Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials
Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) o...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Claudia Sommerer [verfasserIn] Oliver Witzke [verfasserIn] Frank Lehner [verfasserIn] Wolfgang Arns [verfasserIn] Petra Reinke [verfasserIn] Ute Eisenberger [verfasserIn] Bruno Vogt [verfasserIn] Katharina Heller [verfasserIn] Johannes Jacobi [verfasserIn] Markus Guba [verfasserIn] Rolf Stahl [verfasserIn] Ingeborg A. Hauser [verfasserIn] Volker Kliem [verfasserIn] Rudolf P. Wüthrich [verfasserIn] Anja Mühlfeld [verfasserIn] Barbara Suwelack [verfasserIn] Michael Duerr [verfasserIn] Eva-Maria Paulus [verfasserIn] Martin Zeier [verfasserIn] Martina Porstner [verfasserIn] Klemens Budde [verfasserIn] on behalf of the ZEUS and HERAKLES study investigators [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2018 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: BMC Nephrology - BMC, 2003, 19(2018), 1, Seite 13 |
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| Übergeordnetes Werk: |
volume:19 ; year:2018 ; number:1 ; pages:13 |
| Links: |
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| DOI / URN: |
10.1186/s12882-018-1031-1 |
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| Katalog-ID: |
DOAJ040201333 |
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| 245 | 1 | 0 | |a Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials |
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| 520 | |a Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). | ||
| 650 | 4 | |a Diabetes | |
| 650 | 4 | |a Everolimus | |
| 650 | 4 | |a Kidney transplantation | |
| 650 | 4 | |a TOR inhibitor | |
| 650 | 4 | |a PTDM | |
| 650 | 4 | |a Post-transplant | |
| 653 | 0 | |a Diseases of the genitourinary system. Urology | |
| 700 | 0 | |a Oliver Witzke |e verfasserin |4 aut | |
| 700 | 0 | |a Frank Lehner |e verfasserin |4 aut | |
| 700 | 0 | |a Wolfgang Arns |e verfasserin |4 aut | |
| 700 | 0 | |a Petra Reinke |e verfasserin |4 aut | |
| 700 | 0 | |a Ute Eisenberger |e verfasserin |4 aut | |
| 700 | 0 | |a Bruno Vogt |e verfasserin |4 aut | |
| 700 | 0 | |a Katharina Heller |e verfasserin |4 aut | |
| 700 | 0 | |a Johannes Jacobi |e verfasserin |4 aut | |
| 700 | 0 | |a Markus Guba |e verfasserin |4 aut | |
| 700 | 0 | |a Rolf Stahl |e verfasserin |4 aut | |
| 700 | 0 | |a Ingeborg A. Hauser |e verfasserin |4 aut | |
| 700 | 0 | |a Volker Kliem |e verfasserin |4 aut | |
| 700 | 0 | |a Rudolf P. Wüthrich |e verfasserin |4 aut | |
| 700 | 0 | |a Anja Mühlfeld |e verfasserin |4 aut | |
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| 700 | 0 | |a Eva-Maria Paulus |e verfasserin |4 aut | |
| 700 | 0 | |a Martin Zeier |e verfasserin |4 aut | |
| 700 | 0 | |a Martina Porstner |e verfasserin |4 aut | |
| 700 | 0 | |a Klemens Budde |e verfasserin |4 aut | |
| 700 | 0 | |a on behalf of the ZEUS and HERAKLES study investigators |e verfasserin |4 aut | |
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10.1186/s12882-018-1031-1 doi (DE-627)DOAJ040201333 (DE-599)DOAJ03ee2b06a3cf4b8ba50f0091731a8e25 DE-627 ger DE-627 rakwb eng RC870-923 Claudia Sommerer verfasserin aut Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). Diabetes Everolimus Kidney transplantation TOR inhibitor PTDM Post-transplant Diseases of the genitourinary system. Urology Oliver Witzke verfasserin aut Frank Lehner verfasserin aut Wolfgang Arns verfasserin aut Petra Reinke verfasserin aut Ute Eisenberger verfasserin aut Bruno Vogt verfasserin aut Katharina Heller verfasserin aut Johannes Jacobi verfasserin aut Markus Guba verfasserin aut Rolf Stahl verfasserin aut Ingeborg A. Hauser verfasserin aut Volker Kliem verfasserin aut Rudolf P. Wüthrich verfasserin aut Anja Mühlfeld verfasserin aut Barbara Suwelack verfasserin aut Michael Duerr verfasserin aut Eva-Maria Paulus verfasserin aut Martin Zeier verfasserin aut Martina Porstner verfasserin aut Klemens Budde verfasserin aut on behalf of the ZEUS and HERAKLES study investigators verfasserin aut In BMC Nephrology BMC, 2003 19(2018), 1, Seite 13 (DE-627)326643672 (DE-600)2041348-8 14712369 nnns volume:19 year:2018 number:1 pages:13 https://doi.org/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/article/03ee2b06a3cf4b8ba50f0091731a8e25 kostenfrei http://link.springer.com/article/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/toc/1471-2369 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 13 |
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10.1186/s12882-018-1031-1 doi (DE-627)DOAJ040201333 (DE-599)DOAJ03ee2b06a3cf4b8ba50f0091731a8e25 DE-627 ger DE-627 rakwb eng RC870-923 Claudia Sommerer verfasserin aut Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). Diabetes Everolimus Kidney transplantation TOR inhibitor PTDM Post-transplant Diseases of the genitourinary system. Urology Oliver Witzke verfasserin aut Frank Lehner verfasserin aut Wolfgang Arns verfasserin aut Petra Reinke verfasserin aut Ute Eisenberger verfasserin aut Bruno Vogt verfasserin aut Katharina Heller verfasserin aut Johannes Jacobi verfasserin aut Markus Guba verfasserin aut Rolf Stahl verfasserin aut Ingeborg A. Hauser verfasserin aut Volker Kliem verfasserin aut Rudolf P. Wüthrich verfasserin aut Anja Mühlfeld verfasserin aut Barbara Suwelack verfasserin aut Michael Duerr verfasserin aut Eva-Maria Paulus verfasserin aut Martin Zeier verfasserin aut Martina Porstner verfasserin aut Klemens Budde verfasserin aut on behalf of the ZEUS and HERAKLES study investigators verfasserin aut In BMC Nephrology BMC, 2003 19(2018), 1, Seite 13 (DE-627)326643672 (DE-600)2041348-8 14712369 nnns volume:19 year:2018 number:1 pages:13 https://doi.org/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/article/03ee2b06a3cf4b8ba50f0091731a8e25 kostenfrei http://link.springer.com/article/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/toc/1471-2369 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 13 |
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10.1186/s12882-018-1031-1 doi (DE-627)DOAJ040201333 (DE-599)DOAJ03ee2b06a3cf4b8ba50f0091731a8e25 DE-627 ger DE-627 rakwb eng RC870-923 Claudia Sommerer verfasserin aut Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). Diabetes Everolimus Kidney transplantation TOR inhibitor PTDM Post-transplant Diseases of the genitourinary system. Urology Oliver Witzke verfasserin aut Frank Lehner verfasserin aut Wolfgang Arns verfasserin aut Petra Reinke verfasserin aut Ute Eisenberger verfasserin aut Bruno Vogt verfasserin aut Katharina Heller verfasserin aut Johannes Jacobi verfasserin aut Markus Guba verfasserin aut Rolf Stahl verfasserin aut Ingeborg A. Hauser verfasserin aut Volker Kliem verfasserin aut Rudolf P. Wüthrich verfasserin aut Anja Mühlfeld verfasserin aut Barbara Suwelack verfasserin aut Michael Duerr verfasserin aut Eva-Maria Paulus verfasserin aut Martin Zeier verfasserin aut Martina Porstner verfasserin aut Klemens Budde verfasserin aut on behalf of the ZEUS and HERAKLES study investigators verfasserin aut In BMC Nephrology BMC, 2003 19(2018), 1, Seite 13 (DE-627)326643672 (DE-600)2041348-8 14712369 nnns volume:19 year:2018 number:1 pages:13 https://doi.org/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/article/03ee2b06a3cf4b8ba50f0091731a8e25 kostenfrei http://link.springer.com/article/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/toc/1471-2369 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 13 |
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10.1186/s12882-018-1031-1 doi (DE-627)DOAJ040201333 (DE-599)DOAJ03ee2b06a3cf4b8ba50f0091731a8e25 DE-627 ger DE-627 rakwb eng RC870-923 Claudia Sommerer verfasserin aut Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). Diabetes Everolimus Kidney transplantation TOR inhibitor PTDM Post-transplant Diseases of the genitourinary system. Urology Oliver Witzke verfasserin aut Frank Lehner verfasserin aut Wolfgang Arns verfasserin aut Petra Reinke verfasserin aut Ute Eisenberger verfasserin aut Bruno Vogt verfasserin aut Katharina Heller verfasserin aut Johannes Jacobi verfasserin aut Markus Guba verfasserin aut Rolf Stahl verfasserin aut Ingeborg A. Hauser verfasserin aut Volker Kliem verfasserin aut Rudolf P. Wüthrich verfasserin aut Anja Mühlfeld verfasserin aut Barbara Suwelack verfasserin aut Michael Duerr verfasserin aut Eva-Maria Paulus verfasserin aut Martin Zeier verfasserin aut Martina Porstner verfasserin aut Klemens Budde verfasserin aut on behalf of the ZEUS and HERAKLES study investigators verfasserin aut In BMC Nephrology BMC, 2003 19(2018), 1, Seite 13 (DE-627)326643672 (DE-600)2041348-8 14712369 nnns volume:19 year:2018 number:1 pages:13 https://doi.org/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/article/03ee2b06a3cf4b8ba50f0091731a8e25 kostenfrei http://link.springer.com/article/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/toc/1471-2369 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 13 |
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10.1186/s12882-018-1031-1 doi (DE-627)DOAJ040201333 (DE-599)DOAJ03ee2b06a3cf4b8ba50f0091731a8e25 DE-627 ger DE-627 rakwb eng RC870-923 Claudia Sommerer verfasserin aut Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). Diabetes Everolimus Kidney transplantation TOR inhibitor PTDM Post-transplant Diseases of the genitourinary system. Urology Oliver Witzke verfasserin aut Frank Lehner verfasserin aut Wolfgang Arns verfasserin aut Petra Reinke verfasserin aut Ute Eisenberger verfasserin aut Bruno Vogt verfasserin aut Katharina Heller verfasserin aut Johannes Jacobi verfasserin aut Markus Guba verfasserin aut Rolf Stahl verfasserin aut Ingeborg A. Hauser verfasserin aut Volker Kliem verfasserin aut Rudolf P. Wüthrich verfasserin aut Anja Mühlfeld verfasserin aut Barbara Suwelack verfasserin aut Michael Duerr verfasserin aut Eva-Maria Paulus verfasserin aut Martin Zeier verfasserin aut Martina Porstner verfasserin aut Klemens Budde verfasserin aut on behalf of the ZEUS and HERAKLES study investigators verfasserin aut In BMC Nephrology BMC, 2003 19(2018), 1, Seite 13 (DE-627)326643672 (DE-600)2041348-8 14712369 nnns volume:19 year:2018 number:1 pages:13 https://doi.org/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/article/03ee2b06a3cf4b8ba50f0091731a8e25 kostenfrei http://link.springer.com/article/10.1186/s12882-018-1031-1 kostenfrei https://doaj.org/toc/1471-2369 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 13 |
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Claudia Sommerer @@aut@@ Oliver Witzke @@aut@@ Frank Lehner @@aut@@ Wolfgang Arns @@aut@@ Petra Reinke @@aut@@ Ute Eisenberger @@aut@@ Bruno Vogt @@aut@@ Katharina Heller @@aut@@ Johannes Jacobi @@aut@@ Markus Guba @@aut@@ Rolf Stahl @@aut@@ Ingeborg A. Hauser @@aut@@ Volker Kliem @@aut@@ Rudolf P. Wüthrich @@aut@@ Anja Mühlfeld @@aut@@ Barbara Suwelack @@aut@@ Michael Duerr @@aut@@ Eva-Maria Paulus @@aut@@ Martin Zeier @@aut@@ Martina Porstner @@aut@@ Klemens Budde @@aut@@ on behalf of the ZEUS and HERAKLES study investigators @@aut@@ |
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RC870-923 Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials Diabetes Everolimus Kidney transplantation TOR inhibitor PTDM Post-transplant |
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Claudia Sommerer Oliver Witzke Frank Lehner Wolfgang Arns Petra Reinke Ute Eisenberger Bruno Vogt Katharina Heller Johannes Jacobi Markus Guba Rolf Stahl Ingeborg A. Hauser Volker Kliem Rudolf P. Wüthrich Anja Mühlfeld Barbara Suwelack Michael Duerr Eva-Maria Paulus Martin Zeier Martina Porstner Klemens Budde on behalf of the ZEUS and HERAKLES study investigators |
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onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials |
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Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials |
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Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). |
| abstractGer |
Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). |
| abstract_unstemmed |
Abstract Background Conversion from calcineurin inhibitor (CNI) therapy to a mammalian target of rapamycin (mTOR) inhibitor following kidney transplantation may help to preserve graft function. Data are sparse, however, concerning the impact of conversion on posttransplant diabetes mellitus (PTDM) or the progression of pre-existing diabetes. Methods PTDM and other diabetes-related parameters were assessed post hoc in two large open-label multicenter trials. Kidney transplant recipients were randomized (i) at month 4.5 to switch to everolimus or remain on a standard cyclosporine (CsA)-based regimen (ZEUS, n = 300), or (ii) at month 3 to switch to everolimus, remain on standard CNI therapy or convert to everolimus with reduced-exposure CsA (HERAKLES, n = 497). Results There were no significant differences in the incidence of PTDM between treatment groups (log rank p = 0.97 [ZEUS], p = 0.90 [HERAKLES]). The mean change in random blood glucose from randomization to month 12 was also similar between treatment groups in both trials for patients with or without PTDM, and with or without pre-existing diabetes. The change in eGFR from randomization to month 12 showed a benefit for everolimus versus comparator groups in all subpopulations, but only reached significance in larger subgroups (no PTDM or no pre-existing diabetes). Conclusions Within the restrictions of this post hoc analysis, including non-standardized diagnostic criteria and limited glycemia laboratory parameters, these data do not indicate any difference in the incidence or severity of PTDM with early conversion from a CsA-based regimen to everolimus, or in the progression of pre-existing diabetes. Trial registration clinicaltrials.gov, NCT00154310 (registered September 2005) and NCT00514514 (registered August 2007); EudraCT (2006-007021-32 and 2004-004346-40). |
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Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials |
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Oliver Witzke Frank Lehner Wolfgang Arns Petra Reinke Ute Eisenberger Bruno Vogt Katharina Heller Johannes Jacobi Markus Guba Rolf Stahl Ingeborg A. Hauser Volker Kliem Rudolf P. Wüthrich Anja Mühlfeld Barbara Suwelack Michael Duerr Eva-Maria Paulus Martin Zeier Martina Porstner Klemens Budde on behalf of the ZEUS and HERAKLES study investigators |
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