Everolimus vs Mycophenolate Mofetil in Combination With Tacrolimus: A Propensity Score-matched Analysis in Liver Transplantation

No trial has investigated the long-term outcome of everolimus (EVR)-incorporating immunosuppression vs tacrolimus (TAC) and mycophenolate mofetil (MMF) after liver transplantation. With a propensity score methodology, 178 recipients on TAC and MMF were compared to 178 patients on TAC and EVR. At a m...

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Veröffentlicht in:Transplantation proceedings 2018-12, Vol.50 (10), p.3615-3620
Hauptverfasser: De Simone, P., Carrai, P., Coletti, L., Ghinolfi, D., Petruccelli, S., Precisi, A., Campani, D., Marchetti, P., Filipponi, F.
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container_end_page 3620
container_issue 10
container_start_page 3615
container_title Transplantation proceedings
container_volume 50
creator De Simone, P.
Carrai, P.
Coletti, L.
Ghinolfi, D.
Petruccelli, S.
Precisi, A.
Campani, D.
Marchetti, P.
Filipponi, F.
description No trial has investigated the long-term outcome of everolimus (EVR)-incorporating immunosuppression vs tacrolimus (TAC) and mycophenolate mofetil (MMF) after liver transplantation. With a propensity score methodology, 178 recipients on TAC and MMF were compared to 178 patients on TAC and EVR. At a median (interquartile range) follow-up of 45 (46.3) months, the probability of treated biopsy-proven acute rejection, graft loss, and death was 36.6% for MMF and 28.1% for EVR (P = .0891). Treated biopsy-proven acute rejection was numerically lower for EVR (3.3% vs 7.3%, P = .09), while adverse events (70.2% vs 58.9%, P = .02) and drug discontinuations (21.3% vs 11.8%, P = .01) were significantly higher with regard to hypercholesterolemia (P = .001), thrombocytopenia (P = .0062), and edema (P = .0107). Patients on MMF showed more hypertension (P = .0315), tremor (P = .0006), cytomegalovirus infection (P = .0165), and malignancies (P = .0175). EVR was associated with lesser deterioration in mean (SD) renal function at the latest follow-up (−2.2 (1.8) vs −5.1 (3.2) mL/min/1.73 m2, t = 3.6, P = .005). The efficacy of the combination of TAC and EVR is comparable to that of TAC and MMF. Drug discontinuations and adverse events were higher for patients on EVR, but these latter showed less hypertension, cytomegalovirus infection, and renal dysfunction. The observed reduction in posttransplant malignancies for EVR requires longer follow-up to be confirmed. •So far, no trial has investigated the long-term outcome of everolimus everolimus-incorporating immunosuppression versus tacrolimus and mycophenolate mofetil after liver transplantation.•With a propensity score methodology, 178 recipients on tacrolimus and mycophenolate mofetil were retrospectively compared to 178 patients on tacrolimus and everolimus.•Treated biopsy-proven acute rejection was numerically lower for everolimus, while adverse events and drug discontinuations were higher, in regard to hypercholesterolemia (P = .001), thrombocytopenia (P = .0062), and edema (P = .0107).•Patients on tacrolimus and mycophenolate showed more hypertension (P = .0315), tremor (P = .0006), cytomegalovirus infection (P = .0165), and malignancies (P = .0175).•Everolimus was associated with less deterioration in renal function at the latest follow-up.
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With a propensity score methodology, 178 recipients on TAC and MMF were compared to 178 patients on TAC and EVR. At a median (interquartile range) follow-up of 45 (46.3) months, the probability of treated biopsy-proven acute rejection, graft loss, and death was 36.6% for MMF and 28.1% for EVR (P = .0891). Treated biopsy-proven acute rejection was numerically lower for EVR (3.3% vs 7.3%, P = .09), while adverse events (70.2% vs 58.9%, P = .02) and drug discontinuations (21.3% vs 11.8%, P = .01) were significantly higher with regard to hypercholesterolemia (P = .001), thrombocytopenia (P = .0062), and edema (P = .0107). Patients on MMF showed more hypertension (P = .0315), tremor (P = .0006), cytomegalovirus infection (P = .0165), and malignancies (P = .0175). EVR was associated with lesser deterioration in mean (SD) renal function at the latest follow-up (−2.2 (1.8) vs −5.1 (3.2) mL/min/1.73 m2, t = 3.6, P = .005). The efficacy of the combination of TAC and EVR is comparable to that of TAC and MMF. Drug discontinuations and adverse events were higher for patients on EVR, but these latter showed less hypertension, cytomegalovirus infection, and renal dysfunction. The observed reduction in posttransplant malignancies for EVR requires longer follow-up to be confirmed. •So far, no trial has investigated the long-term outcome of everolimus everolimus-incorporating immunosuppression versus tacrolimus and mycophenolate mofetil after liver transplantation.•With a propensity score methodology, 178 recipients on tacrolimus and mycophenolate mofetil were retrospectively compared to 178 patients on tacrolimus and everolimus.•Treated biopsy-proven acute rejection was numerically lower for everolimus, while adverse events and drug discontinuations were higher, in regard to hypercholesterolemia (P = .001), thrombocytopenia (P = .0062), and edema (P = .0107).•Patients on tacrolimus and mycophenolate showed more hypertension (P = .0315), tremor (P = .0006), cytomegalovirus infection (P = .0165), and malignancies (P = .0175).•Everolimus was associated with less deterioration in renal function at the latest follow-up.</description><identifier>ISSN: 0041-1345</identifier><identifier>EISSN: 1873-2623</identifier><identifier>DOI: 10.1016/j.transproceed.2018.07.011</identifier><identifier>PMID: 30577246</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Everolimus - administration &amp; dosage ; Female ; Graft Rejection - prevention &amp; control ; Humans ; Immunosuppression - methods ; Immunosuppressive Agents - administration &amp; dosage ; Liver Transplantation - methods ; Male ; Middle Aged ; Mycophenolic Acid - administration &amp; dosage ; Propensity Score ; Retrospective Studies ; Tacrolimus - administration &amp; dosage</subject><ispartof>Transplantation proceedings, 2018-12, Vol.50 (10), p.3615-3620</ispartof><rights>2018 Elsevier Inc.</rights><rights>Copyright © 2018 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c380t-1b7c3179ae5a439e74bf01868cd2c01f2fe0d04ed9bf2765bbea0fa3d6bd86223</citedby><cites>FETCH-LOGICAL-c380t-1b7c3179ae5a439e74bf01868cd2c01f2fe0d04ed9bf2765bbea0fa3d6bd86223</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0041134518309357$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30577246$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>De Simone, P.</creatorcontrib><creatorcontrib>Carrai, P.</creatorcontrib><creatorcontrib>Coletti, L.</creatorcontrib><creatorcontrib>Ghinolfi, D.</creatorcontrib><creatorcontrib>Petruccelli, S.</creatorcontrib><creatorcontrib>Precisi, A.</creatorcontrib><creatorcontrib>Campani, D.</creatorcontrib><creatorcontrib>Marchetti, P.</creatorcontrib><creatorcontrib>Filipponi, F.</creatorcontrib><title>Everolimus vs Mycophenolate Mofetil in Combination With Tacrolimus: A Propensity Score-matched Analysis in Liver Transplantation</title><title>Transplantation proceedings</title><addtitle>Transplant Proc</addtitle><description>No trial has investigated the long-term outcome of everolimus (EVR)-incorporating immunosuppression vs tacrolimus (TAC) and mycophenolate mofetil (MMF) after liver transplantation. With a propensity score methodology, 178 recipients on TAC and MMF were compared to 178 patients on TAC and EVR. At a median (interquartile range) follow-up of 45 (46.3) months, the probability of treated biopsy-proven acute rejection, graft loss, and death was 36.6% for MMF and 28.1% for EVR (P = .0891). Treated biopsy-proven acute rejection was numerically lower for EVR (3.3% vs 7.3%, P = .09), while adverse events (70.2% vs 58.9%, P = .02) and drug discontinuations (21.3% vs 11.8%, P = .01) were significantly higher with regard to hypercholesterolemia (P = .001), thrombocytopenia (P = .0062), and edema (P = .0107). Patients on MMF showed more hypertension (P = .0315), tremor (P = .0006), cytomegalovirus infection (P = .0165), and malignancies (P = .0175). EVR was associated with lesser deterioration in mean (SD) renal function at the latest follow-up (−2.2 (1.8) vs −5.1 (3.2) mL/min/1.73 m2, t = 3.6, P = .005). 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With a propensity score methodology, 178 recipients on TAC and MMF were compared to 178 patients on TAC and EVR. At a median (interquartile range) follow-up of 45 (46.3) months, the probability of treated biopsy-proven acute rejection, graft loss, and death was 36.6% for MMF and 28.1% for EVR (P = .0891). Treated biopsy-proven acute rejection was numerically lower for EVR (3.3% vs 7.3%, P = .09), while adverse events (70.2% vs 58.9%, P = .02) and drug discontinuations (21.3% vs 11.8%, P = .01) were significantly higher with regard to hypercholesterolemia (P = .001), thrombocytopenia (P = .0062), and edema (P = .0107). Patients on MMF showed more hypertension (P = .0315), tremor (P = .0006), cytomegalovirus infection (P = .0165), and malignancies (P = .0175). EVR was associated with lesser deterioration in mean (SD) renal function at the latest follow-up (−2.2 (1.8) vs −5.1 (3.2) mL/min/1.73 m2, t = 3.6, P = .005). The efficacy of the combination of TAC and EVR is comparable to that of TAC and MMF. Drug discontinuations and adverse events were higher for patients on EVR, but these latter showed less hypertension, cytomegalovirus infection, and renal dysfunction. The observed reduction in posttransplant malignancies for EVR requires longer follow-up to be confirmed. •So far, no trial has investigated the long-term outcome of everolimus everolimus-incorporating immunosuppression versus tacrolimus and mycophenolate mofetil after liver transplantation.•With a propensity score methodology, 178 recipients on tacrolimus and mycophenolate mofetil were retrospectively compared to 178 patients on tacrolimus and everolimus.•Treated biopsy-proven acute rejection was numerically lower for everolimus, while adverse events and drug discontinuations were higher, in regard to hypercholesterolemia (P = .001), thrombocytopenia (P = .0062), and edema (P = .0107).•Patients on tacrolimus and mycophenolate showed more hypertension (P = .0315), tremor (P = .0006), cytomegalovirus infection (P = .0165), and malignancies (P = .0175).•Everolimus was associated with less deterioration in renal function at the latest follow-up.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>30577246</pmid><doi>10.1016/j.transproceed.2018.07.011</doi><tpages>6</tpages></addata></record>
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subjects Adult
Aged
Everolimus - administration & dosage
Female
Graft Rejection - prevention & control
Humans
Immunosuppression - methods
Immunosuppressive Agents - administration & dosage
Liver Transplantation - methods
Male
Middle Aged
Mycophenolic Acid - administration & dosage
Propensity Score
Retrospective Studies
Tacrolimus - administration & dosage
title Everolimus vs Mycophenolate Mofetil in Combination With Tacrolimus: A Propensity Score-matched Analysis in Liver Transplantation
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