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https://www.readbyqxmd.com/read/28449404/changes-in-prescribing-and-healthcare-resource-utilization-after-fda-drug-safety-communications-involving-zolpidem-containing-medications
#1
Aaron S Kesselheim, Macarius Donneyong, Gerald J Dal Pan, Esther H Zhou, Jerry Avorn, Sebastian Schneeweiss, John D Seeger
PURPOSE: Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next-morning impairment and recommending lower starting doses particularly for women. This study aimed to assess whether zolpidem DSCs were associated with prescribing-pattern changes between January 2011 and December 2013. METHODS: We assessed overall dispensings of zolpidem-containing products between January 2011 and December 2013 by conducting a time-series analysis...
April 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28449367/metoprolol-pridopidine-drug-drug-interaction-and-food-effect-assessments-of-pridopidine-a-new-drug-for-treatment-of-huntington-disease
#2
Laura Rabinovich-Guilatt, Lilach Steiner, Hussein Hallak, Gina Pastino, Pierandrea Muglia, Ofer Spiegelstein
AIM: Pridopidine is an oral drug in clinical development for treatment of patients with Huntington disease. This study examined the interactions of pridopidine with in vitro cytochrome P450 activity and characterized the effects of pridopidine on CYP2D6 activity in healthy volunteers using metoprolol as a probe substrate. The effect of food on pridopidine exposure was assessed. METHODS: The ability of pridopidine to inhibit and/or induce in vitro activity of drug metabolising enzymes was examined in human liver microsomes and fresh hepatocytes...
April 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28449366/moving-forward-with-the-neuromuscular-junction
#3
REVIEW
Claire Legay, Lin Mei
The neuromuscular junction (NMJ) is indispensable for survival. This synapse between motoneurons and skeletal muscle fibers allows posture, movement and respiration. Therefore, its dysfunction creates pathologies than can be lethal. The molecular mechanisms of NMJ development and maintenance are the subject of intensive studies. This mini-review focuses on some of the most recent discoveries. An unexpected role for a protein, rapsyn, which has been known for 40 years to aggregate acetylcholine receptors has emerged...
April 27, 2017: Journal of Neurochemistry
https://www.readbyqxmd.com/read/28449353/how-excluding-some-benefits-from-value-assessment-of-new-drugs-impacts-innovation
#4
Joseph P Cook, Joseph Golec
Payers often assess the benefits of new drugs relative to costs for reimbursement purposes, but they frequently exclude some drugs' option-related benefits, reducing their reimbursement chances, and making them less attractive R&D investments. We develop and test a real options model of R&D investment that shows that excluding option-related benefits heightens drug developers' incentives to avoid high-risk (volatile) R&D investments and instead encourages them to focus on "safer" (positively skewed) investments...
April 27, 2017: Health Economics
https://www.readbyqxmd.com/read/28449208/complex-modulation-by-stress-of-the-effect-of-seizures-on-long-term-potentiation-in-mouse-hippocampal-slices
#5
Nicola Maggio, Efrat Shavit Stein, Menahem Segal
Stress has a profound effect on ability to express neuronal plasticity, learning and memory. Likewise, epileptic seizures lead to massive changes in brain connectivity, and in ability to undergo long term changes in reactivity to afferent stimulation. In the present study we analyzed possible long lasting interactions between a stressful experience and reactivity to pilocarpine, on the ability to produce long term potentiation (LTP) in a mouse hippocampus. Pilocarpine lowers paired pulse potentiation (PPP) as well as LTP in CA1 region of the mouse hippocampal slice...
April 27, 2017: Hippocampus
https://www.readbyqxmd.com/read/28449079/small-non-coding-rna-and-cancer
#6
Giulia Romano, Dario Veneziano, Mario Acunzo, Carlo M Croce
The ENCODE project has reported that at least 80% of the human genome is biologically active, yet only a small part of human DNA encodes for protein. The massive amount of RNA transcribed but not translated into protein can be classified as housekeeping RNA (such as rRNA, tRNA) and regulatory RNA (such as miRNA, piRNA, lncRNA). Small non-coding RNAs, in particular, have been the focus of many studies in the last 20 years and their fundamental role in many human diseases is currently well established. Inter alia, their role in cancer development and progression, as well as in drug resistance, is being increasingly investigated...
April 26, 2017: Carcinogenesis
https://www.readbyqxmd.com/read/28449068/development-of-a-novel-human-recellularized-endometrium-that-responds-to-a-28-day-hormone-treatment
#7
Susan A Olalekan, Joanna E Burdette, Spiro Getsios, Teresa K Woodruff, J Julie Kim
Three dimensional (3D) in vitro models have been established to study the physiology and pathophysiology of the endometrium. With emerging evidence that the native extracellular matrix (ECM) provides appropriate cues and growth factors essential for tissue homeostasis, we describe, a novel 3D endometrium in vitro model developed from decellularized human endometrial tissue repopulated with primary endometrial cells. Analysis of the decellularized endometrium using mass spectrometry analysis revealed an enrichment of cell adhesion molecules, cytoskeletal proteins and ECM proteins such as Collagen IV and Laminin...
April 25, 2017: Biology of Reproduction
https://www.readbyqxmd.com/read/28448946/oral-administration-of-methysticin-improves-cognitive-deficits-in-a-mouse-model-of-alzheimer-s-disease
#8
Athanassios Fragoulis, Stephanie Siegl, Markus Fendt, Sandra Jansen, Ulf Soppa, Lars-Ove Brandenburg, Thomas Pufe, Joachim Weis, Christoph Jan Wruck
INTRODUCTION: There is increasing evidence for the involvement of chronic inflammation and oxidative stress in the pathogenesis of Alzheimer's disease (AD). Nuclear factor erythroid 2-related factor 2 (Nrf2) is an anti-inflammatory transcription factor that regulates the oxidative stress defense. Our previous experiments demonstrated that kavalactones protect neuronal cells against Amyloid β (Aβ)-induced oxidative stress in vitro by Nrf2 pathway activation. Here, we tested an in vivo kavalactone treatment in a mouse model of AD...
April 19, 2017: Redox Biology
https://www.readbyqxmd.com/read/28448888/isolation-identification-and-characterization-of-potential-impurities-of-anidulafungin
#9
Lanning Zhao, Qilong Wang, Yi Bie, Xiaoxia Lu
Eight impurities ranging from 0.03 to 0.97% in anidulafungin bulk drug were detected by HPLC. Four impurities (Imp-I, Imp-II, Imp-III and Imp-VIII) among impurities were isolated from the self-prepared or marketed samples of anidulafungin bulk drug by means of preparative HPLC. A thorough study was undertaken to characterize these impurities and based on 1D ((1)H, (13)C, H-D, DEPT 90 and 135) and 2D (COSY, TOCSY, HSQC, HMBC) NMR and ESI-MS spectral data. Based on the characterization data, Imp-I was found to be known open-chain hydrolysis product formed during the synthesis and degradation...
April 17, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28448853/a-cluster-of-aspartic-residues-in-the-extracellular-loop-ii-of-par-4-is-important-for-thrombin-interaction-and-activation-of-platelets
#10
Daniel Sánchez Centellas, Sushanth Gudlur, Alejandro Vicente-Carrillo, Sofia Ramström, Tomas L Lindahl
Thrombin activates platelets via proteolytic cleavage of protease-activated receptors (PARs) 1 and 4. The two PARs have distinct but complementary roles. The mechanisms responsible for PAR1 activation by thrombin have been extensively studied. However, much less is known regarding thrombin activation of PAR4, especially the potential involvement of regions of PAR4 other than the N-terminal, which is bound to the catalytic site of thrombin. We have studied PAR4 in S. cerevisiae strain MMY12, an expression system in which the GPCR receptors are connected to a Lac Z reporter gene resulting in increased β-galactosidase activity...
April 13, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/28448782/amcp-partnership-forum-driving-value-and-outcomes-in-oncology
#11
(no author information available yet)
Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28448772/the-effect-of-a-federal-controlled-substance-act-schedule-change-on-hydrocodone-combination-products-claims-in-a-medicaid-population
#12
Stephanie Tran, Pavel Lavitas, Karen Stevens, Bonnie C Greenwood, Karen Clements, Caroline J Alper, Kimberly Lenz, Mylissa Price, Tasmina Hydery, Jennifer L Arnold, Mito Takeshita, Rachel Bacon, Justin P Peristere, Paul L Jeffrey
BACKGROUND: In 2012, hydrocodone combination products (HCPs) were the most prescribed medications in the United States. Under the Controlled Substance Act of 1970, hydrocodone alone was classified as a Schedule II drug, while HCPs were classified as Schedule III, indicating a lower risk for abuse and misuse. However, according to a Drug Enforcement Agency analysis, the addition of nonopioids has not been shown to diminish abuse potential of hydrocodone. In response to concerns for drug abuse and overdose, the Drug Enforcement Agency rescheduled HCPs to Schedule II in October 2014, with the intent of limiting overprescribing and increasing awareness of their abuse potential...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28448685/adult-neurobehavioral-alterations-in-male-and-female-mice-following-developmental-exposure-to-paracetamol-acetaminophen-characterization-of-a-critical-period
#13
Gaëtan Philippot, Torsten Gordh, Anders Fredriksson, Henrik Viberg
Paracetamol (acetaminophen) is a widely used non-prescription drug with analgesic and antipyretic properties. Among pregnant women and young children, paracetamol is one of the most frequently used drugs and is considered the first-choice treatment for pain and/or fever. Recent findings in both human and animal studies have shown associations between paracetamol intake during brain development and adverse behavioral outcomes later in life. The present study was undertaken to investigate if the induction of these effects depend on when the exposure occurs during a critical period of brain development and if male and female mice are equally affected...
April 27, 2017: Journal of Applied Toxicology: JAT
https://www.readbyqxmd.com/read/28448670/molecular-mechanisms-underlying-the-filtration-bleb-maintaining-effects-of-suberoylanilide-hydroxamic-acid-saha
#14
Akiko Futakuchi, Toshihiro Inoue, Tomokazu Fujimoto, Utako Kuroda, Miyuki Inoue-Mochita, Eri Takahashi, Saori Ohira, Hidenobu Tanihara
Purpose: Suberoylanilide hydroxamic acid (SAHA) has been shown to support the maintenance of experimental filtration blebs in animal models. This study was performed to investigate the molecular mechanisms underlying the bleb-maintaining effects of SAHA in modulating wound healing activities of conjunctival fibroblasts. Methods: Human conjunctival fibroblasts (HConFs) were pretreated with SAHA before treatment with TGF-β2. Microarray-based screening was used to investigate the gene expression profiles...
April 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28448593/benzodiazepines-z-drugs-and-the-risk-of-hip-fracture-a-systematic-review-and-meta-analysis
#15
Karen Donnelly, Robert Bracchi, Jonathan Hewitt, Philip A Routledge, Ben Carter
BACKGROUND: Hip fractures in the older person lead to an increased risk of mortality, poorer quality of life and increased morbidity. Benzodiazepine (BNZ) use is associated with increased hip fracture rate, consequently Z-drugs are fast becoming the physician's hypnotic prescription of choice yet data on their use is limited. We compared the risk of hip fracture associated with Z-drugs and BNZ medications, respectively, and examined if this risk varied with longer-term use. METHODS AND FINDINGS: We carried out a systematic review of the literature and meta-analysis...
2017: PloS One
https://www.readbyqxmd.com/read/28448574/fusion-expression-of-occludin-extracellular-loops-and-an-%C3%AE-helical-bundle-a-new-research-model-for-tight-junction
#16
Xiaojing Chi, Xia Zhao, Wei Wang, Yuqiang Niu, Min Cheng, Xiuying Liu, Sheng Cui, Wei Yang
Tight junctions (TJs) are the outermost structures of intercellular junctions and are highly specialized membrane domains involved in many important cellular processes. However, most TJ proteins are four-time transmembrane proteins and are difficult to express in their correct soluble form, which limits their functional study and therapeutic application. Human occludin (OCLN) is a major component of TJs and an essential co-receptor for hepatitis C virus (HCV) cell entry. To explore expression strategy for recombinant TJ proteins possessing integrated and functional extracellular loops, OCLN was here used as a model molecule, and several prokaryotic fusion constructs were designed by docking OCLN extracellular loops (ECLs) to HIV-1 gp41 NHR and CHR six-helical bundle (6HV1); then their biophysical features and anti-HCV activity were evaluated...
2017: PloS One
https://www.readbyqxmd.com/read/28448505/polyphenolic-extract-of-insp-5-ptase-expressing-tomato-plants-reduce-the-proliferation-of-mcf-7-breast-cancer-cells
#17
Mohammad Alimohammadi, Mohamed Hassen Lahiani, Diamond McGehee, Mariya Khodakovskaya
In recent years, by extensive achievements in understanding the mechanisms and the pathways affected by cancer, the focus of cancer research is shifting from developing new chemotherapy methods to using natural compounds with therapeutic properties to reduce the adverse effects of synthetic drugs on human health. We used fruit extracts from previously generated human type I InsP 5-ptase gene expressing transgenic tomato plants for assessment of the anti-cancer activity of established genetically modified tomato lines...
2017: PloS One
https://www.readbyqxmd.com/read/28448381/higher-surgical-morbidity-for-ulcerative-colitis-patients-in-the-era-of-biologics
#18
Jonathan S Abelson, Fabrizio Michelassi, Jialin Mao, Art Sedrakyan, Heather Yeo
OBJECTIVE: To investigate differences in surgical approach and postoperative outcomes for patients with ulcerative colitis (UC) before and after the introduction of biologic therapy. BACKGROUND: Biologic use has dramatically increased since Food and Drug Administration approval of infliximab. Studies conflict as to the effect of these agents on surgical outcomes with some demonstrating worse surgical outcomes whereas others have found no difference. METHODS: We used an administrative, all-payer, all-age group database located in New York State...
April 26, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28448171/novel-investigational-drugs-active-as-single-agents-in-multiple-myeloma
#19
Mattia D'Agostino, Marco Salvini, Antonio Palumbo, Alessandra Larocca, Francesca Gay
Multiple myeloma (MM) is a hematologic malignancy characterized by proliferation of malignant plasma cells. Patient outcome has improved markedly over the last decades due to the introduction of novel therapeutic agents such as bortezomib, thalidomide and lenalidomide. However, MM still remains largely incurable and patients eventually become refractory to available treatments. To address this unmet medical need, a variety of new molecules are currently being developed in preclinical models and/or are being investigated in clinical studies...
April 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28448028/system-for-efficacy-and-cytotoxicity-screening-of-inhibitors-targeting-intracellular-mycobacterium-tuberculosis
#20
Xingji Zheng, Yossef Av-Gay
Mycobacterium tuberculosis, the causative agent of tuberculosis (TB), is a leading cause of morbidity and mortality worldwide. With the increased spread of multi drug-resistant TB (MDR-TB), there is a real urgency to develop new therapeutic strategies against M. tuberculosis infections. Traditionally, compounds are evaluated based on their antibacterial activity under in vitro growth conditions in broth; however, results are often misleading for intracellular pathogens like M. tuberculosis since in-broth phenotypic screening conditions are significantly different from the actual disease conditions within the human body...
April 5, 2017: Journal of Visualized Experiments: JoVE
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