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https://www.readbyqxmd.com/read/28905245/identification-of-polymorphic-forms-of-active-pharmaceutical-ingredient-in-low-concentration-dry-powder-formulations-by-synchrotron-x-ray-powder-diffraction
#1
Kenji Egusa, Fumiaki Okazaki, Joerg Schiewe, Ulrike Werthmann, Markus Wolkenhauer
BACKGROUND: The identification of different (pseudo) polymorphs of an active pharmaceutical ingredient in dry powder formulations is of importance during development and entire product lifecycle, e.g., quality control. Whereas determination of polymorphic differences of pure substances is rather easy, in dry powder formulations, it is generally difficult and the difficulties increase particularly, if the substance of interest is present only in low concentrations in the formulation. Such a formulation is SpirivaR inhalation powder (Boehringer Ingelheim), which contains only 0...
September 13, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28877027/tiotropium-in-early-stage-chronic-obstructive-pulmonary-disease
#2
Yumin Zhou, Nan-Shan Zhong, Xiaochen Li, Shuyun Chen, Jinping Zheng, Dongxing Zhao, Weimin Yao, Rongchang Zhi, Liping Wei, Bingwen He, Xiangyan Zhang, Changli Yang, Ying Li, Fenglei Li, Juan Du, Jianping Gui, Bin Hu, Chunxue Bai, Ping Huang, Gang Chen, Yongjian Xu, Changzheng Wang, Biao Liang, Yinhuan Li, Guoping Hu, Hui Tan, Xianwei Ye, Xitao Ma, Yan Chen, Xiwei Hu, Jia Tian, Xiaodan Zhu, Zhe Shi, Xiufang Du, Minjing Li, Shengming Liu, Ronghuan Yu, Jianping Zhao, Qianli Ma, Canmao Xie, Xiongbin Li, Tao Chen, Yingxiang Lin, Lizhen Zeng, Changxiu Ye, Weishu Ye, Xiangwen Luo, Lingshan Zeng, Shuqing Yu, Wei-Jie Guan, Pixin Ran
BACKGROUND: Patients with mild or moderate chronic obstructive pulmonary disease (COPD) rarely receive medications, because they have few symptoms. We hypothesized that long-term use of tiotropium would improve lung function and ameliorate the decline in lung function in patients with mild or moderate COPD. METHODS: In a multicenter, randomized, double-blind, placebo-controlled trial that was conducted in China, we randomly assigned 841 patients with COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 1 (mild) or 2 (moderate) severity to receive a once-daily inhaled dose (18 μg) of tiotropium (419 patients) or matching placebo (422) for 2 years...
September 7, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28865211/evaluation-of-in-feed-larch-sawdust-anti-inflammatory-effect-in-sows
#3
E D Tzika, P D Tassis, V G Papatsiros, E M Pferschy-Wenzig, A Siochu, R Bauer, C Alexopoulos, S C Kyriakis, C Franz
The study aimed to investigate the possible anti-inflammatory activity of larch sawdust as feed supplement in lactating sows' diet and its possible effect on the prevalence of Postpartum Dysgalactia Syndrome under field conditions. In a Greek farrow-to-finish pig farm, fifteen sows were randomly and equally allocated to a negative control group (NC group), a positive control group (PC group), and a treatment group (LT group). The animals of the first two groups received 99% basic diet and 1% corn starch, while LT group animals received 99% basic diet and 1% larch sawdust...
March 1, 2017: Polish Journal of Veterinary Sciences
https://www.readbyqxmd.com/read/28859942/a-multifaceted-intervention-to-improve-treatment-with-oral-anticoagulants-in-atrial-fibrillation-impact-af-an-international-cluster-randomised-trial
#4
Dragos Vinereanu, Renato D Lopes, M Cecilia Bahit, Denis Xavier, Jie Jiang, Hussein R Al-Khalidi, Wensheng He, Ying Xian, Andrea O Ciobanu, Deepak Y Kamath, Kathleen A Fox, Meena P Rao, Sean D Pokorney, Otavio Berwanger, Carlos Tajer, Pedro G M de Barros E Silva, Mayme L Roettig, Yong Huo, Christopher B Granger
BACKGROUND: Oral anticoagulation is underused in patients with atrial fibrillation. We assessed the impact of a multifaceted educational intervention, versus usual care, on oral anticoagulant use in patients with atrial fibrillation. METHODS: This study was a two-arm, prospective, international, cluster-randomised, controlled trial. Patients were included who had atrial fibrillation and an indication for oral anticoagulation. Clusters were randomised (1:1) to receive a quality improvement educational intervention (intervention group) or usual care (control group)...
August 25, 2017: Lancet
https://www.readbyqxmd.com/read/28844193/dual-antithrombotic-therapy-with-dabigatran-after-pci-in-atrial-fibrillation
#5
Christopher P Cannon, Deepak L Bhatt, Jonas Oldgren, Gregory Y H Lip, Stephen G Ellis, Takeshi Kimura, Michael Maeng, Bela Merkely, Uwe Zeymer, Savion Gropper, Matias Nordaby, Eva Kleine, Ruth Harper, Jenny Manassie, James L Januzzi, Jurrien M Ten Berg, P Gabriel Steg, Stefan H Hohnloser
Background Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding. Methods In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups)...
August 27, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28819835/efficacy-and-safety-of-linagliptin-in-2681-asian-patients-stratified-by-age-obesity-and-renal-function-a-pooled-analysis-of-randomized-clinical-trials
#6
Guang Ning, Tushar Bandgar, Uwe Hehnke, Jisoo Lee, Juliana C N Chan
INTRODUCTION: Asian patients with type 2 diabetes (T2D) are younger, leaner, and more likely to develop renal dysfunction than White populations. In this multiethnic analysis of data from phase 3 trials, we investigated the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in Asians stratified by these subphenotypes. METHODS: Data from randomized, double-blind, placebo-controlled trials evaluating linagliptin (as monotherapy, add-on therapy to metformin ± sulfonylurea, combined with pioglitazone or added to insulin) were pooled with efficacy data from 11 randomized trials of at least 24 weeks and safety data from 15 trials of various durations...
August 17, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28801654/perceptions-of-asthma-control-in-the-united-kingdom-a-cross-sectional-study-comparing-patient-and-healthcare-professionals-perceptions-of-asthma-control-with-validated-act-scores
#7
Andrew Menzies-Gow, Gavin Chiu
Perceptions of asthma control often vary between patients and physicians. This cross-sectional survey provided UK-specific data on actual and perceived asthma control in patients (18-75 years) attending routine asthma reviews in primary, secondary and tertiary settings. Differences between healthcare professionals' (HCP) and patients' perceptions of asthma control were evaluated via an online questionnaire and compared to a control-the validated asthma control test (ACT)-which patients completed. Treated patients (at least a short acting ß-agonist) with a documented diagnosis of asthma were enroled and consented within a month of their last appointment...
August 11, 2017: NPJ Primary Care Respiratory Medicine
https://www.readbyqxmd.com/read/28792217/kinase-crystal-miner-a-powerful-approach-to-repurposing-3d-hinge-binding-fragments-and-its-application-to-finding-novel-bruton-tyrosine-kinase-inhibitors
#8
Prasenjit Mukherjee, Jörg Bentzien, Todd Bosanac, Wang Mao, Michael Burke, Ingo Muegge
Protein kinases represent an important target class for drug discovery because of their role in signaling pathways involved in disease areas such as oncology and immunology. A key element of many ATP-competitive kinase inhibitors is their hinge-binding motif. Here, we describe Kinase Crystal Miner (KCM)-a new approach developed at Boehringer Ingelheim (BI) that harvests the existing crystallographic information on kinase-inhibitor co-crystal structures from internal and external databases. About 1000 unique three-dimensional kinase inhibitor hinge binding motifs have been extracted from structures covering more than 180 different protein kinases...
August 28, 2017: Journal of Chemical Information and Modeling
https://www.readbyqxmd.com/read/28772332/-expert-knowledge-and-supporting-advice-for-the-clinical-use-of-nintedanib-in-patients-with-idiopathic-pulmonary-fibrosis
#9
J Behr, A Günther, M Kreuter, D Koschel, A Prasse, M Pfeifer, U Costabel
In October 2016, a group of German IPF experts were invited by Boehringer Ingelheim to meet in Frankfurt with the aim, (a) to discuss relevant aspects of the management and treatment of idiopathic pulmonary fibrosis (IPF) using nintedanib; and, (b) to provide supportive advice for daily clinical practice with nintedanib. The resulting information compiled in this document is confined to practical issues regarding the use of nintedanib in patients with IPF. Where different therapeutic options were available, the choice of IPF medication was not discussed and the experts alluded to current guidelines for the diagnosis and treatment of IPF...
September 2017: Pneumologie
https://www.readbyqxmd.com/read/28752507/intravenous-alteplase-for-acute-ischemic-stroke-in-taiwan-can-we-expand-the-national-health-insurance-s-reimbursement-criteria
#10
Cheng-Yang Hsieh
lization of intravenous thrombolysis with alteplase was very low in Taiwanese patients with acute ischemic stroke(1). One of the reasons is the strict reimbursement guideline made by the Bureau of National Health Insurance (NHI) in 2004(2). In this issue of the Acta Neurologica Taiwanica, Yu-Hsiang Su and co-authors(3) retrospectively evaluated outcomes of their thrombolysed stroke patients who were "mismatched" between updated clinical practice guideline and NHI reimbursement criteria. They concluded that the outcomes of patients treated according to guidelines were comparable between the reimbursement and non-reimbursement groups...
March 15, 2017: Acta Neurologica Taiwanica
https://www.readbyqxmd.com/read/28693366/idarucizumab-for-dabigatran-reversal-full-cohort-analysis
#11
MULTICENTER STUDY
Charles V Pollack, Paul A Reilly, Joanne van Ryn, John W Eikelboom, Stephan Glund, Richard A Bernstein, Robert Dubiel, Menno V Huisman, Elaine M Hylek, Chak-Wah Kam, Pieter W Kamphuisen, Jörg Kreuzer, Jerrold H Levy, Gordon Royle, Frank W Sellke, Joachim Stangier, Thorsten Steiner, Peter Verhamme, Bushi Wang, Laura Young, Jeffrey I Weitz
BACKGROUND: Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran. METHODS: We performed a multicenter, prospective, open-label study to determine whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding (group A) or were about to undergo an urgent procedure (group B). The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the diluted thrombin time or ecarin clotting time...
August 3, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28680960/efficacy-and-safety-results-of-the-afatinib-expanded-access-program
#12
Edward S Kim, Balazs Halmos, Ingrid F Kohut, Taral Patel, Regan D Rostorfer, Alexander I Spira, Agnieszka Cseh, John McKay, Gudrun Wallenstein, Kathryn F Mileham
INTRODUCTION: Afatinib is an oral, irreversible ErbB family blocker approved for first-line treatment of metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The expanded access program (EAP) allowed early access to afatinib and provided additional data on its safety, tolerability, and efficacy. METHODS: The afatinib EAP was an open-label, multicenter, single-arm program in the United States that treated and followed patients with locally advanced or metastatic NSCLC harboring EGFR mutations...
2017: Oncology and Therapy
https://www.readbyqxmd.com/read/28668987/a-case-of-fatal-idiosyncratic-reaction-to-the-designer-drug-3-4-methylenedioxypyrovalerone-mdpv-and-review-of-the-literature
#13
Brigitte Desharnais, Yann Dazé, Laura M Huppertz, Pascal Mireault, Cameron D Skinner
The stimulant designer drug 3,4-methylenedioxypyrovalerone (MDPV) was first synthesized by Boehringer Ingelheim in 1969 and introduced on the black market in 2006. Only a small number of fatal intoxication cases have been reported in the literature, all with significant blood MDPV concentrations. In this report, we describe one fatality attributed to an idiosyncratic reaction to MDPV. The victim displayed agitation, violent behavior and delirium followed by cardiac arrest. Hyperthermia was observed at the hospital...
July 1, 2017: Forensic Science, Medicine, and Pathology
https://www.readbyqxmd.com/read/28666775/effects-of-empagliflozin-on-the-urinary-albumin-to-creatinine-ratio-in-patients-with-type-2-diabetes-and-established-cardiovascular-disease-an-exploratory-analysis-from-the-empa-reg-outcome-randomised-placebo-controlled-trial
#14
David Z I Cherney, Bernard Zinman, Silvio E Inzucchi, Audrey Koitka-Weber, Michaela Mattheus, Maximilian von Eynatten, Christoph Wanner
BACKGROUND: In a pooled analysis of short-term trials, short-term treatment with the sodium-glucose co-transporter-2 (SGLT2) inhibitor empagliflozin reduced albuminuria in patients with type 2 diabetes and prevalent albuminuria. In this exploratory analysis of the EMPA-REG OUTCOME trial, we report the short-term and long-term effects of empagliflozin on albuminuria in patients with type 2 diabetes and established cardiovascular disease, according to patients' baseline albuminuria status...
August 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28656944/a-comparative-pharmacokinetics-study-of-the-anti-parkinsonian-drug-pramipexole
#15
Ratih S I Putri, Effi Setiawati, Syifa A Aziswan, Fenny Ong, Raymond R Tjandrawinata, Liana W Susanto
The present study aimed to compare pharmacokinetic parameters of two pramipexole 0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized, open-label, two-period, two-sequence, and crossover design, involving 23 healthy volunteers. One of the 0.25 mg formulations of pramipexole evaluated in the study was manufactured by PT Dexa Medica, Palembang, Indonesia, the other, used as the reference, by Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. All eligible subjects were required to fast before each drug administration period, which was separated by a one-week washout period...
November 18, 2016: Scientia Pharmaceutica
https://www.readbyqxmd.com/read/28631216/safety-and-tolerability-of-empagliflozin-in-patients-with-type-2-diabetes-pooled-analysis-of-phase-i-iii-clinical-trials
#16
Sven Kohler, Cordula Zeller, Hristo Iliev, Stefan Kaspers
INTRODUCTION: We characterized the safety and tolerability of empagliflozin in patients with type 2 diabetes (T2DM) randomized 1:1:1 to placebo, empagliflozin 10 mg, or empagliflozin 25 mg in clinical trials. METHODS: Pooled data were analyzed from patients with T2DM treated with placebo (N = 4203), empagliflozin 10 mg (N = 4221), or empagliflozin 25 mg (N = 4196) in 15 randomized phase I-III trials plus four extension studies. Adverse events (AEs) were assessed descriptively in participants who took at least one dose of study drug...
July 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28610629/the-use-of-imepitoin-pexion%C3%A2-on-fear-and-anxiety-related-problems-in-dogs-a-case-series
#17
Kevin J McPeake, Daniel S Mills
BACKGROUND: Fear and anxiety based problems are common in dogs. Alongside behaviour modification programmes, a range of psychopharmacological agents may be recommended to treat such problems, but few are licensed for use in dogs and the onset of action of some can be delayed. The low affinity partial benzodiazepine receptor agonist imepitoin (Pexion™, Boehringer Ingelheim) is licensed for treating canine epilepsy, has a fast onset of action in dogs and has demonstrated anxiolytic properties in rodent models...
June 13, 2017: BMC Veterinary Research
https://www.readbyqxmd.com/read/28576343/economic-assessment-of-ostertagia-ostertagi-and-fasciola-hepatica-infections-in-dairy-cattle-herds-in-germany-using-paracalc-%C3%A2
#18
Jane Fanke, Johannes Charlier, Torsten Steppin, Georg von Samson-Himmelstjerna, Jozef Vercruysse, Janina Demeler
The aim of the current study was to estimate economic costs of Ostertagia ostertagi and Fasciola hepatica infections in dairy cattle herds in Germany using the online calculation programme Paracalc(®). Following a questionnaire, survey data were available from 464 farms in 14 federal states. On those farms bulk tank milk (BTM) samples and additionally up to six serum samples collected from first season grazing calves were analysed, using a commercially available ELISA (Boehringer Ingelheim SVANOVA Biotech AB, Uppsala, Sweden), an in-house ELISA (F...
June 15, 2017: Veterinary Parasitology
https://www.readbyqxmd.com/read/28560037/instant-velocity-and-consistency-of-emitted-cloud-change-by-the-different-levels-of-canister-filling-with-metered-dose-inhalers-mdis-but-not-with-soft-mist-inhalers-smis-a%C3%A2-bench-study
#19
Roberto W Dal Negro, Pietro Longo, Orestepaolo Villanis Ziani, Luca Bonadiman, Paola Turco
BACKGROUND: Inhalation is the preferred route for respiratory drug delivery, but several factors contribute to the variability of the respirable dose fraction. Instant velocity and the dynamic characteristics of the droplet cloud represent crucial factors. Aim was to measure and compare the instant velocity and the consistency of emitted cloud from five different MDIs (A - Salbutamol sulphate 100mcg, GSK; B - Salbutamol sulphate 100mcg, Valeas; C - Salmeterol xinafoate/Fluticasone propionate 25/125mcg, GSK; D - Formoterol fumarate/Bechlomethasone propionate 6/100mcg, Chiesi; E - Formoterol fumarate/Fluticasone dipropionate 5/125mcg, Mundipharma) and one SMI (Tiotropium bromide 5mcg, Boehringer Ingelheim), at different distance from the nozzle and canister filling...
2017: Multidisciplinary Respiratory Medicine
https://www.readbyqxmd.com/read/28537001/study-design-of-vesuto-%C3%A2-efficacy-of-tiotropium-olodaterol-on-lung-hyperinflation-exercise-capacity-and-physical-activity-in-japanese-patients-with-chronic-obstructive-pulmonary-disease
#20
Masakazu Ichinose, Yoshiaki Minakata, Takashi Motegi, Jun Ueki, Tetsuo Seki, Tatsuhiko Anzai, Ayako Takizawa, Lars Grönke, Kazuto Hirata
INTRODUCTION: The superiority of tiotropium/olodaterol is demonstrated in improvement of lung function, dyspnea, lung hyperinflation, and quality of life compared with either monotherapy in patients with chronic obstructive pulmonary disease (COPD). Japanese Respiratory Society Guidelines for COPD management include improvement of exercise tolerance and daily physical activity as the treatment goals; however, there is limited evidence in Japanese patients with COPD. METHODS: A protocol is developed for the VESUTO(®) study that investigates the efficacy of tiotropium/olodaterol fixed-dose combination (FDC) compared with tiotropium alone on inspiratory capacity (IC, volume from functional residual capacity to total lung capacity), exercise capacity, and daily physical activity in Japanese patients with COPD...
July 2017: Advances in Therapy
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