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Everolimus kidney transplantation

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https://www.readbyqxmd.com/read/28141897/association-of-clinical-events-with-everolimus-exposure-in-kidney-transplant-patients-receiving-low-doses-of-tacrolimus
#1
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
#2
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/28125504/therapeutic-drug-monitoring-of-everolimus-comparability-of-concentrations-determined-by-two-immunoassays-and-a-lc-ms-ms-method
#3
Maria Shipkova, Sonja Rapp, Raül Rigo-Bonnin, Eberhard Wieland, Andreas Peter
BACKGROUND: Therapeutic drug monitoring (TDM) is recommended to guide therapy with the immunosuppressant Everolimus (EVL) in solid organ transplantation to prevent rejections and to limit toxicity. For TDM, pre-dose EVL concentrations are measured in whole blood mainly by liquid chromatography tandem mass spectrometry (LC-MS/MS). In addition, two immunoassays (QMS® Everolimus and Elecsys® Everolimus) are commercially available. The aim of this study was to evaluate the comparability of EVL results determined with the two immunoassays and a validated LC-MS/MS test using samples from kidney (KT)-liver (LT)- and heart (HT) transplant recipients...
January 24, 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
#4
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
#5
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
https://www.readbyqxmd.com/read/28109543/the-risk-of-cancer-in-kidney-transplant-recipients-may-be-reduced-in-those-maintained-on-everolimus-and-reduced-cyclosporine
#6
Wai H Lim, Graeme R Russ, Germaine Wong, Helen Pilmore, John Kanellis, Steven J Chadban
Kidney transplant recipients are at a high risk of developing cancers after transplantation. Switching from calcineurin inhibitors to sirolimus has been shown to prevent secondary nonmelanoma skin cancer but whether everolimus with reduced exposure to calcineurin inhibitors has similar anti-cancer effects remains unknown. Therefore, we compared the risk of incident cancer over seven years of follow-up among kidney transplant recipients randomized to everolimus plus reduced exposure cyclosporine versus mycophenolate sodium and standard exposure cyclosporine...
January 18, 2017: Kidney International
https://www.readbyqxmd.com/read/28107397/efficacy-and-safety-of-everolimus-for-maintenance-immunosuppression-of-kidney-transplantation-a-meta-analysis-of-randomized-controlled-trials
#7
Jinyu Liu, Dong Liu, Juan Li, Lan Zhu, Chengliang Zhang, Kai Lei, Qiling Xu, Ruxu You
BACKGROUND: Conversion to everolimus is often used in kidney transplantation to overcome calcineurin inhibitor (CNI) nephrotoxicity but there is conflicting evidence for this approach. OBJECTIVES: To investigate the benefits and harm from randomized clinical trials (RCTs) involving the conversion from CNI to everolimus after kidney transplantation. METHODS: Databases were searched up to March 2016. Two reviewers independently assessed trials for eligibility and quality, and extracted data...
2017: PloS One
https://www.readbyqxmd.com/read/28104155/immunosuppression-modification-by-everolimus-with-minimization-of-calcineurin-inhibitors-recovers-kidney-graft-function-even-in-patients-with-very-late-conversion-and-also-with-poor-graft-function
#8
M Nojima, Y Yamada, Y Higuchi, K Shimatani, A Kanematsu, S Yamamoto
BACKGROUND: Although kidney graft survival within 5 years after transplantation is now achieved in >95% of recipients, chronic graft deterioration remains a factor limiting long-term survival. Chronic nephrotoxicity induced by calcineurin inhibitors (CNIs) is one of the major causes of chronic graft injury; thus, minimization of CNIs by administration of everolimus (EVR) is expected to relieve their toxic effects. METHODS: Fifty-six kidney transplant recipients receiving CNI-based immunosuppression (tacrolimus, n = 34; cyclosporine, n = 22) were analyzed...
January 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28104152/experience-of-quatro-therapy-with-everolimus-to-minimize-calcineurin-inhibitor-for-kidney-transplant-recipients
#9
N Nakamura, T Miyazaki, H Matsuzaki, R Furuya, S Miyajima, S Irie, H Matsuoka, M Tanaka
BACKGROUND: This study was divided into three phases, on the occasion of the introduction of everolimus (EVR) in our hospital. METHODS: In the first phase, a study group of six maintenance patients (three living related donors, three deceased donors) who had a history of malignant disease with less than 500 mg/day of proteinuria were enrolled; a high serum creatinine and upper limit of duration after kidney transplant operation was not considered. EVR was discontinued in four of the six patients because of side effects or worsening renal function...
January 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28104132/everolimus-induced-systemic-serositis-after-simultaneous-liver-and-kidney-transplantation-a-case-report
#10
K Kim, D W Jeong, Y H Lee, Y G Kim, J-Y Moon, K-H Jeong, T W Lee, C-G Ihm, S-H Joo, H-C Park, S-H Lee
Although everolimus, a mammalian target of rapamycin inhibitor, has been used as a potent immunosuppressive agent in organ transplantation, data regarding its adverse effect profile compared with that of sirolimus in clinical circumstances are limited. A 50-year-old man who underwent simultaneous liver and kidney transplantation 14 months previously was admitted with large pleural effusion, pericardial effusion, and ascites. Laboratory findings and cultures for possible infectious causes were all negative. Pericardial window surgery with drainage of the pericardial fluid was performed on day 3...
January 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28058211/organ-transplantation-and-drug-eluting-stents-perioperative-challenges
#11
REVIEW
Aparna Dalal
Patients listed for organ transplant frequently have severe coronary artery disease (CAD), which may be treated with drug eluting stents (DES). Everolimus and zotarolimus eluting stents are commonly used. Newer generation biolimus and novolimus eluting biodegradable stents are becoming increasingly popular. Patients undergoing transplant surgery soon after the placement of DES are at increased risk of stent thrombosis (ST) in the perioperative period. Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor such as clopidogrel, prasugrel and ticagrelor is instated post stenting to decrease the incident of ST...
December 24, 2016: World Journal of Transplantation
https://www.readbyqxmd.com/read/28027625/early-conversion-from-calcineurin-inhibitor-to-everolimus-based-therapy-following-kidney-transplantation-results-of-the-randomized-elevate-trial
#12
Johan W de Fijter, Hallvard Holdaas, Ole Øyen, Jan-Stephan Sanders, Sankaran Sundar, Frederike J Bemelman, Claudia Sommerer, Julio Pascual, Yingyos Avihingsanon, Cholatip Pongskul, Frederic Oppenheimer, Lorenzo Toselli, Graeme Russ, Zailong Wang, Patricia Lopez, Jossy Kochuparampil, Josep M Cruzado, Markus van der Giet
In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10-14 weeks to convert to everolimus (n=359) or remain on standard calcineurin inhibitor (CNI) therapy (n=356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and steroids. The primary endpoint, change in estimated GFR from randomization to month 12, was similar for everolimus versus CNI: mean (SE) 0.3(1.5)mL/min/1.73(2) versus -1.5(1.5)mL/min/1.73(2) (p=0.116). At month 24, mean (SD) estimated GFR was 62...
December 27, 2016: American Journal of Transplantation
https://www.readbyqxmd.com/read/27932158/everolimus-and-advagraf-ab-initio-in-combined-liver-and-kidney-transplant-with-donor-specific-antibodies-a-case-report
#13
L Tariciotti, T M Manzia, D Sforza, A Anselmo, G Tisone
Although donor-specific antibodies are regarded as a contraindication for kidney transplantation, the data available for combined liver and kidney transplantation (cLKTx) are scarce, and there is no established therapeutic approach for this category of transplant recipients. De novo use of everolimus and a reduced dose of calcineurin inhibitor reportedly provides excellent kidney function compared with a standard regimen containing a calcineurin inhibitor. This strategy, however, has been applied in only some recipient categories...
November 2016: Transplantation Proceedings
https://www.readbyqxmd.com/read/27807479/everolimus-and-malignancy-after-solid-organ-transplantation-a-clinical-update
#14
REVIEW
Hallvard Holdaas, Paolo De Simone, Andreas Zuckermann
Malignancy after solid organ transplantation remains a major cause of posttransplant mortality. The mammalian target of rapamycin (mTOR) inhibitor class of immunosuppressants exerts various antioncogenic effects, and the mTOR inhibitor everolimus is licensed for the treatment of several solid cancers. In kidney transplantation, evidence from registry studies indicates a lower rate of de novo malignancy under mTOR inhibition, with some potentially supportive data from randomized trials of everolimus. Case reports and small single-center series have suggested that switch to everolimus may be beneficial following diagnosis of posttransplant malignancy, particularly for Kaposi's sarcoma and nonmelanoma skin cancer, but prospective studies are lacking...
2016: Journal of Transplantation
https://www.readbyqxmd.com/read/27793122/acute-pancreatitis-associated-with-everolimus-after-kidney-transplantation-a-case-report
#15
Francesco Fontana, Gianni Cappelli
BACKGROUND: Acute pancreatitis (AP) following KT is a rare and often fatal complication of the early post-transplant period. Common causative factors for AP are rare after KT; anti-rejection drugs as CyA, prednisone and MMF have been implicated, although evidence is not strong and we found no reports on possible causative role for mTOR inhibitors. CASE PRESENTATION: A 55-year-old Caucasian man with end-stage renal disease due to idiopathic membrano-prolipherative glomerulonephritis underwent single kidney transplantation (KT) from cadaveric donor...
October 28, 2016: BMC Nephrology
https://www.readbyqxmd.com/read/27742386/the-bad-and-the-good-news-on-cancer-immunotherapy-implications-for-organ-transplant-recipients
#16
REVIEW
Umberto Maggiore, Julio Pascual
Cancer immunotherapy, especially the use of checkpoint inhibitors, is expanding and can be efficacious in organ transplant recipients with malignant neoplasia. In this review, we summarize clinical findings and evolution of several patients treated with CTL4-4 or PD-1 inhibitors reported in the literature. The CTL-4 inhibitor ipilimumab has been safely used in several liver and kidney allograft recipients. PD1-inhibitors look promising for tumor shrinking, but acute rejection is the rule, so they should be avoided in recipients of life-saving organs...
September 2016: Advances in Chronic Kidney Disease
https://www.readbyqxmd.com/read/27742384/costimulatory-blockade-and-use-of-mammalian-target-of-rapamycin-inhibitors-avoiding-injury-part-1
#17
REVIEW
Joshua Augustine, Donald E Hricik
Although calcineurin inhibitor drugs have been the mostly used therapy in modern immunosuppression in kidney transplantation, their effect on kidney allograft dysfunction has been suboptimal as far as preservation of kidney function is concerned. Additionally, there are metabolic and other nonmetabolic effects including increased risk of malignancy that has necessitated the use of mammalian target of rapamycin inhibitors to reduce exposure to calcineurin inhibitors. Mammalian target of rapamycin inhibitors, both sirolimus and everolimus, have been studied in several trials to facilitate preservation of kidney function with variable effects on kidney allograft function and immunogenicity...
September 2016: Advances in Chronic Kidney Disease
https://www.readbyqxmd.com/read/27659512/mtor-inhibitors-in-pancreas-transplant-adverse-effects-and-drug-drug-interactions
#18
Gabriel Fernandes-Silva, Mayara Ivani de Paula, Érika B Rangel
INTRODUCTION: Patient and pancreas allograft survival improved following reductions in surgical complications, tighter donor selection and optimization in immunosuppressive protocols. However, long-term survival of pancreas allografts is adversely affected by rejection and immunosuppressive regimen toxicity. AREAS COVERED: This article reviews the existing literature and knowledge of mammalian target of rapamycin inhibitors (mTORi). Some clinically relevant drug-drug interactions are highlighted...
September 23, 2016: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/27648523/controlled-randomized-study-comparing-the-cardiovascular-profile-of-everolimus-with-tacrolimus-in-renal-transplantation
#19
Josep M Cruzado, Julio Pascual, Ana Sánchez-Fructuoso, Daniel Serón, Joan M Díaz, Manuel Rengel, Federico Oppenheimer, Domingo Hernández, Alexandra Paravisini, Núria Saval, José M Morales
Left ventricular hypertrophy (LVH) regression after kidney transplantation may be influenced by immunosuppression. In a 24-month open-label, multicenter, phase-IV study, 71 kidney allograft recipients without previous acute rejection, showing eGFR >40 ml/min and proteinuria <500 mg/day and between 6 months and 3 years post-transplantation, were randomized to receive everolimus (EVR) + mycophenolic acid (MPA) or were maintained on tacrolimus (TAC) + MPA. The aim was to assess whether the conversion to EVR could reduce left ventricular mass index (LVMi) at month-24...
December 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/27639176/incidence-of-bk-polyomavirus-infection-after-kidney-transplantation-is-independent-of-type-of-immunosuppressive-therapy
#20
Josephine Radtke, Nina Dietze, Lutz Fischer, Eike-Gert Achilles, Jun Li, Silke Scheidat, Friedrich Thaiss, Bjoern Nashan, Martina Koch
BACKGROUND: BK polyomavirus (BKV) infection and BKV nephropathy (BKVN) are risk factors for allograft function and survival. METHODS: We retrospectively analyzed BK viremia and BKVN in 348 patients who received a kidney transplantation donated after brain death (n=232) or living donation (n=116) between 2008 and 2013. A total of 266 patients were treated with standard immunosuppression consisting of basiliximab induction, calcineurin inhibitor (CNI), and mycophenolic acid (MPA, n=219) or everolimus (n=47); 82 patients received more intense immunosuppression with lymphocyte depletion, CNI and MPA (n=38) or everolimus (n=44)...
December 2016: Transplant Infectious Disease: An Official Journal of the Transplantation Society
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