Single-centre first experience with everolimus and CSA for de novo heart transplant recipients

Everolimus is a proliferation signal inhibitor that allows for cyclosporin (CsA) dose reduction in heart transplantation (HTX) patients. We report the initial results of a single-centre experience with 20 de novo HTX patients treated with oral everolimus and CsA. Methods/materials: Each patient received everolimus 0.75 mgb. i.d. with weekly monitoring to ensure blood levels of 3–8 ng/mL and concomitant CsA with C0 target levels of 200–250 ng/mL (1 month), 175–200 ng/mL (2–3 months) and 135–150 ng/mL (4–6 months). Results: Mean CsA levels were 217 ng/mL (range: 194–368 ng/mL) at 2 weeks after HTX. These were reduced at 4 weeks to a mean level of 185 ng/mL (range: 170–262 ng/mL) and further reduced at 3 months to a mean level of 172 ng/mL (range: 114–225 ng/mL). Post-transplant everolimus troughs were 7.2 ng/mL (range: 3.5–13.1 ng/mL) at 2 weeks, 6.8 ng/mL (range: 3.2–12.1 ng/mL) at 4 weeks and 5.9ng/mL (range: 3.0–9.4 ng/mL) at 3 months. Mean creatinine levels were 1.6mg/dL (range: 0.8–2.5mg/dL) prior to HTX. Post-transplant, creatinine levels were 2.2mg/dL (range: 1.0–3.9mg/dL) at 2 weeks, 2.0mg/dL (range: 0.9–3.2mg/dL) at 4 weeks and 1.6mg/dL (range 0.6–2.4mg/dL) at 3 months. Non-invasive rejection monitoring using echocardiography and intramyocardial electrocardiography revealed that 28.5% of patients experienced rejection. Routine 4–6 weeks biopsy showed that 5/20 patients (25%) experienced acute rejection of maximum ISHLT grade 1A. Conclusions: Everolimus troughs were maintained within a range of 3–8ng/mL soon after the transplant with high patient compliance. CsA does was reduced, which did not lead to an increase in the number of reject.