title: Randomized trial of tacrolimus monotherapy: tacrolimus in combination, tacrolimus alone compared (the TICTAC trial).
abstract: BACKGROUND
  Prior retrospective studies have suggested that tacrolimus monotherapy is an option associated with excellent outcomes and reduced toxicities.
  
  
  METHODS
  We conducted a prospective, randomized, 2-center study of tacrolimus combination therapy vs monotherapy. From April 16, 2004, to September 15, 2005, 58 adult heart transplant patients were studied. All received oral tacrolimus, mycophenolate mofetil, and corticosteroids. Patients were then randomized to a group where mycophenolate was maintained (COMBO) or to a group where it was discontinued (MONO) 14 days post-transplant. Corticosteroids were rapidly withdrawn in both groups between 8 and 12 weeks.
  
  
  RESULTS
  The primary end point (mean 6-month International Society of Heart and Lung Transplantation biopsy score) was 0.44 +/- 0.04 in the MONO group and 0.60 +/- 0.05 in the COMBO group (p = 0.013, unpaired Student's t-test). The freedom from rejection grade of 2R or higher at 6 and 12 months was 93.3% with MONO and 92.9% with COMBO (p = NS).
  
  
  CONCLUSIONS
  Tacrolimus monotherapy appears to be safe and efficacious in heart transplant recipients and is not associated with excess rejection in the first year post-transplant. Further studies of this approach are warranted.
authors.affiliation: Department of Medicine, Division of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey 07112, USA. DBaran@SBHCS.com
authors.forename: David A
authors.initials: DA
authors.lastname: Baran
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Zucker
authors.forename: Luis H
authors.initials: LH
authors.lastname: Arroyo
authors.forename: Mamata M
authors.initials: MM
authors.lastname: Alwarshetty
authors.forename: Maria R
authors.initials: MR
authors.lastname: Ramirez
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Prendergast
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Goldstein
authors.forename: Margarita
authors.initials: M
authors.lastname: Camacho
authors.forename: Alan L
authors.initials: AL
authors.lastname: Gass
authors.forename: Candace
authors.initials: C
authors.lastname: Carr
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D003586:Cytomegalovirus Infections / Q000139:chemically induced; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006085:Graft Survival; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011183:Postoperative Complications; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus