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tacrolimus and sirolimus

Oleg O Rummo, Mario Carmellini, Lionel Rostaing, Rainer Oberbauer, Maarten H L Christiaans, Christiane Mousson, Robert M Langer, Franco Citterio, Bernard Charpentier, Malcolm Brown, Gbenga Kazeem, Frank Lehner
ADHERE was a randomized, open-label, Phase IV study comparing renal function at Week 52 post-kidney transplant, in patients who received prolonged-release tacrolimus-based immunosuppressive regimens. On days 0-27, patients received prolonged-release tacrolimus (initially 0.2mg/kg/day), corticosteroids and mycophenolate mofetil (MMF). Patients were randomized on Day 28 to receive either prolonged-release tacrolimus plus MMF (Arm 1) or prolonged-release tacrolimus (≥25% dose-reduction on Day 42) plus sirolimus (Arm 2)...
October 18, 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
Paula Schaiquevich, Paula Taich, Natalia Riva, Francisco Leone, Nora Paternoster, Gabriel Mato, Paulo Cáceres Guido
Objective Determine the status of analytical laboratories that quantify immunosuppressants in transplant patients who are under therapeutic drug monitoring (TDM) for these drugs in Argentina in order to identify potential perfectible areas for action. Methods A survey of the clinical and analytical TDM centers in Argentina was conducted between September 2013 and November 2014 under the direction of the Garrahan Hospital Clinical Pharmacokinetics Unit and the National Unified Central Institute for Ablation and Implant Coordination...
March 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Lucy Chen, Lisa Liberatore, Tom Chin, Scott Walker, Helen Fanous, Michelle M Nash, Lindita Rapi, Jennie Huckle, Jeffrey S Zaltzman, G V Ramesh Prasad
BACKGROUND: Ensuring reliable gastrointestinal drug absorption of orally-administered immunosuppressive medications posttransplant is critical to ensuring graft survival. METHODS: A 66 year old man of East Asian origin with a previous total gastrectomy was evaluated for living donor kidney transplantation. Pretransplant pharmacokinetic testing was performed to determine the most appropriate posttransplant medication strategy. The Gastrointestinal Quality of Life Index and Gastrointestinal Rating Scale questionnaires were administered to gauge immunosuppressive medication-related side effects in the absence of a stomach...
September 29, 2016: Transplantation
Jian Jin, Sun Woo Lim, Long Jin, Ji Hyun Yu, Hyun Seon Kim, Byung Ha Chung, Chul Woo Yang
Background/Aims: Metformin (MET) is a first-line drug for type 2 diabetes mellitus (DM); its effect on new-onset diabetes after transplantation caused by immunosuppressant therapy is unclear. We compared the effects of MET on DM caused by tacrolimus (TAC) or sirolimus (SRL). Methods: DM was induced by injection of TAC (1.5 mg/kg) or SRL (0.3 mg/kg) for 2 weeks in rats, and MET (200 mg/kg) was injected for 2 more weeks. The effects of MET on DM caused by TAC or SRL were evaluated using an intraperitoneal glucose tolerance test (IPGTT) and by measuring plasma insulin concentration, islet size, and glucose-stimulated insulin secretion (GSIS)...
September 30, 2016: Korean Journal of Internal Medicine
Johan Törlén, Olle Ringdén, Karin Garming-Legert, Per Ljungman, Jacek Winiarski, Kari Remes, Maija Itälä-Remes, Mats Remberger, Jonas Mattsson
Improvement of graft-versus-host disease prophylaxis remains an important goal in allogeneic hematopoietic stem cell transplantation. Based on reports of possibly preferential properties of sirolimus, we compared the standard regimen of cyclosporine and methotrexate (n=106) with a combination of tacrolimus and sirolimus (n=103) as graft-versus host disease prophylaxis after allogeneic hematopoietic stem cell transplantation in a prospective, open, randomized trial. The hypothesis was that the tacrolimus/sirolimus regimen would lead to less acute graft-versus-host disease and reduced transplant-related mortality...
August 4, 2016: Haematologica
Aiman Obed, Abdalla Bashir, Anwar Jarrad
BACKGROUND Hepatitis C virus (HCV) genotype 4 (GT-4) is widespread in the Middle East, where it is responsible for the majority of HCV infections. It shows moderate treatment response rates when compared to other genotypes in the current era of interferon-based regimens. However, in the era of direct acting antiviral (DAA) drugs, its response is at least as good as observed for HCV genotypes 1-3. CASE REPORT We present a case of a 44-year-old patient with HCV cirrhosis. Since 2007, he has been treated for HCV infection with multiple ineffective regimens of interferon (INF) and ribavirin...
September 20, 2016: American Journal of Case Reports
Tracey Jones-Hughes, Tristan Snowsill, Marcela Haasova, Helen Coelho, Louise Crathorne, Chris Cooper, Ruben Mujica-Mota, Jaime Peters, Jo Varley-Campbell, Nicola Huxley, Jason Moore, Matt Allwood, Jenny Lowe, Chris Hyde, Martin Hoyle, Mary Bond, Rob Anderson
BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring renal replacement therapy: kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation, followed by immunosuppressive therapy (induction and maintenance therapy) to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect(®), Novartis Pharmaceuticals UK Ltd) and rabbit anti-human thymocyte immunoglobulin (rATG) (Thymoglobulin(®), Sanofi) as induction therapy, and immediate-release tacrolimus (TAC) (Adoport(®), Sandoz; Capexion(®), Mylan; Modigraf(®), Astellas Pharma; Perixis(®), Accord Healthcare; Prograf(®), Astellas Pharma; Tacni(®), Teva; Vivadex(®), Dexcel Pharma), prolonged-release tacrolimus (Advagraf(®) Astellas Pharma), belatacept (BEL) (Nulojix(®), Bristol-Myers Squibb), mycophenolate mofetil (MMF) (Arzip(®), Zentiva; CellCept(®), Roche Products; Myfenax(®), Teva), mycophenolate sodium (MPS) (Myfortic(®), Novartis Pharmaceuticals UK Ltd), sirolimus (SRL) (Rapamune(®), Pfizer) and everolimus (EVL) (Certican(®), Novartis) as maintenance therapy in adult renal transplantation...
August 2016: Health Technology Assessment: HTA
Vikas R Dharnidharka, Mark A Schnitzler, Jiajing Chen, Daniel C Brennan, David Axelrod, Dorry L Segev, Kenneth B Schechtman, Jie Zheng, Krista L Lentine
We examined integrated national transplant registry, pharmacy fill and medical claims data for Medicare-insured kidney transplant recipients in 2000-2011 (n=45,164) from the United States Renal Data System to assess efficacy and safety endpoints associated with 7 early (first 90 days) immunosuppression (ISx) regimens. Risks of clinical complications over 3 years according to IS regimens were assessed with multivariate regression, including adjustment for covariates and propensity for receipt of a non-reference ISx regimen...
August 26, 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
Marcela Haasova, Tristan Snowsill, Tracey Jones-Hughes, Louise Crathorne, Chris Cooper, Jo Varley-Campbell, Ruben Mujica-Mota, Helen Coelho, Nicola Huxley, Jenny Lowe, Jan Dudley, Stephen Marks, Chris Hyde, Mary Bond, Rob Anderson
BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation followed by induction and maintenance immunosuppressive therapy to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To systematically review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect,(®) Novartis Pharmaceuticals) and rabbit antihuman thymocyte immunoglobulin (Thymoglobuline,(®) Sanofi) as induction therapy and immediate-release tacrolimus [Adoport(®) (Sandoz); Capexion(®) (Mylan); Modigraf(®) (Astellas Pharma); Perixis(®) (Accord Healthcare); Prograf(®) (Astellas Pharma); Tacni(®) (Teva); Vivadex(®) (Dexcel Pharma)], prolonged-release tacrolimus (Advagraf,(®) Astellas Pharma); belatacept (BEL) (Nulojix,(®) Bristol-Myers Squibb), mycophenolate mofetil (MMF) [Arzip(®) (Zentiva), CellCept(®) (Roche Products), Myfenax(®) (Teva), generic MMF is manufactured by Accord Healthcare, Actavis, Arrow Pharmaceuticals, Dr Reddy's Laboratories, Mylan, Sandoz and Wockhardt], mycophenolate sodium, sirolimus (Rapamune,(®) Pfizer) and everolimus (Certican,(®) Novartis Pharmaceuticals) as maintenance therapy in children and adolescents undergoing renal transplantation...
August 2016: Health Technology Assessment: HTA
Elena Navarro-Villarán, José Tinoco, Granada Jiménez, Sheila Pereira, Jize Wang, Sara Aliseda, María A Rodríguez-Hernández, Raúl González, Luís M Marín-Gómez, Miguel A Gómez-Bravo, Francisco J Padillo, José M Álamo-Martínez, Jordi Muntané
Orthotopic liver transplantation (OLT) is the recommended treatment for patients at early stages of hepatocarcinoma (HCC) with potential portal hypertension and/or bilirubinemia, but without vascular-associated diseases. The patients are receiving immunosuppressive therapy to reduce graft rejection, but differential side effects have been related to calcineurin and mTOR inhibitor administration regarding tumor recurrence and nephrotoxicity. The in vitro studies showed that Tacrolimus exerted a more potent pro-apoptotic effect than Everolimus (Huh 7>Hep 3B>HepG2), being sirolimus only active in Hep3B cell line...
2016: PloS One
Helio Tedesco-Silva, V Ram Peddi, Ana Sánchez-Fructuoso, Brad A Marder, Graeme R Russ, Fritz Diekmann, Alison Flynn, Carolyn M Hahn, Huihua Li, Michael A Tortorici, Seth L Schulman
UNLABELLED: Calcineurin inhibitor-associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients. METHODS: This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus...
April 2016: Transplantation Direct
Youngil Chang, Tariq Shah, David I Min, Jae Wook Yang
BACKGROUND: Anemia is a very common occurrence in post-renal transplant patients. Post-transplantation anemia (PTA) is associated with significant graft loss or cardiovascular morbidity. The objective of this study is to identify clinical risk factors associated with anemia after kidney transplantation. METHODS: Our retrospective cohort study included a total of 570 renal transplant recipients. For the definition of anemia, we adopted "the lower limit of normal for Hgb concentration of blood" proposed by Beutler E and Waalen J [14], which has adjustments for age, gender and ethnicity...
September 2016: Transplant Immunology
A Capron, V Haufroid, P Wallemacq
Immunosuppressive drugs (IS) used in solid organ transplantation are critical dose drugs with high intra- and inter-subject variability. Therefore, IS therapeutic drug monitoring (TDM), mainly as trough levels analysis, is a major support to patient management, mandatory to optimize clinical outcome. Even though transplant patients undoubtedly benefited by this pre-dose (C0) monitoring, the relationship between these C0 concentrations and the incidence of graft rejections remains hardly predictable. Identification and validation of additional biomarkers of efficacy are therefore very much needed...
September 2016: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Radim Vrzal, Peter Illes, Zdenek Dvorak
BACKGROUND: We carried out a test whether or not transplant drugs such as cyclosporine A, Rapamycin (Sirolimus), Tacrolimus, Everolimus and Mycophenolate mofetil affects the expression of phase II enzymes comprising of UDP-glucuronosyltransferases (UGTs) and glutathione-S-transferases (GSTs), and antioxidant enzymes that consist of glutathione reductase (GSR), glutathione peroxidase 1 (GPX1) and heme-oxygenase 1 (HMOX1). METHODS: Experiments were performed in primary cultures of human hepatocytes and in human hepatocarcinoma HepG2 cells, the models of metabolically competent and incompetent cells, respectively...
October 2016: Pharmacological Reports: PR
Anton Pohanka, Staffan Rosenborg, Jonatan D Lindh, Olof Beck
A liquid chromatography-tandem mass spectrometry method is presented that was applied for over five years for routine measurement of the immunosuppressant drugs ciclosporin, everolimus, sirolimus and tacrolimus in blood. The method has been used for analysis of 142 thousand unknowns and has been running 7days a week without a single day shutdown during the entire time. The measuring ranges were 10-1500ng/mL for ciclosporin and 1-50ng/mL for everolimus, sirolimus and tacrolimus. The method validation showed performance meeting the EMA validation guideline requirements and acceptable performance in a proficiency control program...
September 2016: Clinical Biochemistry
Yun-Wei Guo, Hua-Ying Gu, Kodjo-Kunale Abassa, Xian-Yi Lin, Xiu-Qing Wei
Although gastroduodenal ulcers are common in solid organ transplant patients, there are few reports on multiple giant ulcers in the distal ileum and ileocecal valve caused by immunosuppressants Herein, we report on a liver transplant recipient and a renal transplant recipient with multiple large ulcers in the distal ileum and ileocecal valve who rapidly achieved ulcer healing upon withdrawal of sirolimus or tacrolimus and administration of thalidomide. In case 1, a 56-year-old man with primary hepatocellular carcinoma had received a liver transplantation...
June 28, 2016: World Journal of Gastroenterology: WJG
Andrei Alexandru Constantinescu, Malak Abbas, Mohamad Kassem, Céline Gleizes, Guillaume Kreutter, Valerie Schini-Kerth, Ioan Liviu Mitrea, Florence Toti, Laurence Kessler
To examine and compare the mitochondria-related cellular mechanisms by which tacrolimus (TAC) or sirolimus (SIR) immunosuppressive drugs alter the pancreatic exocrine and endocrine β-cell fate. Human exocrine PANC-1 and rat endocrine insulin-secreting RIN-m5F cells and isolated rat islets were submitted to 1-100 nM TAC or SIR. In cultures, insulin secretion was measured as endocrine cell function marker. Apoptosis was quantified by annexin 5 and propidium iodide staining. Cleaved caspase-3, Bax apoptosis indicators, and p53, p21 cell cycle regulators were detected by Western blot...
July 2016: Molecular and Cellular Biochemistry
Chie Emoto, Alexander A Vinks, Tsuyoshi Fukuda
BACKGROUND: Sirolimus is a mammalian target of rapamycin inhibitor that is being used to prevent organ rejection in kidney transplant patients often in combination with calcineurin inhibitors (CNIs; cyclosporine and tacrolimus). All 3 drugs are metabolized primarily by CYP3As. Clinical drug-drug interaction (DDI) studies of cyclosporine on sirolimus pharmacokinetics have been reported; however, there are a few clinical DDI data related to tacrolimus. METHODS: In vitro inhibition assay with sirolimus were conducted using recombinant CYP3As and human microsomes in the presence and absence of CNIs...
October 2016: Therapeutic Drug Monitoring
R Parody, L López-Corral, O Lopez-Godino, C Martinez, R Martino, C Solano, P Barba, D Caballero, I García-Cadenas, J L Piñana, F J Marquez-Malaver, L Vazquez, A Esquirol, J C H Boluda, F Sanchez-Guijo, J A Pérez-Simon
No abstract text is available yet for this article.
June 13, 2016: Bone Marrow Transplantation
Helio Tedesco Silva, Claudia Rosso Felipe, Jose Osmar Medina Pestana
Here, we review 15 years of clinical use of sirolimus in our transplant center, in context with the developing immunosuppressive strategies use worldwide. The majority of studies were conducted in de novo kidney transplant recipients, using sirolimus (SRL) in combination with calcineurin inhibitors (CNIs). We also explored steroid (ST) or CNI-sparing therapies, including CNI minimization, elimination, or conversion strategies in combination with mycophenolate (MMF/MPS). Pooled long-term outcomes were comparable with those obtained with CNI and antimetabolite combination...
2015: Transplantation Research
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