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Darcy A Krueger, Jamie K Capal, Paolo Curatolo, Orrin Devinsky, Kevin Ess, Michal Tzadok, Mary K Koenig, Vinodh Narayanan, Federico Ramos, Sergiusz Jozwiak, Petrus de Vries, Anna C Jansen, Michael Wong, David Mowat, John Lawson, Stephanie Bruns, David Neal Franz
OBJECTIVE: To evaluate the safety of mTOR inhibitors (sirolimus or everolimus) in infants and very young children with tuberous sclerosis complex (TSC) under two years of age. METHODS: Study design was retrospective to capture medical record data from 52 international TSC Centres who initiated treatment with sirolimus or everolimus in TSC children before the age of two years. Data collection included demographic and clinical information including reason(s) for initiating treatment with mTOR inhibitors, treatment duration, dosing, and corresponding serum trough levels, response to treatment, and adverse events (AE)...
July 4, 2018: European Journal of Paediatric Neurology: EJPN
Manabu Kashiwagi, Takashi Tanimoto, Hironori Kitabata
A 74-year old man presented recurrent angina pectoris due to in-stent restenosis (ISR) with severely calcified neointima. In-stent neoatherosclerosis (NA) is associated with late stent failure, and NA with calcified neointima occurs in some cases. Because the presence of neointimal calcification could lead to underexpansion of newly implanted stent for ISR, a scoring balloon was selected for predilatation to obtain maximum extrusion of the neointimal plaque and subsequently, an everolimus-eluting stent was implanted...
2018: Case Reports in Cardiology
Masahiro Shimoda, Hirohiko Ando, Kazuhiro Naito, Akihiro Suzuki, Shinichiro Sakurai, Yusuke Nakano, Akiyoshi Kurita, Katsuhisa Waseda, Hiroaki Takashima, Kenta Murotani, Tadayuki Uetani, Tetsuya Amano
BACKGROUND: Despite the revolution of coronary stents, there remain concerns about the risk of stent thrombosis, especially in patients with ST-elevation myocardial infarction (STEMI). The present study compared early vascular healing as a contributing factor to reducing stent thrombosis between Xience everolimus-eluting stents (X-EES) and Synergy everolimus-eluting stents (S-EES) in patients with STEMI.Methods and Results:The present study included 47 patients with STEMI requiring primary percutaneous coronary intervention with X-EES (n=25) or S-EES (n=22)...
July 11, 2018: Circulation Journal: Official Journal of the Japanese Circulation Society
Jing Li, Zhaoyun Liu, Yanqi Li, Qian Jing, Honglei Wang, Hui Liu, Jin Chen, Junru Feng, Qing Shao, Rong Fu
Multiple myeloma (MM) is characterized by the proliferation of malignant plasma cells and a subsequent overabundance of monoclonal paraproteins (M proteins). Everolimus works similarly to sirolimus as a mammalian target of rapamycin (mTOR) inhibitor. Bortezomib was the first therapeutic proteasome inhibitor to be tested in humans with MM. However, the combination of these two drugs for the treatment of MM has been rarely reported. In this study, we compared the therapeutic effects of everolimus and bortezomib, as well as those of a combination of everolimus and bortezomib, using an in vitro MM cell line model and in vivo xenograft mouse model...
July 11, 2018: Journal of Investigative Medicine: the Official Publication of the American Federation for Clinical Research
Hans Tesch, Oliver Stoetzer, Thomas Decker, Christian M Kurbacher, Frederik Marmé, Andreas Schneeweiss, Christoph Mundhenke, Andrea Distelrath, Peter A Fasching, Michael P Lux, Diana Lüftner, Hadji Peyman, Wolfgang Janni, Mathias Muth, Julia Kreuzeder, Claudia Quiering, Florin-Andrei Taran
In BOLERO-2, adding everolimus to exemestane resulted in a twofold increase in median progression-free survival (PFS) vs exemestane in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (aBC) after progression on a non-steroidal aromatase inhibitor (NSAI). Here, we report on the open-label, single-arm, phase IIIB 4EVER trial (NCT01626222). This trial evaluated the clinical effectiveness of everolimus plus exemestane in postmenopausal women with HR+, HER2- aBC who had progressed on or after an NSAI, but with no restrictions on the time of progression after NSAI, prior chemotherapy for advanced disease, or previous exemestane...
July 11, 2018: International Journal of Cancer. Journal International du Cancer
François Pierre Combes, Guillaume Baneyx, Neva Coello, Penny Zhu, William Sallas, Hequn Yin, Jerry Nedelman
Everolimus is approved in Europe and in the USA for the adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex. The objective of this analysis was to establish a population pharmacokinetic (PK)/pharmacodynamic model describing the relationship between seizure frequency and everolimus exposure to confirm the recommended target concentration range of 5-15 ng/mL. The PK model was a two-compartment model with first order absorption and clearance...
July 10, 2018: Journal of Pharmacokinetics and Pharmacodynamics
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 if everolimus induces HLA-G expression and inhibits human coronary artery smooth muscle cell (HCASMC) proliferation, a critical event in CAV. Also, we examined if 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
Sung-Min Park, Byung-Soo Kim, Moon-Bum Kim, Yun-Jin Lee, Hyun-Chang Ko
[This corrects the article on p. 247 in vol. 30, PMID: 29606832.].
August 2018: Annals of Dermatology
Akihide Konishi, Masamichi Iwasaki, Toshiro Shinke, Hiromasa Otake, Tomofumi Takaya, Tsuyoshi Osue, Ryo Nishio, Hiroto Kinutani, Masaru Kuroda, Hachidai Takahashi, Daisuke Terashita, Junya Shite, Ken-Ichi Hirata
BACKGROUND: Although a prospective randomized control study revealed that 3-month dual anti-platelet therapy (DAPT) is safe and does not compromise the efficacy of everolimus-eluting stent (EES) in selected patients, detailed vessel healing at early phase after EES implantation has yet to be investigated in Japanese patients. METHODS AND RESULTS: A total of 27 lesions in 19 patients treated with EES were serially evaluated by using optical coherence tomography (OCT) at 3, 6, and 12 months after stent implantation...
July 3, 2018: Journal of Cardiology
Alan K Burnett, Emma Das Gupta, Steve Knapper, Asim Khwaja, Marion Sweeney, Lars Kjeldsen, Timothy Hawkins, Sophie E Betteridge, Paul Cahalin, Richard E Clark, Robert K Hills, Nigel H Russell
As part of the UK NCRI AML17 trial, adult acute myeloid leukaemia patients in remission could be randomised to receive the mTOR inhibitor everolimus, sequentially with post-induction chemotherapy. Three hundred and thirty-nine patients were randomised (2:1) to receive everolimus or not for a maximum of 84 days between chemotherapy courses. The primary endpoint was relapse free survival (RFS). At 5 years there was no difference in Relapse Free Survival (29% vs 40%; OR 1.19 (0.9-1.59) p=0.2), cumulative incidence of relapse (60% vs 54%: OR 1...
July 5, 2018: Haematologica
Patrick W Serruys, Rafael Cavalcante, Carlos Collet, Arie Pieter Kappetein, Joseph F Sabik, Adrian P Banning, David P Taggart, Manel Sabaté, Jose Pomar, Piet W Boonstra, Nicholas J Lembo, Yoshinobu Onuma, Charles A Simonton, Marie-Claude Morice, Thomas McAndrew, Ovidiu Dressler, Gregg W Stone
OBJECTIVES: The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease. BACKGROUND: In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG...
July 9, 2018: JACC. Cardiovascular Interventions
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(6mg/kg) and the steroids were withdrawn at day 7...
July 3, 2018: Transplant International: Official Journal of the European Society for Organ Transplantation
Yuki Katagiri, Patrick W Serruys, Erhan Tenekecioglu, Taku Asano, Carlos Collet, Yosuke Miyazaki, Athanasios Katsikis, Jan J Piek, Joanna J Wykrzykowska, Bernard Chevalier, Gary S Mintz, Gregg W Stone, Yoshinobu Onuma
AIMS: To investigate relocation of minimal lumen area (MLA) after implantation of bioresorbable scaffold (BRS). METHODS AND RESULTS: In the ABSORB II randomized trial [BRS vs. everolimus-eluting stent (EES)], lesions were investigated by serial intravascular ultrasound pre-procedure, post-procedure, and at 3-year. MLA relocation was defined as an axial MLA shift of more than 2.4 mm. MLA relocation from post-procedure to 3-year was observed in 163/237 (68.8%) and 75/129 (58...
July 3, 2018: EuroIntervention
Akihide Konishi, Masamichi Iwasaki, Toshiro Shinke, Hiromasa Otake, Masayuki Nakagawa, Hirotoshi Hariki, Tsuyoshi Osue, Takumi Inoue, Yu Taniguchi, Ryo Nishio, Hiroto Kinutani, Noritoshi Hiranuma, Masaru Kuroda, Ken-Ichi Hirata, Shigeru Saito, Masato Nakamura, Junya Shite, Takashi Akasaka
Intra-stent thrombus (IS-Th) formed immediately after percutaneous coronary intervention (PCI) is associated with subsequent adverse coronary events. However, the impact of on-treatment platelet reactivity on IS-Th is unknown. PRASFIT-Elective is a multicenter study of PCI patients receiving prasugrel (20/3.75 mg, loading/maintenance dose) or clopidogrel (300/75 mg), with aspirin (100 mg). Among the 742 study patients, 111 were pre-specified for the OCT sub-study. Of these, 82 underwent OCT immediately after PCI to assess IS-Th and at an 8-month follow-up to evaluate the fate of the IS-Th...
July 2, 2018: Heart and Vessels
Sammy San Myint Aung, Htun Latt, Kyaw Kyaw, Chanwit Roongsritong
Coronary interventions are the mainstay of treatment for stenotic coronary vascular lesions. New stent designs are constantly being evaluated to improve stent performances and clinical outcomes. Coronary stent fracture is uncommon; however, it is associated with potential major consequences including acute coronary syndrome and the need for repeated target vessel revascularization due to in-stent restenosis or stent thrombosis. We report a case of a 66-year-old man with an extensive cardiac disease history, who presented with intractable angina and was found to have a fracture of a current generation, platinum chromium everolimus-eluting stent (Synergy, Boston Scientific Inc...
2018: Case Reports in Cardiology
Carole Vitellius, Lionel Fizanne, Elodie Menager-Tabourel, Joelle Nader, Nathalie Baize, Margot Laly, Emilie Lermite, Sandrine Bertrais, F X Caroli-Bosc
Background: Gemcitabine is a standard treatment for pancreatic adenocarcinoma. Many mechanisms are involved in gemcitabine resistance, such as reduced expression of the human equilibrative nucleoside transporter 1 (hENT1) membrane transporter, deoxycytidine kinase deficiency, and changes in the signal transmission of mitogen-activity protein kinase (MAPK) and the phosphoinositide 3-kinase (PI3K) pathways. Aim: To evaluate the anti-tumor efficiency of blocking signaling pathways using combined action of gemcitabine, everolimus and zoledronic acid versus gemcitabine alone in a mouse subcutaneous xenograft...
June 15, 2018: Oncotarget
Hiroki Watanabe, Takeshi Morimoto, Hiroki Shiomi, Masahiro Natsuaki, Kazuya Kawai, Ken Kozuma, Keiichi Igarashi, Kazushige Kadota, Kengo Tanabe, Yoshihiro Morino, Kiyoshi Hibi, Takashi Akasaka, Mitsuru Abe, Satoru Suwa, Toshiya Muramatsu, Masakazu Kobayashi, Kazuoki Dai, Koichi Nakao, Yasuhiro Tarutani, Kenshi Fujii, Takeshi Kimura
BACKGROUND: Previous intravascular ultrasound studies suggested the association of stent underexpansion with increased risk of stent thrombosis and restenosis. However, no previous study has addressed the association of the suboptimal angiographic result with target-lesion revascularization (TLR) in patients receiving new-generation drug-eluting stents (DES). METHODS AND RESULTS: RESET (Randomized evaluation of sirolimus-eluting versus everolimus-eluting stent trial) and NEXT (NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial) are prospective, multicenter, randomized "DES versus DES" trials; 3196 patients and 3235 patients were enrolled in the RESET and NEXT, respectively...
June 30, 2018: Journal of the American Heart Association
Koji Kuroda, Hiromasa Otake, Toshiro Shinke, Takayoshi Toba, Masaru Kuroda, Hachidai Takahashi, Daisuke Terashita, Kenzo Uzu, Daiji Kashiwagi, Yoshinori Nagasawa, Yuichiro Nagano, Ken-Ichi Hirata
AIMS: Peri-strut low-intensity area (PLIA) assessed by optical coherence tomography (OCT) has been reported as a potential marker of abnormal neointimal healing. We aimed to evaluate the impact of PLIA on clinical events and its risk factors. METHODS AND RESULTS: We enrolled 264 consecutive patients treated with everolimus-eluting stent (EES) who underwent follow-up OCT 6-12 months after stenting. Target lesion revascularisation (TLR) was evaluated at a mean 42...
June 26, 2018: EuroIntervention
Ugo De Giorgi, Giacomo Cartenì, Diana Giannarelli, Umberto Basso, Luca Galli, Enrico Cortesi, Claudia Caserta, Sandro Pignata, Roberto Sabbatini, Alessandra Bearz, Sebastiano Buti, Giovanni Lo Re, Alfredo Berruti, Sergio Bracarda, Francesco Cognetti, Francesca Rastelli, Giuseppe Fornarini, Camillo Porta, Daniele Turci, Cora N Sternberg, Giuseppe Procopio
OBJECTIVE: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Early Access Program. PATIENTS AND METHODS: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AEs) using CTCAE v...
June 29, 2018: BJU International
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
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