50: Everolimus (Certican) after Heart Transplantation: 2 Years' Single Center Follow-Up in Calcineurin Inhibitor-Free Immunosuppression (original) (raw)

2010, Journal of Heart and Lung Transplantation

Purpose: Everolimus is a proliferation signal inhibitor introduced for heart transplantion in 2004. This study reports the 2 years' results of CNI-free immunosuppression using everolimus after HTx. There is only sparse data on this issue. Methods and Materials: Patients after HTx being switched to everolimus due to CNI-induced adverse drug effects as deterioration of kidney function and recurrent rejections were continuously enrolled. 60 pats underwent standardized switching protocols, 42 pats completed 24-months follow-up. Blood was sampled for lipid status, renal function, and levels of everolimus. On days 0, 14, 28, and then every 3 months, echocardiography and physical examination were performed. Biopsies were carried out only if rejection was suspected. An angiogram and a myocardial scintigraphy were performed before and 1 year after switching. Results: After switching to everolimus, most pats recovered from the side effects associated with CNIs. Renal function improved significantly after 12 months and after 24 months (creatinine: 2.1Ϯ0.6 vs. 1.8Ϯ1 mg/dL, PϽ0.001; creatinine clearance: 41.8Ϯ22 vs. 48.6Ϯ21.8 mL/min, PϽ0.001 at baseline and 24 months). Tremor, peripheral edema, hirsutism, and gingival hyperplasia markedly improved. Levels of interleukin 6 where stable when comparing baseline and 24 months. Temporary adverse events occurred in 62 cases (84% of them light adverse events [light: skin disorders (acne) (nϭ23), edema (nϭ11), lipometabolic disorders (nϭ10), other (nϭ2); moderate/severe: influenzal infection (nϭ6), pneumonia (nϭ6), rejection (nϭ1), other (nϭ4).] There were no relevant signs for deterioration of heart function in echocardiograms, angiograms and scintigrams. Conclusions: CNI-free immunosuppression using everolimus is safe, with excellent efficacy and acceptance after HTX. Renal function significantly improved. CNI-induced side effects such as tremor and peripheral edema markedly improved in most patients. Everolimus prevents long term morbidity after HTX and possibly improves quality of live.