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Rajendra Kumar Jain, Padmanabha Chakravarthi, Rajan Shetty, Padmakumar Ramchandra, Raghava Sarma Polavarapu, Gurupreet Singh Wander, Bishav Mohan, Darshan Navinchandra Banker, Aniruddha Dharmadhikari, Shyam Sundar Bansal, Neeraj Jain, Dharmesh Solanki, Jagdish Dhakaan, Ved Prakash Sharma, Padhinhare P Mohanan, Parayaru Kottayal Ashokan, Bagur Venkat Manjunath, Narendra Hiregoudar, Chandrashekar Patil, Narasimha Balakrishnan
OBJECTIVES: The aim of the merit-3 study was to determine the safety and performance of the BioMime Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one-year clinical follow-up period. METHODS: The meriT-3 was a multi-centre, observational, post-marketing study conducted in 1161 patients with CAD who were implanted with BioMime SES at 15 sites in India. The primary endpoint was major adverse cardiac event (MACE) at one year defined as the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR)...
September 2016: Indian Heart Journal
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
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
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
Hirohiko Ando, Akihiro Suzuki, Shinichiro Sakurai, Soichiro Kumagai, Akiyoshi Kurita, Katsuhisa Waseda, Hiroaki Takashima, Tetsuya Amano
Although late restenosis is one of the long-term complications of stent implantation, its pathogenesis has not been fully elucidated. For consecutive patients who developed in-stent restenosis (ISR) after stent implantation, integrated backscatter (IB) intravascular ultrasound was performed for ISR lesions. The tissue characteristics of neointima within the stented segment were compared between lesions with early restenosis and those with late restenosis. Of 73 ISR lesions arising after sirolimus-eluting stent (SES; n = 25) or bare-metal stent (BMS; n = 48) implantation, early and late restenosis were documented in 52 and 21 lesions, respectively...
October 11, 2016: Heart and Vessels
Paloma Triana, Mariela Dore, Vanesa Nuñez Cerezo, Manuel Cervantes, Alejandra Vilanova Sánchez, Miriam Miguel Ferrero, Mercedes Díaz González, Juan Carlos Lopez-Gutierrez
Aim of the Study mTOR inhibitors are showing promising results in the management of vascular anomalies. Although current controlled trials remain to be completed, many individual experiences are being published. We present our series of children with complex vascular anomalies treated with sirolimus. Patients and Methods A retrospective review of 41 patients treated with sirolimus between January 2011 and December 2015 was performed: 15% (n = 6) had vascular tumors (4 kaposiform hemangioendotheliomas, 1 PTEN) and 85% (n = 35) had malformations (13 generalized lymphatic anomalies/Gorham-Stout diseases [GSD], 1 kaposiform lymphangiomatosis [KLA], 11 large lymphatic malformations (LMs) in critical areas, 2 lymphedemas, 4 venous malformations, and 4 aggressive arteriovenous malformations [AVM])...
October 10, 2016: European Journal of Pediatric Surgery
Michelle H T Ta, Kristina G Schwensen, Sheryl Foster, Mayuresh Korgaonkar, Justyna E Ozimek-Kulik, Jacqueline K Phillips, Anthony Peduto, Gopala K Rangan
The disease-modifying effects of target of rapamycin complex 1 (TORC1) inhibitors during different stages of polycystic kidney disease (PKD) are not well defined. In this study, male Lewis Polycystic Kidney Disease (LPK) rats (a genetic ortholog of human NPHP9, phenotypically characterised by diffuse distal nephron cystic growth) and Lewis controls received either vehicle (V) or sirolimus (S, 0.2 mg/kg by intraperitoneal injection 5 days per week) during the early (postnatal weeks 3 to 10) or late stages of disease (weeks 10 to 20)...
2016: PloS One
Alexandre Minetto Brabo, Nayrana Soares Do Carmo Reis, Pasqual Barretti, Daniela Ponce
Encapsulating peritoneal sclerosis (EPS) is a rare complication of peritoneal dialysis that carries a high morbidity and mortality. Although its pathogenesis is still not clear, the "two hit theory" suggests that long term deterioration of the peritoneum combined with intraperitoneal inflammation is needed in the pathogenesis of EPS. To date, there is no proven effective therapy with an absence of randomized controlled trials. Individual case reports and small case series have reported on the use of tamoxifen and corticosteroids for medical management of EPS...
October 9, 2016: Hemodialysis International
Akshit Peer, Rabin Dhakal, Rana Biswas, Jaeyoun Kim
We compare the rates of drug release from nanopatterned and flat biodegradable polymer surfaces, and observe significantly lower release rates from the nanopatterned surfaces. Specifically, we nanopattern poly(l-lactic acid) (PLLA), a biodegradable polymer frequently used for fabricating drug-eluting coronary stents, through microtransfer molding and solvent casting and investigate the nanopattern's impact on the release of sirolimus, an immunosuppressant agent, coated on the PLLA surface using high performance liquid chromatography/mass spectrometry...
October 5, 2016: Nanoscale
Fernando Alfonso, Marcos García-Guimarães, Gonzalo Navarrete, Javier Cuesta, Teresa Bastante, Amparo Benedicto, Fernando Rivero, Bernardo Cortese
Drug-eluting balloons (DEB) may be considered as a "quiet revolution" in percutaneous coronary interventions. Early-generation DEB eluting paclitaxel proved to be very effective in animal models to reduce neointimal hyperplasia. Areas covered: Review of DEB efficacy in patients with coronary de novo lesions and in-stent restenosis (ISR). Expert opinion: Many randomized clinical trials and meta-analyses have demonstrated the value of DEB in patients with ISR. In this setting, DEB are safe and effective with clinical and angiographic results superior to plain balloon angioplasty and at least equivalent to first generation drug-eluting stents (DES)...
October 8, 2016: Expert Opinion on Drug Delivery
J Ribamar Costa, Daniel Chamié, Alexandre A C Abizaid, Expedito Ribeiro, George C Meireles, Maurício Prudente, Carlos A Campos, Juliana P Castro, Ricardo Costa, Pedro A Lemos
We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months...
October 6, 2016: International Journal of Cardiovascular Imaging
Yanping Cheng, Pawel Gasior, Masahiko Shibuya, Kamal Ramzipoor, Chang Lee, Edward A Estrada, Daniell Dokko, Jenn C McGregor, Gerard B Conditt, Greg L Kaluza, Juan F Granada
BACKGROUND: Clinically available bioresorbable scaffolds (BRS) rely on polymer crystallinity to achieve mechanical strength resulting in limited overexpansion capabilities and structural integrity when exposed to high-loading conditions. We aimed to evaluate the biomechanical behavior and vascular healing profile of a novel, sirolimus-eluting, high-molecular-weight, amorphous poly-l-lactic acid-based BRS (Amaranth BRS). METHODS AND RESULTS: In vitro biomechanical testing was performed under static and cyclic conditions...
October 2016: Circulation. Cardiovascular Interventions
Quan Dong Nguyen, Pauline T Merrill, W Lloyd Clark, Alay S Banker, Christine Fardeau, Pablo Franco, Phuc LeHoang, Shigeaki Ohno, Sivakumar R Rathinam, Stephan Thurau, Abu Abraham, Laura Wilson, Yang Yang, Naveed Shams
PURPOSE: To evaluate the efficacy and safety of intravitreal sirolimus in the treatment of noninfectious uveitis (NIU) of the posterior segment (i.e., posterior, intermediate, or panuveitis). DESIGN: Phase III, randomized, double-masked, active-controlled, 6-month study with intravitreal sirolimus. PARTICIPANTS: Adults with active NIU of the posterior segment (intermediate, posterior, or panuveitis), defined as a vitreous haze (VH) score >1+...
September 27, 2016: Ophthalmology
Vjekoslav Tomulić, David Gobić, Davorka Lulić, David Židan, Luka Zaputović
Adhesion molecules play an important role in inflammation, atherosclerosis and coronary artery disease (CAD). These molecules are expressed on the surface of dysfunctional endothelial cells, causing inflammatory cells from the circulation to adhere and migrate through the endothelium. Their expression is upregulated in acute coronary syndrome (ACS) and after percutaneous coronary intervention (PCI). The contact between stent struts and endothelium upregulates endothelial cell gene expression, endothelial cell activation and inflammation...
October 2016: Medical Hypotheses
Marie Szymanowski, Maria Salomon Estebanez, Raja Padidela, Bing Han, Karolina Mosinska, Adam Stevens, Lena Damaj, Florence Pihan-Le Bars, Emilie Lascouts, Rachel Reynaud, Catherine Ferreira, Claire Bansept, Pascale de Lonlay, Cécile Saint-Martin, Mark J Dunne, Indraneel Banerjee, Jean-Baptiste Arnoux
CONTEXT: Congenital hyperinsulinism (CHI) is the commonest cause of persistent hypoglycemia in neonates and infants. In medically unresponsive CHI, subtotal pancreatectomy is performed to achieve euglycaemia with consequent diabetes in later life. Sirolimus, a mammalian target of rapamycin (mTOR) inhibitor has been reported to obviate the need for pancreatectomy, but experience is limited. OBJECTIVE: We have investigated the efficacy and adverse effect profile of mTOR inhibitors in the treatment of severe CHI...
October 3, 2016: Journal of Clinical Endocrinology and Metabolism
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
Ester García-Casarrubios, Carlos de Moura, Ana I Arroba, Nuria Pescador, María Calderon-Dominguez, Laura Garcia, Laura Herrero, Dolors Serra, Susana Cadenas, Flavio Reis, Eugenia Carvalho, Maria Jesus Obregon, Ángela M Valverde
New onset diabetes after transplantation (NODAT) is a metabolic disorder that affects 40% of patients on immunosuppressive agent (IA) treatment, such as rapamycin (also known as sirolimus). IAs negatively modulate insulin action in peripheral tissues including skeletal muscle, liver and white fat. However, the effects of IAs on insulin sensitivity and thermogenesis in brown adipose tissue (BAT) have not been investigated. We have analyzed the impact of rapamycin on insulin signaling, thermogenic gene-expression and mitochondrial respiration in BAT...
September 26, 2016: Biochimica et Biophysica Acta
Soe Hee Ann, Suk Min Seo, Pum-Joon Kim, Yoon-Seok Koh, Sung-Ho Her, Dong Il Shin, Hun-Jun Park, Chul Soo Park, Jong Min Lee, Dong-Bin Kim, Kiyuk Chang, Wook-Sung Chung, Ki-Bae Seung
BACKGROUND: Renal insufficiency (RI) is an independent risk factor for the adverse cardiovascular events. Long-term clinical outcome of percutaneous coronary intervention (PCI) in patients with RI is unknown especially in the era of first generation drug-eluting stents (DES). This study aims at comparing clinical outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) based on large scaled registry. METHODS: Patients who underwent PCI with DES from January 2004 to December 2009 in the Catholic University of Korea-PCI (COACT) registry were prospectively enrolled...
September 26, 2016: Cardiology Journal
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