title: Clinical experience of tacrolimus with everolimus in heart transplantation.
abstract: BACKGROUND
  Tacrolimus (Tac) in combination with mycophenolate mofetil is widely used after heart transplantation (HT). Everolimus (EVR), a new potent proliferation signal inhibitor can be used with a carcineurin inhibitor to reduce the occurrence of rejection. The purpose of this study was to evaluate the efficacy and safety of Tac combined with EVR in de novo HT.
  
  
  METHODS
  From January 2009 to April 2011, 33/62 patients who underwent HT were prescribed Tac and EVR as de novo immunosuppression. The main exclusion criteria were poor kidney function (serum creatinine > 2.8 mg/dL), panel-reactive antibodies > 25%, donors > 60 years old, or cold ischemia time > 6 hours. All patients received Tac (C0 blood level 5-10 ng/mL during the first 6 months, then 3-5 ng/mL), EVR (C0 target 3-8 ng/mL), and corticosteroids. After transplantation, routine examinations included echocardiogram and protocol endomyocardial biopsy.
  
  
  RESULTS
  There was no operative mortality. The 1- and 3-year actuarial survivals were 95.74% ± 3.49%. One patient who had undergone coronary artery bypass grafting previously and received intra-aortic balloon pumping and extracorporeal membrane oxygenator-assisted cardiopulmonary resuscitation before HT died of Aspergillus septicemia 58 days after HT. No biopsy-proven acute rejection > grade 2R or acute rejection associated with hemodynamic compromise was observed. Hyperlipemia was noted in 16 cases (48.5%), hypertension in 11 (33.3% 5%), and diabetes mellitus in 12 (36.4%). No other severe adverse events were noted.
  
  
  CONCLUSIONS
  Concentration-controlled EVR (C0 target 3-8 ng/mL) in combination with Tac achieved good efficacy and safety. The 1- and 3-year actuarial survivals were 95.74% ± 3.49%.
authors.affiliation: Department of Cardiovascular Surgery, National Taiwan University Hospital, Taipei, Taiwan. wangp@ntu.edu.tw
authors.forename: S-S
authors.initials: SS
authors.lastname: Wang
authors.forename: N-K
authors.initials: NK
authors.lastname: Chou
authors.forename: N-H
authors.initials: NH
authors.lastname: Chi
authors.forename: S-C
authors.initials: SC
authors.lastname: Huang
authors.forename: I-H
authors.initials: IH
authors.lastname: Wu
authors.forename: C-H
authors.initials: CH
authors.lastname: Wang
authors.forename: H-Y
authors.initials: HY
authors.lastname: Yu
authors.forename: Y-S
authors.initials: YS
authors.lastname: Chen
authors.forename: C-I
authors.initials: CI
authors.lastname: Tsao
authors.forename: W-J
authors.initials: WJ
authors.lastname: Ko
authors.forename: C-T
authors.initials: CT
authors.lastname: Shun
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003920:Diabetes Mellitus / Q000209:etiology; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D016027:Heart Transplantation / Q000009:adverse effects / Q000276:immunology / Q000401:mortality; D006801:Humans; D006949:Hyperlipidemias / Q000209:etiology; D006973:Hypertension / Q000209:etiology; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016019:Survival Analysis; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus; D016559:Tacrolimus