Everolimus in different combinations as maintenance immunosuppressive therapy in heart transplant recipients

OBJECTIVES: We examined the experiences of heart transplant recipients receiving everolimus as maintenance therapy in different combinations over a long time. MATERIALS AND METHODS: Between 2004 and 2009, forty patients (29 men, 11 women; mean age, 51.6 y) were switched from a routine immunosuppressive regimen to everolimus. Indications were other (2), renal insufficiency (17), cardiac allograft vasculopathy (14), and ongoing cellular rejection (7). Combinations were either along with cyclosporine (24), mycophenolate mofetil (14), or others (2). Indications for the introduction of everolimus including safety, efficacy, different combinations of everolimus, biopsy-proven acute rejections, renal function, and infections were evaluated retrospectively. RESULTS: Five patients died, 4 of them were still on everolimus at the time of death; they died from intracerebral hemorrhage (1), embolism (1), cardiac arrest (2), and unknown (1). Everolimus was discontinued in 6 patients owing to severe adverse effects: Edema (2), gastrointestinal adverse effects (3), and dermal adverse effects (1). Mean everolimus trough levels were 5.8 μmol/L at 6 months and 4.9 at 60 months. Mean cyclosporine levels were 67.62 μmol/L at 6 months and 47.3 μmol/L at 60 months. Mean serum creatinine levels were stable (147.9 μmol/L after 60 months). Four life-threatening infections (all pneumonia) occurred but resulted in complete recovery. CONCLUSIONS: Everolimus is safe with different immunosuppressive combinations after receiving a heart transplant