|Title:||Everolimus versus mycophenolate mofetil in heart transplantation: A randomized, multicenter trial||Authors:||Eisen H.J.
Van Bakel A.
|Issue Date:||2013||Journal Volume:||13||Journal Issue:||5||Start page/Pages:||1203-1216||Source:||American Journal of Transplantation||Abstract:||
In an open-label, 24-month trial, 721 de novo heart transplant recipients were randomized to everolimus 1.5 mg or 3.0 mg with reduced-dose cyclosporine, or mycophenolate mofetil (MMF) 3 g/day with standard-dose cyclosporine (plus corticosteroids ± induction). Primary efficacy endpoint was the 12-month composite incidence of biopsy-proven acute rejection, acute rejection associated with hemodynamic compromise, graft loss/retransplant, death or loss to follow-up. Everolimus 1.5 mg was noninferior to MMF for this endpoint at month 12 (35.1% vs. 33.6%; difference 1.5% [97.5% CI: -7.5%, 10.6%]) and month 24. Mortality to month 3 was higher with everolimus 1.5 mg versus MMF in patients receiving rabbit antithymocyte globulin (rATG) induction, mainly due to infection, but 24-month mortality was similar (everolimus 1.5 mg 10.6% [30/282], MMF 9.2% [25/271]). Everolimus 3.0 mg was terminated prematurely due to higher mortality. The mean (SD) 12-month increase in maximal intimal thickness was 0.03 (0.05) mm with everolimus 1.5 mg versus 0.07 (0.11) mm with MMF (p < 0.001). Everolimus 1.5 mg was inferior to MMF for renal function but comparable in patients achieving predefined reduced cyclosporine trough concentrations. Nonfatal serious adverse events were more frequent with everolimus 1.5 mg versus MMF. Everolimus 1.5 mg with reduced-dose cyclosporine offers similar efficacy to MMF with standard-dose cyclosporine and reduces intimal proliferation at 12 months in de novo heart transplant recipients. In this study comparing cardiac transplant recipients receiving one of two doses of everolimus with reduced dose cyclosporine to patients receiving mycophenolate mofetil with standard dose cyclosporine, the authors find no effect on acute cellular rejection, modestly reduced renal function, and a reduction in the incidence and severity of lesions defined by intravascular ultrasound. See editorial by Mehra on page 1119. ? 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.
|ISSN:||1600-6135||DOI:||10.1111/ajt.12181||metadata.dc.subject.other:||cyclosporin; everolimus; mycophenolic acid 2 morpholinoethyl ester; adult; anemia; article; bacterial infection; cardiac graft rejection; constipation; controlled study; coughing; cytomegalovirus infection; death; diabetes mellitus; diarrhea; drug fever; drug induced headache; dyspnea; female; heart transplantation; human; hyperlipidemia; hypertension; immunosuppressive treatment; incidence; insomnia; interstitial lung disease; leukopenia; major clinical study; male; mouth ulcer; multicenter study; mycosis; nausea; neoplasm; neutropenia; pericardial effusion; peripheral edema; pleura effusion; priority journal; proteinuria; randomized controlled trial; stomatitis; thrombocytopenia; thrombotic thrombocytopenic purpura; tremor; wound healing; Acute Disease; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; Asia; Australia; Biopsy; Dose-Response Relationship, Drug; Europe; Female; Follow-Up Studies; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Mycophenolic Acid; Myocardium; North America; Prospective Studies; Sirolimus; South America; Treatment Outcome; Ultrasonography, Interventional
|Appears in Collections:||醫學系|
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