title: First experience with de novo calcineurin-inhibitor-free immunosuppression following cardiac transplantation.
abstract: The aim of this pilot study was to investigate whether de novo calcineurin-inhibitor-free immunosuppression after cardiac transplantation is efficacious and can prevent post-operative renal impairment. Eight patients were treated by combining trough level adjusted sirolimus and mycophenolate mofetil; corticosteroids were given for the first 6 post-operative months only. Survival data, acute rejection episodes and adverse events with a special emphasis on renal impairment, myelosuppression, hypercholesterolemia, hypertriglyceridemia and infections, were recorded. With a follow-up of 3-12 months, patient survival was 100% and freedom from rejection 75%. The mean creatinine levels initially decreased and remained stable thereafter. A moderate myelosuppressive effect did not necessitate dose reduction of immunosuppressants, intermittently elevated cholesterol- and triglyceride levels decreased over time. Most frequent adverse events were pericardial effusions and peripheral edema. Complete abandonment of calcineurin inhibitor therapy by de novo use of the combination sirolimus/mycophenolate mofetil resulted in low rejection rate and avoidance of renal impairment, but should not be used without further evaluation of potential complications in a lager setting.
authors.affiliation: Department of Cardiac Surgery, University of Munich, Grosshadern Medical Center, Marchioninistrasse, Munich, Germany. bruno.meiser@hch.med.uni-muechen.de
authors.forename: Bruno
authors.initials: B
authors.lastname: Meiser
authors.forename: Bruno
authors.initials: B
authors.lastname: Reichart
authors.forename: Ioannis
authors.initials: I
authors.lastname: Adamidis
authors.forename: Peter
authors.initials: P
authors.lastname: Uberfuhr
authors.forename: Ingo
authors.initials: I
authors.lastname: Kaczmarek
mesh_terms: D000328:Adult; D065095:Calcineurin Inhibitors; D003404:Creatinine / Q000097:blood; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology*; D007668:Kidney / Q000187:drug effects; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D051437:Renal Insufficiency / Q000517:prevention & control*
chemical_list: D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D008055:Lipids; D003404:Creatinine