Tacrolimus with mycophenolate mofetil (MMF) or sirolimus vs. cyclosporine with MMF in cardiac transplant patients: 1-Year report

J. A. Kobashigawa, L. W. Miller, S. D. Russell, G. A. Ewald, M. J. Zucker, L. R. Goldberg, Howard Eisen, K. Salm, D. Tolzman, J. Gao, W. Fitzsimmons, R. First

Research output: Contribution to journalArticle

207 Citations (Scopus)

Abstract

The most advantageous combination of immunosuppressive agents for cardiac transplant recipients has not yet been established. Between November 2001 and June 2003, 343 de novo cardiac transplant recipients were randomized to receive steroids and either tacrolimus (TAC) + sirolimus (SRL), TAC + mycophenolate mofetil (MMF) or cyclosporine (CYA) + MMF. Antilymphocyte induction therapy was allowed for up to 5 days. The primary endpoint of ≥3A rejection or hemodynamic compromise rejection requiring treatment showed no significant difference at 6 months (TAC/MMF 22.4%, TAC/SRL 24.3%, CYA/MMF 31.6%, p = 0.271) and 1 year (p = 0.056), but it was significantly lower in the TAC/MMF group when compared only to the CYA/MMF group at 1 year (23.4% vs. 36.8%; p = 0.029). Differences in the incidence of any treated rejection were significant (TAC/SRL = 35%, TAC/MMF = 42%, CYA/MMF = 59%; p < 0.001), as were median levels of serum creatinine (TAC/SRL = 1.5 mg/dL, TAC/MMF = 1.3 mg/dL, CYA/MMF = 1.5 mg/dL; p = 0.032) and triglycerides (TAC/SRL = 162 mg/dL, TAC/MMF = 126 mg/dL, CYA/MMF = 154 mg/dL; p = 0.028). The TAC/SRL group encountered fewer viral infections but more fungal infections and impaired wound healing. These secondary endpoints suggest that the TAC/MMF combination appears to offer more advantages than TAC/SRL or CYA/MMF in cardiac transplant patients, including fewer ≥3A rejections or hemodynamic compromise rejections and an improved side-effect profile.

Original languageEnglish (US)
Pages (from-to)1377-1386
Number of pages10
JournalAmerican Journal of Transplantation
Volume6
Issue number6
DOIs
StatePublished - Jun 1 2006

Fingerprint

Mycophenolic Acid
Tacrolimus
Sirolimus
Cyclosporine
Transplants
Hemodynamics
Mycoses
Virus Diseases
Immunosuppressive Agents

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

Cite this

Kobashigawa, J. A. ; Miller, L. W. ; Russell, S. D. ; Ewald, G. A. ; Zucker, M. J. ; Goldberg, L. R. ; Eisen, Howard ; Salm, K. ; Tolzman, D. ; Gao, J. ; Fitzsimmons, W. ; First, R. / Tacrolimus with mycophenolate mofetil (MMF) or sirolimus vs. cyclosporine with MMF in cardiac transplant patients : 1-Year report. In: American Journal of Transplantation. 2006 ; Vol. 6, No. 6. pp. 1377-1386.
@article{446c016787c64619a5b683abc21b6dbe,
title = "Tacrolimus with mycophenolate mofetil (MMF) or sirolimus vs. cyclosporine with MMF in cardiac transplant patients: 1-Year report",
abstract = "The most advantageous combination of immunosuppressive agents for cardiac transplant recipients has not yet been established. Between November 2001 and June 2003, 343 de novo cardiac transplant recipients were randomized to receive steroids and either tacrolimus (TAC) + sirolimus (SRL), TAC + mycophenolate mofetil (MMF) or cyclosporine (CYA) + MMF. Antilymphocyte induction therapy was allowed for up to 5 days. The primary endpoint of ≥3A rejection or hemodynamic compromise rejection requiring treatment showed no significant difference at 6 months (TAC/MMF 22.4{\%}, TAC/SRL 24.3{\%}, CYA/MMF 31.6{\%}, p = 0.271) and 1 year (p = 0.056), but it was significantly lower in the TAC/MMF group when compared only to the CYA/MMF group at 1 year (23.4{\%} vs. 36.8{\%}; p = 0.029). Differences in the incidence of any treated rejection were significant (TAC/SRL = 35{\%}, TAC/MMF = 42{\%}, CYA/MMF = 59{\%}; p < 0.001), as were median levels of serum creatinine (TAC/SRL = 1.5 mg/dL, TAC/MMF = 1.3 mg/dL, CYA/MMF = 1.5 mg/dL; p = 0.032) and triglycerides (TAC/SRL = 162 mg/dL, TAC/MMF = 126 mg/dL, CYA/MMF = 154 mg/dL; p = 0.028). The TAC/SRL group encountered fewer viral infections but more fungal infections and impaired wound healing. These secondary endpoints suggest that the TAC/MMF combination appears to offer more advantages than TAC/SRL or CYA/MMF in cardiac transplant patients, including fewer ≥3A rejections or hemodynamic compromise rejections and an improved side-effect profile.",
author = "Kobashigawa, {J. A.} and Miller, {L. W.} and Russell, {S. D.} and Ewald, {G. A.} and Zucker, {M. J.} and Goldberg, {L. R.} and Howard Eisen and K. Salm and D. Tolzman and J. Gao and W. Fitzsimmons and R. First",
year = "2006",
month = "6",
day = "1",
doi = "10.1111/j.1600-6143.2006.01290.x",
language = "English (US)",
volume = "6",
pages = "1377--1386",
journal = "American Journal of Transplantation",
issn = "1600-6135",
publisher = "Wiley-Blackwell",
number = "6",

}

Kobashigawa, JA, Miller, LW, Russell, SD, Ewald, GA, Zucker, MJ, Goldberg, LR, Eisen, H, Salm, K, Tolzman, D, Gao, J, Fitzsimmons, W & First, R 2006, 'Tacrolimus with mycophenolate mofetil (MMF) or sirolimus vs. cyclosporine with MMF in cardiac transplant patients: 1-Year report', American Journal of Transplantation, vol. 6, no. 6, pp. 1377-1386. https://doi.org/10.1111/j.1600-6143.2006.01290.x

Tacrolimus with mycophenolate mofetil (MMF) or sirolimus vs. cyclosporine with MMF in cardiac transplant patients : 1-Year report. / Kobashigawa, J. A.; Miller, L. W.; Russell, S. D.; Ewald, G. A.; Zucker, M. J.; Goldberg, L. R.; Eisen, Howard; Salm, K.; Tolzman, D.; Gao, J.; Fitzsimmons, W.; First, R.

In: American Journal of Transplantation, Vol. 6, No. 6, 01.06.2006, p. 1377-1386.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Tacrolimus with mycophenolate mofetil (MMF) or sirolimus vs. cyclosporine with MMF in cardiac transplant patients

T2 - 1-Year report

AU - Kobashigawa, J. A.

AU - Miller, L. W.

AU - Russell, S. D.

AU - Ewald, G. A.

AU - Zucker, M. J.

AU - Goldberg, L. R.

AU - Eisen, Howard

AU - Salm, K.

AU - Tolzman, D.

AU - Gao, J.

AU - Fitzsimmons, W.

AU - First, R.

PY - 2006/6/1

Y1 - 2006/6/1

N2 - The most advantageous combination of immunosuppressive agents for cardiac transplant recipients has not yet been established. Between November 2001 and June 2003, 343 de novo cardiac transplant recipients were randomized to receive steroids and either tacrolimus (TAC) + sirolimus (SRL), TAC + mycophenolate mofetil (MMF) or cyclosporine (CYA) + MMF. Antilymphocyte induction therapy was allowed for up to 5 days. The primary endpoint of ≥3A rejection or hemodynamic compromise rejection requiring treatment showed no significant difference at 6 months (TAC/MMF 22.4%, TAC/SRL 24.3%, CYA/MMF 31.6%, p = 0.271) and 1 year (p = 0.056), but it was significantly lower in the TAC/MMF group when compared only to the CYA/MMF group at 1 year (23.4% vs. 36.8%; p = 0.029). Differences in the incidence of any treated rejection were significant (TAC/SRL = 35%, TAC/MMF = 42%, CYA/MMF = 59%; p < 0.001), as were median levels of serum creatinine (TAC/SRL = 1.5 mg/dL, TAC/MMF = 1.3 mg/dL, CYA/MMF = 1.5 mg/dL; p = 0.032) and triglycerides (TAC/SRL = 162 mg/dL, TAC/MMF = 126 mg/dL, CYA/MMF = 154 mg/dL; p = 0.028). The TAC/SRL group encountered fewer viral infections but more fungal infections and impaired wound healing. These secondary endpoints suggest that the TAC/MMF combination appears to offer more advantages than TAC/SRL or CYA/MMF in cardiac transplant patients, including fewer ≥3A rejections or hemodynamic compromise rejections and an improved side-effect profile.

AB - The most advantageous combination of immunosuppressive agents for cardiac transplant recipients has not yet been established. Between November 2001 and June 2003, 343 de novo cardiac transplant recipients were randomized to receive steroids and either tacrolimus (TAC) + sirolimus (SRL), TAC + mycophenolate mofetil (MMF) or cyclosporine (CYA) + MMF. Antilymphocyte induction therapy was allowed for up to 5 days. The primary endpoint of ≥3A rejection or hemodynamic compromise rejection requiring treatment showed no significant difference at 6 months (TAC/MMF 22.4%, TAC/SRL 24.3%, CYA/MMF 31.6%, p = 0.271) and 1 year (p = 0.056), but it was significantly lower in the TAC/MMF group when compared only to the CYA/MMF group at 1 year (23.4% vs. 36.8%; p = 0.029). Differences in the incidence of any treated rejection were significant (TAC/SRL = 35%, TAC/MMF = 42%, CYA/MMF = 59%; p < 0.001), as were median levels of serum creatinine (TAC/SRL = 1.5 mg/dL, TAC/MMF = 1.3 mg/dL, CYA/MMF = 1.5 mg/dL; p = 0.032) and triglycerides (TAC/SRL = 162 mg/dL, TAC/MMF = 126 mg/dL, CYA/MMF = 154 mg/dL; p = 0.028). The TAC/SRL group encountered fewer viral infections but more fungal infections and impaired wound healing. These secondary endpoints suggest that the TAC/MMF combination appears to offer more advantages than TAC/SRL or CYA/MMF in cardiac transplant patients, including fewer ≥3A rejections or hemodynamic compromise rejections and an improved side-effect profile.

UR - http://www.scopus.com/inward/record.url?scp=33745393847&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33745393847&partnerID=8YFLogxK

U2 - 10.1111/j.1600-6143.2006.01290.x

DO - 10.1111/j.1600-6143.2006.01290.x

M3 - Article

C2 - 16686761

AN - SCOPUS:33745393847

VL - 6

SP - 1377

EP - 1386

JO - American Journal of Transplantation

JF - American Journal of Transplantation

SN - 1600-6135

IS - 6

ER -