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New drugs of 2015

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https://www.readbyqxmd.com/read/28428321/sulfonylureas-and-the-risks-of-cardiovascular-events-and-death-a-methodological-meta-regression-analysis-of-the-observational-studies
#1
REVIEW
Laurent Azoulay, Samy Suissa
Recent randomized trials have compared the newer antidiabetic agents to treatments involving sulfonylureas, drugs associated with increased cardiovascular risks and mortality in some observational studies with conflicting results. We reviewed the methodology of these observational studies by searching MEDLINE from inception to December 2015 for all studies of the association between sulfonylureas and cardiovascular events or mortality. Each study was appraised with respect to the comparator, the outcome, and study design-related sources of bias...
May 2017: Diabetes Care
https://www.readbyqxmd.com/read/28427409/efficacies-of-dha-ppq-and-as-sp-in-patients-with-uncomplicated-plasmodium-falciparum-malaria-in-an-area-of-an-unstable-seasonal-transmission-in-sudan
#2
Abdelrahim O Mohamed, Muzamil M Abdel Hamid, Omer S Mohamed, Nuha S Elkando, Abdelmaroof Suliman, Mariam A Adam, Fahad Awad Ali Elnour, Elfatih M Malik
BACKGROUND: Artemisinin-based combination therapy (ACT), together with other control measures, have reduced the burden of falciparum malaria in sub-Saharan countries, including Sudan. Sudan adopted ACT in 2004 with a remarkable reduction in mortality due to falciparum malaria. However, emergence of resistance to the first-line treatment artesunate and sulfadoxine/pyrimethamine (AS/SP) has created new challenges to the control of malaria in Sudan. A search for an alternative drug of choice for treating uncomplicated malaria has become inevitable...
April 20, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28427072/anti-vascular-endothelial-growth-factor-injections-the-new-standard-of-care-in-proliferative-diabetic-retinopathy
#3
Xintong Li, Marco A Zarbin, Neelakshi Bhagat
For decades, panretinal photocoagulation (PRP) has been the standard of care for the treatment of proliferative diabetic retinopathy (PDR). The relatively recent advent of anti-vascular endothelial growth factor (VEGF) formulations for intravitreal injection has provided a fresh perspective on PDR treatment, especially in eyes with concurrent diabetic macular edema (DME). The anti-VEGF agent ranibizumab has demonstrated a potentially protective effect on eyes with DME in terms of progression to PDR in the RIDE/RISE trials, as has aflibercept in the VIVID/VISTA trials...
2017: Developments in Ophthalmology
https://www.readbyqxmd.com/read/28423702/experience-with-precision-genomics-and-tumor-board-indicates-frequent-target-identification-but-barriers-to-delivery
#4
Alan H Bryce, Jan B Egan, Mitesh J Borad, A Keith Stewart, Grzegorz S Nowakowski, Asher Chanan-Khan, Mrinal M Patnaik, Stephen M Ansell, Michaela S Banck, Steven I Robinson, Aaron S Mansfield, Eric W Klee, Gavin R Oliver, Jennifer B McCormick, Norine E Huneke, Colleen M Tagtow, Robert B Jenkins, Kandelaria M Rumilla, Sarah E Kerr, Jean-Pierre A Kocher, Scott A Beck, Martin E Fernandez-Zapico, Gianrico Farrugia, Konstantinos N Lazaridis, Robert R McWilliams
BACKGROUND: The ability to analyze the genomics of malignancies has opened up new possibilities for off-label targeted therapy in cancers that are refractory to standard therapy. At Mayo Clinic these efforts are organized through the Center for Individualized Medicine (CIM). RESULTS: Prior to GTB, datasets were analyzed and integrated by a team of bioinformaticians and cancer biologists. Therapeutically actionable mutations were identified in 65% (92/141) of the patients tested with 32% (29/92) receiving genomically targeted therapy with FDA approved drugs or in an independent clinical trial with 45% (13/29) responding...
March 9, 2017: Oncotarget
https://www.readbyqxmd.com/read/28421836/analytical-confirmation-of-synthetic-cannabinoids-in-a-cohort-of-179-presentations-with-acute-recreational-drug-toxicity-to-an-emergency-department-in-london-uk-in-the-first-half-of-2015
#5
Rachelle Abouchedid, Simon Hudson, Natalie Thurtle, Takahiro Yamamoto, James H Ho, George Bailey, Michelle Wood, Nele Sadones, Christophe P Stove, Alison Dines, John R H Archer, David M Wood, Paul I Dargan
CONTEXT: Synthetic cannabinoid receptor agonists are the largest group of new psychoactive substances reported in the last decade; in this study we investigated how commonly these drugs are found in patients presenting to the Emergency Department with acute recreational drug toxicity. METHODS: We conducted an observational cohort study enrolling consecutive adult patients presenting to an Emergency Department (ED) in London (UK) January-July 2015 (6 months) with acute recreational drug toxicity...
June 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28420989/fda-facilitated-regulatory-pathways-visualizing-their-characteristics-development-and-authorization-timelines
#6
Lawrence Liberti, Magda Bujar, Alasdair Breckenridge, Jarno Hoekman, Neil McAuslane, Pieter Stolk, Hubert Leufkens
The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA). Only PR specifies an expedited review timeline (6 months). We sought to determine to what extent the combination of two or more FRPs influenced development and approval times. We developed a "metro map" to illustrate FRP elements and their influence on review times. We assessed 125 new active substances (approved January 2013 to December 2015) 74 of which used one or more FRPs...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28420403/molecular-surveillance-of-plasmodium-falciparum-drug-resistance-in-the-republic-of-congo-four-and-nine-years-after-the-introduction-of-artemisinin-based-combination-therapy
#7
Felix Koukouikila-Koussounda, Sankarganesh Jeyaraj, Christian N Nguetse, Charles Nchotebah Nkonganyi, Kossiwa Clarisse Kokou, Mandingha K Etoka-Beka, Francine Ntoumi, Thirumalaisamy P Velavan
BACKGROUND: Resistance to anti-malarial drugs hinders efforts on malaria elimination and eradication. Following the global spread of chloroquine-resistant parasites, the Republic of Congo adopted artemisinin-based combination therapy (ACT) in 2006 as a first-line treatment for uncomplicated malaria. To assess the impacts after implementation of ACT, a molecular surveillance for anti-malarial drug resistance was conducted in Congo 4 and 9 years after the introduction of ACT. METHODS: Blood samples of 431 febrile children aged 1-10 years were utilized from two previous studies conducted in 2010 (N = 311) and 2015 (N = 120)...
April 19, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28418263/systematic-bias-in-predictions-of-new-drugs-budget-impact-analysis-of-a-sample-of-recent-us-drug-launches
#8
Michael S Broder, Jenelle M Zambrano, Jackie Lee, Richard S Marken
OBJECTIVE: Expectations about the budget impact of new drug launches may affect payer behavior and ultimately consumer costs. Therefore, we evaluated the accuracy of pre-launch US budget impact estimates for a sample of new drugs. METHODS: We searched for publicly available budget impact estimates made pre-launch for drugs approved in the US from 1(st) September 2010 to 1(st) September 2015 and compared them to actual sales. Accuracy was calculated as the ratio of pre-launch estimate to actual sales...
April 18, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28412575/the-role-of-illicit-licit-and-designer-drugs-in-the-traffic-in-hungary
#9
László Institóris, Előd Hidvégi, Adrienn Dobos, Éva Sija, Éva M Kereszty, László Balázs Tajti, Gábor Pál Somogyi, Tibor Varga
The aim of this study was to investigate the prevalence and pattern of psychoactive substances among suspected DUID (Driving Under the Influence of Drugs) drivers in Hungary in 2014 and 2015. Blood and/or urine samples of 1252 suspected drivers (600 in 2014 and 652 in 2015) were analyzed for classical illicit and licit drugs, stimulant designer drugs (SDDs), and for synthetic cannabinoids, with 78.3% and 79.6% positive cases for at least one substance in 2014, and 2015, respectively. Impairment was proven in 39...
April 3, 2017: Forensic Science International
https://www.readbyqxmd.com/read/28406713/an-observational-study-of-outcomes-and-tolerances-in-patients-with-cystic-fibrosis-initiated-on-lumacaftor-ivacaftor
#10
Mark T Jennings, Rebecca Dezube, Shruti Paranjape, Natalie E West, Gina Hong, Andrew Braun, Jonathan Grant, Christian A Merlo, Noah Lechtzin
RATIONALE: In July 2015, the FDA approved lumacaftor/ivacaftor for use in patients with CF. This drug targets the primary defect in the CFTR protein that is conferred by the F508del CFTR mutation. OBJECTIVE: As there is limited experience with this therapy outside of clinical trials, this study aims to examine the clinical experience of this new drug in a CF population. METHODS: Retrospective cohort study of individuals followed at the Johns Hopkins CF Center, who initiated treatment with lumacaftor/ivacaftor...
April 13, 2017: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/28404108/ombitasvir-paritaprevir-and-ritonavir-plus-ribavirin-in-adults-with-hepatitis-c-virus-genotype-4-infection-and-cirrhosis-agate-i-a-multicentre-phase-3-randomised-open-label-trial
#11
Tarik Asselah, Christophe Hézode, Roula B Qaqish, Magdy ElKhashab, Tarek Hassanein, George Papatheodoridis, Jordan J Feld, Christophe Moreno, Stefan Zeuzem, Peter Ferenci, Yao Yu, Rebecca Redman, Tami Pilot-Matias, Niloufar Mobashery
BACKGROUND: Hepatitis C virus (HCV) genotype 4 infection is most commonly reported in sub-Saharan Africa and the Middle East; however, prevalence is increasing worldwide through immigration. HCV genotype 4 accounts for 20% of all infections, but clinical trial data for treatment remain limited. We assessed the combination of two direct-acting antivirals, ombitasvir (NS5A inhibitor) and paritaprevir (NS3/4A protease inhibitor; co-dosed with ritonavir) plus ribavirin in patients with HCV genotype 4 infection and compensated cirrhosis...
September 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28402929/kidney-disease-and-hiv-infection
#12
Christina M Wyatt
The risk of acute and chronic kidney disease remains higher in HIV-infected persons than in the general population, and kidney disease in HIV-infected persons is associated with poor outcomes, including increased mortality. HIV-associated nephropathy occurs less frequently in the era of antiretroviral therapy. HIV immune complex kidney disease is being diagnosed more frequently, but the term is currently used to refer to a heterogeneous group of kidney diseases. Comorbid chronic kidney disease poses a growing burden in HIV-infected persons due to an overrepresentation of risk factors such as black race, diabetes, hypertension, and coinfection with hepatitis C virus...
February 2017: Topics in Antiviral Medicine
https://www.readbyqxmd.com/read/28400490/flavour-chemicals-in-a-sample-of-non-cigarette-tobacco-products-without-explicit-flavour-names-sold-in-new-york-city-in-2015
#13
Shannon M Farley, Kevin Rj Schroth, Victoria Grimshaw, Wentai Luo, Julia L DeGagne, Peyton A Tierney, Kilsun Kim, James F Pankow
BACKGROUND: Youth who experiment with tobacco often start with flavoured products. In New York City (NYC), local law restricts sales of all tobacco products with 'characterising flavours' except for 'tobacco, menthol, mint and wintergreen'. Enforcement is based on packaging: explicit use of a flavour name (eg, 'strawberry') or image depicting a flavour (eg, a fruit) is presumptive evidence that a product is flavoured and therefore prohibited. However, a tobacco product may contain significant levels of added flavour chemicals even when the label does not explicitly use a flavour name...
April 11, 2017: Tobacco Control
https://www.readbyqxmd.com/read/28397671/-flibanserin-as-pharmacological-therapy-of-inhibited-sexual-desire-in-women
#14
Anne Sofie Eldon, Annamaria Giraldi
Flibanserin was approved by the Food and Drug Administration in the USA in August 2015 as the first drug for the treatment of American women with the dysfunction hypoactive sexual desire disorder (HSDD) and is a 5-HT1A agonist and 5-HT2A antagonist. The neurophysiological effects of flibanserin on these receptors are consistent with the clinical effects, i.e. significantly increasing sexual desire and frequency of satisfying sexual experiences. As such, shifting the balance between inhibitory and excitatory neurotransmitters of importance to sexual desire, flibanserin pharmacologically broaches a possible new approach to the treatment of HSDD...
February 13, 2017: Ugeskrift for Laeger
https://www.readbyqxmd.com/read/28394465/integrating-new-pharmacologic-agents-into-heart-failure-care-role-of-heart-failure-practice-guidelines-in-meeting-this-challenge
#15
Kirkwood F Adams, Erika M Giblin, Natalie Pearce, J Herbert Patterson
Heart failure is well recognized as a major public health concern not only due to severe and frequent adverse health outcomes but also related to the major financial burden this syndrome presents with advancing age in Western societies. Despite the dire need for more efficacious therapies and better application of existing advances, treatment gaps persist, and outcomes in heart failure remain poor, with continually high mortality and morbidity. Treatment guidelines provide one strategy for advancing quality of care in patients with heart failure...
April 10, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28392910/drug-shortages-in-israel-regulatory-perspectives-challenges-and-solutions
#16
Eyal Schwartzberg, Denize Ainbinder, Alla Vishkauzan, Ronni Gamzu
BACKGROUND: Pharmaceutical drug shortages (DSs) are a global problem which presents challenges to countries around the world. Shortages of pharmaceutical products may have a direct detrimental impact on public health and patients' wellbeing by causing delayed, or even lack of, treatment. Moreover, DSs may force both patients and caregivers to use unfamiliar drugs, which could lead to medication errors. The objective of our study was to analyze DSs in Israel during the years 2013-2015, assessing their etiology and exploring the steps taken for their mitigation and prevention...
2017: Israel Journal of Health Policy Research
https://www.readbyqxmd.com/read/28392863/efficacy-of-intravenous-administration-of-landiolol-in-patients-with-acute-heart-failure-and-supraventricular-tachyarrhythmia
#17
Shunsuke Kiuchi, Hiroto Aikawa, Shinji Hisatake, Takayuki Kabuki, Takashi Oka, Shintaro Dobashi, Takahiro Fujii, Takanori Ikeda
BACKGROUND: Patients with acute heart failure (HF) complicated by supraventricular tachyarrhythmia (SVT) often receive continuous intravenous infusion of landiolol or diltiazem for rate control. It is unclear whether the interval from initiation of infusion to commencement of oral beta-blocker (BB) therapy differs for these two drugs. METHODS: From January 2013 to July 2015, 94 consecutive patients were hospitalized for acute HF complicated by SVT. After 35 patients were excluded, the remaining 59 were divided into groups treated with diltiazem or landiolol...
May 2017: Journal of Clinical Medicine Research
https://www.readbyqxmd.com/read/28391063/drugclust-a-machine-learning-approach-for-drugs-side-effects-prediction
#18
Giovanna Maria Dimitri, Pietro Lió
BACKGROUND: Identification of underlying mechanisms behind drugs side effects is of extreme interest and importance in drugs discovery today. Therefore machine learning methodology, linking such different multi features aspects and able to make predictions, are crucial for understanding side effects. METHODS: In this paper we present DrugClust, a machine learning algorithm for drugs side effects prediction. DrugClust pipeline works as follows: first drugs are clustered with respect to their features and then side effects predictions are made, according to Bayesian scores...
March 30, 2017: Computational Biology and Chemistry
https://www.readbyqxmd.com/read/28388932/the-efficacy-of-sodium-benzoate-as-an-adjunctive-treatment-in-early-psychosis-cadence-bz-study-protocol-for-a-randomized-controlled-trial
#19
Alex Ryan, Andrea Baker, Frances Dark, Sharon Foley, Anne Gordon, Sean Hatherill, Stephen Stathis, Sukanta Saha, George Bruxner, Martin Beckman, Drew Richardson, Michael Berk, Olivia Dean, John McGrath, Cadence Working Group, James Scott
BACKGROUND: Psychotic disorders affect up to 3% of the population and are often chronic and disabling. Innovation in the pharmacological treatment of psychosis has remained stagnant in recent decades. In order to improve outcomes for those with psychotic disorders, we present a protocol for the trial of a common food preservative, sodium benzoate, as an adjunctive treatment in early psychosis. METHODS: Persons experiencing early psychosis (n = 160) will be recruited through hospitals and community mental health services in Queensland, Australia...
April 7, 2017: Trials
https://www.readbyqxmd.com/read/28382858/new-japanese-regulatory-frameworks-for-clinical-research-and-marketing-authorization-of-gene-therapy-and-cellular-therapy-products
#20
Sumimasa Nagai, Keiya Ozawa
In Japan, the Pharmaceuticals and Medical Devices Law was passed in 2014. In this new law, regenerative medical products were defined, and a conditional and term-limited approval system only for regenerative medical products was instituted. Gene therapy and adoptive cellular therapy are categorized as regenerative medical products. This law is intended for registration trials for marketing authorization. The Act on the Safety of Regenerative Medicine was also implemented in 2014. This act is intended for clinical research and medical practice involving processed cells other than registration trials...
April 6, 2017: Current Gene Therapy
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