De novo immunosuppression with sirolimus and tacrolimus in heart transplant recipients compared with cyclosporine and mycophenolate mofetil

A one-year follow-up analysis

M. J. Zucker, D. A. Baran, L. H. Arroyo, Daniel J. Goldstein, C. Neacy, L. Mele, A. D. Weinberg, T. W. Prendergast, H. S. Ribner

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background. Limited data exist regarding the safety and efficacy of sirolimus in combination with a calcineurin inhibitor in heart transplant recipients. Methods. From January 2001 to June 2002, 31 de novo heart transplant recipients (treatment group) received a combination of sirolimus, tacrolimus, low-dose rabbit antithymocyte globulin, and glucocorticoids. Outcomes, such as actuarial survival, rate of rejection, incidence of infection, probability of developing diabetes mellitus, renal function, platelet and white blood cell counts, and incidence of coronary artery disease at 1 year, were compared with a cohort of 25 patients (control group) who underwent transplantation primarily in 2000 and in early 2002 treated with cyclosporine, mycophenolate mofetil, and glucocorticoids. All patients were followed up for at least 12 months. Results. Kaplan-Meier actuarial 1-year survival rates were equivalent between groups (97% for the treatment group and 88% for the control group), as was freedom from allograft rejection (48% and 42% for treatment and control groups, respectively). No cases of transplant arteriopathy were noted within the first posttransplantation year. Renal function was not significantly affected in either group. There was a striking increased incidence of mediastinitis in the treatment group (19%) versus 0% in the control group (P = .02). Tacrolimus-sirolimus therapy was associated with a nearly 11-fold increased incidence of new-onset diabetes mellitus as well (P = .004). Conclusion. Tacrolimus, sirolimus, and steroids (following low-dose rabbit antithymocyte globulin) were associated with an increased incidence of mediastinitis and posttransplantation diabetes mellitus. No obvious long-term benefit on survival, arteriopathy, or renal function was noted.

Original languageEnglish (US)
Pages (from-to)2231-2239
Number of pages9
JournalTransplantation Proceedings
Volume37
Issue number5
DOIs
StatePublished - Jun 2005
Externally publishedYes

Fingerprint

Mycophenolic Acid
Tacrolimus
Sirolimus
Immunosuppression
Cyclosporine
Incidence
Mediastinitis
Diabetes Mellitus
Control Groups
Antilymphocyte Serum
Kidney
Glucocorticoids
Survival Rate
Rabbits
Therapeutics
Leukocyte Count
Allografts
Coronary Artery Disease
Blood Platelets
Transplantation

ASJC Scopus subject areas

  • Surgery
  • Transplantation

Cite this

De novo immunosuppression with sirolimus and tacrolimus in heart transplant recipients compared with cyclosporine and mycophenolate mofetil : A one-year follow-up analysis. / Zucker, M. J.; Baran, D. A.; Arroyo, L. H.; Goldstein, Daniel J.; Neacy, C.; Mele, L.; Weinberg, A. D.; Prendergast, T. W.; Ribner, H. S.

In: Transplantation Proceedings, Vol. 37, No. 5, 06.2005, p. 2231-2239.

Research output: Contribution to journalArticle

Zucker, M. J. ; Baran, D. A. ; Arroyo, L. H. ; Goldstein, Daniel J. ; Neacy, C. ; Mele, L. ; Weinberg, A. D. ; Prendergast, T. W. ; Ribner, H. S. / De novo immunosuppression with sirolimus and tacrolimus in heart transplant recipients compared with cyclosporine and mycophenolate mofetil : A one-year follow-up analysis. In: Transplantation Proceedings. 2005 ; Vol. 37, No. 5. pp. 2231-2239.
@article{9a3e864390a84faeac62ef6ba7f80a0e,
title = "De novo immunosuppression with sirolimus and tacrolimus in heart transplant recipients compared with cyclosporine and mycophenolate mofetil: A one-year follow-up analysis",
abstract = "Background. Limited data exist regarding the safety and efficacy of sirolimus in combination with a calcineurin inhibitor in heart transplant recipients. Methods. From January 2001 to June 2002, 31 de novo heart transplant recipients (treatment group) received a combination of sirolimus, tacrolimus, low-dose rabbit antithymocyte globulin, and glucocorticoids. Outcomes, such as actuarial survival, rate of rejection, incidence of infection, probability of developing diabetes mellitus, renal function, platelet and white blood cell counts, and incidence of coronary artery disease at 1 year, were compared with a cohort of 25 patients (control group) who underwent transplantation primarily in 2000 and in early 2002 treated with cyclosporine, mycophenolate mofetil, and glucocorticoids. All patients were followed up for at least 12 months. Results. Kaplan-Meier actuarial 1-year survival rates were equivalent between groups (97{\%} for the treatment group and 88{\%} for the control group), as was freedom from allograft rejection (48{\%} and 42{\%} for treatment and control groups, respectively). No cases of transplant arteriopathy were noted within the first posttransplantation year. Renal function was not significantly affected in either group. There was a striking increased incidence of mediastinitis in the treatment group (19{\%}) versus 0{\%} in the control group (P = .02). Tacrolimus-sirolimus therapy was associated with a nearly 11-fold increased incidence of new-onset diabetes mellitus as well (P = .004). Conclusion. Tacrolimus, sirolimus, and steroids (following low-dose rabbit antithymocyte globulin) were associated with an increased incidence of mediastinitis and posttransplantation diabetes mellitus. No obvious long-term benefit on survival, arteriopathy, or renal function was noted.",
author = "Zucker, {M. J.} and Baran, {D. A.} and Arroyo, {L. H.} and Goldstein, {Daniel J.} and C. Neacy and L. Mele and Weinberg, {A. D.} and Prendergast, {T. W.} and Ribner, {H. S.}",
year = "2005",
month = "6",
doi = "10.1016/j.transproceed.2005.03.086",
language = "English (US)",
volume = "37",
pages = "2231--2239",
journal = "Transplantation Proceedings",
issn = "0041-1345",
publisher = "Elsevier USA",
number = "5",

}

TY - JOUR

T1 - De novo immunosuppression with sirolimus and tacrolimus in heart transplant recipients compared with cyclosporine and mycophenolate mofetil

T2 - A one-year follow-up analysis

AU - Zucker, M. J.

AU - Baran, D. A.

AU - Arroyo, L. H.

AU - Goldstein, Daniel J.

AU - Neacy, C.

AU - Mele, L.

AU - Weinberg, A. D.

AU - Prendergast, T. W.

AU - Ribner, H. S.

PY - 2005/6

Y1 - 2005/6

N2 - Background. Limited data exist regarding the safety and efficacy of sirolimus in combination with a calcineurin inhibitor in heart transplant recipients. Methods. From January 2001 to June 2002, 31 de novo heart transplant recipients (treatment group) received a combination of sirolimus, tacrolimus, low-dose rabbit antithymocyte globulin, and glucocorticoids. Outcomes, such as actuarial survival, rate of rejection, incidence of infection, probability of developing diabetes mellitus, renal function, platelet and white blood cell counts, and incidence of coronary artery disease at 1 year, were compared with a cohort of 25 patients (control group) who underwent transplantation primarily in 2000 and in early 2002 treated with cyclosporine, mycophenolate mofetil, and glucocorticoids. All patients were followed up for at least 12 months. Results. Kaplan-Meier actuarial 1-year survival rates were equivalent between groups (97% for the treatment group and 88% for the control group), as was freedom from allograft rejection (48% and 42% for treatment and control groups, respectively). No cases of transplant arteriopathy were noted within the first posttransplantation year. Renal function was not significantly affected in either group. There was a striking increased incidence of mediastinitis in the treatment group (19%) versus 0% in the control group (P = .02). Tacrolimus-sirolimus therapy was associated with a nearly 11-fold increased incidence of new-onset diabetes mellitus as well (P = .004). Conclusion. Tacrolimus, sirolimus, and steroids (following low-dose rabbit antithymocyte globulin) were associated with an increased incidence of mediastinitis and posttransplantation diabetes mellitus. No obvious long-term benefit on survival, arteriopathy, or renal function was noted.

AB - Background. Limited data exist regarding the safety and efficacy of sirolimus in combination with a calcineurin inhibitor in heart transplant recipients. Methods. From January 2001 to June 2002, 31 de novo heart transplant recipients (treatment group) received a combination of sirolimus, tacrolimus, low-dose rabbit antithymocyte globulin, and glucocorticoids. Outcomes, such as actuarial survival, rate of rejection, incidence of infection, probability of developing diabetes mellitus, renal function, platelet and white blood cell counts, and incidence of coronary artery disease at 1 year, were compared with a cohort of 25 patients (control group) who underwent transplantation primarily in 2000 and in early 2002 treated with cyclosporine, mycophenolate mofetil, and glucocorticoids. All patients were followed up for at least 12 months. Results. Kaplan-Meier actuarial 1-year survival rates were equivalent between groups (97% for the treatment group and 88% for the control group), as was freedom from allograft rejection (48% and 42% for treatment and control groups, respectively). No cases of transplant arteriopathy were noted within the first posttransplantation year. Renal function was not significantly affected in either group. There was a striking increased incidence of mediastinitis in the treatment group (19%) versus 0% in the control group (P = .02). Tacrolimus-sirolimus therapy was associated with a nearly 11-fold increased incidence of new-onset diabetes mellitus as well (P = .004). Conclusion. Tacrolimus, sirolimus, and steroids (following low-dose rabbit antithymocyte globulin) were associated with an increased incidence of mediastinitis and posttransplantation diabetes mellitus. No obvious long-term benefit on survival, arteriopathy, or renal function was noted.

UR - http://www.scopus.com/inward/record.url?scp=21844459476&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=21844459476&partnerID=8YFLogxK

U2 - 10.1016/j.transproceed.2005.03.086

DO - 10.1016/j.transproceed.2005.03.086

M3 - Article

VL - 37

SP - 2231

EP - 2239

JO - Transplantation Proceedings

JF - Transplantation Proceedings

SN - 0041-1345

IS - 5

ER -