A Comparison of Tacrolimus (Fk506) and Cyclosporine for Immunosuppression After Cadaveric Renal Transplantation1

Pirsch, John D.; Miller, Joshua; Deierhoi, Mark H.; Vincenti, Flavio; Filo, Ronald S.

doi:10.1097/00007890-199704150-00013

Cited by 1,067 publications

(581 citation statements)

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“…The relatively lower reversibility in the American Phase III Multicenter Trial is probably related to a protocol-driven minimum dose of prednisone in that trial. 4,5 Given the improved immunosuppressive efficacy associated with tacrolimus, 1-6 the transiently increased incidence of PTDM may well be considered clinically acceptable. Certainly, the potential for PTDM has not prevented the successful use of tacrolimus in kidney/pancreas transplantation, where a number of reports have described its efficacy.…”

Section: Discussionmentioning

confidence: 99%

“…and the final incidence ranged from 1.4% to 12.6%, with a reversibility of 37% to 83%. 1,4,5,[12][13][14][15] Subgroup analysis was performed in only one study, the American Phase III Multicenter Trial. It showed a higher incidence of PTDM in African American than in Caucasian recipients, and an association in all patients with higher tacrolimus levels and steroid doses.…”

Section: Review Of the Literaturementioning

confidence: 99%

“…6 However, there have been reports of an increased incidence of posttransplant diabetes (PTDM) under tacrolimus-based therapy. 4,5 We have reported on the reversibility of tacrolimus-induced PTDM in our own renal transplant patients. 7,8 In this article, we present an illustrative case demonstrating the reversibility of PTDM and review both the published and unpublished literature.…”

mentioning

confidence: 96%

“…It showed a higher incidence of PTDM in African American than in Caucasian recipients, and an association in all patients with higher tacrolimus levels and steroid doses. 4,5 Address reprint requests to Ron Shapiro, MD, 4th Floor Falk, …”

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Reversibility of tacrolimus-induced posttransplant diabetes: an illustrative case and review of the literature

Shapiro

Scantlebury

Jordan

et al. 1997

Transplantation Proceedings

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Tacrolimus is a potent immunosuppressive agent. It has been reported to have superior immunosuppressive efficacy when compared with the standard formulation of cyclosporine (CyA), 1 based on its ability to rescue patients with failing allografts under CyA-based therapy, 2,3 lower rejection rates when used as a primary immunosuppressive agent, 4,5 and longer projected half-life. 6 However, there have been reports of an increased incidence of posttransplant diabetes (PTDM) under tacrolimus-based therapy. 4,5 We have reported on the reversibility of tacrolimus-induced PTDM in our own renal transplant patients. 7,8 In this article, we present an illustrative case demonstrating the reversibility of PTDM and review both the published and unpublished literature. The data suggest that the initial incidence of PTDM in the renal transplant population may be higher under tacrolimus than under CyA-based therapy, but the final incidence is comparable. 9-11 ILLUSTRATIVE CASEThe patient was a 64-year old black female with end-stage renal disease secondary to hypertension, who received a kidney from her son. The allograft functioned immediately, and she never experienced rejection. Her serum creatinine, tacrolimus dosages and levels, prednisone dosages, fasting blood glucose levels, and insulin requirements are shown in Table 1. Basically, she was normoglycemic until 13 weeks after transplantation, when her fasting blood glucose level was 280 mg/dL. One week later, it was 555 mg/dL, and she was admitted to the hospital and started on insulin. As her tacrolimus and steroid dosages were tapered, her blood sugars normalized, and her insulin was tapered off by 26 weeks after transplantation. She continues to have normal renal function 1.5 years after transplantation, with a serum creatinine of 1.0 mg/dL, on tacrolimus 1 mg orally twice per day and no prednisone. Her tacrolimus level is 8.7 ng/mL, and her fasting blood glucose is 140 mg/dL. Review of the LiteratureThe initial and final incidences of PTDM in various studies of tacrolimus in renal transplantation are summarized in Table 2. The initial incidence ranged from 6% to 28.3%. and the final incidence ranged from 1.4% to 12.6%, with a reversibility of 37% to 83%. 1,4,5,[12][13][14][15] Subgroup analysis was performed in only one study, the American Phase III Multicenter Trial. It showed a higher incidence of PTDM in African American than in Caucasian recipients, and an association in all patients with higher tacrolimus levels and steroid doses. 4,5 Address reprint requests to Ron Shapiro, MD, 4th Floor Falk,

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Section: Discussionmentioning

confidence: 99%

Section: Review Of the Literaturementioning

confidence: 99%

mentioning

confidence: 96%

mentioning

confidence: 99%

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Reversibility of tacrolimus-induced posttransplant diabetes: an illustrative case and review of the literature

Shapiro

Scantlebury

Jordan

et al. 1997

Transplantation Proceedings

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“…[1][2][3][4] The use of this agent in the pediatric population is less well described. We and others have previously reported that its use in pediatric patients is associated with excellent patient and graft survival results in a relatively small number of patients.…”

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confidence: 99%

Tacrolimus-based immunosuppression in pediatric renal transplantation

Jordan

Shapiro

Scantlebury

et al. 1999

Transplantation Proceedings

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Tacrolimus has been shown to be a safe and effective immunosuppressive agent in adult renal transplantation with significant advantages, including the ability to taper corticosteroids in up to 65% of recipients. [1][2][3][4] The use of this agent in the pediatric population is less well described. We and others have previously reported that its use in pediatric patients is associated with excellent patient and graft survival results in a relatively small number of patients. 5-9 Here we report our expanded experience on the use of tacrolimus in pediatric renal transplantation. PATIENTS AND METHODSBetween December 1989 and December 1996, 82 pediatric renal transplants were performed using tacrolimus-based immunosuppression without antilymphocyte antibody induction therapy. The mean age of the recipients was 10.6 ± 5.2 years (range 0.7 to 17.9 years). More than one-quarter of patients could be categorized as 'high-risk' with 18 (22%) cases being retransplantations and 6 (7%) patients having panel reactive antibody (PRA) levels ≥40%. A total of 34 (41%) cases were with living donors and 48 (59%) were with cadaveric donors, with a mean donor age of 27.3 ± 14.6 years (range 0.7 to 50 years), and a mean cold ischemia time in the cadaveric cases of 26.5 ± 8.8 hours. The mean number of HLA matches and mismatches was 2.8 ± 1.2 and 2.9 ± 1.3. respectively, and there were five (6%) O-antigen mismatches. The mean duration of follow-up was 4.0 ± 0.2 years (range 0.6 to 7.5 years). Immunosuppression consisted of a 0.15 mg/kg oral dose of tacrolimus preoperatively, with postoperative administration at 0.05 to 0.10 mg/kg as a continuous intravenous infusion. Patients were subsequently converted to oral administration of tacrolimus at a dose of 0.15 mg/ kg twice daily. The dose of tacrolimus was adjusted according to target whole blood trough levels. The levels aimed for were 20 to 25 ng/mL during the first 2 weeks, 15 to 20 ng/mL at 1 month, 10 to 15 ng/mL at 3 months, and <5 to 8 to 9 ng/mL over the long term. Patients also received tapered corticosteroid therapy, the aim being to withdraw corticosteroids completely by month 6. RESULTSOne-and 4-year actuarial patient survival was 99% and 94%, and actuarial graft survival was 98% and 84%, respectively (Table 1). There was no significant difference in patient and graft survival between the living donor and cadaveric donor recipients. However, 4-year graft survival was significantly higher in patients receiving a primary transplant compared with retransplant patients (P < .02). PRA levels were also a prognostic indicator of graft survival, with 87% 4-year survival in those with levels <40% and 57% in patients with levels ≥40%

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International issues in transplantation biotechnology, including the use of non-human cells, tissues and organs

Desselberger¹

1998

Rev. Med. Virol.

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A Comparison of Tacrolimus (Fk506) and Cyclosporine for Immunosuppression After Cadaveric Renal Transplantation1

Cited by 1,067 publications

References 13 publications

Reversibility of tacrolimus-induced posttransplant diabetes: an illustrative case and review of the literature

Reversibility of tacrolimus-induced posttransplant diabetes: an illustrative case and review of the literature

Tacrolimus-based immunosuppression in pediatric renal transplantation

International issues in transplantation biotechnology, including the use of non-human cells, tissues and organs

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