Effects of tacrolimus on hyperlipidemia after successful renal transplantation: A southeastern organ procurement foundation multicenter clinical study

Thomas R. McCune, Leroy R. Thacker, Thomas G. Peters, Laura L Mulloy, Michael S. Rohr, Patricia A. Adams, Jackson Yium, Jimmy A. Light, Timothy Pruett, A. Osama Gaber, Steven H. Selman, Johann Jonsson, Joseph M. Hayes, Francis H. Wright, Thomas Armata, Jack Blanton, James F. Burdick

Research output: Contribution to journalArticle

129 Citations (Scopus)

Abstract

Background. Tacrolimus has been shown to have a less adverse effect on the lipid profiles of transplant patients when the drug is started as induction therapy. In order to determine the effect tacrolimus has on lipid profiles in stable cyclosporine-treated renal transplant patients with established hyperlipidemia, a randomized prospective study was undertaken by the Southeastern Organ Procurement Foundation. Methods. Patients of the 13 transplant centers, with cholesterol of 240 mg/dl or greater, who were at least 1 year posttransplant with stable renal function, were randomly assigned to remain on cyclosporine (control) or converted to tacrolimus. Patients converted to tacrolimus were maintained at a level of 5-15 ng/ml, and control patients remained at their previous levels of cyclosporine. Concurrent immunosuppressants were not changed. Levels of total cholesterol, triglycerides, tom high-density lipoprotein, low-density lipoprotein (LDL), very-low-density lipoprotein, and apoproteins A and B were monitored before conversion and at months 1, 3, and 6. Renal function and glucose control were evaluated at the beginning and end of the study (month 6). Results. A total of 65 patients were enrolled; 12 patients failed to complete the study. None were removed as a result of acute rejection or graft failure. Fifty-three patients were available for analysis (27 in the tacrolimus group and 26 controls). Demographics were not different between groups. In patients converted to tacrolimus treatment, there was a -55 mg/dl (-16%) (P=0.0031) change in cholesterol, a -48 mg/dl (-25%) (P=0.0014) change in LDL cholesterol, and a -36 mg/dl (-23%) (P=0.034) change in apolipoprotein B. There was no change in renal function, glycemic control, or incidence of new onset diabetes mellitus in the tacrolimus group. Conclusion. Conversion from cyclosporine to tacrolimus can be safely done after successful transplantation. Introduction of tacrolimus to a stable renal patient does not effect renal function or glycemic control Tacrolimus can lower cholesterol, LDL, and apolipoprotein B. Conversion to tacrolimus from cyclosporine should be considered in the treatment of posttransplant hyperlipidemia.

Original languageEnglish (US)
Pages (from-to)87-92
Number of pages6
JournalTransplantation
Volume65
Issue number1
DOIs
StatePublished - Jan 15 1998

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Tissue and Organ Procurement
Tacrolimus
Hyperlipidemias
Kidney Transplantation
Multicenter Studies
Cyclosporine
Kidney
Apolipoproteins B
Cholesterol
Transplants
LDL Cholesterol
Clinical Studies
Lipids
Lipoprotein(a)
VLDL Lipoproteins
Graft Rejection
HDL Lipoproteins
Immunosuppressive Agents
LDL Lipoproteins
Diabetes Mellitus

ASJC Scopus subject areas

  • Transplantation

Cite this

Effects of tacrolimus on hyperlipidemia after successful renal transplantation : A southeastern organ procurement foundation multicenter clinical study. / McCune, Thomas R.; Thacker, Leroy R.; Peters, Thomas G.; Mulloy, Laura L; Rohr, Michael S.; Adams, Patricia A.; Yium, Jackson; Light, Jimmy A.; Pruett, Timothy; Gaber, A. Osama; Selman, Steven H.; Jonsson, Johann; Hayes, Joseph M.; Wright, Francis H.; Armata, Thomas; Blanton, Jack; Burdick, James F.

In: Transplantation, Vol. 65, No. 1, 15.01.1998, p. 87-92.

Research output: Contribution to journalArticle

McCune, TR, Thacker, LR, Peters, TG, Mulloy, LL, Rohr, MS, Adams, PA, Yium, J, Light, JA, Pruett, T, Gaber, AO, Selman, SH, Jonsson, J, Hayes, JM, Wright, FH, Armata, T, Blanton, J & Burdick, JF 1998, 'Effects of tacrolimus on hyperlipidemia after successful renal transplantation: A southeastern organ procurement foundation multicenter clinical study', Transplantation, vol. 65, no. 1, pp. 87-92. https://doi.org/10.1097/00007890-199801150-00017
McCune, Thomas R. ; Thacker, Leroy R. ; Peters, Thomas G. ; Mulloy, Laura L ; Rohr, Michael S. ; Adams, Patricia A. ; Yium, Jackson ; Light, Jimmy A. ; Pruett, Timothy ; Gaber, A. Osama ; Selman, Steven H. ; Jonsson, Johann ; Hayes, Joseph M. ; Wright, Francis H. ; Armata, Thomas ; Blanton, Jack ; Burdick, James F. / Effects of tacrolimus on hyperlipidemia after successful renal transplantation : A southeastern organ procurement foundation multicenter clinical study. In: Transplantation. 1998 ; Vol. 65, No. 1. pp. 87-92.
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abstract = "Background. Tacrolimus has been shown to have a less adverse effect on the lipid profiles of transplant patients when the drug is started as induction therapy. In order to determine the effect tacrolimus has on lipid profiles in stable cyclosporine-treated renal transplant patients with established hyperlipidemia, a randomized prospective study was undertaken by the Southeastern Organ Procurement Foundation. Methods. Patients of the 13 transplant centers, with cholesterol of 240 mg/dl or greater, who were at least 1 year posttransplant with stable renal function, were randomly assigned to remain on cyclosporine (control) or converted to tacrolimus. Patients converted to tacrolimus were maintained at a level of 5-15 ng/ml, and control patients remained at their previous levels of cyclosporine. Concurrent immunosuppressants were not changed. Levels of total cholesterol, triglycerides, tom high-density lipoprotein, low-density lipoprotein (LDL), very-low-density lipoprotein, and apoproteins A and B were monitored before conversion and at months 1, 3, and 6. Renal function and glucose control were evaluated at the beginning and end of the study (month 6). Results. A total of 65 patients were enrolled; 12 patients failed to complete the study. None were removed as a result of acute rejection or graft failure. Fifty-three patients were available for analysis (27 in the tacrolimus group and 26 controls). Demographics were not different between groups. In patients converted to tacrolimus treatment, there was a -55 mg/dl (-16{\%}) (P=0.0031) change in cholesterol, a -48 mg/dl (-25{\%}) (P=0.0014) change in LDL cholesterol, and a -36 mg/dl (-23{\%}) (P=0.034) change in apolipoprotein B. There was no change in renal function, glycemic control, or incidence of new onset diabetes mellitus in the tacrolimus group. Conclusion. Conversion from cyclosporine to tacrolimus can be safely done after successful transplantation. Introduction of tacrolimus to a stable renal patient does not effect renal function or glycemic control Tacrolimus can lower cholesterol, LDL, and apolipoprotein B. Conversion to tacrolimus from cyclosporine should be considered in the treatment of posttransplant hyperlipidemia.",
author = "McCune, {Thomas R.} and Thacker, {Leroy R.} and Peters, {Thomas G.} and Mulloy, {Laura L} and Rohr, {Michael S.} and Adams, {Patricia A.} and Jackson Yium and Light, {Jimmy A.} and Timothy Pruett and Gaber, {A. Osama} and Selman, {Steven H.} and Johann Jonsson and Hayes, {Joseph M.} and Wright, {Francis H.} and Thomas Armata and Jack Blanton and Burdick, {James F.}",
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T1 - Effects of tacrolimus on hyperlipidemia after successful renal transplantation

T2 - A southeastern organ procurement foundation multicenter clinical study

AU - McCune, Thomas R.

AU - Thacker, Leroy R.

AU - Peters, Thomas G.

AU - Mulloy, Laura L

AU - Rohr, Michael S.

AU - Adams, Patricia A.

AU - Yium, Jackson

AU - Light, Jimmy A.

AU - Pruett, Timothy

AU - Gaber, A. Osama

AU - Selman, Steven H.

AU - Jonsson, Johann

AU - Hayes, Joseph M.

AU - Wright, Francis H.

AU - Armata, Thomas

AU - Blanton, Jack

AU - Burdick, James F.

PY - 1998/1/15

Y1 - 1998/1/15

N2 - Background. Tacrolimus has been shown to have a less adverse effect on the lipid profiles of transplant patients when the drug is started as induction therapy. In order to determine the effect tacrolimus has on lipid profiles in stable cyclosporine-treated renal transplant patients with established hyperlipidemia, a randomized prospective study was undertaken by the Southeastern Organ Procurement Foundation. Methods. Patients of the 13 transplant centers, with cholesterol of 240 mg/dl or greater, who were at least 1 year posttransplant with stable renal function, were randomly assigned to remain on cyclosporine (control) or converted to tacrolimus. Patients converted to tacrolimus were maintained at a level of 5-15 ng/ml, and control patients remained at their previous levels of cyclosporine. Concurrent immunosuppressants were not changed. Levels of total cholesterol, triglycerides, tom high-density lipoprotein, low-density lipoprotein (LDL), very-low-density lipoprotein, and apoproteins A and B were monitored before conversion and at months 1, 3, and 6. Renal function and glucose control were evaluated at the beginning and end of the study (month 6). Results. A total of 65 patients were enrolled; 12 patients failed to complete the study. None were removed as a result of acute rejection or graft failure. Fifty-three patients were available for analysis (27 in the tacrolimus group and 26 controls). Demographics were not different between groups. In patients converted to tacrolimus treatment, there was a -55 mg/dl (-16%) (P=0.0031) change in cholesterol, a -48 mg/dl (-25%) (P=0.0014) change in LDL cholesterol, and a -36 mg/dl (-23%) (P=0.034) change in apolipoprotein B. There was no change in renal function, glycemic control, or incidence of new onset diabetes mellitus in the tacrolimus group. Conclusion. Conversion from cyclosporine to tacrolimus can be safely done after successful transplantation. Introduction of tacrolimus to a stable renal patient does not effect renal function or glycemic control Tacrolimus can lower cholesterol, LDL, and apolipoprotein B. Conversion to tacrolimus from cyclosporine should be considered in the treatment of posttransplant hyperlipidemia.

AB - Background. Tacrolimus has been shown to have a less adverse effect on the lipid profiles of transplant patients when the drug is started as induction therapy. In order to determine the effect tacrolimus has on lipid profiles in stable cyclosporine-treated renal transplant patients with established hyperlipidemia, a randomized prospective study was undertaken by the Southeastern Organ Procurement Foundation. Methods. Patients of the 13 transplant centers, with cholesterol of 240 mg/dl or greater, who were at least 1 year posttransplant with stable renal function, were randomly assigned to remain on cyclosporine (control) or converted to tacrolimus. Patients converted to tacrolimus were maintained at a level of 5-15 ng/ml, and control patients remained at their previous levels of cyclosporine. Concurrent immunosuppressants were not changed. Levels of total cholesterol, triglycerides, tom high-density lipoprotein, low-density lipoprotein (LDL), very-low-density lipoprotein, and apoproteins A and B were monitored before conversion and at months 1, 3, and 6. Renal function and glucose control were evaluated at the beginning and end of the study (month 6). Results. A total of 65 patients were enrolled; 12 patients failed to complete the study. None were removed as a result of acute rejection or graft failure. Fifty-three patients were available for analysis (27 in the tacrolimus group and 26 controls). Demographics were not different between groups. In patients converted to tacrolimus treatment, there was a -55 mg/dl (-16%) (P=0.0031) change in cholesterol, a -48 mg/dl (-25%) (P=0.0014) change in LDL cholesterol, and a -36 mg/dl (-23%) (P=0.034) change in apolipoprotein B. There was no change in renal function, glycemic control, or incidence of new onset diabetes mellitus in the tacrolimus group. Conclusion. Conversion from cyclosporine to tacrolimus can be safely done after successful transplantation. Introduction of tacrolimus to a stable renal patient does not effect renal function or glycemic control Tacrolimus can lower cholesterol, LDL, and apolipoprotein B. Conversion to tacrolimus from cyclosporine should be considered in the treatment of posttransplant hyperlipidemia.

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