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Everolimus AND aging

Haci Murat Gunes, Filiz Kizilirmak Yılmaz, Tayyar Gokdeniz, Gultekin Gunhan Demir, Ekrem Guler, Gamze Babur Guler, Oğuz Karaca, Beytullah Cakal, Ersin İbişoğlu, Bilal Boztosun
OBJECTIVE: The aim of the present study was to investigate the relationship between glomerular filtration rate (GFR) and acute post-scaffold recoil (PSR) in patients undergoing bioresorbable scaffold (BVS) implantation. METHODS: We included 130 patients who underwent everolimus-eluting BVS device (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) or the novolimus-eluting BVS device (Elixir Medical Corporation) implantations for single or multi-vessel disease. Clinical, angiographic variables and procedural characteristics were defined and pre-procedural GFR was calculated for each patient...
September 20, 2016: International Journal of Cardiology
Bernard Escudier, Vincent Molinie, Sergio Bracarda, Pablo Maroto, Cezary Szczylik, Paul Nathan, Sylvie Negrier, Claudia Weiss, Camillo Porta, Viktor Grünwald, Laurence Albiges
BACKGROUND: Papillary histology accounts for 10-15% of renal cell carcinoma (RCC), and treatment options for patients with this subtype are limited. The RAPTOR (RAD001 in Advanced Papillary Tumor Program in Europe;, NCT00688753) study evaluated first-line everolimus in patients with papillary metastatic RCC (mRCC). METHODS: This phase 2 trial enrolled previously untreated patients with type 1 or type 2 papillary mRCC. Papillary histology was confirmed by central review and was performed for every patient...
September 24, 2016: European Journal of Cancer
Joanna Trelinska, Wojciech Fendler, Iwona Dachowska, Katarzyna Kotulska, Sergiusz Jozwiak, Karolina Antosik, Piotr Gnys, Maciej Borowiec, Wojciech Mlynarski
BACKGROUND: Tuberous sclerosis (TSC) is a monogenic disease resulting from defects of the TSC1 or TSC2 genes, which encode the proteins forming hamartin-tuberin tumor suppressor complex, the mammalian target of rapamycin complex (mTOR). The mTOR pathway is constitutively activated in response to tuberin or hamartin defects. The mTOR pathway is also regulated by a multitude of epigenetic mechanisms, one of which is regulation by microRNA (miRNA) inhibition. This leads us to hypothesize that organ-level abnormalities of miRNA expression patterns are widespread in TSC...
September 29, 2016: Orphanet Journal of Rare Diseases
Nicolás Roberto Robles, Ramón Peces, Álvaro Gómez-Ferrer, Felipe Villacampa, Jose Luis Álvarez-Ossorio, Pedro Pérez-Segura, Juan Morote, Bernardo Herrera-Imbroda, Javier Nieto, Joaquín Carballido, Urbano Anido, Marian Valero, Cristina Meseguer, Roser Torra
BACKGROUND: Renal angiomyolipomas (AML) are usual manifestations of tuberous sclerosis complex (TSC) that may cause aneurism-related haemorrhages and renal impairment. Everolimus has emerged as an alternative to surgery/embolization. We provide further insight into everolimus safety and efficacy for TSC-related AML. METHODS: This was a Spanish expanded access trial including patients aged ≥18 years with TSC-related AML. They received 10 mg everolimus once daily until AML progression, unacceptable toxicity, death/withdrawal, commercialisation for TSC-related AML, or 1 year after first patient enrolment...
September 26, 2016: Orphanet Journal of Rare Diseases
Gonca Koc, Sam Sugimoto, Rachel Kuperman, Bamidele F Kammen, S Pinar Karakas
BACKGROUND: Pancreatic neuroendocrine tumors are not included in the diagnostic criteria for tuberous sclerosis complex, although an association has been described. OBJECTIVE: To investigate the association of pancreatic neuroendocrine tumor in children and young adults with tuberous sclerosis complex and define MRI characteristics of the tumor. MATERIALS AND METHODS: We retrospectively evaluated the abdominal MRI scans of 55 children and young adults with tuberous sclerosis complex for the presence of a pancreatic mass...
September 17, 2016: Pediatric Radiology
J Radtke, N Dietze, L Fischer, E-G Achilles, J Li, S Scheidat, F Thaiss, B Nashan, M 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. 266 patients were treated with standard immunosuppression consisting of basiliximab induction, calcineurin inhibitor (CNI), and mycophenolate (MPA, n = 219) or everolimus (n = 47)...
September 17, 2016: Transplant Infectious Disease: An Official Journal of the Transplantation Society
Soon Jun Hong, Chul Min Ahn, Byeong-Keuk Kim, Young-Guk Ko, Seung-Ho Hur, Cheol Woong Yu, Seung-Jin Lee, Cheol Ung Choi, Je Sang Kim, Jung-Han Yoon, Young Joon Hong, Jae-Woong Choi, Seung-Hyuk Choi, Yangsoo Jang, Do-Sun Lim
AIMS: At present no proven standard treatment for drug-eluting stent (DES) restenosis is available, and the efficacy and safety of everolimus-eluting stent (EES) and zotarolimus-eluting stent (ZES) for DES restenosis are limited. The purpose of this prospective, randomized 9-month intracoronary ultrasound (IVUS) and 3-year clinical follow-up study was to compare the effects of EESs and ZESs on neointima volume and major adverse cardiovascular events (MACEs) such as death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis in DES restenosis patients...
September 15, 2016: European Heart Journal
Jacqueline A French, John A Lawson, Zuhal Yapici, Hiroko Ikeda, Tilman Polster, Rima Nabbout, Paolo Curatolo, Petrus J de Vries, Dennis J Dlugos, Noah Berkowitz, Maurizio Voi, Severine Peyrard, Diana Pelov, David N Franz
BACKGROUND: Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has been used for various benign tumours associated with tuberous sclerosis complex. We assessed the efficacy and safety of two trough exposure concentrations of everolimus, 3-7 ng/mL (low exposure) and 9-15 ng/mL (high exposure), compared with placebo as adjunctive therapy for treatment-resistant focal-onset seizures in tuberous sclerosis complex. METHODS: In this phase 3, randomised, double-blind, placebo-controlled study, eligible patients aged 2-65 years with tuberous sclerosis complex and treatment-resistant seizures (≥16 in an 8-week baseline phase) receiving one to three concomitant antiepileptic drugs were recruited from 99 centres across 25 countries...
September 6, 2016: Lancet
S Brakemeier, C Grohé, F Bachmann, K Budde
Lymphangioleiomyomatosis (LAM) is a rare multi-system disorder affecting predominantly women of childbearing age. The disease entity is divided in sporadic LAM (sLAM) and LAM associated with tuberous sclerosis complex (TSC). In up to 50 % of female TSC-patients pulmonary involvement (TSC-LAM) can be found, with first clinical symptoms usually starting between 25 and 30 years of age. Progressive deterioration of lung function of 3 - 11 % of diffusion capacity per year has been described, that's why all female TSC patients should be screened for LAM (pulmonary function testing, 6-minute walk test, high-resolution chest CT scan)...
September 1, 2016: Pneumologie
Johan W de Fijter
Malignancy is the second most common single cause of death observed in organ transplant recipients. The excess cancer risk is related to intensity and duration of immunosuppressive therapy and inversely to recipient age. Immunodeficiency and (chronic/oncogenic) viral infections together constitute a major risk. Nonmelanoma skin cancer, Kaposi sarcoma and posttransplant lymphoproliferative disease (PTLD) have standardized incidence ratios exceeding 10- or 50-fold. The mammalian target of rapamycin (mTOR) inhibitors, sirolimus and everolimus, are increasingly used after organ transplantation with potential advantages in virus-associated post-transplant malignancies as well as anti-cancer properties...
August 10, 2016: Transplantation
Elizabeth Randell, Rachel McNamara, D Mark Davies, Eleri Owen-Jones, Nigel Kirby, Lianna Angel, Cheney Drew, Rebecca Cannings-John, Michelle Smalley, Anurag Saxena, Emer McDermott, Laura Stockwell, Petrus J de Vries, Kerry Hood, Julian R Sampson
BACKGROUND: Tuberous sclerosis complex (TSC) is a genetic disorder affecting about 1 in 6000 people and is characterised by the development of tumours in many organs, including the skin and kidneys, and by a range of neurological and neuropsychiatric manifestations. TSC-associated neuropsychiatric disorders (TAND) occur in the majority of those with TSC, and they have a significant impact on patients and their families, given the everyday impact of TAND on education, employment, family and social life...
2016: Trials
Michael Mühlstädt
We present the case of a 73-year-old male patient who had received a first renal transplant at 36 years and a second one at the age of 55 years. He is currently under immunosuppression with everolimus 2.5 mg/day and prednisone 5 mg/day. The patient presented with multiple actinic keratoses on both cheeks and the forehead and received treatment by ingenol mebutate 150 µg/g gel daily on 3 consecutive days on his right cheek and methyl aminolevulinate (MAL) photodynamic therapy activated by daylight (MAL-dPDT) on the forehead and the left cheek...
2016: Dermatology: International Journal for Clinical and Investigative Dermatology
Andras Fogarasi, Liesbeth De Waele, Gabriella Bartalini, Sergiusz Jozwiak, Nicola Laforgia, Helene Verhelst, Borivoj Petrak, Jean-Michel Pedespan, Olaf Witt, Ramon Castellana, Stefania Crippa, Gabriella Gislimberti, Zsuzsanna Gyorsok
BACKGROUND: Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has been shown to be effective and safe in the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC). The Everolimus For Fast Expanded aCcess in TSC SEGA (EFFECTS) study was designed to provide everolimus access to patients with SEGA associated with TSC and to mainly assess the safety and also efficacy of everolimus in a real-world setting. METHODS: EFFECTS was a phase 3b, open-label, noncomparative, multicenter, expanded access study...
2016: BMC Neurology
Wail Nammas, Adam de Belder, Matti Niemelä, Jussi Sia, Hannu Romppanen, Mika Laine, Pasi P Karjalainen
BACKGROUND: The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial. METHODS: We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR)...
August 4, 2016: European Journal of Internal Medicine
D Gojowy, M Adamczak, S Dudzicz, M Gazda, H Karkoszka, A Wiecek
BACKGROUND: Cardiovascular diseases are among the most frequent causes of patient death after liver transplantation. The aim of this retrospective clinical study was to estimate the prevalence of arterial hypertension among patients after successful liver transplantation and the role of immunosuppressive drugs in the pathogenesis of hypertension in these patients. PATIENTS AND METHODS: A total of 88 patients (age 47 .5 ±  12.1 years; 33 women and 55 men) who had undergone successful liver transplantation and completed 24 months follow-up were studied...
June 2016: Transplantation Proceedings
Joanna Trelińska, Iwona Dachowska, Katarzyna Kotulska, Sergiusz Jóźwiak, Wojciech Fendler, Wojciech Młynarski
BACKGROUND: The purpose of the study was to evaluate lipid homeostasis before and after treatment of everolimus, the mammalian target of the rapamycin (mTOR) inhibitor, among patients with tuberous sclerosis complex (TSC). METHODS: The study group consisted of 15 patients with a diagnosis of subependymal giant cell astrocytoma (SEGA) related to TSC. The following lipid parameters were determined: total serum cholesterol (TCh), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), total serum triglyceride (TG) concentration at baseline, then after three and 12 months of observation...
October 2016: Pharmacological Reports: PR
Teguh H Sasongko, Nur Farrah Dila Ismail, Zamh Zabidi-Hussin
BACKGROUND: Previous studies have shown potential benefits of rapamycin or rapalogs for treating people with tuberous sclerosis complex. Although everolimus (a rapalog) is currently approved by the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency) for tuberous sclerosis complex-associated renal angiomyolipoma and subependymal giant cell astrocytoma, applications for other manifestations of tuberous sclerosis complex have not yet been established. A systematic review is necessary to establish the clinical value of rapamycin or rapalogs for various manifestations in tuberous sclerosis complex...
2016: Cochrane Database of Systematic Reviews
Daisuke Sueta, Yuichiro Arima, Seiji Hokimoto, Toshifumi Mukunoki, Noriaki Tabata, Tomonori Akasaka, Takahiro Sato, Jun Otani, Hisao Ogawa
BACKGROUND: Percutaneous coronary intervention (PCI) for unprotected left main truncus (LMT) lesions is controversial. Inoperable status with advanced age, renal dysfunction, frailty, or patient request may require an unprotected left main PCI. PCI for LMT is not recommended in the typical clinical situation; however, when it is the only feasible option, the performance is not bad. We demonstrated the result of a cobalt-chromium everolimus-eluting stent (CoCr-EES) in the LMT stenting and serial changes via micro-computed tomography (μCT)...
October 15, 2016: International Journal of Cardiology
Patrick B Johnston, Betsy LaPlant, Ellen McPhail, Thomas M Habermann, David J Inwards, Ivana N Micallef, Joseph P Colgan, Grzegorz S Nowakowski, Stephen M Ansell, Thomas E Witzig
BACKGROUND: The PI3K-mTORC pathway is upregulated in diffuse large B-cell lymphoma (DLBCL) and can be targeted with the mTOR complex 1 (mTORC1) inhibitor everolimus. Everolimus has activity in relapsed DLBCL. These data provide the rationale to combine everolimus with standard treatment for DLBCL of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone delivered in a 21-day cycle (R-CHOP-21) for six cycles. METHODS: We did a phase 1 and feasibility study (NCCTG 1085) of oral everolimus 10 mg/day plus R-CHOP-21 in patients aged at least 18 years with new, untreated, CD20-positive DLBCL (stages II-IV) in the NCCTG (Alliance) National Cancer Institute Cooperative Group (USA)...
July 2016: Lancet Haematology
G Jerusalem, G Mariani, E M Ciruelos, M Martin, V C G Tjan-Heijnen, P Neven, J G Gavila, A Michelotti, F Montemurro, D Generali, E Simoncini, I Lang, J Mardiak, B Naume, M Camozzi, K Lorizzo, S Bianchetti, P Conte
BACKGROUND: This European phase IIIb, expanded-access multicenter trial evaluated the safety of EVE plus EXE in a patient population similar to BOLERO-2. PATIENTS AND METHODS: Post-menopausal women aged ≥18 years with hormone receptor-positive, human epidermal growth factor-receptor-2-negative advanced breast cancer (ABC) recurring/progressing during/after prior non-steroidal aromatase inhibitors were enrolled. The primary objective was safety of EVE plus EXE based on frequency of adverse events (AEs), and serious AEs (SAEs)...
September 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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