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Mycophenolate and sirolimus as calcineurin inhibitor-free immunosuppression improves renal function better than calcineurin inhibitor-reduction in late cardiac transplant recipients with chronic renal failure

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Mycophenolate and sirolimus as calcineurin inhibitor-free immunosuppression improves renal function better than calcineurin inhibitor-reduction in late cardiac transplant recipients with chronic renal failure. / Groetzner, Jan; Kaczmarek, Ingo; Schulz, Uwe; Stegemann, Emilia; Kaiser, Kristina; Wittwer, Thorsten; Schirmer, Johannes; Voss, Meinolf; Strauch, Justus; Wahlers, Thorsten; Sohn, Hae-Young; Wagner, Florian; Tenderich, Gero; Stempfle, Hans-Ulrich; Mueller-Ehmsen, Jochen; Schmid, Christof; Vogeser, Michael; Koch, Karrl Christian; Reichenspurner, Hermann; Daebritz, Sabine; Meiser, Bruno; Reichart, Bruno; VENINAHTx-Investigators.

In: TRANSPLANTATION, Vol. 87, No. 5, 15.03.2009, p. 726-733.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Groetzner, J, Kaczmarek, I, Schulz, U, Stegemann, E, Kaiser, K, Wittwer, T, Schirmer, J, Voss, M, Strauch, J, Wahlers, T, Sohn, H-Y, Wagner, F, Tenderich, G, Stempfle, H-U, Mueller-Ehmsen, J, Schmid, C, Vogeser, M, Koch, KC, Reichenspurner, H, Daebritz, S, Meiser, B, Reichart, B & VENINAHTx-Investigators 2009, 'Mycophenolate and sirolimus as calcineurin inhibitor-free immunosuppression improves renal function better than calcineurin inhibitor-reduction in late cardiac transplant recipients with chronic renal failure', TRANSPLANTATION, vol. 87, no. 5, pp. 726-733. https://doi.org/10.1097/TP.0b013e3181963371

APA

Groetzner, J., Kaczmarek, I., Schulz, U., Stegemann, E., Kaiser, K., Wittwer, T., Schirmer, J., Voss, M., Strauch, J., Wahlers, T., Sohn, H-Y., Wagner, F., Tenderich, G., Stempfle, H-U., Mueller-Ehmsen, J., Schmid, C., Vogeser, M., Koch, K. C., Reichenspurner, H., ... VENINAHTx-Investigators (2009). Mycophenolate and sirolimus as calcineurin inhibitor-free immunosuppression improves renal function better than calcineurin inhibitor-reduction in late cardiac transplant recipients with chronic renal failure. TRANSPLANTATION, 87(5), 726-733. https://doi.org/10.1097/TP.0b013e3181963371

Vancouver

Groetzner J, Kaczmarek I, Schulz U, Stegemann E, Kaiser K, Wittwer T et al. Mycophenolate and sirolimus as calcineurin inhibitor-free immunosuppression improves renal function better than calcineurin inhibitor-reduction in late cardiac transplant recipients with chronic renal failure. TRANSPLANTATION. 2009 Mar 15;87(5):726-733. https://doi.org/10.1097/TP.0b013e3181963371

Bibtex

@article{ffee7e2375f646b0ad73baf4148d39ea,
title = "Mycophenolate and sirolimus as calcineurin inhibitor-free immunosuppression improves renal function better than calcineurin inhibitor-reduction in late cardiac transplant recipients with chronic renal failure",
abstract = "BACKGROUND: Calcineurin-inhibitor-(CNI)-induced renal failure is one major cause of morbidity in cardiac transplantation (HTx). In this prospective, randomized, multicenter trial, the impact of immunosuppressive conversion toward CNI-free (mycophenolate mofetil [MMF] and sirolimus) or a CNI-reduced immunosuppressive regimen on renal function, efficacy, and safety was evaluated.METHODS: Since 2004, 63 HTx-patients (0.5-18.4 years after HTx) with CNI-based immunosuppression and reduced creatinine clearance less than 60 mL/min (39+/-15 mL/min) were included in this trial. Patients in the CNI-free-Group (group 1) were converted to sirolimus that was started with 2 mg/day until target trough levels (8-14 ng/mL) were achieved. Subsequently, CNIs were withdrawn. In CNI-reduction-Group (group 2), CNI target trough levels were reduced by 40%. In both groups MMF was continued and trough level adjusted (1.5-4 microg/mL).RESULTS: Patients demographics and survival (mean follow-up time: 16.7+/-9 months) was equal (100%). Renal function improved significantly after complete CNI withdrawal while remaining unchanged with CNI-reduction (Creatinine clearance after 12 months: 53+/-24 mg/dL [group 1] vs. 38+/-20 mg/dL [group 2], P=0.01). End-stage renal failure (hemodialysis) was avoided by CNI-withdrawal and occurred only after CNI reduction (n=6; P=0.01). Acute rejection episodes were more common in group 2 (4 vs. 2). Graft function remained stable (echocardiography) within both groups. Adverse events were more common in group 1 (65%) than in group 2 (n=40%) and were responsible for discontinuation in 4 and 0 cases, respectively.CONCLUSIONS: Conversion toward a CNI-free immunosuppression (Mycophenolate, sirolimus) is superior to CNI-reduced immunosuppression in improving renal failure in late HTx-recipients. However, this benefit is relativized by the increased incidence and severity of sirolimus/MMF-associated side effects.",
keywords = "Adult, Aged, Calcineurin Inhibitors, Female, Heart Transplantation/immunology, Humans, Immunosuppressive Agents/therapeutic use, Kidney/drug effects, Kidney Failure, Chronic/complications, Kidney Function Tests, Male, Middle Aged, Mycophenolic Acid/analogs & derivatives, Patient Selection, Sirolimus/therapeutic use",
author = "Jan Groetzner and Ingo Kaczmarek and Uwe Schulz and Emilia Stegemann and Kristina Kaiser and Thorsten Wittwer and Johannes Schirmer and Meinolf Voss and Justus Strauch and Thorsten Wahlers and Hae-Young Sohn and Florian Wagner and Gero Tenderich and Hans-Ulrich Stempfle and Jochen Mueller-Ehmsen and Christof Schmid and Michael Vogeser and Koch, {Karrl Christian} and Hermann Reichenspurner and Sabine Daebritz and Bruno Meiser and Bruno Reichart and VENINAHTx-Investigators",
year = "2009",
month = mar,
day = "15",
doi = "10.1097/TP.0b013e3181963371",
language = "English",
volume = "87",
pages = "726--733",
journal = "TRANSPLANTATION",
issn = "0041-1337",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

RIS

TY - JOUR

T1 - Mycophenolate and sirolimus as calcineurin inhibitor-free immunosuppression improves renal function better than calcineurin inhibitor-reduction in late cardiac transplant recipients with chronic renal failure

AU - Groetzner, Jan

AU - Kaczmarek, Ingo

AU - Schulz, Uwe

AU - Stegemann, Emilia

AU - Kaiser, Kristina

AU - Wittwer, Thorsten

AU - Schirmer, Johannes

AU - Voss, Meinolf

AU - Strauch, Justus

AU - Wahlers, Thorsten

AU - Sohn, Hae-Young

AU - Wagner, Florian

AU - Tenderich, Gero

AU - Stempfle, Hans-Ulrich

AU - Mueller-Ehmsen, Jochen

AU - Schmid, Christof

AU - Vogeser, Michael

AU - Koch, Karrl Christian

AU - Reichenspurner, Hermann

AU - Daebritz, Sabine

AU - Meiser, Bruno

AU - Reichart, Bruno

AU - VENINAHTx-Investigators

PY - 2009/3/15

Y1 - 2009/3/15

N2 - BACKGROUND: Calcineurin-inhibitor-(CNI)-induced renal failure is one major cause of morbidity in cardiac transplantation (HTx). In this prospective, randomized, multicenter trial, the impact of immunosuppressive conversion toward CNI-free (mycophenolate mofetil [MMF] and sirolimus) or a CNI-reduced immunosuppressive regimen on renal function, efficacy, and safety was evaluated.METHODS: Since 2004, 63 HTx-patients (0.5-18.4 years after HTx) with CNI-based immunosuppression and reduced creatinine clearance less than 60 mL/min (39+/-15 mL/min) were included in this trial. Patients in the CNI-free-Group (group 1) were converted to sirolimus that was started with 2 mg/day until target trough levels (8-14 ng/mL) were achieved. Subsequently, CNIs were withdrawn. In CNI-reduction-Group (group 2), CNI target trough levels were reduced by 40%. In both groups MMF was continued and trough level adjusted (1.5-4 microg/mL).RESULTS: Patients demographics and survival (mean follow-up time: 16.7+/-9 months) was equal (100%). Renal function improved significantly after complete CNI withdrawal while remaining unchanged with CNI-reduction (Creatinine clearance after 12 months: 53+/-24 mg/dL [group 1] vs. 38+/-20 mg/dL [group 2], P=0.01). End-stage renal failure (hemodialysis) was avoided by CNI-withdrawal and occurred only after CNI reduction (n=6; P=0.01). Acute rejection episodes were more common in group 2 (4 vs. 2). Graft function remained stable (echocardiography) within both groups. Adverse events were more common in group 1 (65%) than in group 2 (n=40%) and were responsible for discontinuation in 4 and 0 cases, respectively.CONCLUSIONS: Conversion toward a CNI-free immunosuppression (Mycophenolate, sirolimus) is superior to CNI-reduced immunosuppression in improving renal failure in late HTx-recipients. However, this benefit is relativized by the increased incidence and severity of sirolimus/MMF-associated side effects.

AB - BACKGROUND: Calcineurin-inhibitor-(CNI)-induced renal failure is one major cause of morbidity in cardiac transplantation (HTx). In this prospective, randomized, multicenter trial, the impact of immunosuppressive conversion toward CNI-free (mycophenolate mofetil [MMF] and sirolimus) or a CNI-reduced immunosuppressive regimen on renal function, efficacy, and safety was evaluated.METHODS: Since 2004, 63 HTx-patients (0.5-18.4 years after HTx) with CNI-based immunosuppression and reduced creatinine clearance less than 60 mL/min (39+/-15 mL/min) were included in this trial. Patients in the CNI-free-Group (group 1) were converted to sirolimus that was started with 2 mg/day until target trough levels (8-14 ng/mL) were achieved. Subsequently, CNIs were withdrawn. In CNI-reduction-Group (group 2), CNI target trough levels were reduced by 40%. In both groups MMF was continued and trough level adjusted (1.5-4 microg/mL).RESULTS: Patients demographics and survival (mean follow-up time: 16.7+/-9 months) was equal (100%). Renal function improved significantly after complete CNI withdrawal while remaining unchanged with CNI-reduction (Creatinine clearance after 12 months: 53+/-24 mg/dL [group 1] vs. 38+/-20 mg/dL [group 2], P=0.01). End-stage renal failure (hemodialysis) was avoided by CNI-withdrawal and occurred only after CNI reduction (n=6; P=0.01). Acute rejection episodes were more common in group 2 (4 vs. 2). Graft function remained stable (echocardiography) within both groups. Adverse events were more common in group 1 (65%) than in group 2 (n=40%) and were responsible for discontinuation in 4 and 0 cases, respectively.CONCLUSIONS: Conversion toward a CNI-free immunosuppression (Mycophenolate, sirolimus) is superior to CNI-reduced immunosuppression in improving renal failure in late HTx-recipients. However, this benefit is relativized by the increased incidence and severity of sirolimus/MMF-associated side effects.

KW - Adult

KW - Aged

KW - Calcineurin Inhibitors

KW - Female

KW - Heart Transplantation/immunology

KW - Humans

KW - Immunosuppressive Agents/therapeutic use

KW - Kidney/drug effects

KW - Kidney Failure, Chronic/complications

KW - Kidney Function Tests

KW - Male

KW - Middle Aged

KW - Mycophenolic Acid/analogs & derivatives

KW - Patient Selection

KW - Sirolimus/therapeutic use

U2 - 10.1097/TP.0b013e3181963371

DO - 10.1097/TP.0b013e3181963371

M3 - SCORING: Journal article

C2 - 19295318

VL - 87

SP - 726

EP - 733

JO - TRANSPLANTATION

JF - TRANSPLANTATION

SN - 0041-1337

IS - 5

ER -