Clinical Experience With Certican® (Everolimus) in De Novo Heart Transplant Patients at the Deutsches Herzzentrum Berlin

Multidisciplinary Insights on Clinical Guidance for the Use of Proliferation Signal Inhibitors in Heart Transplantation

“…6 The efficacy of everolimus and low-dose CsA in heart transplantation has been reported from single-center studies and from clinical experience. [7][8][9][10] The efficacy of everolimus and low-dose CsA is currently being assessed in a pilot clinical trial in maintenance heart transplant recipients, 11 and is also being compared with MMF and conventional CsA in a large, randomized clinical trial in de novo cardiac allograft recipients. 12 In addition, there is growing clinical experience with everolimus and low-dose tacrolimus, with preliminary data suggesting improvement of long-term renal function after substantial CNI reduction.…”

Observational Study With Everolimus (Certican) in Combination With Low-dose Cyclosporine in De Novo Heart Transplant Recipients

“…Steroids (prednisolone 1 mg/kg) were tapered to 0.1 mg/kg by Month 12 and fluvastatin 40 to 80 mg/day was introduced, in accordance with our standard practice. 14 Using mass spectrometry, everolimus trough (C0) blood levels were routinely monitored twice weekly or 5 to 7 days after dose changes, because the steady state of everolimus is reached within 4 days. CsA C0 blood levels were measured daily until the patient was discharged from the hospital.…”

Recommendations for the Use of Everolimus (Certican) in Heart Transplantation: Results From the Second German–Austrian Certican Consensus Conference

“…10,[13][14][15] A combination of reduced-dose CsA and everolimus was not associated with an increased risk of biopsy-proven acute rejection (BPAR) in seven de novo heart transplant recipients, with two patients experiencing clinically insignificant BPAR (Grade 1A), which was easily treated with a temporarily increased corticosteroid dose. 13 The concomitant administration of everolimus and CNI in the first year after heart transplantation is necessary to maintain adequate immunosuppression. If no severe rejection episodes occurred within this period, CNI doses can be reduced to CsA C0 blood levels of 120 to 150 ng/ml after 3 months, and to target levels of 100 ng/ml after 6 months.…”

“…Co-medication of low-dose CsA and everolimus might be feasible to normalize elevated blood pressure. [13][14][15]35 Interstitial Pneumonia…”

“…46 There are have been many studies showing that use of everolimus plus CNI is efficacious in heart and renal transplantation. 10,[13][14][15][16]35,45,[47][48][49][50][51][52] We have been able to provide the first results of CNI-free immunosuppression using everolimus in 60 maintenance heart transplant recipients over a 9-month period. 53 Primary end-points were renal function and arterial hypertension, and secondary end-points were tremor, hirsutism, peripheral edemas and gingival hyperplasia.…”