title: Long-term results of tacrolimus monotherapy in cardiac transplant recipients.
abstract: BACKGROUND
  Conventional immunosuppression for heart transplantation is associated with various adverse effects. Tacrolimus monotherapy (TM) is an alternative strategy that minimizes exposure to additional immunosuppressants.
  
  
  METHODS
  We retrospectively reviewed clinical data for all adult transplant recipients between January 1, 1996 and May 1, 2004. Clinical outcomes were analyzed according to immunosuppressive regimen.
  
  
  RESULTS
  A total of 167 heart transplants were performed at our center. Eight patients died before receiving calcineurin inhibitors and were excluded from analysis. The mean follow-up for the 159 surviving patients was 1,520 +/- 78 days. Ninety of 124 patients initially treated with tacrolimus and corticosteroids were weaned to TM without the use of an anti-proliferative agent (Group A), resulting in an overall success rate of 75% at an average of 271 +/- 18 days after transplant. The remaining 69 recipients were treated with other tacrolimus- or cyclosporine-based regimens (Group B). Survival was significantly greater in Group A. The prevalence of high-grade rejection within the first year and incidence of cardiac allograft vasculopathy were similar between groups. Ten patients (11%) in Group A required recommencement of combination immunosuppression at an average of 768 +/- 772 days.
  
  
  CONCLUSIONS
  TM is achievable in the majority of cardiac transplant recipients. Patients who tolerated reduced immunosuppression enjoyed greater survival than those treated with other regimens, without additional high-grade rejection or vasculopathy. These promising results remain to be confirmed in a prospective trial.
authors.affiliation: Mount Sinai Medical Center, New York, New York, USA.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Lubitz
authors.forename: David A
authors.initials: DA
authors.lastname: Baran
authors.forename: Mamata M
authors.initials: MM
authors.lastname: Alwarshetty
authors.forename: Sean
authors.initials: S
authors.lastname: Pinney
authors.forename: Sarah
authors.initials: S
authors.lastname: Kaplan
authors.forename: Ming
authors.initials: M
authors.lastname: Chan
authors.forename: Mary C
authors.initials: MC
authors.lastname: Courtney
authors.forename: Steven L
authors.initials: SL
authors.lastname: Lansman
authors.forename: David
authors.initials: D
authors.lastname: Spielvogel
authors.forename: Alan L
authors.initials: AL
authors.lastname: Gass
mesh_terms: D000328:Adult; D017023:Coronary Angiography; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D016027:Heart Transplantation / Q000276:immunology* / Q000401:mortality; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D012189:Retrospective Studies; D016019:Survival Analysis; D016559:Tacrolimus / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D003404:Creatinine; D009173:Mycophenolic Acid; D016559:Tacrolimus