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https://www.readbyqxmd.com/read/28088030/efficacy-and-safety-of-linagliptin-metformin-single-pill-combination-as-initial-therapy-in-drug-na%C3%A3-ve-asian-patients-with-type-2-diabetes
#1
Yiming Mu, Changyu Pan, Bei Fan, Uwe Hehnke, Xiuzhen Zhang, Xuejun Zhang, Xiaoyue Wang, Jingdong Liu, Ying Zhang, Jianling Du, Jianhua Ma, Yan Gong
AIM: To assess efficacy/safety of initial linagliptin/metformin single-pill combination (SPC) therapies versus individual drug components over 24weeks in treatment-naïve Asian patients with type 2 diabetes mellitus and insufficient glycemic control. METHODS: Patients (initial glycated hemoglobin [HbA1c] ⩾7.5% to <11.0% [58-97mmol/mol]; main group) were randomized to: linagliptin 5mg once daily (qd); metformin 500mg twice daily (bid); metformin 1000mg bid; linagliptin 2...
December 5, 2016: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/28079558/once-daily-tacrolimus-in-liver-transplantation-a-me-too-drug-or-a-therapeutic-advantage
#2
Pavel Trunečka
PURPOSE OF REVIEW: To provide latest information on differences between standard tacrolimus (TAC BID) and slow-released formulation of tacrolimus (Advagraf) in liver transplantation (LTx), and to discuss the latter's therapeutic value as a distinct entity. RECENT FINDINGS: Two articles on de-novo studies, several on conversion and one on survival analysis from the European Liver Transplant Registry published recently showed that low-dose Advagraf immediately after transplantation provided same protection to the kidney as standard dose delayed until day 5, and was associated with lower rejection rate; to maintain the same trough level after late conversion to Advagraf, an approximately 1...
January 11, 2017: Current Opinion in Organ Transplantation
https://www.readbyqxmd.com/read/28079500/efficacy-and-safety-of-tofacitinib-in-older-and-younger-patients-with-rheumatoid-arthritis
#3
Jeffrey R Curtis, Hendrik Schulze-Koops, Liza Takiya, Charles A Mebus, Ketti K Terry, Pinaki Biswas, Thomas V Jones
OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the efficacy and safety of tofacitinib 5 or 10 mg twice daily (BID), in patients with moderate to severe RA, aged ≥65 and <65 years. METHODS: Data were pooled from five Phase 3 trials and, separately, from two open-label long-term extension (LTE) studies (data cut-off April, 2012). Patients received tofacitinib, or placebo (Phase 3 only), with/without conventional synthetic DMARDs (mainly methotrexate)...
January 4, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28078541/glucagon-like-peptide-1-receptor-agonist-glp-1ra-therapy-adherence-for-patients-with-type-2-diabetes-in-a-medicare-population
#4
Hiep Nguyen, Robert Dufour, Amanda Caldwell-Tarr
INTRODUCTION: Anti-diabetes medication regimen adherence is a clinical challenge in elderly patients with type 2 diabetes (T2D) and other comorbidities associated with aging. Glucagon-like peptide-1 receptor agonists (GLP-1RA) therapies such as exenatide once weekly (QW), exenatide twice daily (BID), and liraglutide once daily (QD) are an increasingly used class of drugs with proven efficacy and tolerability. Real-world evidence on adherence to GLP-1RAs in elderly or disabled patients is limited...
January 11, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28075066/efficacy-and-safety-of-fixed-dose-combination-therapy-alogliptin-plus-metformin-in-asian-patients-with-type-2-diabetes-a-phase-3-trial
#5
Linong Ji, Ling Li, Jian Kuang, Tao Yang, Dong-Jun Kim, Azidah Abdul Kadir, Chien-Ning Huang, Douglas Lee
This study evaluated the efficacy and safety of 26 weeks of twice-daily (BID) alogliptin + metformin fixed-dose combination (FDC) therapy in Asian patients with type 2 diabetes. Patients aged 18 - 75 years with hemoglobin A1c (HbA1c) 7.5 - 10.0% after ≥2 months of diet and exercise and a 4-week placebo run-in were enrolled. Eligible patients were randomized (1:1:1:1) to placebo, alogliptin 12.5 mg BID, metformin 500 mg BID, or alogliptin 12.5 mg plus metformin 500 mg FDC BID. The primary endpoint was change in HbA1c from baseline to end of treatment (Week 26)...
January 11, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28073006/bcl9l-dysfunction-impairs-caspase-2-expression-permitting-aneuploidy-tolerance-in-colorectal-cancer
#6
Carlos López-García, Laurent Sansregret, Enric Domingo, Nicholas McGranahan, Sebastijan Hobor, Nicolai Juul Birkbak, Stuart Horswell, Eva Grönroos, Francesco Favero, Andrew J Rowan, Nicholas Matthews, Sharmin Begum, Benjamin Phillimore, Rebecca Burrell, Dahmane Oukrif, Bradley Spencer-Dene, Michal Kovac, Gordon Stamp, Aengus Stewart, Havard Danielsen, Marco Novelli, Ian Tomlinson, Charles Swanton
Chromosomal instability (CIN) contributes to cancer evolution, intratumor heterogeneity, and drug resistance. CIN is driven by chromosome segregation errors and a tolerance phenotype that permits the propagation of aneuploid genomes. Through genomic analysis of colorectal cancers and cell lines, we find frequent loss of heterozygosity and mutations in BCL9L in aneuploid tumors. BCL9L deficiency promoted tolerance of chromosome missegregation events, propagation of aneuploidy, and genetic heterogeneity in xenograft models likely through modulation of Wnt signaling...
January 9, 2017: Cancer Cell
https://www.readbyqxmd.com/read/28070720/safety-tolerability-and-pharmacokinetics-of-the-fibroblast-growth-factor-receptor-inhibitor-azd4547-in-japanese-patients-with-advanced-solid-tumours-a-phase-i-study
#7
Hideo Saka, Chiyoe Kitagawa, Yoshihito Kogure, Yasuo Takahashi, Koshi Fujikawa, Tamotsu Sagawa, Satoru Iwasa, Naoki Takahashi, Taro Fukao, Catherine Tchinou, Dónal Landers, Yasuhide Yamada
Background AZD4547 is a potent, oral, highly selective fibroblast growth factor receptor (FGFR) inhibitor in clinical development for treating tumours with a range of FGFR aberrations, including FGFR mutations, amplifications and fusions. Methods This open-label, Phase I, multicentre study (NCT01213160) evaluated the safety, pharmacokinetics, and preliminary antitumour efficacy (RECIST v1.1) of AZD4547 monotherapy in Japanese patients with advanced solid tumours. Part A was a dose-escalation part; Part B was a dose-expansion part in patients with FGFR-amplified tumours, confirmed by fluorescence in situ hybridization...
January 10, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28069354/bufadienolides-from-amphibians-a-promising-source-of-anticancer-prototypes-for-radical-innovation-apoptosis-triggering-and-na-k-atpase-inhibition
#8
REVIEW
Lívia Queiroz de Sousa, Kátia da Conceição Machado, Samara Ferreira de Carvalho Oliveira, Lidiane da Silva Araújo, Evaldo Dos Santos Monção-Filho, Ana Amélia de Carvalho Melo-Cavalcante, Gerardo Magela Vieira-Júnior, Paulo Michel Pinheiro Ferreira
Amphibians present pharmacologically active aliphatic, aromatic and heterocyclic molecules in their skin as defense against microorganisms, predators and infections, such as steroids, alkaloids, biogenic amines, guanidine derivatives, proteins and peptides. Based on the discovered bioactive potential of bufadienolides, this work reviewed the contribution of amphibians, especially from members of Bufonidae family, as source of new cytotoxic and antitumor molecules, highlighting the mechanisms responsible for such amazing biological potentialities...
January 6, 2017: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/28069068/the-sygma-programme-of-phase-3-trials-to-evaluate-the-efficacy-and-safety-of-budesonide-formoterol-given-as-needed-in-mild-asthma-study-protocols-for-two-randomised-controlled-trials
#9
Paul M O'Byrne, J Mark FitzGerald, Nanshan Zhong, Eric Bateman, Peter J Barnes, Christina Keen, Gun Almqvist, Kristine Pemberton, Carin Jorup, Stefan Ivanov, Helen K Reddel
BACKGROUND: In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poor control of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol 'as needed' in response to symptoms may represent an alternative treatment option for patients with mild asthma...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28068431/cil-102-induced-cell-cycle-arrest-and-apoptosis-in-colorectal-cancer-cells-via-upregulation-of-p21-and-gadd45
#10
Wen-Shih Huang, Yi-Hung Kuo, Hsing-Chun Kuo, Meng-Chiao Hsieh, Cheng-Yi Huang, Ko-Chao Lee, Kam-Fai Lee, Chien-Heng Shen, Shui-Yi Tung, Chih-Chuan Teng
CIL-102 (1-[4-(furo[2,3-b]quinolin-4-ylamino)phenyl]ethanone) is a well-known, major active agent of the alkaloid derivative of Camptotheca acuminata with valuable biological properties, including anti-tumorigenic activity. In this study, we investigated the molecular mechanisms by which CIL-102 mediated the induction of cell death, and we performed cell cycle G2/M arrest to clarify molecular changes in colorectal cancer cells (CRC). Treatment of DLD-1 cells with CIL-102 resulted in triggering the extrinsic apoptosis pathway through the activation of Fas-L, caspase-8 and the induction of Bid cleavage and cytochrome c release in a time-dependent manner...
2017: PloS One
https://www.readbyqxmd.com/read/28065254/pulmonary-eosinophilia-from-inhaled-colistin
#11
Pierre-Alexis Lépine, Alain Dumas, Louis-Philippe Boulet
We report the case of a patient with a history of chronic bronchiectasis that presented with new onset fatigue, shortness of breath, peripheral blood eosinophilia and infiltrates on chest radiograph. Eight days previously, she was prescribed inhaled colistimethate sodium 75 mg bid to prevent exacerbations of her respiratory condition. To our knowledge, our case is the first to show the clinical and radiologic features of inhaled-colistimethate-induced pulmonary eosinophilia. It also shows the rapid resolution of its features following treatment with oral corticosteroids...
January 2017: Chest
https://www.readbyqxmd.com/read/28062136/p2y12-receptor-inhibition-with-prasugrel-and-ticagrelor-in-stemi-patients-after-fibrinolytic-therapy-analysis-from-the-sampa-randomized-trial
#12
Leonardo de F C Guimarães, Philippe Généreux, Diego Silveira, Antonio Eduardo Pesaro, Felipe Falcão, Bruno Robalinho C Barbosa, Cristiano Freitas de Souza, Francisco A H Fonseca, Cláudia Maria Rodrigues Alves, Antônio Carlos de Camargo Carvalho, Gregg W Stone, Adriano Caixeta
BACKGROUND: A pharmacodynamic comparison between ticagrelor and prasugrel after fibrinolytic therapy has not yet been performed. METHODS: In the single-center SAMPA trial, 50 consecutive STEMI patients previously treated with clopidogrel and undergoing a pharmacoinvasive strategy were randomized to either a ticagrelor (n=25) 180mg loading dose followed by 90mg bid, or a prasugrel (n=25) 60mg loading dose followed by 10mg/day, initiated after fibrinolytic therapy but before angiography...
December 27, 2016: International Journal of Cardiology
https://www.readbyqxmd.com/read/28061907/a-randomized-seven-day-study-to-assess-the-efficacy-and-safety-of-a-glycopyrrolate-formoterol-fumarate-fixed-dose-combination-metered-dose-inhaler-using-novel-co-suspension%C3%A2-delivery-technology-in-patients-with-moderate-to-very-severe-chronic-obstructive-pulmonary
#13
Colin Reisner, Leonardo M Fabbri, Edward M Kerwin, Charles Fogarty, Selwyn Spangenthal, Klaus F Rabe, Gary T Ferguson, Fernando J Martinez, James F Donohue, Patrick Darken, Earl St Rose, Chad Orevillo, Shannon Strom, Tracy Fischer, Michael Golden, Sarvajna Dwivedi
BACKGROUND: Long-acting muscarinic antagonist/long-acting β2-agonist combinations are recommended for patients whose chronic obstructive pulmonary disease (COPD) is not managed with monotherapy. We assessed the efficacy and safety of glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination delivered via a Co-Suspension™ Delivery Technology-based metered dose inhaler (MDI) (GFF MDI). METHODS: This was a Phase IIb randomized, multicenter, placebo-controlled, double-blind, chronic-dosing (7 days), crossover study in patients with moderate-to-very severe COPD ( NCT01085045 )...
January 6, 2017: Respiratory Research
https://www.readbyqxmd.com/read/28058769/upper-and-or-lower-gastrointestinal-adverse-events-with-glp-1-receptor-agonists-incidences-and-consequences
#14
Michael Horowitz, Vanita R Aroda, Jenny Han, Elise Hardy, Chris K Rayner
AIMS: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are associated with gastrointestinal adverse events (AEs), although type and frequency may differ across the class. We characterized gastrointestinal AEs with different GLP-1RAs. METHODS: Two retrospective intent-to-treat analyses of 6-month patient-level data were conducted. Data from three studies comparing exenatide once weekly (QW; n = 617) with exenatide twice daily (BID; n = 606) were pooled, and one (DURATION-6) comparing exenatide QW (n = 461) with liraglutide (n = 450) was analyzed separately...
January 6, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28056874/sorafenib-versus-sunitinib-as-first-line-treatment-agents-in-chinese-patients-with-metastatic-renal-cell-carcinoma-the-largest-multicenter-retrospective-analysis-of-survival-and-prognostic-factors
#15
Hai-Liang Zhang, Xi-Nan Sheng, Xue-Song Li, Hong-Kai Wang, Zhi-Hong Chi, Zhi-Song He, Ding-Wei Ye, Jun Guo
BACKGROUND: To compare the efficacy of sorafenib and sunitinib with regard to overall survival (OS) and progression free survival (PFS) in Chinese patients with metastatic renal cell carcinoma (mRCC). METHODS: A multicenter, retrospective study was performed to elucidate the relationship between clinical variables and prognosis comparing sorafenib and sunitinib as first-line treatment agents in Chinese patients with mRCC. Between September 2006 and December 2014, 845 patients received either sorafenib (400 mg bid; n = 483) or sunitinib (50 mg q...
January 5, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28055107/results-of-a-phase-i-ii-study-of-fenretinide-and-rituximab-for-patients-with-indolent-b-cell-lymphoma-and-mantle-cell-lymphoma
#16
Andrew J Cowan, Phillip A Stevenson, Ted A Gooley, Shani L Frayo, George R Oliveira, Stephen D Smith, Damian J Green, Jennifer E Roden, John M Pagel, Brent L Wood, Oliver W Press, Ajay K Gopal
Fenretinide, a synthetic retinoid, induces apoptotic cell death in B-cell non-Hodgkin lymphoma (B-NHL) and acts synergistically with rituximab in preclinical models. We report results from a phase I-II study of fenretinide with rituximab for B-NHLs. Eligible diagnoses included indolent B-NHL or mantle cell lymphoma. The phase I design de-escalated from fenretinide at 900 mg/m(2) PO BID for days 1-5 of a 7-day cycle. The phase II portion added 375 mg/m(2) IV rituximab weekly on weeks 5-9 then every 3 months...
January 5, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28053292/randomized-placebo-controlled-trial-evaluating-the-safety-of-one-year-administration-of-green-tea-catechins
#17
Nagi B Kumar, Julio Pow-Sang, Philippe E Spiess, Jong Park, Raoul Salup, Christopher R Williams, Howard Parnes, Michael J Schell
PURPOSE: Although preclinical, epidemiological and prior clinical trial data suggest that green tea catechins (GTCs) may reduce prostate cancer (PCa) risk, several preclinical studies and case reports have reported liver toxicities and acute gastrointestinal bleeding. Based on these observations, regulatory bodies have required stringent inclusion criteria with frequent, excessive toxicity monitoring and early stopping rules in clinical trials. These requirements have impeded recruitment and retention of subjects in chemoprevention trials and subsequent progress in agent development efforts...
October 25, 2016: Oncotarget
https://www.readbyqxmd.com/read/28053104/structural-insight-into-african-swine-fever-virus-a179l-mediated-inhibition-of-apoptosis
#18
Suresh Banjara, Sofia Caria, Linda K Dixon, Mark G Hinds, Marc Kvansakul
: Programmed cell death is a tightly controlled process critical for the removal of damaged or infected cells. Pro- and anti-apoptotic proteins of the Bcl-2 family are pivotal mediators of this process. African Swine Fever virus (ASFV) is a large DNA virus, the only member of the Asfarviridae family, and harbors A179L, a putative Bcl-2 like protein. A179L has been shown to bind to several pro-apoptotic Bcl-2 proteins, however the hierarchy of binding and the structural basis for apoptosis inhibition are currently not understood...
January 4, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28053022/phase-1-study-of-ont-380-a-her2-inhibitor-in-patients-with-her2-advanced-solid-tumors-with-an-expansion-cohort-in-her2-metastatic-breast-cancer-mbc
#19
Stacy Moulder-Thompson, Virginia F Borges, Tara D Baetz, Tessa Mcspadden, Gina Fernetich, Rashmi K Murthy, Renae Chavira, Kari Guthrie, Emma Barrett, Stephen Chia
PURPOSE: ONT-380 (ARRY-380) is a potent and selective oral HER2 inhibitor. This Phase 1 study determined the maximum tolerated dose (MTD), pharmacokinetics (PK) and antitumor activity of ONT-380 in HER2 positive advanced solid tumors, with an expansion cohort of patients with HER2-positive MBC. EXPERIMENTAL DESIGN: ONT-380 was administered twice daily (BID) in continuous 28-day cycles. After a modified 3+3 dose escalation design determined the MTD, the expansion cohort was enrolled...
January 4, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28053021/first-in-human-phase-1-study-of-the-oral-inhibitor-of-indoleamine-2-3-dioxygenase-1-epacadostat-incb024360-in-patients-with-advanced-solid-malignancies
#20
Gregory L Beatty, Peter J O'Dwyer, Jason Clark, Jack G Shi, Kevin J Bowman, Peggy Scherle, Robert C Newton, Richard Schaub, Janet Maleski, Lance Leopold, Thomas F Gajewski
PURPOSE: Indoleamine 2,3-dioxygenase-1 (IDO1) catalyzes the degradation of tryptophan to N-formyl-kynurenine. Overexpressed in many solid malignancies, IDO1 can promote tumor escape from host immunosurveillance. This first-in-human phase 1 study investigated the maximum tolerated dose, safety, pharmacokinetics, pharmacodynamics, and antitumor activity of epacadostat (INCB024360), a potent and selective inhibitor of IDO1. PATIENTS AND METHODS: Fifty-two patients with advanced solid malignancies were treated with epacadostat (50 mg once daily or 50, 100, 300, 400, 500, 600, or 700 mg twice daily [BID]) in a dose-escalation 3 + 3 design and evaluated in 28-day cycles...
January 4, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
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