Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from 6 months after heart transplantation: The randomized MANDELA study
In the 12-month, open-label MANDELA study, patients were randomized at month 6 after heart transplantation to (1) convert to calcineurin inhibitor (CNI)-free immunosuppression with everolimus (EVR), mycophenolic acid and steroids (CNI-free, n = 71), or to (2) continue reduced-exposure CNI, with EVR...
Gespeichert in:
| Hauptverfasser: | , , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
20 October 2019
|
| In: |
American journal of transplantation
Year: 2019, Jahrgang: 19, Heft: 11, Pages: 3006-3017 |
| ISSN: | 1600-6143 |
| DOI: | 10.1111/ajt.15361 |
| Online-Zugang: | Verlag, Volltext: https://doi.org/10.1111/ajt.15361 Verlag: https://onlinelibrary.wiley.com/doi/abs/10.1111/ajt.15361 
|
| Verfasserangaben: | Markus J. Barten, Stephan W. Hirt, Jens Garbade, Christoph Bara, Andreas O. Doesch, Christoph Knosalla, Carola Grinninger, Jörg Stypmann, Christian Sieder, Hans B. Lehmkuhl, Martina Porstner, Uwe Schulz |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1685955312 | ||
| 003 | DE-627 | ||
| 005 | 20220817194241.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 191219s2019 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1111/ajt.15361 |2 doi | |
| 035 | |a (DE-627)1685955312 | ||
| 035 | |a (DE-599)KXP1685955312 | ||
| 035 | |a (OCoLC)1341286618 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Barten, Markus Johannes |d 1966- |e VerfasserIn |0 (DE-588)136638783 |0 (DE-627)694536466 |0 (DE-576)30118173X |4 aut | |
| 245 | 1 | 0 | |a Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from 6 months after heart transplantation |b The randomized MANDELA study |c Markus J. Barten, Stephan W. Hirt, Jens Garbade, Christoph Bara, Andreas O. Doesch, Christoph Knosalla, Carola Grinninger, Jörg Stypmann, Christian Sieder, Hans B. Lehmkuhl, Martina Porstner, Uwe Schulz |
| 264 | 1 | |c 20 October 2019 | |
| 300 | |a 12 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Gesehen am 19.12.2019 | ||
| 520 | |a In the 12-month, open-label MANDELA study, patients were randomized at month 6 after heart transplantation to (1) convert to calcineurin inhibitor (CNI)-free immunosuppression with everolimus (EVR), mycophenolic acid and steroids (CNI-free, n = 71), or to (2) continue reduced-exposure CNI, with EVR and steroids (EVR/redCNI, n = 74). Tacrolimus was administered in 48.8% of EVR/redCNI patients and 52.6% of CNI-free patients at randomization. Both strategies improved and stabilized renal function based on the primary endpoint (estimated GFR at month 18 posttransplant postrandomization) with superiority of the CNI-free group vs EVR/redCNI: mean 64.1 mL/min/1.73 m2 vs 52.9 mL/min/1.73 m2; difference + 11.3 mL/min/1.73 m2 (P < .001). By month 18, estimated GFR had increased by ≥ 10 mL/min/1.73 m2 in 31.8% and 55.2% of EVR/redCNI and CNI-free patients, respectively, and by ≥ 25 mL/min/1.73 m2 in 4.5% and 20.9%. Rates of biopsy-proven acute rejection (BPAR) were 6.8% and 21.1%; all cases were without hemodynamic compromise. BPAR was less frequent with EVR/redCNI vs the CNI-free regimen (P = .015); 6 of 15 episodes in CNI-free patients occurred with EVR concentration < 5 ng/mL. Rates of adverse events and associated discontinuations were comparable. EVR/redCNI from month 6 achieved stable renal function with infrequent BPAR. One-year renal function can be improved by early conversion to EVR-based CNI-free therapy but requires close EVR monitoring. Clinical trials registry: ClinicalTrials.gov NCT00862979. | ||
| 650 | 4 | |a clinical research/practice | |
| 650 | 4 | |a everolimus | |
| 650 | 4 | |a heart transplantation/cardiology | |
| 650 | 4 | |a immunosuppressant—calcineurin inhibitor (CNI) | |
| 650 | 4 | |a immunosuppressant—mechanistic target of rapamycin (mTOR) | |
| 650 | 4 | |a immunosuppression/immune modulation | |
| 650 | 4 | |a tacrolimus | |
| 700 | 1 | |a Hirt, Stephan |e VerfasserIn |0 (DE-588)137311052 |0 (DE-627)591603721 |0 (DE-576)302907181 |4 aut | |
| 700 | 1 | |a Dösch, Andreas |d 1976- |e VerfasserIn |0 (DE-588)129172758 |0 (DE-627)390355798 |0 (DE-576)297522310 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t American journal of transplantation |d [Amsterdam] : Elsevier, 2001 |g 19(2019), 11, Seite 3006-3017 |h Online-Ressource |w (DE-627)328318353 |w (DE-600)2045621-9 |w (DE-576)094404267 |x 1600-6143 |7 nnas |a Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from 6 months after heart transplantation The randomized MANDELA study |
| 773 | 1 | 8 | |g volume:19 |g year:2019 |g number:11 |g pages:3006-3017 |g extent:12 |a Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from 6 months after heart transplantation The randomized MANDELA study |
| 856 | 4 | 0 | |u https://doi.org/10.1111/ajt.15361 |x Verlag |x Resolving-System |3 Volltext |
| 856 | 4 | 0 | |u https://onlinelibrary.wiley.com/doi/abs/10.1111/ajt.15361 |x Verlag |
| 951 | |a AR | ||
| 992 | |a 20191219 | ||
| 993 | |a Article | ||
| 994 | |a 2019 | ||
| 998 | |g 129172758 |a Dösch, Andreas |m 129172758:Dösch, Andreas |p 5 | ||
| 999 | |a KXP-PPN1685955312 |e 3566927260 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"relHost":[{"physDesc":[{"extent":"Online-Ressource"}],"origin":[{"publisherPlace":"[Amsterdam] ; Copenhagen ; Oxford [u.a.] ; Oxford [u.a.]","dateIssuedDisp":"2001-","dateIssuedKey":"2001","publisher":"Elsevier ; Munksgaard ; Blackwell ; Wiley-Blackwell"}],"id":{"eki":["328318353"],"doi":["10.1111/(ISSN)1600-6143"],"zdb":["2045621-9"],"issn":["1600-6143"]},"pubHistory":["1.2001 -"],"part":{"text":"19(2019), 11, Seite 3006-3017","volume":"19","extent":"12","year":"2019","issue":"11","pages":"3006-3017"},"disp":"Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from 6 months after heart transplantation The randomized MANDELA studyAmerican journal of transplantation","note":["Gesehen am 16.06.25"],"type":{"bibl":"periodical","media":"Online-Ressource"},"language":["eng"],"recId":"328318353","title":[{"subtitle":"official journal of the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (AST)","title":"American journal of transplantation","title_sort":"American journal of transplantation"}]}],"physDesc":[{"extent":"12 S."}],"name":{"displayForm":["Markus J. Barten, Stephan W. Hirt, Jens Garbade, Christoph Bara, Andreas O. Doesch, Christoph Knosalla, Carola Grinninger, Jörg Stypmann, Christian Sieder, Hans B. Lehmkuhl, Martina Porstner, Uwe Schulz"]},"id":{"eki":["1685955312"],"doi":["10.1111/ajt.15361"]},"origin":[{"dateIssuedKey":"2019","dateIssuedDisp":"20 October 2019"}],"recId":"1685955312","language":["eng"],"type":{"media":"Online-Ressource","bibl":"article-journal"},"note":["Gesehen am 19.12.2019"],"person":[{"given":"Markus Johannes","family":"Barten","role":"aut","display":"Barten, Markus Johannes","roleDisplay":"VerfasserIn"},{"given":"Stephan","family":"Hirt","role":"aut","display":"Hirt, Stephan","roleDisplay":"VerfasserIn"},{"given":"Andreas","family":"Dösch","role":"aut","display":"Dösch, Andreas","roleDisplay":"VerfasserIn"}],"title":[{"title_sort":"Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from 6 months after heart transplantation","title":"Comparing everolimus-based immunosuppression with reduction or withdrawal of calcineurin inhibitor reduction from 6 months after heart transplantation","subtitle":"The randomized MANDELA study"}]} | ||
| SRT | |a BARTENMARKCOMPARINGE2020 | ||