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everolimus and transplantation

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https://www.readbyqxmd.com/read/28333860/cardiovascular-parameters-to-2-years-after-kidney-transplantation-following-early-switch-to-everolimus-without-calcineurin-inhibitor-therapy-an-analysis-of-the-randomized-elevate-study
#1
Hallvard Holdaas, Johan W de Fijter, Josep M Cruzado, Pablo Massari, Björn Nashan, John Kanellis, Oliver Witzke, Alex Gutierrez-Dalmau, Aydin Turkmen, Zailong Wang, Patricia Lopez, Peter Bernhardt, Jossy Kochuparampil, Markus van der Giet, Klaus Murbraech
BACKGROUND: Mammalian target of rapamycin (mTOR) inhibitors may confer cardioprotective advantages but clinical data are limited. METHODS: In the open-label ELEVATE trial, kidney transplant patients were randomized at 10-14 weeks posttransplant to convert from calcineurin inhibitor (CNI) to everolimus or remain on standard CNI therapy. Prespecified endpoints included left ventricular mass index (LVMi) and, in a subpopulation of patients, arterial stiffness as measured by pulse wave velocity (PWV)...
March 22, 2017: Transplantation
https://www.readbyqxmd.com/read/28332959/de-novo-donor-specific-antibody-formation-in-tacrolimus-based-mycophenolate-versus-mammalian-target-of-rapamycin-immunosuppressive-regimens
#2
Zain Mithani, Jane Gralla, Oluwafisayo Adebiyi, Patrick Klem, James E Cooper, Alexander C Wiseman
OBJECTIVES: De novo donor-specific antibody formation posttransplant is associated with decreased graft survival. It is not known whether mammalian target of rapamycin inhibitors may be advantageous or detrimental compared with mycophenolate in the prevention of de novo donor-specific antibody formation. MATERIALS AND METHODS: We compared 66 kidney and kidney-pancreas transplant recipients who received tacrolimus, mammalian target of rapamycin inhibitor, and prednisone (group 1; 36 of whom received everolimus and 30 of whom received sirolimus) versus 132 patients who received tacrolimus, mycophenolate, and prednisone (group 2) matched for age, sex, race, and type/timing of transplant from 2007 to 2012...
March 22, 2017: Experimental and Clinical Transplantation
https://www.readbyqxmd.com/read/28316834/the-cecari-study-everolimus-certican%C3%A2-initiation-and-calcineurin-inhibitor-withdrawal-in-maintenance-heart-transplant-recipients-with-renal-insufficiency-a-multicenter-randomized-trial
#3
Jan Van Keer, David Derthoo, Olivier Van Caenegem, Michel De Pauw, Eric Nellessen, Nathalie Duerinckx, Walter Droogne, Gábor Vörös, Bart Meyns, Ann Belmans, Stefan Janssens, Johan Van Cleemput, Johan Vanhaecke
In this 3-year, open-label, multicenter study, 57 maintenance heart transplant recipients (>1 year after transplant) with renal insufficiency (eGFR 30-60 mL/min/1.73 m(2)) were randomized to start everolimus with CNI withdrawal (N = 29) or continue their current CNI-based immunosuppression (N = 28). The primary endpoint, change in measured glomerular filtration rate (mGFR) from baseline to year 3, did not differ significantly between both groups (+7.0 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p = 0...
2017: Journal of Transplantation
https://www.readbyqxmd.com/read/28279567/optimizing-everolimus-exposure-when-combined-with-calcineurin-inhibitors-in-solid-organ-transplantation
#4
REVIEW
Teun van Gelder, Lutz Fischer, Fuad Shihab, Maria Shipkova
The mammalian target of rapamycin (mTOR) inhibitor everolimus is a narrow therapeutic index drug for which optimal exposure levels are essential. The consistent pharmacokinetic profile of everolimus allows trough concentration (C0) measurement to be an appropriate and reliable index for therapeutic drug monitoring (TDM). Exposure-response analyses of data from early fixed-dose trials demonstrated that rates of biopsy-proven acute rejection (BPAR) are significantly higher if everolimus C0 declines below 3 ng/mL, an observation confirmed in subsequent concentration-controlled trials...
February 27, 2017: Transplantation Reviews
https://www.readbyqxmd.com/read/28276629/improved-fetal-hemoglobin-with-mtor-inhibitor-based-immunosuppression-in-a-kidney-transplant-recipient-with-sickle-cell-disease
#5
Noémie Gaudre, Pierre Cougoul, Pablo Bartolucci, Gaëlle Dörr, Alessandra Bura-Riviere, Nassim Kamar, Arnaud Del Bello
Fetal hemoglobin induction is a key-point in the management of sickle-cell disease (SCD). Herein, we report on a kidney-transplant recipient with SCD that was treated with everolimus, a mammalian target of rapamycin inhibitor. At 10 months after initiating therapy, HbF level was dramatically increased (from 4.8% to 15%) and there was excellent tolerance to treatment. This article is protected by copyright. All rights reserved.
March 9, 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/28263222/mtor-and-cardiovascular-diseases-diabetes-mellitus
#6
Bruno Vergès
The mammalian targets of rapamycin (mTOR) inhibitors are potent immunosuppressors used for prevention of acute rejection following transplantation and have been more recently used as anticancer drugs. mTOR inhibitors have a significant impact on glucose metabolism and induce frequently diabetes. mTOR inhibitors, when used as immunosuppressive agents (sirolimus, everolimus), can induce diabetes with an incidence which is low when used without calcineurin inhibitors (CNI) but high when used in combination with CNI (from 11...
March 4, 2017: Transplantation
https://www.readbyqxmd.com/read/28258601/incidence-and-outcome-of-bk-polyomavirus-infection-in-a-multicenter-randomized-controlled-trial-with-renal-transplant-patients-receiving-cyclosporine-mycophenolate-sodium-or-everolimus-based-low-dose-immunosuppressive-therapy
#7
Willem B van Doesum, Lilli Gard, Frederike J Bemelman, Johan W de Fijter, Jaap J Homan van der Heide, Hubert G M Niesters, Willem J van Son, Coen A Stegeman, Henk Groen, Annelies Riezebos-Brilman, Jan Stephan F Sanders
INTRODUCTION: It remains unclear whether overall degree of immunosuppression or specific effects of individual immunosuppressive agents are causal for increased occurrence of BK polyomavirus (BKPyV) infection in renal transplant recipients (RTR). METHODS: A prospective, multicenter, open-label randomized controlled trial in 361 de novo RTR was performed. A total of 224 RTR were randomized at 6 months into three treatment groups with dual therapy consisting of prednisolone (Pred) plus either cyclosporine (CsA), mycophenolate sodium (MPS), or everolimus (EVL)...
March 4, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28258506/persistent-hepatitis-e-infection-in-a-patient-with-tuberous-sclerosis-complex-treated-with-everolimus-a-case-report
#8
Wobke E M van Dijk, Menno A M H Vergeer, Joop E Arends
INTRODUCTION: The incidence of hepatitis E (HEV) genotype 3 is rising in developed countries. HEV infections are usually self-limiting, but can become chronic in immunocompromised patients. This might lead to rapid fibrosis development even resulting in cirrhosis. Chronic HEV is mainly described in patients after solid-organ or hematological transplantations. We present the first case of HEV infection in a patient with tuberous sclerosis complex (TSC) treated with everolimus, a mammalian target of rapamycin (mTOR) inhibitor...
March 3, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/28247521/combination-of-leflunomide-and-everolimus-for-treatment-of-bk-virus-nephropathy
#9
Juli Jaw, Prue Hill, David Goodman
BK nephropathy (BKN) is a common cause of graft dysfunction following kidney transplantation. Minimization of immunosuppressive therapy remains the first line of therapy, but this may lead to rejection and graft loss. In some cases, despite lowering immunosuppression, BK infection can persist, leading to chronic damage and kidney failure. Currently, there is no specific anti-BK viral therapy. Recent in vitro experiments have demonstrated a reduction in BK viral replication when infected cells are treated with the combination of Leflunomide and Everolimus...
April 2017: Nephrology
https://www.readbyqxmd.com/read/28230646/effect-of-calcineurin-inhibitor-free-everolimus-based-immunosuppressive-regimen-on-albuminuria-and-glomerular-filtration-rate-after-heart-transplantation
#10
Lærke M Nelson, Arne K Andreassen, Bert Andersson, Einar Gude, Hans Eiskjær, Göran Rådegran, Göran Dellgren, Lars Gullestad, Finn Gustafsson
BACKGROUND: Albuminuria in maintenance heart transplantation (HTx) is associated with poor renal response when switching to a calcineurin inhibitor (CNI)-lowered or free immunosuppressive regimen using everolimus (EVR), but the significance of albuminuria associated with EVR treatment after early CNI withdrawal in de novo HTx is unknown. METHODS: We tested if glomerular filtration rate (mGFR, measured by CrEDTA clearance) was associated with urine albumin/creatinine ratio (UACR) post-HTx in a subgroup of patients included in the SCHEDULE trial, where de novo HTx patients (n=115) were randomized to EVR with complete CNI elimination 7-11 weeks post-HTx or standard CNI immunosuppression...
February 23, 2017: Transplantation
https://www.readbyqxmd.com/read/28230643/mtor-inhibition-clinical-transplantation-pancreas-islet
#11
Thierry Berney, Axel Andres, Christian Toso, Pietro Majno, Jean-Paul Squifflet
This brief overview discusses the beneficial and deleterious effects of mTOR inhibitors on beta-cells, and how sirolimus- and everolimus-based immunosuppression have impacted on practices and outcomes of pancreas and islet transplantation. Sirolimus was the cornerstone of immunosuppressive regimens in islet transplantation at the turn of the millenium, but utilization of mTOR inhibitors has progressively decreased from >80% to <50% of islet transplant recipients in more recent years. For whole pancreas transplantation, mTOR inhibitors were used in approximately 20% of patients in the early 2000s, but this dropped over the years to <10% currently...
February 23, 2017: Transplantation
https://www.readbyqxmd.com/read/28230639/mammalian-target-of-rapamycin-inhibition-clinical-transplantation-liver
#12
Björn Nashan
The evidence base concerning use of mammalian target of rapamycin (mTOR) inhibitor therapy after liver transplantation is evolving rapidly, clarifying their benefits and disadvantages in different clinical scenarios. The H2304 trial showed that starting everolimus at 1 month posttransplant, with reduced tacrolimus, achieves a sustained improvement in renal function versus standard tacrolimus-based therapy, with at least equivalent immunosuppressive efficacy. Randomized studies evaluating early discontinuation of CNI therapy after introduction of an mTOR inhibitor consistently demonstrated a substantial improvement in renal function versus standard CNI therapy...
February 23, 2017: Transplantation
https://www.readbyqxmd.com/read/28185318/cognitive-function-after-heart-transplantation-comparing-everolimus-based-and-calcineurin-inhibitor-based-regimens
#13
Britta S Bürker, Lars Gullestad, Einar Gude, Anne R Authen, Ingelin Grov, Per K Hol, Arne K Andreassen, Satish Arora, Mary Amanda Dew, Arnt E Fiane, Ira R H Haraldsen, Ulrik F Malt, Stein Andersson
BACKGROUND: Studies have shown conflicting results concerning the occurrence of cognitive impairment after successful heart transplantation (HTx). Another unresolved issue is the possible differential impact of immunosuppressants on cognitive function. In this study, we describe cognitive function in a cohort of HTx recipients and subsequently compare cognitive function between subjects on either everolimus- or calcineurin inhibitor (CNI)-based immunosuppression. METHODS: Cognitive function, covering attention, processing speed, executive functions, memory, and language functions, was assessed with a neuropsychological test battery...
February 10, 2017: Clinical Transplantation
https://www.readbyqxmd.com/read/28183681/relapse-of-hodgkin-lymphoma-after-autologous-transplantation-time-to-rethink-treatment
#14
REVIEW
Yogesh Jethava, Guru Subramanian Guru Murthy, Mehdi Hamadani
Relapse of Hodgkin lymphoma after autologous hematopoietic cell transplantation (autologous HCT) is a major therapeutic challenge. Its management, at least in younger patients, traditionally involves salvage chemotherapy aiming to achieve disease remission followed by consolidation with allogeneic hematopoietic cell transplantation (allogeneic HCT) in eligible patients. The efficacy of salvage therapy is variable and newer combination chemotherapy regimens have improved the outcomes. Factors such as shorter time to relapse after autologous HCT and poor performance status have been identified as predictors of poor outcome...
February 1, 2017: Hematology/oncology and Stem Cell Therapy
https://www.readbyqxmd.com/read/28141897/association-of-clinical-events-with-everolimus-exposure-in-kidney-transplant-patients-receiving-low-doses-of-tacrolimus
#15
F Shihab, Y Qazi, S Mulgaonkar, K McCague, D Patel, V R Peddi, D Shaffer
A key objective in the use of immunosuppression following kidney transplantation is to attain the optimal balance between efficacy and safety. In a Phase IIIb, multi-center, randomized, open-label, non-inferiority study, incidence of clinical events, renal dysfunction and adverse events (AEs) were analyzed at 12 months in 309 de novo renal transplant recipients receiving everolimus (EVR), low-dose Tac (LTac) and prednisone. Cox proportional hazard regression modeling was used to estimate the probability of clinical events at specified combinations of time-normalized EVR and Tac trough concentrations...
January 31, 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/28134984/conversion-from-sirolimus-to-everolimus-in-long-term-liver-graft-recipients
#16
Nina Weiler, Nigar Bilge, Sven Troetschler, Johannes Vermehren, Andreas Anton Schnitzbauer, Eva Herrmann, Christoph Sarrazin, Stefan Zeuzem, Martin-Walter Welker
Immunosuppression by inhibition of the mechanistic target of rapamycin (mTOR) is a promising approach after liver transplantation. The mTOR inhibitor sirolimus was used in selected liver graft recipients despite safety concerns and lack of approval. Everolimus is another mTOR inhibitor approved after liver transplantation. It is currently unknown, whether conversion of sirolimus to everolimus is safe in long-term liver graft recipients. Long-term liver graft recipients treated with sirolimus were converted to everolimus...
January 30, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28133906/efficacy-and-safety-of-everolimus-and-mycophenolic-acid-with-early-tacrolimus-withdrawal-after-liver-transplantation-a-multicenter-randomized-trial
#17
Faouzi Saliba, Christophe Duvoux, Jean Gugenheim, Nassim Kamar, Sébastien Dharancy, Ephrem Salamé, Martine Neau-Cransac, François Durand, Pauline Houssel-Debry, Claire Vanlemmens, Georges Pageaux, Jean Hardwigsen, Daniel Eyraud, Yvon Calmus, Fabienne Di Giambattista, Jérôme Dumortier, Filomena Conti
SIMCER was a six-month, multicenter, open-label trial. Selected de novo liver transplant recipients were randomized (week 4) to everolimus with low-exposure tacrolimus discontinued by month 4 (n=93), or tacrolimus-based therapy (n=95), both with basiliximab induction and enteric-coated mycophenolate sodium ± steroids. The primary endpoint, change in estimated GFR (eGFR, MDRD) from randomization to week 24 post-transplant, was superior with everolimus: mean eGFR change +1.1mL/min/1.73m(2)  for everolimus versus -13...
January 30, 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/28125504/therapeutic-drug-monitoring-of-everolimus-comparability-of-concentrations-determined-by-2-immunoassays-and-a-liquid-chromatography-tandem-mass-spectrometry-method
#18
Maria Shipkova, Sonja Rapp, Raül Rigo-Bonnin, Eberhard Wieland, Andreas Peter
BACKGROUND: Therapeutic drug monitoring is recommended to guide therapy with the immunosuppressant everolimus (EVL) in solid organ transplantation to prevent rejections and to limit toxicity. For therapeutic drug monitoring, predose EVL concentrations are measured in whole blood mainly by liquid chromatography tandem mass spectrometry (LC-MS/MS). In addition, 2 immunoassays [Quantitative Microsphere System (QMS) EVL and Elecsys EVL] are commercially available. The aim of this study was to evaluate the comparability of EVL results determined with the 2 immunoassays and a validated LC-MS/MS test using samples from kidney, liver, and heart transplant (KT, LT, and HT, respectively) recipients...
April 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28121741/effect-of-early-everolimus-facilitated-reduction-of-tacrolimus-on-efficacy-and-renal-function-in-de-novo-liver-transplant-recipients-24-month-results-for-the-north-american-subpopulation
#19
William C Chapman, Robert S Brown, Kenneth D Chavin, Debra Sudan, Baburao Koneru, Guido Junge, Gaohong Dong, Dharmesh Patel, Lewis Teperman, John J Fung
BACKGROUND: A recent randomized phase III study of 719 de novo liver transplant recipients showed that early everolimus plus reduced-dose tacrolimus (EVR + rTAC) led to significantly better kidney function than standard TAC (TAC-C), without compromising efficacy. In that study, patients from North America (n = 211) had increased risk factors for posttransplant renal insufficiency at study start, relative to patients from Europe and rest of world (eg, worse renal function, more diabetes, older age)...
February 2017: Transplantation
https://www.readbyqxmd.com/read/28119255/limitations-of-current-liver-transplant-immunosuppressive-regimens-renal-considerations
#20
Wei Zhang, John Fung
BACKGROUND: The use of calcineurin inhibitor (CNI)-based immunosuppressive regimens following liver transplantation (LTx) has improved the outcomes of the recipients. However, CNI has nephrotoxicity and causes short- and long-term renal complications. The progressive structural changes can be irreversible in the long-term, leading to chronic kidney dysfunction. The present review was to evaluate the different strategies of CNI application to renal function in liver recipients. DATA SOURCES: PubMed database was searched for relevant articles in English on the issue of immunosuppressive regimen and kidney injury that related to early minimization of CNI after LTx...
February 2017: Hepatobiliary & Pancreatic Diseases International: HBPD INT
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