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https://www.readbyqxmd.com/read/27912982/should-recommendations-about-starting-inhaled-corticosteroid-treatment-for-mild-asthma-be-based-on-symptom-frequency-a-post-hoc-efficacy-analysis-of-the-start-study
#1
Helen K Reddel, William W Busse, Søren Pedersen, Wan C Tan, Yu-Zhi Chen, Carin Jorup, Dan Lythgoe, Paul M O'Byrne
BACKGROUND: Low-dose inhaled corticosteroids (ICS) are highly effective for reducing asthma exacerbations and mortality. Conventionally, ICS treatment is recommended for patients with symptoms on more than 2 days per week, but this criterion has scant evidence. We aimed to assess the validity of the previous symptom-based cutoff for starting ICS by establishing whether there was a differential response to budesonide versus placebo for severe asthma exacerbations, lung function, and asthma symptom control across subgroups identified by baseline asthma symptom frequency...
November 29, 2016: Lancet
https://www.readbyqxmd.com/read/27908454/fulvestrant-500-mg-versus-anastrozole-1-mg-for-hormone-receptor-positive-advanced-breast-cancer-falcon-an-international-randomised-double-blind-phase-3-trial
#2
John F R Robertson, Igor M Bondarenko, Ekaterina Trishkina, Mikhail Dvorkin, Lawrence Panasci, Alexey Manikhas, Yaroslav Shparyk, Servando Cardona-Huerta, Kwok-Leung Cheung, Manuel Jesus Philco-Salas, Manuel Ruiz-Borrego, Zhimin Shao, Shinzaburo Noguchi, Jacqui Rowbottom, Mary Stuart, Lynda M Grinsted, Mehdi Fazal, Matthew J Ellis
BACKGROUND: Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine therapy. METHODS: In this phase 3, randomised, double-blind trial, we recruited eligible patients with histologically confirmed oestrogen receptor-positive or progesterone receptor-positive, or both, locally advanced or metastatic breast cancer from 113 academic hospitals and community centres in 20 countries...
November 28, 2016: Lancet
https://www.readbyqxmd.com/read/27831940/pseudo-bullous-dermatosis-induced-by-topical-anesthetic-agent-clues-to-this-localized-toxic-reaction
#3
Christopher R Kieliszak, John R Griffin, Tess H Pollinger, Jacqueline M Junkins-Hopkins
Eutectic mixture of 2.5% lidocaine and 2.5% prilocaine (EMLA AstraZeneca, DE) is a widely used topical anesthetic cream for preprocedural cutaneous analgesia. In addition to potential clinical cutaneous and systemic adverse effects, EMLA may also induce microscopic changes detectable by light and electron microscopy leading to difficulty in accurate diagnosis. We report the case of a biopsy demonstrating EMLA-induced histopathologic changes. The biopsy was taken from the back of a 5-month-old infant and submitted to rule out psoriasis...
October 26, 2016: American Journal of Dermatopathology
https://www.readbyqxmd.com/read/27783548/patterns-of-adherence-to-oral-atypical-antipsychotics-among-patients-diagnosed-with-schizophrenia
#4
Joanna P MacEwan, Felicia M Forma, Jason Shafrin, Ainslie Hatch, Darius N Lakdawalla, Jean-Pierre Lindenmayer
BACKGROUND: Poor medication adherence contributes to negative treatment response, symptom relapse, and hospitalizations in schizophrenia. Many health plans use claims-based measures like medication possession ratios or proportion of days covered (PDC) to measure patient adherence to antipsychotics. Classifying patients solely on the basis of a single average PDC measure, however, may mask clinically meaningful variations over time in how patients arrive at an average PDC level. OBJECTIVE: To model patterns of medication adherence evolving over time for patients with schizophrenia who initiated treatment with an oral atypical antipsychotic and, based on these patterns, to identify groups of patients with different adherence behaviors...
November 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27751847/osimertinib-for-pretreated-egfr-thr790met-positive-advanced-non-small-cell-lung-cancer-aura2-a-multicentre-open-label-single-arm-phase-2-study
#5
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
https://www.readbyqxmd.com/read/27747520/disease-control-health-resource-use-healthcare-costs-and-predictors-in-gout-patients-in-the-united-states-the-united-kingdom-germany-and-france-a-retrospective-analysis
#6
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: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27724045/p2x7-receptor-antagonists-a-patent-review-2010-2015
#7
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
https://www.readbyqxmd.com/read/27703782/ketamine-stimulating-antidepressant-treatment
#8
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
https://www.readbyqxmd.com/read/27703769/testing-the-social-competition-hypothesis-of-depression-using-a-simple-economic-game
#9
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
https://www.readbyqxmd.com/read/27703766/the-effect-of-second-generation-antipsychotics-on-hippocampal-volume-in-first-episode-of-psychosis-longitudinal-study
#10
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
https://www.readbyqxmd.com/read/27671328/clinical-implications-of-switching-lipid-lowering-treatment-from-rosuvastatin-to-other-agents-in-primary-care
#11
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...
November 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27651331/exenatide-once-weekly-plus-dapagliflozin-once-daily-versus-exenatide-or-dapagliflozin-alone-in-patients-with-type-2-diabetes-inadequately-controlled-with-metformin-monotherapy-duration-8-a-28-week-multicentre-double-blind-phase-3-randomised-controlled-trial
#12
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...
December 2016: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/27617661/overall-survival-in-patients-with-platinum-sensitive-recurrent-serous-ovarian-cancer-receiving-olaparib-maintenance-monotherapy-an-updated-analysis-from-a-randomised-placebo-controlled-double-blind-phase-2-trial
#13
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
https://www.readbyqxmd.com/read/27609408/efficacy-and-safety-of-benralizumab-for-patients-with-severe-asthma-uncontrolled-with-high-dosage-inhaled-corticosteroids-and-long-acting-%C3%AE-2-agonists-sirocco-a-randomised-multicentre-placebo-controlled-phase-3-trial
#14
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
https://www.readbyqxmd.com/read/27609406/benralizumab-an-anti-interleukin-5-receptor-%C3%AE-monoclonal-antibody-as-add-on-treatment-for-patients-with-severe-uncontrolled-eosinophilic-asthma-calima-a-randomised-double-blind-placebo-controlled-phase-3-trial
#15
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
https://www.readbyqxmd.com/read/27585582/glycated-hemoglobin-body-weight-and-blood-pressure-in-type-2-diabetes-patients-initiating-dapagliflozin-treatment-in-primary-care-a-retrospective-study
#16
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
https://www.readbyqxmd.com/read/27579635/serious-asthma-events-with-budesonide-plus-formoterol-vs-budesonide-alone
#17
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/27574788/efficacy-and-safety-of-a-cxcr2-antagonist-azd5069-in-patients-with-uncontrolled-persistent-asthma-a-randomised-double-blind-placebo-controlled-trial
#18
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
https://www.readbyqxmd.com/read/27567348/availability-affordability-and-consumption-of-fruits-and-vegetables-in-18-countries-across-income-levels-findings-from-the-prospective-urban-rural-epidemiology-pure-study
#19
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
https://www.readbyqxmd.com/read/27546350/development-of-a-rational-design-space-for-optimizing-mixing-conditions-for-formation-of-adhesive-mixtures-for-dry-powder-inhaler-formulations
#20
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
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