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https://www.readbyqxmd.com/read/28423301/risankizumab-versus-ustekinumab-for-moderate-to-severe-plaque-psoriasis
#1
Kim A Papp, Andrew Blauvelt, Michael Bukhalo, Melinda Gooderham, James 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
#2
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 12, 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
#3
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
#4
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...
April 5, 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
#5
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
#6
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...
March 30, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28317415/uninterrupted-dabigatran-versus-warfarin-for-ablation-in-atrial-fibrillation
#7
Hugh Calkins, Stephan Willems, Edward P Gerstenfeld, Atul Verma, Richard Schilling, Stefan H Hohnloser, Ken Okumura, Harvey Serota, Matias Nordaby, Kelly Guiver, Branislav Biss, Marc A Brouwer, Massimo Grimaldi
Background Catheter ablation of atrial fibrillation is typically performed with uninterrupted anticoagulation with warfarin or interrupted non-vitamin K antagonist oral anticoagulant therapy. Uninterrupted anticoagulation with a non-vitamin K antagonist oral anticoagulant, such as dabigatran, may be safer; however, controlled data are lacking. We investigated the safety of uninterrupted dabigatran versus warfarin in patients undergoing ablation of atrial fibrillation. Methods In this randomized, open-label, multicenter, controlled trial with blinded adjudicated end-point assessments, we randomly assigned patients scheduled for catheter ablation of paroxysmal or persistent atrial fibrillation to receive either dabigatran (150 mg twice daily) or warfarin (target international normalized ratio, 2...
March 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28287348/survival-in-idiopathic-pulmonary-fibrosis-perspectives-from-pulmonary-arterial-hypertension
#8
Toby M Maher, Fred Dejonckheere, Steven D Nathan
Maher has received grants, consulting fees, and speaker fees from GlaxoSmithKline and UCB and grants from Novartis. He has also received consulting fees and speaker fees from AstraZeneca, Bayer, Biogen Idec, Boehringer Ingelheim, Cipla, Lanthio, InterMune International AG (a wholly owned Roche subsidiary since 2014), F. Hoffmann-La Roche, Sanofi-Aventis, and Takeda. Maher is supported by a National Institute for Health Research Clinician Scientist Fellowship (NIHR Ref: CS:-2013-13-017). Dejonckheere is an employee of F...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28287347/predicting-life-expectancy-for-pirfenidone-in-idiopathic-pulmonary-fibrosis
#9
Mark Fisher, Steven D Nathan, Christian Hill, Jade Marshall, Fred Dejonckheere, Per-Olof Thuresson, Toby M Maher
BACKGROUND: Conducting an adequately powered survival study in idiopathic pulmonary fibrosis (IPF) is challenging due to the rare nature of the disease and the need for extended follow-up. Consequently, registration trials of IPF treatments have not been designed to estimate long-term survival. OBJECTIVE: To predict life expectancy for patients with IPF receiving pirfenidone versus best supportive care (BSC) in a population that met the inclusion criteria of patients enrolled in the ASCEND and CAPACITY trials...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28279763/colon-targeted-delivery-of-solubilized-bisacodyl-by-doubly-enteric-coated-multiple-unit-tablet
#10
Hee J Park, Hyuck J Jung, Myoung J Ho, Dae R Lee, Ha R Cho, Yong S Choi, Joonho Jun, Miwon Son, Myung J Kang
A doubly enteric-coated multiple-unit tablet (DET) of bisacodyl (BD) was formulated to selectively deliver the stimulant laxative to the large intestine. Solubilized BD in surfactants was adsorbed into the porous carrier and primarily coated with different combinations of pH-sensitive polymers (Eudragit S and Eudragit L) and time-dependent release polymer (Eudragit RS). BD-loaded granules were compressed into tablets and coated again with pH-sensitive polymers (Eudragit S:Eudragit L=1:1). The multiple-unit tablet was optimized with respect to the granular coating compositions (Eudragit S:Eudragit L:Eudragit RS=5:1:4) and coating level (12...
March 6, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28230450/characteristics-and-medication-use-of-psoriasis-patients-who-may-or-may-not-qualify-for-randomized-controlled-trials
#11
William Malatestinic, Beth Nordstrom, Jashin J Wu, Orin Goldblum, Kathleen Solotkin, Chen-Yen Lin, Kristin Kistler, Kathy Fraeman, Joseph Johnston, Lcdr Lesley Hawley, Nicholas Sicignano, Andre Araujo
BACKGROUND: Clinical trials impose exclusion criteria that may limit the generalizability of results. OBJECTIVES: To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. METHODS: Moderate-to-severe psoriasis patients were identified from the U...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28230446/economic-impact-of-treatment-duration-and-persistence-with-basal-insulin-in-previously-insulin-naive-users
#12
Samaneh Kalirai, Ran Duan, Dongju Liu, Beverly L Reed
BACKGROUND: Although insulin is a well-established therapy that is associated with improved clinical outcomes, adherence and persistence with insulin regimens are poor in patients with type 2 diabetes mellitus (T2DM). Diabetes-related health care costs and the impact of insulin persistence patterns on these health care costs have been previously studied; however, these aspects of insulin therapy have limited data beyond the first year of use and have not been characterized among patients previously naive to basal insulin...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28212954/evaluation-of-copd-treatments-a-multicriteria-decision-analysis-of-aclidinium-and-tiotropium-in-the-united-states
#13
Kevin Marsh, Erica Zaiser, Panagiotis Orfanos, Suzanne Salverda, Teresa Wilcox, Shawn Sun, Shailja Dixit
BACKGROUND: Comparisons of the use of aclidinium bromide and tiotropium bromide for the treatment of chronic obstructive pulmonary disease often concentrate on key end points (exacerbations) at the expense of other benefits and risks. Multicriteria decision analysis (MCDA) can help overcome this by using stakeholder preferences to combine multiple end points into an overall value estimate. OBJECTIVES: To evaluate the use of aclidinium bromide twice daily via Pressair™ (AstraZeneca Pharmaceuticals LP, Wilmington, DE) and of tiotropium once daily via HandiHaler(®) (Boehringer Ingelheim Pharmaceuticals, Inc...
January 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28187920/holter-electrocardiogram-monitoring-in-patients-with-acute-ischaemic-stroke-find-afrandomised-an-open-label-randomised-controlled-trial
#14
Rolf Wachter, Klaus Gröschel, Götz Gelbrich, Gerhard F Hamann, Pawel Kermer, Jan Liman, Joachim Seegers, Katrin Wasser, Anna Schulte, Falko Jürries, Anna Messerschmid, Nico Behnke, Sonja Gröschel, Timo Uphaus, Anne Grings, Tugba Ibis, Sven Klimpe, Michaela Wagner-Heck, Magdalena Arnold, Evgeny Protsenko, Peter U Heuschmann, David Conen, Mark Weber-Krüger
BACKGROUND: Atrial fibrillation is a major risk factor for recurrent ischaemic stroke, but often remains undiagnosed in patients who have had an acute ischaemic stroke. Enhanced and prolonged Holter-electrocardiogram-monitoring might increase detection of atrial fibrillation. We therefore investigated whether enhanced and prolonged rhythm monitoring was better for detection of atrial fibrillation than standard care procedures in patients with acute ischaemic stroke. METHODS: Find-AFRANDOMISED is an open-label randomised study done at four centres in Germany...
February 8, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28105986/canagliflozin-dapagliflozin-and-empagliflozin-monotherapy-for-treating-type-2-diabetes-systematic-review-and-economic-evaluation
#15
Rhona Johnston, Olalekan Uthman, Ewen Cummins, Christine Clar, Pamela Royle, Jill Colquitt, Bee Kang Tan, Andrew Clegg, Saran Shantikumar, Rachel Court, J Paul O'Hare, David McGrane, Tim Holt, Norman Waugh
BACKGROUND: Most people with type 2 diabetes are overweight, so initial treatment is aimed at reducing weight and increasing physical activity. Even modest weight loss can improve control of blood glucose. If drug treatment is necessary, the drug of first choice is metformin. However, some people cannot tolerate metformin, which causes diarrhoea in about 10%, and it cannot be used in people with renal impairment. This review appraises three of the newest class of drugs for monotherapy when metformin cannot be used, the sodium-glucose co-transporter 2 (SGLT2) inhibitors...
January 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28035951/a-systematic-review-of-the-role-of-dysfunctional-wound-healing-in-the-pathogenesis-and-treatment-of-idiopathic-pulmonary-fibrosis
#16
REVIEW
Alan Betensley, Rabab Sharif, Dimitrios Karamichos
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive interstitial lung disorder showcasing an interaction between genetic predisposition and environmental risks. This usually involves the coaction of a mixture of cell types associated with abnormal wound healing, leading to structural distortion and loss of gas exchange function. IPF bears fatal prognosis due to respiratory failure, revealing a median survival of approximately 2 to 3 years. This review showcases the ongoing progress in understanding the complex pathophysiology of IPF and it highlights the latest potential clinical treatments...
December 26, 2016: Journal of Clinical Medicine
https://www.readbyqxmd.com/read/28031668/bilateral-superficial-femoral-artery-thrombosis-in-a-15-year-old-caucasian-male-with-homozygous-prothrombin-g20210a-genotype-and-associated-antiphospholipid-syndrome
#17
Uzung Yoon, LaiLai Kwok, Ingo Flessenkaemper
Prothrombin mutation was usually associated with other well-established predisposing factors for venous thrombosis such as antiphospholipid antibodies. Recently, even isolated prothrombin gene mutation G20210A has been reported to present severe or unusual vein thrombosis. Less clear is the role of prothrombin mutation in the formation of arterial thrombosis. We present a case of a 15-year-old healthy White male with acute bilateral femoral artery thrombosis. The patient presented with increasing left leg pain for about 1 week...
December 2016: International Journal of Angiology: Official Publication of the International College of Angiology, Inc
https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#18
(no author information available yet)
Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28007896/the-complete-structure-of-the-chloroplast-70s-ribosome-in-complex-with-translation-factor-py
#19
Philipp Bieri, Marc Leibundgut, Martin Saurer, Daniel Boehringer, Nenad Ban
Chloroplasts are cellular organelles of plants and algae that are responsible for energy conversion and carbon fixation by the photosynthetic reaction. As a consequence of their endosymbiotic origin, they still contain their own genome and the machinery for protein biosynthesis. Here, we present the atomic structure of the chloroplast 70S ribosome prepared from spinach leaves and resolved by cryo-EM at 3.4 Å resolution. The complete structure reveals the features of the 4.5S rRNA, which probably evolved by the fragmentation of the 23S rRNA, and all five plastid-specific ribosomal proteins...
December 22, 2016: EMBO Journal
https://www.readbyqxmd.com/read/27979881/an-update-on-the-gliptins
#20
REVIEW
(no author information available yet)
Progressive impairment of insulin secretion in people with type 2 diabetes leads to blood glucose concentrations worsening over time, often resulting in escalation of blood glucose lowering therapy.(1) In 2015/2016, more money was spent on dipeptidyl peptidase-4 (DPP-4) inhibitors ('gliptins') than on any other class of antidiabetic drug except for insulins.(2) In 2008, we reviewed sitagliptin and vildagliptin.(3) Here, we briefly review three other DPP-4 inhibitors, saxagliptin (Onglyza-AstraZeneca), linagliptin (Trajenta-Boehringer Ingelheim) and ▼alogliptin (Vipidia-Takeda), and consider data from recent cardiovascular outcomes studies...
December 2016: Drug and Therapeutics Bulletin
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