First Experience with de novo Calcineurin‐Inhibitor‐Free Immunosuppression Following Cardiac Transplantation

• Published in: American journal of transplantation Vol. 5; no. 4; pp. 827 - 831
• Main Authors: Meiser, Bruno, Reichart, Bruno, Adamidis, Ioannis, Überfuhr, Peter, Kaczmarek, Ingo
• Format: Journal Article
• Language: English
• Published: Oxford, UK Munksgaard International Publishers 01.04.2005; Blackwell
• Subjects: Adult; Biological and medical sciences; Calcineurin Inhibitors; Calcineurin‐inhibitor‐free immunosuppression; cardiac transplantation; Cardiology. Vascular system; Creatinine - blood; Diseases of the pericardium; Disorders of blood lipids. Hyperlipoproteinemia; Female; Graft Rejection - prevention & control; Heart; Heart Transplantation; Humans; Immunosuppressive Agents - pharmacology; Kidney - drug effects; Lipids - blood; Male; Medical sciences; Metabolic diseases; Middle Aged; Nephrology. Urinary tract diseases; Nephropathies. Renovascular diseases. Renal failure; Renal failure; renal impairment; Renal Insufficiency - prevention & control; Heart; Mofetil; Graft(material); Mycophenolic acid; Cardiovascular disease; Homotransplantation; Macrocycle; Heart disease; Surgery; Secondary effect; Graft; Dyslipemia; renal impairment; Human; Corticosteroid; Urinary system disease; Macrolide; Survival; De novo; Infection; Immunosuppression; Hypercholesterolemia; Nephropathy; Renal failure; Pericardial disease; Immunosuppressive agent; Prognosis; Calcineurin inhibitor; Sirolimus; Toxicity; cardiac transplantation; Hyperlipoproteinemia; Transplantation; Enzymopathy; Prevention; Myelosuppression; Kidney disease; Creatinine; Postoperative; Acute; Lactone; Metabolic diseases; Rejection; Treatment; Follow up study; Hypertriglyceridemia; Calcineurin-inhibitor-free immunosuppression; Circulatory system; Mycophenolate mofetil
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/j.1600-6143.2005.00757.x

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.