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https://www.readbyqxmd.com/read/28820359/clinical-outcomes-of-direct-oral-anticoagulants-after-lower-extremity-arterial-procedures
#1
Afsha Aurshina, Pavel Kibrik, Justin Eisenberg, Ahmad Alsheekh, Anil Hingorani, Natalie Marks, Enrico Ascher
Objectives The use of postoperative anticoagulation is not uncommon for patients undergoing lower extremity arterial procedures as adjunctive therapy. Longer postoperative length of stay is necessary to achieve adequate therapeutic international normalized ratio with traditional protocols that call for the use of unfractionated heparin and warfarin therapy. We hypothesized the direct oral anticoagulants are an attractive alternative to provide adequate anticoagulation in patients who undergo lower extremity arterial procedures...
January 1, 2017: Vascular
https://www.readbyqxmd.com/read/28819932/twice-daily-vs-once-daily-dosing-with-0-075-bromfenac-in-durasite-outcomes-from-a-14-day-phase-2-study
#2
William Trattler, Kamran Hosseini
INTRODUCTION: Bromfenac is a well-known topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) that is commercialized in the USA and other regions of the world. A new formulation, 0.075% bromfenac in DuraSite®, was developed to treat postoperative inflammation and reduce pain in patients who have undergone cataract surgery. We hypothesized that efficacy and safety would be enhanced with twice-daily (BID) dosing compared to once-daily (QD) dosing. METHODS: This was a multicenter, double-masked, comparative study in which 40 and 45 subjects were randomized to groups receiving BID dosing and QD dosing, respectively...
August 17, 2017: Ophthalmology and Therapy
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
#3
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/28819782/the-effects-of-%C3%AE-d-mannuronic-acid-m2000-as-a-novel-nsaid-on-cox1-and-cox2-activities-and-gene-expression-in-ankylosing-spondylitis-patients-and-the-murine-monocyte-macrophage-j774-cell-line
#4
Fahimeh Jafarnezhad-Ansariha, Mir Saeed Yekaninejad, Ahmad-Reza Jamshidi, Reza Mansouri, Mahdi Vojdanian, Mahdi Mahmoudi, Mohammad Javad Fattahi, Seyed Naser Hashemi, Bernd H A Rehm, Hidenori Matsuo, Emanuela Esposito, Salvatore Cuzzocrea, Abbas Mirshafiey
Ankylosing spondylitis (AS) is a debilitating chronic inflammatory disease with genetic predisposition, which is characterized by the involvement of spine and sacroiliac joints. Due to the relatively unsuccessful treatments, we designed β-D-mannuronic (M2000) with the beneficial effects in various experimental models as a novel non-steroidal anti-inflammatory drug (NSAID). The aims of our present study were: first, to compare the therapeutic effects of M2000, as a novel designed NSAID, with naproxen and placebo in Iranian patients with AS during 12 weeks; second, to evaluate the effect of M2000 on gene expression of cyclooxygenase enzyme (COX-1/COX-2), a key enzyme in the initiation of inflammatory pathways in AS patients; and third, to assess the activity of COX-1 and COX-2 enzymes in the presence/absence of M2000 at the different doses in the murine macrophage, J774 cell line...
August 17, 2017: Inflammopharmacology
https://www.readbyqxmd.com/read/28819477/evaluation-of-the-adverse-drug-reaction-surveillance-system-kadoma-city-zimbabwe-2015
#5
Caroline Muringazuva, Daniel Chirundu, More Mungati, Gerald Shambira, Notion Gombe, Donewell Bangure, Tsitsi Juru, Mufuta Tshimanga
INTRODUCTION: Medicines have the potential to cause adverse drug reactions and because of this Zimbabwe monitor reactions to medicines through the Adverse Drug Reaction Surveillance System. The Medicines Control Authority of Zimbabwe monitors reactions to medicines through the Adverse Drugs Reactions Surveillance System. The system relies on health professionals to report adverse drug reactions to maximize patient safety. We report results of an evaluation of the Adverse Drugs Reactions Surveillance System in Kadoma District...
2017: Pan African Medical Journal
https://www.readbyqxmd.com/read/28818882/neuropsychiatric-adverse-drug-reactions-in-children-initiated-on-montelukast-in-real-life-practice
#6
Brigitte Benard, Valérie Bastien, Benjamin Vinet, Roger Yang, Maja Krajinovic, Francine M Ducharme
Although montelukast is generally well tolerated, postmarketing studies have reported serious neuropsychiatric adverse drug reactions (ADRs) leading to a United States Food and Drug Administration black box warning. The objective of this study was to determine the incidence of neuropsychiatric ADRs leading to discontinuation of montelukast in asthmatic children.We conducted a retrospective cohort study in children aged 1-17 years initiated on montelukast. In a nested cohort study, children initiated on montelukast as monotherapy or adjunct therapy to inhaled corticosteroids (ICS) were matched to those initiated on ICS monotherapy...
August 2017: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/28818559/-to-boldly-go-where-no-one-has-gone-before
#7
Keith W Kelley
Americans are suffering from a culture of taking pills. Six out of ten Americans utilize at least one prescription drug, and more than one in ten use five or more prescription medicines. Although this torrent of taking pills is already high, drug use in the USA has not yet crested. Prescription drugs have specific targets, but often they adversely affect other tissues and organs. In keeping with the mission of the recently named National Center for Complementary and Integrative Health (NCCIH), Brain, Behavior, and Immunity searches for the underlying cause and potential efficacy of both drug and non-drug interventions...
August 14, 2017: Brain, Behavior, and Immunity
https://www.readbyqxmd.com/read/28818558/current-and-emerging-pharmacotherapies-for-obesity-in-australia
#8
REVIEW
Samantha Hocking, Anthony Dear, Michael A Cowley
BACKGROUND: Obesity is a major issue in Australia and globally. Many individuals struggle to maintain weight loss with lifestyle modification, and adjunctive pharmacotherapy may help. Historically, there have been limited pharmacotherapies for managing obesity. In addition, previous treatments such as phentermine-fenfluramine, rimonabant and sibutramine were withdrawn due to safety issues, resulting in lingering safety concerns. METHODS: This is a narrative review of published data examining four new pharmacotherapy options for weight management in Australia...
August 14, 2017: Obesity Research & Clinical Practice
https://www.readbyqxmd.com/read/28818546/glecaprevir-plus-pibrentasvir-for-chronic-hepatitis-c-virus-genotype-1-2-4-5-or-6-infection-in-adults-with-compensated-cirrhosis-expedition-1-a-single-arm-open-label-multicentre-phase-3-trial
#9
Xavier Forns, Samuel S Lee, Joaquin Valdes, Sabela Lens, Reem Ghalib, Humberto Aguilar, Franco Felizarta, Tarek Hassanein, Holger Hinrichsen, Diego Rincon, Rosa Morillas, Stefan Zeuzem, Yves Horsmans, David R Nelson, Yao Yu, Preethi Krishnan, Chih-Wei Lin, Jens J Kort, Federico J Mensa
BACKGROUND: The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis. METHODS: We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Belgium, Canada, Germany, South Africa, Spain, and the USA...
August 14, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28817753/efficacy-and-safety-of-durvalumab-in-locally-advanced-or-metastatic-urothelial-carcinoma-updated-results-from-a-phase-1-2-open-label-study
#10
Thomas Powles, Peter H O'Donnell, Christophe Massard, Hendrik-Tobias Arkenau, Terence W Friedlander, Christopher J Hoimes, Jae Lyun Lee, Michael Ong, Srikala S Sridhar, Nicholas J Vogelzang, Mayer N Fishman, Jingsong Zhang, Sandy Srinivas, Jigar Parikh, Joyce Antal, Xiaoping Jin, Ashok K Gupta, Yong Ben, Noah M Hahn
Importance: The data reported herein were accepted for assessment by the US Food and Drug Administration for Biologics License Application under priority review to establish the clinical benefit of durvalumab as second-line therapy for locally advanced or metastatic urothelial carcinoma (UC), resulting in its recent US approval. Objective: To report a planned update of the safety and efficacy of durvalumab in patients with locally advanced/metastatic UC. Design, Setting, and Participants: This is an ongoing phase 1/2 open-label study of 191 adult patients with histologically or cytologically confirmed locally advanced/metastatic UC whose disease had progressed on, were ineligible for, or refused prior chemotherapy from 60 sites in 9 countries as reported herein...
August 17, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28817490/an-open-trial-of-iloperidone-for-mixed-episodes-in-bipolar-disorder
#11
Vivek Singh, Jodi Gonzalez Arnold, Thomas J Prihoda, Melissa Martinez, Charles L Bowden
BACKGROUND: Mixed mood states in bipolar disorder are difficult to treat and when present indicate worse illness trajectories. Several medications are US Food and Drug Administration approved to treat mixed episodes; however, the clinical trials have been short term and rarely reported depression response. METHODS: We conducted a 5-month open-label trial examining the tolerability and efficacy of iloperidone for bipolar disorder mixed episodes. RESULTS: Mania and depression scores significantly improved over the course of the study for study completers (ie, 60%-68% improvement for manic symptoms and 41%-49% for depression symptoms)...
August 16, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28817397/real-world-data-on-paliperidone-palmitate-for-the-treatment-of-schizophrenia-and-other-psychotic-disorders-a-systematic-review-of-randomized-and-nonrandomized-studies
#12
Robin Emsley, Eduard Parellada, Miquel Bioque, Berta Herrera, Teresa Hernando, Marta García-Dorado
The aim of this study was to perform a systematic review of the effects of 1-month paliperidone palmitate (PP1M) for the treatment of schizophrenia and related psychotic disorders in terms of outcomes reported in real-world evidence studies. A systematic review of real-world randomized and nonrandomized studies with PP1M was performed and is reported according to PRISMA guidelines. Comparative effectiveness data with oral antipsychotics indicate that PP1M has a lower likelihood of relapse-related events, including rehospitalization, and these differences are clinically relevant...
August 16, 2017: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28817373/cabozantinib-as-salvage-therapy-for-patients-with-tyrosine-kinase-inhibitor-refractory-differentiated-thyroid-cancer-results-of-a-multicenter-phase-ii-international-thyroid-oncology-group-trial
#13
Maria E Cabanillas, Jonas A de Souza, Susan Geyer, Lori J Wirth, Michael E Menefee, Stephen V Liu, Komal Shah, John Wright, Manisha H Shah
Purpose Sorafenib and lenvatinib are oral multikinase inhibitors targeting vascular endothelial growth factor receptor (VEGFR) and approved for radioiodine (RAI)-refractory differentiated thyroid cancer (DTC). However, there are no approved second- or third-line therapies. MET is implicated in resistance to VEGFR inhibitors. Cabozantinib is an oral multikinase inhibitor targeting MET in addition to VEGFR and is approved for medullary thyroid cancer. In a phase I study of cabozantinib, five of eight patients with DTC previously treated with a VEGFR-targeted therapy had an objective response to cabozantinib...
August 17, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28817316/filling-quality-of-the-reports-of-adverse-drug-reactions-received-at-the-pharmacovigilance-centre-of-s%C3%A3-o-paulo-brazil-missing-information-hinders-the-analysis-of-suspected-associations
#14
Adalton Ribeiro, Silvana Lima, Maria-Elisa Zampieri, Mirtes Peinado, Albert Figueras
Background The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). Research Design and Methods A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm...
August 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28817277/discovery-and-characterization-of-r-6-neopentyl-2-pyridin-2-ylmethoxy-6-7-dihydropyrimido-2-1-c-1-4-oxazin-4-9h-one-pf-06462894-an-alkyne-lacking-metabotropic-glutamate-receptor-5-negative-allosteric-modulator-profiled-in-both-rat-and-non-human-primates
#15
Antonia F Stepan, Michelle M Claffey, Matthew R Reese, Gayatri Balan, Gabriela Barreiro, Jason Barricklow, Michael J Bohanon, Brian P Boscoe, Gregg D Cappon, Lois K Chenard, Julie Cianfrogna, Laigao Chen, Karen J Coffman, Susan E Drozda, Joshua R Dunetz, Somraj Ghosh, Xinjun Hou, Christopher Houle, Kapil Karki, John T Lazzaro, Jessica Y Mancuso, John M Marcek, Emily L Miller, Mark A Moen, Steven V O'Neil, Isao Sakurada, Marc Skaddan, Vinod Parikh, Deborah L Smith, Patrick E Trapa, Jamison B Tuttle, Patrick R Verhoest, Daniel P Walker, Annie C Won, Ann S Wright, Jessica Whritenour, Kenneth Zasadny, Margaret M Zaleska, Lei Zhang, Christopher L Shaffer
We previously observed a cutaneous type IV immune response in non-human primates (NHP) with the mGlu5 negative allosteric modulator (NAM) 7. To determine if this adverse event was chemotype- or mechanism-based, we evaluated a distinct series of mGlu5 NAMs. Increasing the sp(3) character of high-throughput screening hit 40 afforded a novel morpholinopyrimidone mGlu5 NAM series. Its prototype, (R)-6-neopentyl-2-(pyridin-2-ylmethoxy)-6,7-dihydropyrimido[2,1-c][1,4]oxazin-4(9H)-one (PF-06462894, 8), possessed favorable properties and a predicted low clinical dose (2 mg twice daily)...
August 17, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28816851/clinical-practice-guideline-safe-medication-use-in-the-icu
#16
Sandra L Kane-Gill, Joseph F Dasta, Mitchell S Buckley, Sandeep Devabhakthuni, Michael Liu, Henry Cohen, Elisabeth L George, Anne S Pohlman, Swati Agarwal, Elizabeth A Henneman, Sharon M Bejian, Sean M Berenholtz, Jodie L Pepin, Mathew C Scanlon, Brian S Smith
OBJECTIVE: To provide ICU clinicians with evidence-based guidance on safe medication use practices for the critically ill. DATA SOURCES: PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL, Scopus, and ISI Web of Science for relevant material to December 2015. STUDY SELECTION: Based on three key components: 1) environment and patients, 2) the medication use process, and 3) the patient safety surveillance system...
September 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28816105/thiazolidinedione-drugs-in-the-treatment-of-type-2-diabetes-mellitus-past-present-and-future
#17
Melissa A Davidson, Donald R Mattison, Laurent Azoulay, Daniel Krewski
Thiazolidinedione (TZD) drugs used in the treatment of type 2 diabetes mellitus (T2DM) have proven effective in improving insulin sensitivity, hyperglycemia, and lipid metabolism. Though well tolerated by some patients, their mechanism of action as ligands of peroxisome proliferator-activated receptors (PPARs) results in the activation of several pathways in addition to those responsible for glycemic control and lipid homeostasis. These pathways, which include those related to inflammation, bone formation, and cell proliferation, may lead to adverse health outcomes...
August 17, 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/28815602/efficacy-and-safety-of-amphotericin-b-formulations-a-network-meta-analysis-and-a-multicriteria-decision-analysis
#18
Fernanda S Tonin, Laiza M Steimbach, Helena H Borba, Andreia C Sanches, Astrid Wiens, Roberto Pontarolo, Fernando Fernandez-Llimos
OBJECTIVES: Despite its broad spectrum, conventional amphotericin B (AB) is associated with serious adverse events. Lipid-based formulations may offer safer options. We aimed to synthesize the evidence of efficacy and safety of AB formulations. METHODS: We performed a systematic review and network meta-analysis (NMA) to compare all available formulations: conventional AB; lipid complex or ABLC; colloidal dispersion or ABCD; liposomal or LAB; AB in Intralipid. Randomized controlled trials were searched in four databases...
August 17, 2017: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/28815428/the-pharmacology-and-toxicology-of-third-generation-anticonvulsant-drugs
#19
REVIEW
Paul LaPenna, Laura M Tormoehlen
Epilepsy is a neurologic disorder affecting approximately 50 million people worldwide, or about 0.7% of the population [1]. Thus, the use of anticonvulsant drugs in the treatment of epilepsy is common and widespread. There are three generations of anticonvulsant drugs, categorized by the year in which they were developed and released. The aim of this review is to discuss the pharmacokinetics, drug-drug interactions, and adverse events of the third generation of anticonvulsant drugs. Where available, overdose data will be included...
August 16, 2017: Journal of Medical Toxicology: Official Journal of the American College of Medical Toxicology
https://www.readbyqxmd.com/read/28815341/de-novo-weekly-and-biweekly-darbepoetin-alfa-dosing-in-pediatric-patients-with-chronic-kidney-disease
#20
Bradley A Warady, John Barcia, Nadine Benador, Augustina Jankauskiene, Kurt Olson, Ludmila Podracka, Aleksey Shavkin, Poyyapakkam Srivaths, Cynthia J Wong, Jeffrey Petersen
BACKGROUND: Darbepoetin alfa is a commonly prescribed erythropoiesis-stimulating agent (ESA) for correcting anemia in pediatric chronic kidney disease (CKD) patients. However, little information exists on its use in ESA-naïve patients. This study evaluated the efficacy and safety of darbepoetin alfa in pediatric patients initiating ESA therapy. METHODS: One-hundred sixteen pediatric ESA-naïve subjects (aged 1-18 years) with CKD stages 3-5D and hemoglobin (Hb) <10 g/dl from 43 centers in the US, Europe, and Mexico were randomized by age (three groups) and dialysis status (yes vs...
August 17, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
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