Everolimus in different combinations as maintenance immunosuppressive therapy in heart transplant recipients.
OBJECTIVE
We examined the experiences of heart transplant recipients receiving everolimus as maintenance therapy in different combinations over a long time.


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.
Department for Surgery, Division for Transplantation Surgery, Medical University Graz, Graz, Austria. martin.schweiger@klinikum-graz.at
Martin
M
Schweiger
Philipp
P
Stiegler
Andreas
A
Puntschart
Michael
M
Sereinigg
Guenther
G
Prenner
Andre
A
Wasler
Karlheinz
K
Tscheliessnigg
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D016572:Cyclosporine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004487:Edema / Q000139:chemically induced / Q000453:epidemiology; D000068338:Everolimus; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006084:Graft Rejection / Q000276:immunology / Q000473:pathology / Q000517:prevention & control*; D016027:Heart Transplantation / Q000276:immunology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015994:Incidence; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012189:Retrospective Studies; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000068338:Everolimus; D009173:Mycophenolic Acid; D020123:Sirolimus