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everolimus and transplantation

Harpal S Sandhu, Joshua Lambert, Yan Xu, Henry J Kaplan
A local immune response has been implicated in the pathogenesis of age-related macular degeneration (AMD), but it is unclear if systemic immunosuppressive/immunomodulatory therapy (IMT) protects against the onset and/or progression of AMD. We performed a retrospective cohort study using a Cox proportional hazards model of two cohorts. Cohort 1 included patients with stage V chronic kidney disease (CKD) status post kidney transplantation, on at least one IMT agent, and older than 50. Cohort 2 included patients with stage IV or V CKD who had not undergone kidney transplantation, were not on IMT, and were older than 50...
2018: PloS One
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
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...
September 19, 2018: BMC Nephrology
Barbara Marconi, Anna Campanati, Melania Giannoni, Francesca Ricotti, Tommaso Bianchelli, Annamaria Offidani
BACKGROUND: Transplant patients need to be strictly followed, since the immunosuppressive therapies they usually receive can increase the risk of skin complications. This study aims to evaluate the prevalence of neoplastic skin complications in transplant patients. METHODS: We analyzed 256 liver or kidney transplant patients. The follow-up mean period was 7+/-3,5 years. It was also evaluated the prevalence of cutaneous neoplastic complications according to the immunosuppressive regimen received by patients as follows: cyclosporine, tacrolimus, steroids, mycophenolate mofetil or everolimus, in single, double or triple therapy...
September 18, 2018: Giornale Italiano di Dermatologia e Venereologia: Organo Ufficiale, Società Italiana di Dermatologia e Sifilografia
Raffaele D Caposiena Caro, Angelo Coppola, Dario Didona
No abstract text is available yet for this article.
September 18, 2018: Giornale Italiano di Dermatologia e Venereologia: Organo Ufficiale, Società Italiana di Dermatologia e Sifilografia
Arne K Andreassen, Kaspar Broch, Hans Eiskjær, Kristjan Karason, Einar Gude, Dorte Mølbak, Wenche Stueflotten, Lars Gullestad
BACKGROUND: Systemic hypertension is prevalent in heart transplant recipients, and has been partially attributed to treatment with calcineurin inhibitors (CNIs). The SCHEDULE trial was the first randomized trial to study early withdrawal of CNIs in de novo heart transplant recipients, comparing an everolimus-based immunosuppressive regimen with conventional CNI-based treatment. As a prespecified secondary endpoint, blood pressure was repeatedly compared across treatment arms. METHODS: SCHEDULE was a prospective, multicenter, randomized, controlled, parallel-group, open-label trial in de novo adult heart transplant recipients, undertaken at transplant centers in Scandinavia...
September 11, 2018: Transplantation
Junji Uchida, Tomoaki Iwai, Tatsuya Nakatani
This minireview focuses on the current knowledge about the introduction of everolimus (EVL), a mammalian target of rapamycin inhibitor, with calcineurin inhibitor (CNI) elimination or minimization in kidney transplant recipients at a late posttransplant stage. Within, we have summarized two major clinical trials, ASCERTAIN and APOLLO, and seven other retrospective or nonrandomized studies. In the open-label multicenter ASCERTAIN study, the estimated glomerular filtration rate (eGFR) at 24 mo after conversion was not significantly different between three groups-EVL with CNI elimination, CNI minimization and continued CNI unchanged-at a mean of 5...
September 10, 2018: World Journal of Transplantation
Junji Uchida, Tomoaki Iwai, Shunji Nishide, Kazuya Kabei, Nobuyuki Kuwabara, Toshihide Naganuma, Norihiko Kumada, Yoshiaki Takemoto, Tatsuya Nakatani
OBJECTIVES: Here, we report our 1-year follow-up data of stable ABO-incompatible kidney transplant recipients who converted from mycophenolate mofetil plus a standard dose of a calcineurin inhibitor to everolimus plus low exposure to calcineurin inhibitors. MATERIALS AND METHODS: Our study included 17 recipients of ABO-incompatible kidney transplant procedures performed at our institution. At baseline and at 3 and 12 months after conversion, graft biopsies were performed to check for acute rejection and C4d deposition...
September 4, 2018: Experimental and Clinical Transplantation
Εvangelos Cholongitas, Ioannis Goulis, Eleni Theocharidou, Nikolaos Antoniadis, Ioannis Fouzas, George Imvrios, Olga Giouleme, Aliki Angelaki, Themistoklis Vasiliadis, Vasilios Papanikolaou, Evangelos Akriviadis
Background: This study evaluated the efficacy, safety, and impact on renal function of everolimus in patients after liver transplantation (LT) with or without mycophenolate mofetil (MMF). Methods: We evaluated LT recipients with calcineurin inhibitor (CNI)-related renal dysfunction after everolimus initiation. Laboratory data, including evaluation of renal function based on glomerular filtration rate (GFR) at baseline (i.e., everolimus initiation) and at the end of follow up, were analyzed...
September 2018: Annals of Gastroenterology: Quarterly Publication of the Hellenic Society of Gastroenterology
Burkhard Tönshoff, Robert Ettenger, Luca Dello Strologo, Stephen D Marks, Lars Pape, Helio Tedesco-Silva Junior, Anna Bjerre, Martin Christian, Matthias Meier, El-Djouher Martzloff, Barbara Rauer, Jennifer Ng, Patricia Lopez
In a 12-month, multicenter, open-label study, 106 children were randomized at 4-6 weeks after kidney transplantation to switch to everolimus with reduced TAC (EVR/rTAC) and steroid elimination from month 5 post-transplant or to continue standard tacrolimus with mycophenolate mofetil (sTAC/MMF) and steroids. The cumulative incidence of a co-primary efficacy endpoint (biopsy-proven acute rejection [BPAR], graft loss or death from randomization to month 12) was 10.3% with EVR/rTAC and 5.8% with sTAC/MMF (difference 4...
August 20, 2018: American Journal of Transplantation
Marja van Dijk, Arie M van Roon, M Yusof Said, Frederike J Bemelman, Jaap J Homan van der Heide, Hans W de Fijter, Aiko P J de Vries, Stephan J L Bakker, Jan Stephan F Sanders
Long-term data on cardiovascular (CV) outcome of renal transplant recipients (RTR) on mTOR-i (mammalian Target Of Rapamycin-inhibitors) are scarce. In a sub-study of the MECANO trial we investigated changes in intima media thickness (IMT), CV risk profile, Major Adverse CV Events (MACE) and survival in RTR on a mTORi versus CNI based regimen. Patients (enrolled 361) were treated with (basiliximab) and triple IS (CsA-Cyclosporine A-(C), MPS (M), prednisolone (P)). At M6 patients were randomized (n = 224) to the CsA group (C, P, N = 89), MPS group (M, P, N = 39) EVL group (Everolimus, P, N = 96)...
August 14, 2018: Transplant International: Official Journal of the European Society for Organ Transplantation
Serena Patel, Michel H Mendler, Mark A Valasek, Shirley M Tsunoda
Drug-induced liver injury (DILI) has not been previously reported as a complication of treatment with everolimus. A 56-year-old Caucasian male liver transplant recipient developed DILI after receiving everolimus. Elevations in transaminase levels occurred within a week of starting everolimus and an upward trend in the transaminase levels continued with supporting histopathologic changes confirmed by liver biopsy. Within one week of drug discontinuation, his liver enzymes normalized to baseline. This report includes a brief review of the pharmacokinetic properties of everolimus, a review of the relevant literature, and an analysis using the RUCAM and Naranjo algorithms...
2018: Case Reports in Transplantation
Leslie Padrnos, Brenda Ernst, Amylou C Dueck, Heidi E Kosiorek, Brenda F Ginos, Angela Toro, Patrick B Johnston, Thomas M Habermann, Jose F Leis, Joseph R Mikhael, Grzegorz S Nowakowski, Joseph Colgan, Luis Porrata, Stephen M Ansell, Thomas E Witzig, Craig Reeder
BACKGROUND: Treatment outcomes have improved in lymphoid malignancies but relapse remains inevitable for most patients. Everolimus and lenalidomide have shown clinical activity as single agents in patients with relapsed and refractory Hodgkin and non-Hodgkin lymphomas. PATIENTS AND METHODS: The present phase I/II trial for patients with relapsed and refractory lymphoid malignancy opened at Mayo Clinic from January 2011 to May 2013. The trial used a standard cohort 3 + 3 design to determine the maximum tolerated dose for the combination...
June 15, 2018: Clinical Lymphoma, Myeloma & Leukemia
Junji Uchida, Shunji Nishide, Kazuya Kabei, Hisao Shimada, Akihiro Kosoku, Tomoaki Iwai, Nobuyuki Kuwabara, Toshihide Naganuma, Norihiko Kumada, Yoshiaki Takemoto, Tatsuya Nakatani
PURPOSE: The purpose of this study was to identify the risk factors for everolimus discontinuation in kidney transplant recipients converted to everolimus with calcineurin inhibitor (CNI) minimization at a late post-transplant stage. MATERIALS AND METHODS: An observational retrospective cohort study was conducted on a total of 38 recipients of kidney transplantation at our institution from June 2012 to March 2015 who were converted from antimetabolites to everolimus at a late post-transplant stage and followed for 1 year...
August 11, 2018: Urology Journal
Amelia G Mociornita, Mitchell B Adamson, Laura C Tumiati, Heather J Ross, Vivek Rao, Diego H Delgado
Human leukocyte antigen-G (HLA-G) expression is modulated by immunosuppressant use and is associated with lower incidence of graft rejection and cardiac allograft vasculopathy (CAV). We examined whether everolimus induces HLA-G expression and inhibits human coronary artery smooth muscle cell (HCASMC) proliferation, a critical event in CAV. Also, we examined whether TNFα-stimulated neutrophil adhesion is inhibited by HLA-G on human coronary artery endothelial cells (HCAECs). HLA-G expression in HCASMCs following everolimus treatment was determined by western-blot densitometric analysis...
July 9, 2018: American Journal of Transplantation
Tainá Veras de Sandes-Freitas, Petrucia Maria Antero Pinheiro, Maria Luíza de Mattos Brito Oliveira Sales, Celi Melo Girão, Érika Fernandes Campos, Ronaldo de Matos Esmeraldo
There is no evidence of whether everolimus (EVR) reduces cytomegalovirus (CMV) events in patients receiving steroid-free regimens. Besides, studies evaluating a tacrolimus (TAC) and EVR regimen are limited to 1-year follow-up. In this single-center prospective randomized trial, the incidence of CMV and 3-year efficacy and safety outcomes of EVR were compared to those of mycophenolate sodium (MPS) in a steroid-free regimen based on low-exposure TAC. Both groups received rabbit anti-thymocyte globulin (r-ATG) induction (6 mg/kg) and the steroids were withdrawn at day 7...
July 3, 2018: Transplant International: Official Journal of the European Society for Organ Transplantation
Ute Eisenberger, Klemens Budde, Frank Lehner, Claudia Sommerer, Petra Reinke, Oliver Witzke, Rudolf P Wüthrich, Rolf Stahl, Katharina Heller, Barbara Suwelack, Anja Mühlfeld, Ingeborg A Hauser, Silvio Nadalin, Martina Porstner, Wolfgang Arns
BACKGROUND: Conversion from calcineurin inhibitor (CNI) therapy to everolimus within 6 months after kidney transplantation improves long-term graft function but can increase the risk of mild biopsy-proven acute cellular rejection (BPAR). We performed a post-hoc analysis of histological data from a randomized trial in order to further analyze histologic information obtained from indication and protocol biopsies up to 5 years after transplantation. METHODS: Biopsy samples obtained up to 5 years post-transplant were analyzed from the randomized ZEUS study, in which kidney transplant patients were randomized at month 4...
June 28, 2018: BMC Nephrology
T Simundic, L Zibar, K Sego
We describe the case of a transplanted patient with high-risk HPV infection that manifested as multiple genital condylomas and abnormal Papanicolaou (Pap) smear. Her immunosuppressants were corticosteroids, cyclosporine, and azathioprine. Since gynecologic treatments to eradicate condylomas were completely unsuccessful, cyclosporine was replaced by everolimus. Soon after, condylomas disappeared, HPV status became negative, and Pap smear returned to normal and has remained normal since.
August 2018: Gynecologic Oncology Reports
Koji Nanmoku, Akira Kurosawa, Taro Kubo, Takahiro Shinzato, Toshihiro Shimizu, Takaaki Kimura, Takashi Yagisawa
OBJECTIVES: Although steroid withdrawal has been attempted to ameliorate various complications in kidney transplant recipients, a steroid-sparing strategy has more frequently led to acute rejection. We investigated the use of everolimus to safely overcome steroid withdrawal in kidney transplant recipients with posttransplant diabetes mellitus under maintenance immunosuppressive therapy. MATERIALS AND METHODS: A total of 75 de novo consecutive kidney transplant recipients received conventional immunosuppressive therapy comprising tacrolimus (trough level of 5 ng/mL), mycophenolate mofetil (1000 mg), and methylprednisolone (4 mg)...
June 18, 2018: Experimental and Clinical Transplantation
Abdulwahab A Alshahrani, Shin Hwang, Gi-Won Song, Deok-Bog Moon, Dong-Hwan Jung, Chul-Soo Ahn, Ki-Hun Kim, Tae-Yong Ha, Gil-Chun Park, Su-Min Ha, Yo-Han Park, Sung-Gyu Lee
Recurrence of hepatocellular carcinoma (HCC) 10 years after liver transplantation (LT) is very rare. Here, we present two cases of peritoneal metastasis of HCC that occurred 10 and 12 years after LT. A 77-year-old male who had undergone deceased-donor LT 10 years earlier showed slow progressive elevation of tumor marker levels over 6 months. Close observation with frequent imaging studies and monthly tumor marker analyses revealed a solitary peritoneal seeding mass. Imaging studies revealed that the mass was highly likely to be metastatic HCC...
May 2018: Annals of Hepato-Biliary-Pancreatic Surgery
Jun Li, Martina Koch, Kathrin Kramer, Katja Kloth, Abdel Rahman Abu Ganim, Silke Scheidat, Franz Rinninger, Friedrich Thaiss, Amit Gulati, Uta Herden, Eike Achilles, Lutz Fischer, Bjoern Nashan
BACKGROUND: To be an optimal immunosuppressive regimen after simultaneous pancreas kidney transplantation (SPK), low dose calcineurin inhibitor and early withdrawal of corticosteroids are desired. METHODS: Immunosuppressive regimen as such has been conducted consecutively in SPK recipients since 2009 in authors' institute. In addition to tacrolimus in low trough level and early corticosteroid withdraw, dual induction with basiliximab and low-dose thymoglobulin in combination with everolimus are the important components of the protocol...
June 6, 2018: Transplant Immunology
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