Immunosuppression: Evolution in Practice and Trends, 1994–2004

Meier-Kriesche, Herwig Ulf; Li, S.; Gruessner, Rainer W.G.; Fung, John J.; Bustami, Rami; Barr, Mark L.; Leichtman, Alan B.

doi:10.1111/j.1600-6143.2006.01270.x

Cited by 457 publications

(354 citation statements)

References 16 publications

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“…This favorable outcome compares with observed higher rejection rates for Groups TAC/SRL and CSA/ SRL, 30% (15/50) and 28% (14/50), respectively, and this difference clearly became significant once the multivariable effects of other prognosticators (race/ethnicity, recipient age, and donor age) were controlled. Although randomization of 50 patients per treatment arm only allowed reasonable statis- 1 Number of patients with the event (actuarial estimate of failure at 96 mo post-transplant Ϯ SE). 2 The P-values listed in this column represent the results of the logrank test (with 2 degrees of freedom) for any differences among the 3 treatment groups' hazard rates failure.…”

Section: Discussionmentioning

confidence: 99%

Randomized Trial of Immunosuppressive Regimens in Renal Transplantation

Guerra

Ciancio

Gaynor

et al. 2011

Journal of the American Society of Nephrology

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The optimal long-term regimen for immunosuppression for kidney transplant recipients is unknown. We conducted a randomized trial involving 150 kidney transplant recipients to compare tacrolimus/sirolimus, tacrolimus/mycophenolate mofetil (MMF), and cyclosporine/sirolimus. All patients received daclizumab induction and maintenance corticosteroids. Median follow-up was 8 yr post-transplant. Acute rejection (AR) occurred significantly less often among those treated with tacrolimus/MMF (12%) than among those treated with tacrolimus/sirolimus (30%) or cyclosporine/sirolimus (28%). Mean estimated GFR was consistently higher in the tacrolimus/MMF arm, especially after controlling for donor age in a multivariable model during the first 36 mo (P Յ 0.008). The rate of dying with a functioning graft was significantly higher among those treated with tacrolimus/sirolimus (26%) than among those treated with tacrolimus/ MMF (12%) or cyclosporine/sirolimus (4%). We did not observe significant differences in actuarial graft survival at 8 yr post-transplant between the groups. Patient noncompliance seemed responsible for 45% (13/29) of observed graft failures, with 11 of these occurring after 36 mo. Significantly more viral infections, protocol violations, and need for antilipid therapy occurred among patients receiving sirolimus, but we did not observe differences between the groups with regard to infections requiring hospitalization or new-onset diabetes. Taken together, these results suggest that maintenance therapy with tacrolimus/MMF is more favorable than either tacrolimus/sirolimus or cyclosporine/sirolimus.

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Section: Discussionmentioning

confidence: 99%

Randomized Trial of Immunosuppressive Regimens in Renal Transplantation

Guerra

Ciancio

Gaynor

et al. 2011

Journal of the American Society of Nephrology

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“…Among patients transplanted in 2001, the change rate for Tac/MMF combination at 3 yr was 43% and that for SRL/MMF combination was up to 65%. 15 We have previously reported on the 2-yr safety and efficacy profile of SRL/steroids based regimens in combination with either low-dose Tac (group A) or MMF (group B) together with basiliximab induction therapy among live-donor renal allotransplant recipients in a prospective randomized study, and it was shown that the SRL/MMF regimen was safe regarding patient and graft survival and was associated with significant better renal function at 2 yr than the Tac/SRL regimen. 14 We hereby report on the long-term safety and efficacy profile of the same randomized patients.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the use of the SRL/MMF combination has remained less than 1%. 15 We have previously reported on the safe and efficient use of SRL/MMF combination regimen together with steroids and basiliximab induction therapy in a short-term prospective randomized trial. 14 We hereby report on the safety and efficacy of the longer-term use of such a regimen in living donor renal transplant recipients.…”

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confidence: 99%

Long-term Efficacy and Safety of a Calcineurin Inhibitor-free Regimen in Live-Donor Renal Transplant Recipients

Hamdy

Bakr²,

Ghoneim³

2008

Journal of the American Society of Nephrology

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Calcineurin inhibitor (CNI) nephrotoxicity is a major concern after renal transplantation. To investigate the safety and efficacy of a CNI-free immunosuppressive regimen, 132 live-donor renal transplant recipients were included in a prospective, randomized controlled trial. All patients received induction therapy with basiliximab and steroids. The patients were randomized to a maintenance immunosuppression regimen that included steroids, sirolimus, and either low-dose tacrolimus or mycophenolate mofetil (MMF). Over a mean follow-up period of approximately 5 yr, patient and graft survival did not significantly differ between the two maintenance regimens. Patient survival was 93.8% and 98.5% in the tacrolimus/sirolimus and MMF/sirolimus groups, respectively, and graft survival was 83% and 88%, respectively. However, the MMF/sirolimus group had significantly better renal function, calculated by Cockcroft-Gault, from the second year post-transplant until the last follow-up. In addition, this group was less likely to require a change in their primary immunosuppression regimen than the tacrolimus/sirolimus group (20.8% versus 53.8%, P ϭ 0.001). The safety profile was similar between groups. In summary, after long-term follow-up, a CNI-free maintenance regimen consisting of sirolimus, MMF, and steroids was both safe and efficacious among low to moderate immunologic risk renal transplant recipients.

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“…Use of induction therapy with ATG/IL-2 receptor blockers have further brought down the rejection rate [14,15]. Recent data reveals that 72% of renal transplant recipients today have tacrolimus, 81% MMF, 21% cyclosporine and 12 % sirolimus on their discharge prescription [1,16]. However, improvement in short term graft survival with tacrolimus has not transformed into long term graft or patient survival.…”

Section: Discussionmentioning

confidence: 99%