
authors.affiliation: Nephrology Department, Fundació Puigvert, Barcelona, Spain.
authors.forename: Joan M
authors.initials: JM
authors.lastname: Díaz
authors.affiliation: Nephrology Department, Hospital Gregorio Marañón, Madrid, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Rengel
authors.affiliation: Kidney Transplant Department, Hospital Clínic i Provincial de Barcelona, Barcelona, Spain.
authors.forename: Federico
authors.initials: F
authors.lastname: Oppenheimer
authors.affiliation: Nephrology Department, Hospital Carlos Haya, Málaga, Spain.
authors.forename: Domingo
authors.initials: D
authors.lastname: Hernández
authors.affiliation: Medical Department, Novartis Farmacéutica, Barcelona, Spain.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Paravisini
authors.affiliation: Medical Department, Novartis Farmacéutica, Barcelona, Spain.
authors.forename: Núria
authors.initials: N
authors.lastname: Saval
authors.affiliation: Nephrology Department, Hospital 12 Octubre, Madrid, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Morales
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000378:metabolism; D001794:Blood Pressure; D016903:Drug Monitoring; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival; D006352:Heart Ventricles / Q000601:surgery; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage*; D061214:Patient Safety; D051437:Renal Insufficiency / Q000601:surgery*; D012307:Risk Factors; D016559:Tacrolimus / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D015415:Biomarkers; D007166:Immunosuppressive Agents; D000068338:Everolimus; D009173:Mycophenolic Acid; D016559:Tacrolimus
keywords: cardiovascular profile; everolimus; left ventricular hypertrophy; tacrolimus