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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
#1
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
#2
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
#3
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...
June 1, 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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
https://www.readbyqxmd.com/read/28423301/risankizumab-versus-ustekinumab-for-moderate-to-severe-plaque-psoriasis
#15
RANDOMIZED CONTROLLED TRIAL
Kim A Papp, Andrew Blauvelt, Michael Bukhalo, Melinda Gooderham, James G Krueger, Jean-Philippe Lacour, Alan Menter, Sandra Philipp, Howard Sofen, Stephen Tyring, Beate R Berner, Sudha Visvanathan, Chandrasena Pamulapati, Nathan Bennett, Mary Flack, Paul Scholl, Steven J Padula
BACKGROUND: Interleukin-23 is thought to be critical to the pathogenesis of psoriasis. We compared risankizumab (BI 655066), a humanized IgG1 monoclonal antibody that inhibits interleukin-23 by specifically targeting the p19 subunit and thus prevents interleukin-23 signaling, and ustekinumab, an interleukin-12 and interleukin-23 inhibitor, in patients with moderate-to-severe plaque psoriasis. METHODS: We randomly assigned a total of 166 patients to receive subcutaneous injections of risankizumab (a single 18-mg dose at week 0 or 90-mg or 180-mg doses at weeks 0, 4, and 16) or ustekinumab (45 or 90 mg, according to body weight, at weeks 0, 4, and 16)...
April 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28411872/induction-therapy-with-the-selective-interleukin-23-inhibitor-risankizumab-in-patients-with-moderate-to-severe-crohn-s-disease-a-randomised-double-blind-placebo-controlled-phase-2-study
#16
Brian G Feagan, William J Sandborn, Geert D'Haens, Julián Panés, Arthur Kaser, Marc Ferrante, Edouard Louis, Denis Franchimont, Olivier Dewit, Ursula Seidler, Kyung-Jo Kim, Markus F Neurath, Stefan Schreiber, Paul Scholl, Chandrasena Pamulapati, Bojan Lalovic, Sudha Visvanathan, Steven J Padula, Ivona Herichova, Adina Soaita, David B Hall, Wulf O Böcher
BACKGROUND: The interleukin-23 pathway is implicated genetically and biologically in the pathogenesis of Crohn's disease. We aimed to assess the efficacy and safety of risankizumab (BI 655066, Boehringer Ingelheim, Ingelheim, Germany), a humanised monoclonal antibody targeting the p19 subunit of interleukin-23, in patients with moderately-to-severely active Crohn's disease. METHODS: In this randomised, double-blind, placebo-controlled phase 2 study, we enrolled patients at 36 referral sites in North America, Europe, and southeast Asia...
April 29, 2017: Lancet
https://www.readbyqxmd.com/read/28390725/comparison-of-a-commercially-available-oral-nutritional-supplement-and-intravenous-fluid-therapy-for-dehydration-in-dairy-calves
#17
Jared D Taylor, Merel Rodenburg, Timothy A Snider
Calf scours is a primary cause of morbidity and mortality in the dairy industry. Effective treatments are needed to minimize death, maximize welfare, and maintain growth and productivity. The objective of this trial was to compare the efficacy of a commercially available nutritional supplement (Diaque, Boehringer-Ingelheim Vetmedica Inc., St. Joseph, MO) and i.v. lactated Ringer's solution (LRS) in rehydrating, preventing acidemia, and correcting electrolyte imbalances in an experimental model for calf scours...
April 5, 2017: Journal of Dairy Science
https://www.readbyqxmd.com/read/28390695/achieved-blood-pressure-and-cardiovascular-outcomes-in-high-risk-patients-results-from-ontarget-and-transcend-trials
#18
Michael Böhm, Helmut Schumacher, Koon K Teo, Eva M Lonn, Felix Mahfoud, Johannes F E Mann, Giuseppe Mancia, Josep Redon, Roland E Schmieder, Karen Sliwa, Michael A Weber, Bryan Williams, Salim Yusuf
BACKGROUND: Studies have challenged the appropriateness of accepted blood pressure targets. We hypothesised that different levels of low blood pressure are associated with benefit for some, but harm for other outcomes. METHODS: In this analysis, we assessed the previously reported outcome data from high-risk patients aged 55 years or older with a history of cardiovascular disease, 70% of whom had hypertension, from the ONTARGET and TRANSCEND trials investigating ramipril, telmisartan, and their combination, with a median follow-up of 56 months...
June 3, 2017: Lancet
https://www.readbyqxmd.com/read/28388260/acute-exacerbation-and-decline-in-forced-vital-capacity-are-associated-with-increased-mortality-in-idiopathic-pulmonary-fibrosis
#19
Miya O Paterniti, Youwei Bi, Dinko Rekić, Yaning Wang, Banu A Karimi-Shah, Badrul A Chowdhury
RATIONALE: Exploration of forced vital capacity (FVC) as it relates to mortality in idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and ultimately fatal parenchymal lung disease, is important both clinically and to the current drug development paradigm. We evaluated the association between FVC decline and mortality in the largest, well-characterized placebo cohort to date. Additionally, we sought to explore the risk of death from acute exacerbations and further validate previously identified baseline predictors of mortality...
April 7, 2017: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/28361463/clinical-outcomes-of-patients-with-diabetes-who-exhibit-upper-quartile-insulin-antibody-responses-after-treatment-with-ly2963016-or-lantus-%C3%A2-insulin-glargine
#20
Liza L Ilag, Timothy M Costigan, Mark A Deeg, Robyn K Pollom, Curtis L Chang, Robert J Konrad, Melvin J Prince
INTRODUCTION: We compared insulin antibody response (IAR) profiles in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who received LY2963016 insulin glargine (LY IGlar) or Lantus(®) insulin glargine (IGlar) and evaluated the potential relationship between higher IARs and clinical and safety outcomes with a focus on patients who exhibited antibody responses in the upper quartile. METHODS: Data from ELEMENT-1 (52-week open-label in T1D) and ELEMENT-2 (24-week, double-blind study in T2D) were analyzed...
June 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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