title: Comparison of conventional tacrolimus versus prolong release formula as initial therapy in heart transplantation.
abstract: BACKGROUND
  A new formulation of tacrolimus that is characterized by prolonged release has been developed to facilitate treatment and patient compliance. Initial therapy with prolonged release formula in heart transplantation is not widely accepted.
  
  
  METHODS
  We enrolled 19 patients into a randomized analysis divided into 2 groups with different initial regimens. There were 8 patients with a mean age of 44 ± 13 years treated by Advagraf, and 11 patients with a mean age of 41 ± 9 years treated by Prograf. Serum concentration of immunosuppressive drug was followed by its oral dosage and endomyocardial biopsy results. Arterial hypertension, kidney function, and incidence of diabetes mellitus were recorded.
  
  
  RESULTS
  There were no perioperative deaths. The risk of acute rejection within 6 months following surgery was 1 (2%) in the Advagraf group and 1 (1.5%) in the Prograf group. Although the serum tacrolimus results were comparable between groups, the drug's daily dosages were different after 6 months of therapy (3 ± 1 mg in the Advagraf group and 6 ± 2 mg in the Prograf group (p<0.05). The low rate of adverse effects throughout the study was noted.
  
  
  CONCLUSIONS
  Prolonged-release tacrolimus formula is an efficient immunosuppressant in heart transplantation. Its initial application after surgery has low risk of adverse effects with similar results to conventional formula.
authors.affiliation: Department of Cardiac Surgery and Transplantology, Poznań University of Medical Sciences, Poznań, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Urbanowicz
authors.affiliation: Department of Cardiology, Poznań University of Medical Sciences, Poznań, Poland.
authors.forename: Hanna
authors.initials: H
authors.lastname: Baszyńska-Wachowiak
authors.affiliation: Department of Cardiac Surgery and Transplantology, Poznań University of Medical Sciences, Poznań, Poland.
authors.forename: Marcin
authors.initials: M
authors.lastname: Ligowski
authors.affiliation: Department of Cardiology, Poznań University of Medical Sciences, Poznań, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Straburzyńska-Migaj
authors.affiliation: Department of Cardiac Surgery and Transplantology, Poznań University of Medical Sciences, Poznań, Poland.
authors.forename: Marcin
authors.initials: M
authors.lastname: Misterski
authors.affiliation: Department of Cardiac Surgery and Transplantology, Poznań University of Medical Sciences, Poznań, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Jemielity
mesh_terms: D000328:Adult; D001706:Biopsy; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy* / Q000453:epidemiology; D016027:Heart Transplantation / Q000706:statistics & numerical data*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009206:Myocardium / Q000473:pathology; D011446:Prospective Studies; D012307:Risk Factors; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D016559:Tacrolimus