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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/28449320/a-randomised-double-blind-trial-of-the-safety-and-efficacy-of-omarigliptin-a-once-weekly-dpp-4-inhibitor-in-subjects-with-type-2-diabetes-and-renal-impairment
#3
Antonio Chacra, Ira Gantz, Geraldine Mendizabal, Lucila Durlach, Edward A O'Neill, Zachary Zimmer, Shailaja Suryawanshi, Samuel S Engel, Eseng Lai
AIMS: To assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2DM) and chronic renal impairment (RI). METHODS: Patients with T2DM with moderate RI (estimated glomerular filtration rate [eGFR] ≥30 to <60 mL/min/1.73 m(2) ) (N=114), severe RI (eGFR <30 mL/min/1.73 m(2) ) (N=55) or end-stage renal disease on dialysis (N=44), who were either not on an antihyperglycaemic agent therapy for at least 12 weeks at screening, washed-off of oral antihyperglycaemic agent monotherapy or low-dose dual combination therapy, or on insulin monotherapy, with baseline glycated haemoglobin (HbA1c) of 6...
April 27, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28449232/safety-pharmacokinetics-and-pharmacologic-effects-of-the-selective-androgen-receptor-modulator-gsk2881078-in-healthy-men-and-postmenopausal-women
#4
Richard V Clark, Ann C Walker, Susan Andrews, Philip Turnbull, Jeffrey A Wald, Mindy H Magee
AIM: Selective androgen receptor modulators (SARMs) induce anabolic effects on muscle without the adverse effects of androgenic steroids. In this first-in-human study, we report safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of the SARM GSK2881078. METHODS: In Part A, healthy young men (n = 10) received a single dose of study drug (0 mg, 0.05 mg, 0.1 mg, 0.2 mg GSK2881078 or matching-placebo). In Part B, repeat-dose cohorts in men (n = 65) were 0...
April 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28449218/development-and-pharmacologic-characterization-of-the-rat-6-hz-model-of-partial-seizures
#5
Cameron S Metcalf, Peter J West, Kyle E Thomson, Sharon F Edwards, Misty D Smith, H S White, Karen S Wilcox
OBJECTIVE: The mouse 6 Hz model of psychomotor seizures is a well-established and commonly used preclinical model for antiseizure drug (ASD) discovery. Despite its widespread use both in the identification and differentiation of novel ASDs in mice, a corresponding assay in rats has not been developed. We established a method for 6 Hz seizure induction in rats, with seizure behaviors similar to those observed in mice including head nod, jaw clonus, and forelimb clonus. METHODS: A convulsive current that elicits these seizure behaviors in 97% of rats (CC97 ) was determined using a Probit analysis...
April 27, 2017: Epilepsia
https://www.readbyqxmd.com/read/28449186/the-risk-of-lower-gastrointestinal-bleeding-in-low-dose-aspirin-users
#6
W-C Chen, K-H Lin, Y-T Huang, T-J Tsai, W-C Sun, S-K Chuah, D-C Wu, P-I Hsu
BACKGROUND: Aspirin increases the risk of gastrointestinal bleeding. AIM: To investigate the risk of lower gastrointestinal bleeding (LGIB) in aspirin users. METHODS: Low-dose (75-325 mg daily) aspirin users and controls matched by age, gender and enrollment time in a 1:5 ratio were selected from 1 million randomly sampled subjects in the National Health Insurance Research Database of Taiwan. Cox proportional hazard regression models were developed to evaluate the predictors of LGIB with adjustments for age, gender, comorbidities including coronary artery disease, ischaemic stroke, diabetes, hypertension, chronic kidney disease, liver cirrhosis, chronic obstructive pulmonary disease, dyslipidemia, uncomplicated peptic ulcer disease, history of peptic ulcer bleeding, and concomitant use of clopidogrel, ticlopidine, warfarin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors, steroids, proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), nitrates, alendronate, selective serotonin reuptake inhibitors (SSRIs) and calcium channel blockers...
April 27, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28448816/protective-effect-of-artemisinin-on-chronic-alcohol-induced-liver-damage-in-mice
#7
Xiaoyan Zhao, Liqing Wang, Hao Zhang, Duoduo Zhang, Zhihao Zhang, Jie Zhang
The liver disease related to chronic alcohol consumption is one of the leading causes of death for alcoholics. The efficient drug to ameliorate the alcoholic liver injury was needed urgently. The present study was performed to investigate whether artemisinin possessed the protective effect against chronic alcohol consumption. 50 male Kunming mice were divided into 5 groups: control group (C): 10ml/kg saline+10ml/kg saline, alcohol group (A): 10ml/kg 56%(v/v) alcohol+10ml/kg saline, low dose group of artemisinin (L): 10ml/kg 56%(v/v) alcohol+30mg/kg/day artemisinin, medium dose group of artemisinin (M): 10ml/kg 56%(v/v) alcohol+60mg/kg/day artemisinin, high dose group of artemisinin (H): 10ml/kg 56%(v/v) alcohol+120mg/kg/day artemisinin...
April 13, 2017: Environmental Toxicology and Pharmacology
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
#8
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/28448702/ketamine-for-depression-1-clinical-summary-of-issues-related-to-efficacy-adverse-effects-and-mechanism-of-action
#9
Chittaranjan Andrade
Ketamine is an anesthetic drug that is also used for off-label indications such as the mediation of analgesia and sedation in various settings. It is additionally recognized as an agent with antidepressant potential. For depression, it is most commonly administered as a slow intravenous infusion in subanesthetic doses (usually 0.5 mg/kg). As an antidepressant, is strikingly different from conventional antidepressant drugs in that it brings about rapid and marked attenuation of depressive symptoms even in patients with refractory depression...
April 2017: Journal of Clinical Psychiatry
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
#10
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/28448604/non-invasive-imaging-assessment-of-the-biodistribution-of-gsk2849330-an-adcc-and-cdc-optimized-anti-her3-mab-and-its-role-in-tumor-macrophage-recruitment-in-human-tumor-bearing-mice
#11
Hasan Alsaid, Tinamarie Skedzielewski, Mary V Rambo, Kristen Hunsinger, Bao Hoang, William Fieles, Edward R Long, James Tunstead, Danielle J Vugts, Matthew Cleveland, Neil Clarke, Christopher Matheny, Beat M Jucker
The purpose of this work was to use various molecular imaging techniques to non-invasively assess GSK2849330 (anti HER3 ADCC and CDC enhanced 'AccretaMab' monoclonal antibody) pharmacokinetics and pharmacodynamics in human xenograft tumor-bearing mice. Immuno-PET biodistribution imaging of radiolabeled 89Zr-GSK2849330 was assessed in mice with HER3 negative (MIA-PaCa-2) and positive (CHL-1) human xenograft tumors. Dose dependency of GSK2849330 disposition was assessed using varying doses of unlabeled GSK2849330 co-injected with 89Zr-GSK2849330...
2017: PloS One
https://www.readbyqxmd.com/read/28448562/the-impact-of-anti-drug-antibodies-on-drug-concentrations-and-clinical-outcomes-in-rheumatoid-arthritis-patients-treated-with-adalimumab-etanercept-or-infliximab-results-from-a-multinational-real-world-clinical-practice-non-interventional-study
#12
Robert J Moots, Ricardo M Xavier, Chi Chiu Mok, Mahboob U Rahman, Wen-Chan Tsai, Mustafa H Al-Maini, Karel Pavelka, Ehab Mahgoub, Sameer Kotak, Joan Korth-Bradley, Ron Pedersen, Linda Mele, Qi Shen, Bonnie Vlahos
OBJECTIVE: To assess the incidence of anti-drug antibodies (ADA) in patients with rheumatoid arthritis (RA) treated with the TNF inhibitors etanercept (ETN), adalimumab (ADL), or infliximab (IFX), and determine the potential relationship with trough drug concentration, efficacy, and patient-reported outcomes. METHODS: This multi-national, non-interventional, cross-sectional study (NCT01981473) enrolled adult patients with RA treated continuously for 6-24 months with ETN, ADL, or IFX...
2017: PloS One
https://www.readbyqxmd.com/read/28448477/evaluation-of-gelatin-tannate-against-symptoms-of-acute-diarrhea-in-pediatric-patients
#13
Eren Çağan, Saime Ceylan, Şenay Mengi, Havva Hasret Çağan
BACKGROUND Acute diarrhea is the second most common cause of morbidity and mortality worldwide, especially in children aged ≤3 years. Some drugs (e.g., the mucoprotector gelatin tannate) plus a reduced osmolality oral rehydration solution (ORS) may effectively reduce symptom duration and severity. The current trial was therefore designed to assess the efficacy and safety of gelatin tannate in pediatric patients with acute diarrhea. MATERIAL AND METHODS This was a randomized, controlled, double-blind, parallel-group, single-center study comparing gelatin tannate plus ORS (103 patients) with ORS plus placebo (100 patients) in children aged 3 months to 12 years with infectious or noninfectious acute diarrhea...
April 27, 2017: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
https://www.readbyqxmd.com/read/28448027/dry-powder-and-nebulized-aerosol-inhalation-of-pharmaceuticals-delivered-to-mice-using-a-nose-only-exposure-system
#14
Jonathan E Phillips, Xuxia Zhang, James A Johnston
Obstructive respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD) are currently treated by inhaled anti-inflammatory and bronchodilator drugs. Despite the availability of multiple treatments, both diseases are growing public health concerns. The majority of asthma patients are well controlled on current inhaled therapies but a substantial number of patients with severe asthma are not. Asthma affects an estimated 300 million people worldwide and approximately 20 percent have a severe form of the disease...
April 6, 2017: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/28447980/disposable-dosators-for-pulmonary-insufflation-of-therapeutic-agents-to-small-animals
#15
Phillip G Durham, Shumaila N Hanif, Lucia Garcia Contreras, Ellen F Young, Miriam S Braunstein, Anthony J Hickey
Development of new therapeutic products requires efficacy testing in an animal model. The pulmonary route of administration can be utilized to deliver drugs locally and systemically. Evaluation of dry powder aerosols necessitates an efficient dispersion mechanism to maintain high concentrations in an exposure chamber or for direct endotracheal administration. While solutions exist to expose animals by passive inhalation to dry powder aerosols, most require masses of powder in large excess of the dose delivered...
March 30, 2017: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/28447886/drug-induced-hyperlactatemia
#16
Eike Blohm, Jeffrey Lai, Mark Neavyn
BACKGROUND: Hyperlactatemia is common in critically ill patients and has a variety of etiologies. Medication toxicity remains an uncommon cause that providers often fail to recognize. In this article, we review several medications that cause hyperlactatemia in either therapeutic or supratherapeutic dosing. When known, the incidence, mortality, pathophysiology, and treatment options are discussed. METHODS: We performed a literature search using PUBMED and Google Scholar for English language articles published after 1980 regarding medication induced hyperlactatemia and its management...
April 27, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28447799/enhanced-transdermal-delivery-by-combined-application-of-dissolving-microneedle-patch-on-serum-treated-skin
#17
Suyong Kim, Manita Dangol, Geonwoo Kang, Shayan F Lahiji, Huisuk Yang, Mingyu Jang, Yonghao Ma, Chengguo Li, Sang Gon Lee, Chang Hyun Kim, Young Wook Choi, So Jeong Kim, Ja Hyun Ryu, Ji Hwoon Baek, Jaesuk Koh, Hyungil Jung
Dissolving microneedle (DMN), a transdermal drug delivery system in which drugs are encapsulated in a biodegradable polymeric micro-structure, is designed to dissolve after skin penetration and release the encapsulated drugs into the body. However, due to limited loading capacity of drugs within micro-sized structures, only small dosage can be delivered which are often insufficient for patients. We propose a novel DMN application that combines topical and DMN application simultaneously to improve skin permeation efficiency...
April 27, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28447766/supervised-dosing-with-a-long-acting-opioid-medication-in-the-management-of-opioid-dependence
#18
REVIEW
Rosella Saulle, Simona Vecchi, Linda Gowing
BACKGROUND: Opioid dependence (OD) is an increasing clinical and public health problem worldwide. International guidelines recommend opioid substitution treatment (OST), such as methadone and buprenorphine, as first-line medication treatment for OD. A negative aspect of OST is that the medication used can be diverted both through sale on the black market, and the unsanctioned use of medications. Daily supervised administration of medications used in OST has the advantage of reducing the risk of diversion, and may promote therapeutic engagement, potentially enhancing the psychosocial aspect of OST, but costs more and is more restrictive on the client than dispensing for off-site consumption...
April 27, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28447703/conserved-effects-and-altered-trafficking-of-cetuximab-antibodies-conjugated-to-gold-nanoparticles-with-precise-control-of-their-number-and-orientation
#19
Lorena García-Fernández, Javier Garcia-Pardo, Olivia Tort, Ian Prior, Mathias Brust, Eudald Casals, Julia Lorenzo, Victor F Puntes
Gold nanoparticles (17 nm) have been functionalized with the antiangiogenic monoclonal antibody drug Cetuximab at a well-defined orientation and coverage density of antibodies. Functionalization has been carried out through site-directed chemistry via the selective oxidation of the carbohydrate moiety of antibodies linked to a thiolated hydrazide. A431 tumor cells have been exposed to these conjugates for in vitro evaluation of their effects. In addition to epithelial growth factor receptor blocking, trafficking and signaling alterations were also observed...
April 27, 2017: Nanoscale
https://www.readbyqxmd.com/read/28447548/preparation-of-wormlike-polymeric-nanoparticles-coated-with-silica-for-delivery-of-methotrexate-and-evaluation-of-anticancer-activity-against-mcf7-cells
#20
Farhad Gharebaghi, Naser Dalali, Ebrahim Ahmadi, Hossein Danafar
Methotrexate is one of the most effective drugs that is commonly used in the treatment of cancer. However, its application is limited due to low solubility, high toxicity and rapid metabolism. Therefore, in the present study, worm-like polymeric nanoparticles as carrier of methotrexate were prepared using biodegradable copolymers (mPEG-PCL). The impact of nanoparticles' geometry on the loading, delivery and drug's anti-cancer activity was investigated. The di-block copolymer mPEG-PCL was being synthesized by a ring opening polymerization of ɛ-caprolactone in the presence of mPEG as the initiator and Sn(oct)2 as the catalyst...
April 2017: Journal of Biomaterials Applications
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