The impact of sirolimus on hormone levels involved in the hypothalamus-pituitary-gonad axis in male heart transplant recipients was investigated.A pair-matched analysis with 132 male heart transplant recipients on either sirolimus based-or calcineurin inhibitor-based immunosuppression was performed. Matching criteria were age, years after transplantation and creatinine levels. Measured parameters were testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), sexual hormone-binding globulin (SHBG) and free androgen index (FAI).Mean testosterone was 3.86 ± 1.41 ng/mL in the sirolimus group and 4.55 ± 1.94 ng/mL in the controls (p = = 0.025). Serum LH was 12.82 ± 11.19 mlU/mL in the sirolimus patients and 6.2 ± 5.25 mlU/mL in the controls (p = = 0.015). Follicle stimulating hormone levels were 13.31 ± 18.4 mlU/mL vs. 7.32 ± 5.53 mlU/mL, respectively (p = = 0.015). The analysis revealed a significant decrease in testosterone and a significant increase in FSH and LH in the sirolimus group. The duration of sirolimus treatment correlated positively with SHBG (p < 0.01), LH (p < 0.05) and FSH (p < 0.05) and negative with the FAI (p < 0.05). Sirolimus trough levels correlated with LH and FSH levels (p < 0.01).Heart transplant recipients treated with sirolimus revealed significantly lower testosterone levels and a significant increase in gonadotropic hormones. These effects were trough-level dependent. All candidates awaiting organ transplantation should be informed about these adverse effects.

† Bruno Meiser and Bruno Reichart contributed equally to this studyThe 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.

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