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Glenwood Goss, Chun-Ming Tsai, Frances A Shepherd, Lyudmila Bazhenova, Jong Seok Lee, Gee-Chen Chang, Lucio Crino, Miyako Satouchi, Quincy Chu, Toyoaki Hida, Ji-Youn Han, Oscar Juan, Frank Dunphy, Makoto Nishio, Jin-Hyoung Kang, Margarita Majem, Helen Mann, Mireille Cantarini, Serban Ghiorghiu, Tetsuya Mitsudomi
BACKGROUND: Osimertinib (AZD9291) is an oral, potent, irreversible EGFR tyrosine-kinase inhibitor selective for EGFR tyrosine-kinase inhibitor sensitising mutations, and the EGFR Thr790Met resistance mutation. We assessed the efficacy and safety of osimertinib in patients with EGFR Thr790Met-positive non-small-cell lung cancer (NSCLC), who had progressed after previous therapy with an approved EGFR tyrosine-kinase inhibitor. METHODS: In this phase 2, open-label, single-arm study (AURA2), patients aged at least 18 years with centrally confirmed EGFR Thr790Met-positive mutations, locally advanced or metastatic (stage IIIB/IV) NSCLC who progressed on previous EGFR tyrosine-kinase inhibitor therapy received osimertinib 80 mg orally once daily; treatment could continue beyond progression if the investigator observed a clinical benefit...
October 14, 2016: Lancet Oncology
Robert Morlock, Pierre Chevalier, Laura Horne, Javier Nuevo, Chris Storgard, Lalitha Aiyer, Dionne M Hines, Xavier Ansolabehere, Fredrik Nyberg
INTRODUCTION: The present study aimed to assess disease control, health resource utilization (HRU), and healthcare costs, and their predictors in gout patients across the USA, UK, Germany, and France. METHODS: Data were extracted from the PharMetrics Plus (USA), Clinical Practice Research Datalink-Hospital Episode Statistics (UK), and Disease Analyzer databases (Germany and France) for adult gout patients over a 3-year period: 2009-2011 (all dates +1 year for France)...
June 2016: Rheumatol Ther
Jin-Hee Park, Yong-Chul Kim
The P2X7 receptor (P2X7R) is a unique subtype among the family of seven purinergic P2X receptors, which are ATP-gated non-selective cation channels. P2X7R has been reported to have pathological roles in various diseases, including autoimmune diseases such as arthritis and inflammatory bowel disease, neurodegenerative diseases, chronic pain, mood disorders and cancers. Therefore, many pharmaceutical companies have endeavored to develop a clinical candidate targeting P2X7R. Areas covered: This review provides a summary of various patents on chemicals and biologics and their clinical use published between 2010 and 2015...
October 10, 2016: Expert Opinion on Therapeutic Patents
Gin S Malhi, Yulisha Byrow, Frederick Cassidy, Andrea Cipriani, Koen Demyttenaere, Mark A Frye, Michael Gitlin, Sidney H Kennedy, Terence A Ketter, Raymond W Lam, Rupert McShane, Alex J Mitchell, Michael J Ostacher, Sakina J Rizvi, Michael E Thase, Mauricio Tohen
SUMMARY: The appeal of ketamine - in promptly ameliorating depressive symptoms even in those with non-response - has led to a dramatic increase in its off-label use. Initial promising results await robust corroboration and key questions remain, particularly concerning its long-term administration. It is, therefore, timely to review the opinions of mood disorder experts worldwide pertaining to ketamine's potential as an option for treating depression and provide a synthesis of perspectives - derived from evidence and clinical experience - and to consider strategies for future investigations...
May 2016: BJPsych Open
Aleksandra Kupferberg, Oliver M Hager, Urs Fischbacher, Laura S Brändle, Melanie Haynes, Gregor Hasler
BACKGROUND: Price's social competition hypothesis interprets the depressive state as an unconscious, involuntary losing strategy, which enables individuals to yield and accept defeat in competitive situations. AIMS: We investigated whether patients who suffer from major depressive disorder (MDD) would avoid competition more often than either patients suffering from borderline personality disorder (BPD) or healthy controls. METHOD: In a simple paper-folding task healthy participants and patiens with MDD and BPD were matched with two opponents, one with an unknown diagnosis and one who shared their clinical diagnosis, and they had to choose either a competitive or cooperative payment scheme for task completion...
March 2016: BJPsych Open
Michael Bodnar, Ashok K Malla, Carolina Makowski, M Mallar Chakravarty, Ridha Joober, Martin Lepage
BACKGROUND: Current neuroscience literature has related treatment with aripiprazole to improved memory performance and subcellular changes in the hippocampus. AIMS: To explore the volumetric changes in hippocampal grey matter in people with a first episode of psychosis (FEP) treated with second-generation antipsychotics. METHOD: Baseline and 1-year follow-up magnetic resonance images were obtained. Hippocampal volumes were estimated by using FreeSurfer and MAGeT-Brain...
March 2016: BJPsych Open
Furio Colivicchi, Michele Massimo Gulizia, Laura Franzini, Giuseppe Imperoli, Lorenzo Castello, Alessandro Aiello, Claudio Ripellino, Nazarena Cataldo
INTRODUCTION: Switching from any statin to another non-equipotent lipid lowering treatment (LLT) may cause a low-density lipoprotein cholesterol increase and has been associated with a higher probability of negative cardiovascular outcomes. The aim of the study was to assess the impact of switching from rosuvastatin to any other LLT on clinical outcomes in primary care. METHODS: This was a retrospective analysis based on data from IMS Health Longitudinal Patient Database, which is a general practice database including information of more than 1...
September 26, 2016: Advances in Therapy
Juan P Frías, Cristian Guja, Elise Hardy, Azazuddin Ahmed, Fang Dong, Peter Öhman, Serge A Jabbour
BACKGROUND: Glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors reduce glycaemia and weight, and improve cardiovascular risk factors via different mechanisms. We aimed to compare the efficacy and safety of co-initiation of the GLP-1 receptor agonist exenatide and the SGLT2 inhibitor dapagliflozin with exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled by metformin. METHODS: DURATION-8 was a 28 week, multicentre, double-blind, randomised, active-controlled phase 3 trial done at 109 sites in six countries...
September 15, 2016: Lancet Diabetes & Endocrinology
Jonathan A Ledermann, Philipp Harter, Charlie Gourley, Michael Friedlander, Ignace Vergote, Gordon Rustin, Clare Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra, Daniela Matei, Anitra Fielding, Stuart Spencer, Philip Rowe, Elizabeth Lowe, Darren Hodgson, Mika A Sovak, Ursula Matulonis
BACKGROUND: In patients with platinum-sensitive recurrent serous ovarian cancer, maintenance monotherapy with the PARP inhibitor olaparib significantly improves progression-free survival versus placebo. We assessed the effect of maintenance olaparib on overall survival in patients with platinum-sensitive recurrent serous ovarian cancer, including those with BRCA1 and BRCA2 mutations (BRCAm). METHODS: In this randomised, placebo-controlled, double-blind, phase 2 trial involving 82 sites across 16 countries, patients with platinum-sensitive recurrent serous ovarian cancer who had received two or more courses of platinum-based chemotherapy and had responded to their latest regimen were randomly assigned (1:1) using a computer-generated sequence to receive oral maintenance olaparib (as capsules; 400 mg twice a day) or a matching placebo by an interactive voice response system...
September 8, 2016: Lancet Oncology
Eugene R Bleecker, J Mark FitzGerald, Pascal Chanez, Alberto Papi, Steven F Weinstein, Peter Barker, Stephanie Sproule, Geoffrey Gilmartin, Magnus Aurivillius, Viktoria Werkström, Mitchell Goldman
BACKGROUND: Eosinophilia is associated with worsening asthma severity and decreased lung function, with increased exacerbation frequency. We assessed the safety and efficacy of benralizumab, a monoclonal antibody against interleukin-5 receptor α that depletes eosinophils by antibody-dependent cell-mediated cytotoxicity, for patients with severe, uncontrolled asthma with eosinophilia. METHODS: We did a randomised, double-blind, parallel-group, placebo-controlled phase 3 study at 374 sites in 17 countries...
September 2, 2016: Lancet
J Mark FitzGerald, Eugene R Bleecker, Parameswaran Nair, Stephanie Korn, Ken Ohta, Marek Lommatzsch, Gary T Ferguson, William W Busse, Peter Barker, Stephanie Sproule, Geoffrey Gilmartin, Viktoria Werkström, Magnus Aurivillius, Mitchell Goldman
BACKGROUND: Benralizumab is a humanised, afucosylated, anti-interleukin-5 receptor α monoclonal antibody that induces direct, rapid, and nearly complete depletion of eosinophils. We aimed to assess the efficacy and safety of benralizumab as add-on therapy for patients with severe, uncontrolled asthma and elevated blood eosinophil counts. METHODS: In this randomised, double-blind, parallel-group, placebo-controlled, phase 3 study (CALIMA) undertaken at 303 sites in 11 countries, we enrolled patients aged 12-75 years with severe asthma uncontrolled by medium-dosage to high-dosage inhaled corticosteroids plus long-acting β₂-agonists (ICS plus LABA) and a history of two or more exacerbations in the previous year...
September 5, 2016: Lancet
John Wilding, Clifford Bailey, Una Rigney, Betina Blak, Wendy Beekman, Cathy Emmas
INTRODUCTION: The present study aimed to describe characteristics of patients with type 2 diabetes (T2D) in UK primary care initiated on dapagliflozin, post-dapagliflozin changes in glycated hemoglobin (HbA1c), body weight and blood pressure, and reasons for adding dapagliflozin to insulin. METHODS: Retrospective study of patients with T2D in the Clinical Practice Research Datalink with first prescription for dapagliflozin. Patients were included in the study if they: (1) had a first prescription for dapagliflozin between November 2012 and September 2014; (2) had a Read code for T2D; (3) were registered with a practice for at least 6 months before starting dapagliflozin; and (4) remained registered for at least 3 months after initiation...
September 1, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Stephen P Peters, Eugene R Bleecker, Giorgio W Canonica, Yong B Park, Ricardo Ramirez, Sally Hollis, Harald Fjallbrant, Carin Jorup, Ubaldo J Martin
BACKGROUND: Concerns remain about the safety of adding long-acting β2-agonists to inhaled glucocorticoids for the treatment of asthma. In a postmarketing safety study mandated by the Food and Drug Administration, we evaluated whether the addition of formoterol to budesonide maintenance therapy increased the risk of serious asthma-related events in patients with asthma. METHODS: In this multicenter, double-blind, 26-week study, we randomly assigned patients, 12 years of age or older, who had persistent asthma, were receiving daily asthma medication, and had had one to four asthma exacerbations in the previous year to receive budesonide-formoterol or budesonide alone...
September 1, 2016: New England Journal of Medicine
Paul M O'Byrne, Hristo Metev, Margareta Puu, Kai Richter, Christina Keen, Mohib Uddin, Bengt Larsson, Marie Cullberg, Parameswaran Nair
BACKGROUND: Airway neutrophilic inflammation is a pathological feature in some patients with severe asthma. Stimulation of the chemokine receptor CXCR2 mediates neutrophil migration into the airways. We investigated the safety and efficacy of AZD5069, a CXCR2 antagonist, as an add-on therapy in patients with uncontrolled severe asthma. METHODS: In this multicentre, randomised, double-blind, placebo-controlled, dose-finding trial, we enrolled patients aged 18 years or older with uncontrolled asthma despite combination therapy with long-acting β2 agonists and medium-dose or high-dose inhaled corticosteroids...
October 2016: Lancet Respiratory Medicine
Victoria Miller, Salim Yusuf, Clara K Chow, Mahshid Dehghan, Daniel J Corsi, Karen Lock, Barry Popkin, Sumathy Rangarajan, Rasha Khatib, Scott A Lear, Prem Mony, Manmeet Kaur, Viswanathan Mohan, Krishnapillai Vijayakumar, Rajeev Gupta, Annamarie Kruger, Lungiswa Tsolekile, Noushin Mohammadifard, Omar Rahman, Annika Rosengren, Alvaro Avezum, Andrés Orlandini, Noorhassim Ismail, Patricio Lopez-Jaramillo, Afzalhussein Yusufali, Kubilay Karsidag, Romaina Iqbal, Jephat Chifamba, Solange Martinez Oakley, Farnaza Ariffin, Katarzyna Zatonska, Paul Poirier, Li Wei, Bo Jian, Chen Hui, Liu Xu, Bai Xiulin, Koon Teo, Andrew Mente
BACKGROUND: Several international guidelines recommend the consumption of two servings of fruits and three servings of vegetables per day, but their intake is thought to be low worldwide. We aimed to determine the extent to which such low intake is related to availability and affordability. METHODS: We assessed fruit and vegetable consumption using data from country-specific, validated semi-quantitative food frequency questionnaires in the Prospective Urban Rural Epidemiology (PURE) study, which enrolled participants from communities in 18 countries between Jan 1, 2003, and Dec 31, 2013...
October 2016: Lancet Global Health
Saurabh Sarkar, Bruna Minatovicz, Kyrre Thalberg, Bodhisattwa Chaudhuri
The purpose of the present study was to develop guidance toward rational choice of blenders and processing conditions to make robust and high performing adhesive mixtures for dry-powder inhalers and to develop quantitative experimental approaches for optimizing the process. Mixing behavior of carrier (LH100) and AstraZeneca fine lactose in high-shear and low-shear double cone blenders was systematically investigated. Process variables impacting the mixing performance were evaluated for both blenders. The performance of the blenders with respect to the mixing time, press-on forces, static charging, and abrasion of carrier fines was monitored, and for some of the parameters, distinct differences could be detected...
August 18, 2016: Journal of Pharmaceutical Sciences
Sanjay Kalra
: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a novel class of drugs that have been extensively investigated for the treatment of hyperglycemia in type 2 diabetes mellitus (T2DM). These drugs reduce hyperglycemia by blocking renal glucose reabsorption, thereby promoting increased renal glucose excretion. Beyond glycemic control, these drugs have other beneficial effects on cardiovascular (CV) risk factors. The present review discusses the potential role of SGLT2 inhibitors in treating CV complications (acute and chronic) associated with T2DM...
August 18, 2016: Cardiology and Therapy
Puya Gharahkhani, Rebecca C Fitzgerald, Thomas L Vaughan, Claire Palles, Ines Gockel, Ian Tomlinson, Matthew F Buas, Andrea May, Christian Gerges, Mario Anders, Jessica Becker, Nicole Kreuser, Tania Noder, Marino Venerito, Lothar Veits, Thomas Schmidt, Hendrik Manner, Claudia Schmidt, Timo Hess, Anne C Böhmer, Jakob R Izbicki, Arnulf H Hölscher, Hauke Lang, Dietmar Lorenz, Brigitte Schumacher, Andreas Hackelsberger, Rupert Mayershofer, Oliver Pech, Yogesh Vashist, Katja Ott, Michael Vieth, Josef Weismüller, Markus M Nöthen, Stephen Attwood, Hugh Barr, Laura Chegwidden, John de Caestecker, Rebecca Harrison, Sharon B Love, David MacDonald, Paul Moayyedi, Hans Prenen, R G Peter Watson, Prasad G Iyer, Lesley A Anderson, Leslie Bernstein, Wong-Ho Chow, Laura J Hardie, Jesper Lagergren, Geoffrey Liu, Harvey A Risch, Anna H Wu, Weimin Ye, Nigel C Bird, Nicholas J Shaheen, Marilie D Gammon, Douglas A Corley, Carlos Caldas, Susanne Moebus, Michael Knapp, Wilbert H M Peters, Horst Neuhaus, Thomas Rösch, Christian Ell, Stuart MacGregor, Paul Pharoah, David C Whiteman, Janusz Jankowski, Johannes Schumacher
BACKGROUND: Oesophageal adenocarcinoma represents one of the fastest rising cancers in high-income countries. Barrett's oesophagus is the premalignant precursor of oesophageal adenocarcinoma. However, only a few patients with Barrett's oesophagus develop adenocarcinoma, which complicates clinical management in the absence of valid predictors. Within an international consortium investigating the genetics of Barrett's oesophagus and oesophageal adenocarcinoma, we aimed to identify novel genetic risk variants for the development of Barrett's oesophagus and oesophageal adenocarcinoma...
October 2016: Lancet Oncology
Juliana Maynard, Sally-Ann Emmas, Francois-Xavier Blé, Hervé Barjat, Emily Lawrie, Urs Hancox, Deborah Oakes, Urszula M Polanska, Simon T Barry
BACKGROUND: The phosphatidylinositol 3 kinase (PI3K) signalling pathway is frequently altered in human cancer and a promising therapeutic target. AZD8186 (AstraZeneca) is a PI3Kβ/δ inhibitor, currently in phase 1 clinical trials. (18)F-fluorodeoxyglucose positron emission tomography ((18)F-FDG PET) is often used as a biomarker for inhibitors targeting the PI3K axis because of the association of this pathway with glucose metabolism. In this study, we assessed if (18)F-FDG PET could be used as a pharmacodynamic marker to monitor PI3Kβ inhibition by AZD8186, and hence have potential as a clinical biomarker of PI3Kβ pathway activation, and for patient selection...
December 2016: EJNMMI Research
Paul Tappenden, Sue Harnan, Shijie Ren, Praveen Thokala, Ruth Wong, Clara Mukuria, Clare Green, Simon Pledge, John Tidy
As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of olaparib (AstraZeneca) to submit evidence on the clinical and cost effectiveness of olaparib for the maintenance treatment of BRCA1/2 mutated (BRCAm), platinum-sensitive relapsed (PSR) ovarian, fallopian tube and peritoneal cancer in people whose relapsed disease has responded to platinum-based chemotherapy. The Evidence Review Group (ERG) produced a critical review of the evidence contained within the company's submission (CS) to NICE...
August 9, 2016: PharmacoEconomics
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