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https://www.readbyqxmd.com/read/28693366/idarucizumab-for-dabigatran-reversal-full-cohort-analysis
#1
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...
July 11, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28683309/the-complete-structure-of-the-mycobacterium-smegmatis-70s-ribosome
#2
Jendrik Hentschel, Chloe Burnside, Ingrid Mignot, Marc Leibundgut, Daniel Boehringer, Nenad Ban
The ribosome carries out the synthesis of proteins in every living cell. It consequently represents a frontline target in anti-microbial therapy. Tuberculosis ranks among the leading causes of death worldwide, due in large part to the combination of difficult-to-treat latency and antibiotic resistance. Here, we present the 3.3-Å cryo-EM structure of the 70S ribosome of Mycobacterium smegmatis, a close relative to the human pathogen Mycobacterium tuberculosis. The structure reveals two additional ribosomal proteins and localizes them to the vicinity of drug-target sites in both the catalytic center and the decoding site of the ribosome...
July 5, 2017: Cell Reports
https://www.readbyqxmd.com/read/28680960/efficacy-and-safety-results-of-the-afatinib-expanded-access-program
#3
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
#4
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
#5
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...
June 27, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28656944/a-comparative-pharmacokinetics-study-of-the-anti-parkinsonian-drug-pramipexole
#6
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
#7
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...
June 19, 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
#8
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/28579410/characterization-of-hormonal-profiles-during-the-luteal-phase-in-regularly-menstruating-women
#9
Rene Ecochard, Thomas Bouchard, Rene Leiva, Saman Abdulla, Olivier Dupuis, Olivia Duterque, Marie Garmier Billard, Hans Boehringer, Christophe Genolini
OBJECTIVE: To characterize the variability of hormonal profiles during the luteal phase in normal cycles. DESIGN: Observational study. SETTING: Not applicable. PATIENT(S): Ninety-nine women contributing 266 menstrual cycles. INTERVENTION(S): The women collected first morning urine samples that were analyzed for estrone-3-glucuronide, pregnanediol-3-alpha-glucuronide (PDG), FSH, and LH. The women had serum P tests (twice per cycle) and underwent ultrasonography to identify the day of ovulation...
July 2017: Fertility and Sterility
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
#10
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
#11
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
#12
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...
May 23, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28530527/health-care-costs-associated-with-addition-titration-and-switching-antihypertensive-medications-after-first-line-treatment-results-from-a-commercially-insured-sample
#13
Kalyani B Sonawane Deshmukh, Jingjing Qian, Kimberly B Garza, Bradley M Wright, Peng Zeng, Cecilia M Ganduglia Cazaban, Richard A Hansen
BACKGROUND: Treatment modifications are necessary for addressing issues related to efficacy and tolerance of first-line monotherapy, but they increase the economic burden on patients and their health plans. Understanding the differences in costs between alternative treatment modification strategies, if any, can serve as a guideline for clinical decision making and for designing cost-containment strategies. OBJECTIVE: To compare the health care utilization costs between (a) addition (i...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28524878/structure-of-the-quaternary-complex-between-srp-sr-and-translocon-bound-to-the-translating-ribosome
#14
Ahmad Jomaa, Yu-Hsien Hwang Fu, Daniel Boehringer, Marc Leibundgut, Shu-Ou Shan, Nenad Ban
During co-translational protein targeting, the signal recognition particle (SRP) binds to the translating ribosome displaying the signal sequence to deliver it to the SRP receptor (SR) on the membrane, where the signal peptide is transferred to the translocon. Using electron cryo-microscopy, we have determined the structure of a quaternary complex of the translating Escherichia coli ribosome, the SRP-SR in the 'activated' state and the translocon. Our structure, supported by biochemical experiments, reveals that the SRP RNA adopts a kinked and untwisted conformation to allow repositioning of the 'activated' SRP-SR complex on the ribosome...
May 19, 2017: Nature Communications
https://www.readbyqxmd.com/read/28521061/extracellular-camp-activates-molecular-signalling-pathways-associated-with-sperm-capacitation-in-bovines
#15
Carlos Agustín I Alonso, Claudia E Osycka-Salut, Luciana Castellano, Andreína Cesari, Nicolás Di Siervi, Adrián Mutto, Anders Johannisson, Jane M Morrell, Carlos Davio, Silvina Perez-Martinez
STUDY QUESTION: Is extracellular cAMP involved in the regulation of signalling pathways in bovine sperm capacitation? SUMMARY ANSWER: Extracellular cAMP-induced sperm capacitation through the activation of different signalling pathways that involve phospholipase C (PLC), PKC/ERK1-2 signalling and an increase in sperm Ca2+ levels, as well as soluble AC and cAMP/protein kinase A (PKA) signalling. WHAT IS KNOWN ALREADY: In order to fertilize the oocyte, ejaculated spermatozoa must undergo a series of changes in the female reproductive tract, known as capacitation...
May 18, 2017: Molecular Human Reproduction
https://www.readbyqxmd.com/read/28485203/expert-panel-recommendations-for-the-identification-and-management-of-hyperkalemia-and-role-of-patiromer-in-patients-with-chronic-kidney-disease-and-heart-failure
#16
Zubaid Rafique, Matthew R Weir, Macaulay Onuigbo, Bertram Pitt, Richard Lafayette, Javed Butler, Maria Lopes, Carolyn Farnum, W Frank Peacock
Virtual panel meetings were conducted among 7 physicians, all of whom are independent experts, including 3 nephrologists, 2 cardiologists, and 2 emergency medicine physicians (the panel). The panel met with the purpose of discussing the current treatment landscape, treatment challenges, economic impact, and gaps in care for patients with hyperkalemia that is associated with heart failure and chronic kidney disease. The stated goal of the panel discussion was to develop practical solutions in the identification and management of hyperkalemia in this patient population...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28476049/corneal-k-values-as-a-diagnostic-screening-tool-for-marfan-syndrome
#17
Jan Luebke, Daniel Boehringer, Philipp Eberwein, Thomas Reinhard
PURPOSE: Marfan syndrome (MFS) is diagnosed based on Ghent nosology, including major and minor criteria such as increased axial length (AXL) and flattened corneal curvature (higher K-values) or myopia of more than -3 diopters (D) in its latest revision. Because corneal flattening may, in part, be caused by AXL increase, it may be helpful to consider K-values separately. We present statistical evaluation of using corneal K-values for identifying MFS. METHODS: A retrospective study of K-values of 74 right eyes of 74 patients with MFS, who were compared with an age- and AXL-matched group of 74 right eyes of 74 patients without MFS...
June 2017: Cornea
https://www.readbyqxmd.com/read/28472661/chronic-loss-of-ca2-transmission-leads-to-hippocampal-hyperexcitability
#18
Roman Boehringer, Denis Polygalov, Arthur J Y Huang, Steven J Middleton, Vincent Robert, Marie E Wintzer, Rebecca A Piskorowski, Vivien Chevaleyre, Thomas J McHugh
Hippocampal CA2 pyramidal cells project into both the neighboring CA1 and CA3 subfields, leaving them well positioned to influence network physiology and information processing for memory and space. While recent work has suggested unique roles for CA2, including encoding position during immobility and generating ripple oscillations, an interventional examination of the integrative functions of these connections has yet to be reported. Here we demonstrate that CA2 recruits feedforward inhibition in CA3 and that chronic genetically engineered shutdown of CA2-pyramidal-cell synaptic transmission consequently results in increased excitability of the recurrent CA3 network...
May 3, 2017: Neuron
https://www.readbyqxmd.com/read/28449695/intermediate-uveitis-pattern-of-etiology-complications-treatment-and-outcome-in-a-tertiary-academic-center
#19
Thomas Ness, Daniel Boehringer, Sonja Heinzelmann
BACKGROUND: Patients with intermediate uveitis (IU) represent a heterogenous group characterized by a wide spectrum of etiologies and regional differences. Aim of the study was to analyze the characteristics of patients with IU examined in an academic center in Germany. METHODS: We conducted a retrospective analysis of the clinical records of all patients with intermediate uveitis referred to the Eye Center, University of Freiburg from 2007 to 2014. Diagnosis followed the Standardization in Uveitis Nomenclature (SUN) criteria...
April 27, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/28448778/economic-impact-of-above-label-dosing-with-etanercept-adalimumab-or-ustekinumab-in-patients-with-psoriasis
#20
Steven R Feldman, Yang Zhao, Huanxue Zhou, Vivian Herrera, Haijun Tian, Yunfeng Li
BACKGROUND: Patients with moderate-to-severe psoriasis may be treated with above-label doses of biologics in an attempt to optimize outcomes. Dose escalation will have an effect on the cost of treatment. OBJECTIVE: To examine costs related to above-label use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: A retrospective study was performed using a large U.S. claims database. Patients were included in the study if they were aged ≥ 18 years with a diagnosis of psoriasis (excluding psoriatic arthritis) and had at least 1 medication fill for etanercept, adalimumab, or ustekinumab between January 1, 2011, and June 30, 2012...
May 2017: Journal of Managed Care & Specialty Pharmacy
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