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https://www.readbyqxmd.com/read/29331313/predictors-of-exacerbation-risk-and-response-to-budesonide-in-patients-with-chronic-obstructive-pulmonary-disease-a-post-hoc-analysis-of-three-randomised-trials
#1
Mona Bafadhel, Stefan Peterson, Miguel A De Blas, Peter M Calverley, Stephen I Rennard, Kai Richter, Malin Fagerås
BACKGROUND: The peripheral blood eosinophil count might help identify those patients with chronic obstructive pulmonary disease (COPD) who will experience fewer exacerbations when taking inhaled corticosteroids (ICS). Previous post-hoc analyses have proposed eosinophil cutoffs that are both arbitrary and limited in evaluating complex interactions of treatment response. We modelled eosinophil count as a continuous variable to determine the characteristics that determine both exacerbation risk and clinical response to ICS in patients with COPD...
January 10, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29325512/an-industry-update-the-latest-developments-in-therapeutic-delivery
#2
Oliver C Steinbach
The present industry update covers the period 1 October-31 October 2017, with information sourced from company press releases, regulatory and patent agencies as well as scientific literature. While the corporate news in October was traditionally dominated by the announcement of the third quarter results, with most of them showing market and revenue growth but also an increasing number of initial public offerings after years of slower financial development, we also saw trends continuing toward an increasing number of convergences of drugs with nanotechnology, devices and 21st century information technology...
February 2018: Therapeutic Delivery
https://www.readbyqxmd.com/read/29304263/the-prevalence-of-adverse-ocular-hemorrhagic-events-in-patients-utilizing-oral-anticoagulant-and-antiplatelet-therapy-in-routine-clinical-practice
#3
Dattanand M Sudarshana, Eleni K Konstantinou, Sruthi Arepalli, Fabiana Q Silva, Andrew P Schachat, Justis P Ehlers, Rishi P Singh
BACKGROUND AND OBJECTIVE: Previous literature assessing ocular hemorrhagic complications of anticoagulant/antiplatelet medications in routine clinical practice is limited. This study evaluates the prevalence of spontaneous ocular hemorrhagic events associated with anticoagulation/antiplatelet therapy. PATIENTS AND METHODS: A retrospective study was performed to identify patients taking anticoagulants (rivaroxaban [Xarelto; Janssen Pharmaceuticals, Beerse, Belgium], bivalirudin [Angiomax; The Medicines Company, Parsippany, NJ], lepirudin [Refludan; Bayer HealthCare Pharmaceuticals, Berlin, Germany], dabigatran [Pradaxa; Boehringer Ingelheim, Ingelheim am Rhein, Germany], and argatroban) and antiplatelet agents (clopidogrel [Plavix; Bristol-Myers Squibb, New York City, NY], prasugrel [Effient; Lilly Medical, Indianapolis, IN], and ticagrelor [Brilinta; AstraZeneca, Cambridge, UK]) who presented for an eye examination...
January 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/29298119/secondary-patents-in-the-pharmaceutical-industry-missing-the-wood-for-the-trees
#4
Saritha Kiran, Mohan Kulkarni
Introduction The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products. Areas covered The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed patents, US patent data...
January 3, 2018: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/29290170/cost-effectiveness-of-drugs-to-treat-relapsed-refractory-multiple-myeloma-in-the-united-states
#5
Josh J Carlson, Gregory F Guzauskas, Richard H Chapman, Patricia G Synnott, Shanshan Liu, Elizabeth T Russo, Steven D Pearson, Elizabeth D Brouwer, Daniel A Ollendorf
BACKGROUND: New 3-drug regimens have been developed and approved to treat multiple myeloma (MM). The absence of direct comparative data and the high cost of treatment support the need to assess the relative clinical and economic outcomes across all approved regimens. OBJECTIVE: To evaluate the cost-effectiveness of treatments for relapsed and/or refractory MM from a U.S. health system perspective. METHODS: We developed a partition survival model with 3 health states (progression-free, progression, and death) to evaluate the following regimens: carfilzomib (CFZ), elotuzumab (ELO), ixazomib (IX), daratumumab (DAR), and panobinostat (PAN) in combination with lenalidomide (LEN) or bortezomib (BOR) plus dexamethasone (DEX) in the second and/or third line of therapy...
January 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29260460/rationale-and-design-for-the-j-discover-study-discovering-the-treatment-reality-of-type-2-diabetes-in-a-real-world-setting-in-japan-a-protocol
#6
Naoto Katakami, Tomoya Mita, Mitsuyoshi Takahara, Kiyoshi Hashigami, Masaru Kawashima, Iichiro Shimomura, Hirotaka Watada
INTRODUCTION: It is estimated that 642 million adults worldwide will have diabetes by 2040, with 80-90% of these having type 2 diabetes mellitus (T2DM). While many new antidiabetic agents have been introduced in recent years, approximately 40% of T2DM patients still fail to achieve the recommended target HbA1c of < 7.0%. Furthermore, many patients with T2DM in Japan are treated by practitioners other than diabetes specialists; therefore, the exact treatment patterns of T2DM in Japan are difficult to quantify...
December 19, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29249325/outcomes-in-patients-with-non-small-cell-lung-cancer-and-acquired-thr790met-mutation-treated-with-osimertinib-a-genomic-study
#7
Chia-Chi Lin, Jin-Yuan Shih, Chong-Jen Yu, Chao-Chi Ho, Wei-Yu Liao, Jih-Hsing Lee, Tzu-Hsiu Tsai, Kang-Yi Su, Min-Shu Hsieh, Yih-Leong Chang, Ya-Ying Bai, Derek De-Rui Huang, Kenneth S Thress, James Chih-Hsin Yang
BACKGROUND: Osimertinib is approved for the treatment of non-small-cell lung cancer in patients who develop the EGFR Thr790Met mutation after treatment with epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitors (TKIs). We assessed outcomes in patients with non-small-cell lung cancer and the EGFR Thr790Met mutation who were treated with osimertinib, a third-generation EGFR TKI, after previous treatment failure with one or more other EGFR TKIs. METHODS: Eligible patients had been enrolled at one centre in the AURA study, had shown resistance to a previous EGFR TKI, and had EGFR-activating mutations and acquired Thr790Met mutation detectable in tumour tissue or plasma...
December 14, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29241979/acalabrutinib-in-relapsed-or-refractory-mantle-cell-lymphoma-ace-ly-004-a-single-arm-multicentre-phase-2-trial
#8
Michael Wang, Simon Rule, Pier Luigi Zinzani, Andre Goy, Olivier Casasnovas, Stephen D Smith, Gandhi Damaj, Jeanette Doorduijn, Thierry Lamy, Franck Morschhauser, Carlos Panizo, Bijal Shah, Andrew Davies, Richard Eek, Jehan Dupuis, Eric Jacobsen, Arnon P Kater, Steven Le Gouill, Lucie Oberic, Taduesz Robak, Todd Covey, Richa Dua, Ahmed Hamdy, Xin Huang, Raquel Izumi, Priti Patel, Wayne Rothbaum, J Greg Slatter, Wojciech Jurczak
BACKGROUND: Bruton tyrosine kinase is a clinically validated target in mantle cell lymphoma. Acalabrutinib (ACP-196) is a highly selective, potent Bruton tyrosine kinase inhibitor developed to minimise off-target activity. METHODS: In this open-label, phase 2 study, oral acalabrutinib (100 mg twice per day) was given to patients with relapsed or refractory mantle cell lymphoma, until disease progression or unacceptable toxicity. The primary endpoint was overall response assessed according to the Lugano classification, and safety analyses were done in all participants...
December 11, 2017: Lancet
https://www.readbyqxmd.com/read/29221659/cardiovascular-outcomes-with-glucagon-like-peptide-1-receptor-agonists-in-patients-with-type-2-diabetes-a-meta-analysis
#9
M Angelyn Bethel, Rishi A Patel, Peter Merrill, Yuliya Lokhnygina, John B Buse, Robert J Mentz, Neha J Pagidipati, Juliana C Chan, Stephanie M Gustavson, Nayyar Iqbal, Aldo P Maggioni, Peter Öhman, Neil R Poulter, Ambady Ramachandran, Bernard Zinman, Adrian F Hernandez, Rury R Holman
BACKGROUND: Glucagon-like peptide-1 (GLP-1) receptor agonists are effective glucose-lowering drugs. Findings from cardiovascular outcome trials showed cardiovascular safety of GLP-1 receptor agonists, but results for cardiovascular efficacy were varied. We aimed to examine overall cardiovascular efficacy for lixisenatide, liraglutide, semaglutide, and extended-release exenatide. METHODS: In this systematic review and meta-analysis, we analysed data from eligible trials that assessed the safety and efficacy of GLP-1 receptor agonists compared with placebo in adult patients (aged 18 years or older) with type 2 diabetes and had a primary outcome including, but not limited to, cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke...
December 5, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29215189/dapagliflozin-as-add-on-therapy-in-asian-patients-with-type-2-diabetes-inadequately-controlled-on-insulin-%C3%A2-oral-antihyperglycemic-drugs-a-randomized-controlled-trial
#10
Wenying Yang, Jianhua Ma, Yiming Li, Yanbing Li, Zhiguang Zhou, Jae Hyeon Kim, June Zhao, Agata Ptaszynska
BACKGROUND: This 24-week, phase 3, double-blind, placebo-controlled study (NCT02096705) assessed the safety and efficacy of dapagliflozin as add-on to insulin ± oral antihyperglycemic drugs (OADs) in Asian patients with inadequately controlled type 2 diabetes. METHODS: Patients (adults; HbA1c ≥7.5-≤10.5%; body mass index ≤45 kg/m2 ; insulin dose ≥20 IU daily) were randomized to dapagliflozin 10 mg (N=139) or placebo (N=133) to assess the 24-week change in HbA1c (primary outcome), fasting plasma glucose (FPG), body weight, total daily dose of insulin (TDDI), and seated systolic blood pressure (SeSBP; exploratory outcome)...
December 7, 2017: Journal of Diabetes
https://www.readbyqxmd.com/read/29174310/gefitinib-versus-vinorelbine-plus-cisplatin-as-adjuvant-treatment-for-stage-ii-iiia-n1-n2-egfr-mutant-nsclc-adjuvant-ctong1104-a-randomised-open-label-phase-3-study
#11
Wen-Zhao Zhong, Qun Wang, Wei-Min Mao, Song-Tao Xu, Lin Wu, Yi Shen, Yong-Yu Liu, Chun Chen, Ying Cheng, Lin Xu, Jun Wang, Ke Fei, Xiao-Fei Li, Jian Li, Cheng Huang, Zhi-Dong Liu, Shun Xu, Ke-Neng Chen, Shi-Dong Xu, Lun-Xu Liu, Ping Yu, Bu-Hai Wang, Hai-Tao Ma, Hong-Hong Yan, Xue-Ning Yang, Qing Zhou, Yi-Long Wu
BACKGROUND: Cisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II-IIIA non-small-cell lung cancer (NSCLC). RADIANT and SELECT trial data suggest patients with EGFR-mutant stage IB-IIIA resected NSCLC could benefit from adjuvant EGFR tyrosine kinase inhibitor treatment. We aimed to compare the efficacy of adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected EGFR-mutant stage II-IIIA (N1-N2) NSCLC. METHODS: We did a randomised, open-label, phase 3 trial at 27 centres in China...
November 21, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29167839/early-life-exposure-to-indoor-air-pollution-or-tobacco-smoke-and-lower-respiratory-tract-illness-and-wheezing-in-african-infants-a-longitudinal-birth-cohort-study
#12
Aneesa Vanker, Whitney Barnett, Lesley Workman, Polite M Nduru, Peter D Sly, Robert P Gie, Heather J Zar
Background: Indoor air pollution (IAP) and environmental tobacco smoke (ETS) are associated with lower respiratory tract illness (LRTI) or wheezing in children. However, the effect of the timing of these exposures, specifically antenatal versus postnatal, and of alternate fuel sources such as the increasingly used volatile organic compounds have not been well studied. We longitudinally investigated the effect of antenatal or postnatal IAP and ETS on LRTI or wheezing prevalence and severity in African infants...
November 2017: Lancet. Planetary Health
https://www.readbyqxmd.com/read/29151359/osimertinib-in-untreated-egfr-mutated-advanced-non-small-cell-lung-cancer
#13
Jean-Charles Soria, Yuichiro Ohe, Johan Vansteenkiste, Thanyanan Reungwetwattana, Busyamas Chewaskulyong, Ki Hyeong Lee, Arunee Dechaphunkul, Fumio Imamura, Naoyuki Nogami, Takayasu Kurata, Isamu Okamoto, Caicun Zhou, Byoung Chul Cho, Ying Cheng, Eun Kyung Cho, Pei Jye Voon, David Planchard, Wu-Chou Su, Jhanelle E Gray, Siow-Ming Lee, Rachel Hodge, Marcelo Marotti, Yuri Rukazenkov, Suresh S Ramalingam
Background Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). Methods In this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion or L858R) advanced NSCLC in a 1:1 ratio to receive either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily)...
November 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29150410/lung-function-in-early-adulthood-and-health-in-later-life-a-transgenerational-cohort-analysis
#14
Alvar Agustí, Guillaume Noell, Josep Brugada, Rosa Faner
BACKGROUND: Early life events can affect health in later life. We hypothesised that low lung function (FEV1 <80% predicted) in early adulthood (25-40 years) is associated with higher prevalence and earlier incidence of respiratory, cardiovascular, and metabolic abnormalities, and premature death. METHODS: In this cohort analysis, we tested this hypothesis using data from the Framingham Offspring Cohort (FOC) and validated our observations in CARDIA (an independent cohort) and GenIII (which includes the direct descendants of FOC participants)...
November 14, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29149439/trends-in-utilization-of-outpatient-respiratory-syncytial-virus-prophylaxis-with-palivizumab-among-medicaid-and-commercially-insured-infants
#15
Melissa Pavilack, Robert A Clifford, Tara Gonzales, Amanda M Kong, Sally Wade, Kimmie K McLaurin
INTRODUCTION: Palivizumab is indicated for the prevention of respiratory syncytial virus (RSV) infection in high-risk children. Previous palivizumab utilization studies examined prior authorization claims but did not examine utilization within insured populations as a whole. This study describes outpatient palivizumab utilization trends and characterizes high-risk infants receiving palivizumab within Medicaid- and commercially insured populations. METHODS: Infants born July 1, 2003 through June 30, 2013 were identified in the MarketScan(®) Multistate Medicaid and Commercial claims databases...
November 17, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/29103871/olaparib-in-combination-with-paclitaxel-in-patients-with-advanced-gastric-cancer-who-have-progressed-following-first-line-therapy-gold-a-double-blind-randomised-placebo-controlled-phase-3-trial
#16
Yung-Jue Bang, Rui-Hua Xu, Keisho Chin, Keun-Wook Lee, Se Hoon Park, Sun Young Rha, Lin Shen, Shukui Qin, Nong Xu, Seock-Ah Im, Gershon Locker, Phil Rowe, Xiaojin Shi, Darren Hodgson, Yu-Zhen Liu, Narikazu Boku
BACKGROUND: Olaparib combined with paclitaxel has previously shown a significant improvement in overall survival versus placebo plus paclitaxel as second-line therapy in a phase 2 study in Asian patients with advanced gastric cancer, especially in those with ataxia-telangiectasia mutated protein (ATM)-negative tumours. Here, we report the primary efficacy and safety analyses from a subsequent phase 3 trial. METHODS: This double-blind, randomised, placebo-controlled, phase 3 study (GOLD) recruited Asian patients aged 18 years or older (≥20 years if Japanese) with advanced gastric cancer that had progressed following, or during, first-line chemotherapy...
November 2, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29083969/personalized-care-and-the-role-of-insulin-as-a-vehicle-to-optimizing-treatments-in-diabetes-care
#17
Nella Bieszk, Michael Grabner, Wenhui Wei, John Barron, Ralph Quimbo, Tingjian Yan, Beth Biel, James W Chu
BACKGROUND: In patients with type 2 diabetes (T2D) with poor glycemic control, there is an unmet need for treatment optimization involving the initiation and/or intensification of insulin therapy, which is often delayed because of clinical inertia. Educational initiatives that target patients and physicians might be one way to address this need. OBJECTIVE: To evaluate the effectiveness of educational materials mailed to physicians and their patients in affecting initiation of insulin therapy and other health care outcomes...
November 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29079252/effect-of-an-intensified-multifactorial-intervention-on-cardiovascular-outcomes-and-mortality-in-type-2-diabetes-j-doit3-an-open-label-randomised-controlled-trial
#18
Kohjiro Ueki, Takayoshi Sasako, Yukiko Okazaki, Masayuki Kato, Sumie Okahata, Hisayuki Katsuyama, Mikiko Haraguchi, Ai Morita, Ken Ohashi, Kazuo Hara, Atsushi Morise, Kazuo Izumi, Naoki Ishizuka, Yasuo Ohashi, Mitsuhiko Noda, Takashi Kadowaki
BACKGROUND: Limited evidence suggests that multifactorial interventions for control of glucose, blood pressure, and lipids reduce macrovascular complications and mortality in patients with type 2 diabetes. However, safe and effective treatment targets for these risk factors have not been determined for such interventions. METHODS: In this multicentre, open-label, randomised, parallel-group trial, undertaken at 81 clinical sites in Japan, we randomly assigned (1:1) patients with type 2 diabetes aged 45-69 years with hypertension, dyslipidaemia, or both, and an HbA1c of 6·9% (52·0 mmol/mol) or higher, to receive conventional therapy for glucose, blood pressure, and lipid control (targets: HbA1c <6·9% [52·0 mmol/mol], blood pressure <130/80 mm Hg, LDL cholesterol <120 mg/dL [or 100 mg/dL in patients with a history of coronary artery disease]) or intensive therapy (HbA1c <6·2% [44·3 mmol/mol], blood pressure <120/75 mm Hg, LDL cholesterol <80 mg/dL [or 70 mg/dL in patients with a history of coronary artery disease])...
December 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29056570/activity-and-safety-of-azd3759-in-egfr-mutant-non-small-cell-lung-cancer-with-cns-metastases-bloom-a-phase-1-open-label-dose-escalation-and-dose-expansion-study
#19
Myung-Ju Ahn, Dong-Wan Kim, Byoung Chul Cho, Sang-We Kim, Jong Seok Lee, Jin-Seok Ahn, Tae Min Kim, Chia-Chi Lin, Hye Ryun Kim, Thomas John, Steven Kao, Jonathan W Goldman, Wu-Chou Su, Ronald Natale, Sarit Rabbie, Bryony Harrop, Philip Overend, Zhenfan Yang, James Chih-Hsin Yang
BACKGROUND: CNS metastases-including brain and leptomeningeal metastases-from epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) are associated with poor prognosis. AZD3759 is a novel EGFR tyrosine kinase inhibitor with high capability to penetrate the blood-brain barrier. We aimed to assess the safety, tolerability, pharmacokinetics, and efficacy of AZD3759 in patients with EGFR-mutant NSCLC with brain and leptomeningeal metastases. METHODS: This open-label, multicentre, phase 1 study was undertaken at 11 centres and hospitals in Australia, South Korea, Taiwan, and the USA...
October 17, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29052971/diabetes-news
#20
Ann M Carracher, Payal H Marathe, Kelly L Close
More than 15,000 attendees from more than130 countries gathered in Lisbon, Portugal for the 2017 European Association for the Study of Diabetes annual meeting. Dr Adrian Hernandez (Duke University, Durham, NC, USA) presented outcomes data from AstraZeneca's (Cambridge, UK) cardiovascular outcomes trial of GLP-1 agonist Bydureon (exenatide once weekly), Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL).(1).
October 20, 2017: Journal of Diabetes
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