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https://www.readbyqxmd.com/read/28646789/data-mining-for-detecting-signals-of-adverse-drug-reactions-of-fluoxetine-using-the-korea-adverse-event-reporting-system-kaers-database
#1
Seonji Kim, Kyounghoon Park, Mi-Sook Kim, Bo Ram Yang, Hyun Jin Choi, Byung-Joo Park
Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database...
June 13, 2017: Psychiatry Research
https://www.readbyqxmd.com/read/28646580/biosimilars-for-psoriasis-worldwide-overview-of-regulatory-guidelines-uptake-and-implications-for-dermatology-clinical-practice
#2
REVIEW
A D Cohen, J J Wu, L Puig, S Chimenti, R Vender, M Rajagopalan, R Romiti, C de la Cruz, L Skov, C Zachariae, H S Young, P Foley, J M van der Walt, L Naldi, A Blauvelt
The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis...
June 24, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28646433/oxcarbazepine-oral-suspension-in-pediatric-patients-with-partial-seizures-and-or-generalized-tonic-clonic-seizures-a-multi-center-single-arm-observational-study-in-china
#3
Yi Wang, Yin-Bo Chen, Yu-Qin Zhang, Rong Luo, Hua Wang, Jun-Lan Lv, Dong Wang, Sui-Qiang Zhu, Zhong-Dong Lin, Jiong Qin
BACKGROUND: To assess efficacy and safety of oxcarbazepine (OXC) oral suspension in pediatric patients aged 2-16 years with partial seizures (PS) and/ or generalized tonic-clonic seizures (GTCS) in real-world clinical practice in China. METHODS: This 26-week, single arm, multicenter and observational study recruited patients aged 2-16 years with PS or GTCS suitable for OXC oral suspension treatment. Enrolled patients received OXC oral suspension treatment for 26 weeks...
June 22, 2017: World Journal of Pediatrics: WJP
https://www.readbyqxmd.com/read/28646375/comparative-efficacy-and-safety-in-esa-biosimilars-vs-originators-in-adults-with-chronic-kidney-disease-a-systematic-review-and-meta-analysis
#4
REVIEW
Laura Amato, Antonio Addis, Rosella Saulle, Francesco Trotta, Zuzana Mitrova, Marina Davoli
BACKGROUND: Several Erythropoiesis-stimulating agents (ESAs) are available to treat anemia in patients with chronic kidney disease (CKD). Questions about the comparability of such therapeutic options are not purely a regulatory or economical matter. Appropriate use of originator or biosimilar in these patients need to be supported by clinical data. Regarding the prevention of blood transfusion, reduction of fatigue, breathlessness and mortality or cardiovascular events, a summary of the comparative efficacy and safety data of these drugs is lacking...
June 23, 2017: Journal of Nephrology
https://www.readbyqxmd.com/read/28646142/efficacy-and-safety-of-tenofovir-disoproxil-fumarate-in-preventing-vertical-transmission-of-hepatitis-b-in-pregnancies-with-high-viral-load
#5
Jun-Ze Chen, Zuo-Wei Liao, Fei-Long Huang, Ru-Kui Su, Wen-Bo Wang, Xue-Yuan Cheng, Jie-Qing Chen, Jia-Qi Liu, Zhong Huang
This study was a meta-analysis of the literature on the efficacy and safety of tenofovir disoproxil fumarate (TDF) in preventing vertical transmission of hepatitis B in pregnancies with high viral load. Four observational studies and one randomized controlled trial involving 585 pregnant women and 595 newborns were included in the meta-analysis. TDF was more effective than the placebo in reducing vertical transmission in HBeAg-positive chronic hepatitis B (CHB) pregnancies with high serum HBV-DNA levels (OR = 0...
June 23, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28645995/mepolizumab-for-the-treatment-of-severe-eosinophilic-asthma
#6
REVIEW
Mara N Poulakos, Shawna M Cargill, Melissa F Waineo, Allen L Wolford
PURPOSE: Published data on the pharmacology, pharmacokinetics and pharmacodynamics, and clinical efficacy and safety of the interleukin-5 antagonist mepolizumab are reviewed. SUMMARY: Asthma of the eosinophilic phenotype is characterized by persistent eosinophilic airway inflammation promoted primarily by T-helper type 2 cytokines, the key regulator of eosinophils. Patients with severe eosinophilic asthma are burdened by the need to administer high doses of corticosteroids to help manage their symptoms...
July 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28645963/effectiveness-and-safety-of-moxibustion-treatment-for-non-specific-lower-back-pain-protocol-for-a-systematic-review
#7
Jungtae Leem, Seunghoon Lee, Yeoncheol Park, Byung-Kwan Seo, Yeeun Cho, Jung Won Kang, Yoon Jae Lee, In-Hyuk Ha, Hyun-Jong Lee, Eun-Jung Kim, Sanghoon Lee, Dongwoo Nam
INTRODUCTION: Many patients experience acute lower back pain that becomes chronic pain. The proportion of patients using complementary and alternative medicine to treat lower back is increasing. Even though several moxibustion clinical trials for lower back pain have been conducted, the effectiveness and safety of moxibustion intervention is controversial. The purpose of this study protocol for a systematic review is to evaluate the effectiveness and safety of moxibustion treatment for non-specific lower back pain patients...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645941/a-first-time-in-human-study-of-gsk2636771-a-phosphoinositide-3-kinase-beta-selective-inhibitor-in-patients-with-advanced-solid-tumors
#8
Joaquin Mateo, Gopinath Ganji, Charlotte Lemech, Howard A Burris, Sae-Won Han, Karen E Swales, Shaun Decordova, Maurice P DeYoung, Deborah A Smith, Shanker Kalyana-Sundaram, Jiuhua Wu, Monica Motwani, Rakesh Kumar, Jerry M Tolson, Sun Young Rha, Hyun Cheol Chung, Joseph Paul Eder, Sunil Sharma, Yung-Jue Bang, Jeffrey R Infante, Li Yan, Johann S de Bono, Hendrik-Tobias Arkenau
The phosphoinositide 3 kinase (PI3K)/protein kinase B (AKT) pathway is commonly activated in several tumor types. Selective targeting of p110β could result in successful pathway inhibition while avoiding the on and off target effects of pan-PI3K inhibitors. GSK2636771 is a potent, orally bioavailable, adenosine triphosphate-competitive, selective inhibitor of PI3Kβ.<br /><br />Experimental Design: <p>We evaluated the safety, pharmacokinetics, pharmacodynamics and antitumor activity of GSK2636771 to define the recommended Phase II dose (RP2D)...
June 23, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28645853/anterior-pallidal-deep-brain-stimulation-for-tourette-s-syndrome-a-randomised-double-blind-controlled-trial
#9
Marie-Laure Welter, Jean-Luc Houeto, Stéphane Thobois, Benoit Bataille, Marc Guenot, Yulia Worbe, Andreas Hartmann, Virginie Czernecki, Eric Bardinet, Jerome Yelnik, Sophie Tezenas du Montcel, Yves Agid, Marie Vidailhet, Philippe Cornu, Audrey Tanguy, Solène Ansquer, Nematollah Jaafari, Emmanuel Poulet, Giulia Serra, Pierre Burbaud, Emmanuel Cuny, Bruno Aouizerate, Pierre Pollak, Stephan Chabardes, Mircea Polosan, Michel Borg, Denys Fontaine, Bruno Giordana, Sylvie Raoul, Tiphaine Rouaud, Anne Sauvaget, Isabelle Jalenques, Carine Karachi, Luc Mallet
BACKGROUND: Deep brain stimulation (DBS) has been proposed to treat patients with severe Tourette's syndrome, and open-label trials and two small double-blind trials have tested DBS of the posterior and the anterior internal globus pallidus (aGPi). We aimed to specifically assess the efficacy of aGPi DBS for severe Tourette's syndrome. METHODS: In this randomised, double-blind, controlled trial, we recruited patients aged 18-60 years with severe and medically refractory Tourette's syndrome from eight hospitals specialised in movement disorders in France...
June 20, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28645776/selective-inhibition-of-flt3-by-gilteritinib-in-relapsed-or-refractory-acute-myeloid-leukaemia-a-multicentre-first-in-human-open-label-phase-1-2-study
#10
Alexander E Perl, Jessica K Altman, Jorge Cortes, Catherine Smith, Mark Litzow, Maria R Baer, David Claxton, Harry P Erba, Stan Gill, Stuart Goldberg, Joseph G Jurcic, Richard A Larson, Chaofeng Liu, Ellen Ritchie, Gary Schiller, Alexander I Spira, Stephen A Strickland, Raoul Tibes, Celalettin Ustun, Eunice S Wang, Robert Stuart, Christoph Röllig, Andreas Neubauer, Giovanni Martinelli, Erkut Bahceci, Mark Levis
BACKGROUND: Internal tandem duplication mutations in FLT3 are common in acute myeloid leukaemia and are associated with rapid relapse and short overall survival. The clinical benefit of FLT3 inhibitors in patients with acute myeloid leukaemia has been limited by rapid generation of resistance mutations, particularly in codon Asp835 (D835). We aimed to assess the highly selective oral FLT3 inhibitor gilteritinib in patients with relapsed or refractory acute myeloid leukaemia. METHODS: In this phase 1-2 trial, we enrolled patients aged 18 years or older with acute myeloid leukaemia who either were refractory to induction therapy or had relapsed after achieving remission with previous treatment...
June 20, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28645757/sympathetic-response-and-outcomes-following-renal-denervation-in-patients-with-chronic-heart-failure-12-month-outcomes-from-the-symplicity-hf-feasibility-study
#11
Ingrid Hopper, Edoardo Gronda, Uta C Hoppe, Bengt Rundqvist, Thomas H Marwick, Sharad Shetty, Christopher Hayward, Thomas Lambert, Dagmara Hering, Murray Esler, Markus Schlaich, Antony Walton, Flavio Airoldi, Mathias-Christoph Brandt, Sidney A Cohen, Pascalle Reiters, Henry Krum
BACKGROUND: Heart failure (HF) is associated with chronic sympathetic activation. Renal denervation (RDN) aims to reduce sympathetic activity by ablating the renal sympathetic nerves. We investigated the effect of RDN in patients with chronic HF and concurrent renal dysfunction, in a prospective, multicenter, single-arm feasibility study. METHODS AND RESULTS: Thirty-nine patients with chronic systolic HF (left ventricular ejection fraction [LVEF] <40%, New York Heart Association class II-III,) and renal impairment (estimated glomerular filtration rate [eGFR; assessed with Modification of Diet in Renal Disease equation] <75 mL/min/1...
June 20, 2017: Journal of Cardiac Failure
https://www.readbyqxmd.com/read/28645740/safety-of-the-2d-3d-direct-acting-antiviral-regimen-in-hcv-induced-child-pugh-a-cirrhosis-a-pooled-analysis
#12
Fred Poordad, David R Nelson, Jordan J Feld, Michael W Fried, Heiner Wedemeyer, Lois Larsen, Daniel E Cohen, Eric Cohen, Niloufar Mobashery, Fernando Tatsch, Graham R Foster
BACKGROUND & AIMS: Chronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit-risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r ± DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis. METHODS: Twelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r ± ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r + DSV ± RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment...
June 20, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28645737/alfapump-system-vs-large-volume-paracentesis-for-refractory-ascites-a-multicenter-randomized-controlled-study
#13
Christophe Bureau, Danielle Adebayo, Mael Chalret de Rieu, Laure Elkrief, Dominique Valla, Markus Peck-Radosavljevic, Anne McCune, Victor Vargas, Macarena Simon-Talero, Juan Cordoba, Paolo Angeli, Silvia Rosi, Stewart MacDonald, Massimo Malago, Maria Stepanova, Zobair M Younossi, Claudia Trepte, Randall Watson, Oleg Borisenko, Sun Sun, Neil Inhaber, Rajiv Jalan
BACKGROUND AND AIMS: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump [AP]) compared with LVP [SoC]. METHODS: Randomized, controlled trial, in 7 centers, with 6M patient observation. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival...
June 20, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28645575/prediction-of-drug-induced-immune-mediated-hepatotoxicity-using-hepatocyte-like-cells-derived-from-human-embryonic-stem-cells
#14
Dong Eon Kim, Mi-Jin Jang, Young Ran Kim, Joo-Young Lee, Eun Byul Cho, Eunha Kim, Yeji Kim, Mi Young Kim, Won-Il Jeong, Seyun Kim, Yong-Mahn Han, Seung-Hyo Lee
Drug-induced liver injury (DILI) is a leading cause of liver disease and a key safety factor during drug development. In addition to the initiation events of drug-specific hepatotoxicity, dysregulated immune responses have been proposed as major pathological events of DILI. Thus, there is a need for a reliable cell culture model with which to assess drug-induced immune reactions to predict hepatotoxicity for drug development. To this end, stem cell-derived hepatocytes have shown great potentials. Here we report that hepatocyte-like cells derived from human embryonic stem cells (hES-HLCs) can be used to evaluate drug-induced hepatotoxic immunological events...
June 20, 2017: Toxicology
https://www.readbyqxmd.com/read/28645491/systematic-review-of-immune-checkpoint-inhibition-in-urological-cancers
#15
REVIEW
Maud Rijnders, Ronald de Wit, Joost L Boormans, Martijn P J Lolkema, Astrid A M van der Veldt
CONTEXT: In patients with advanced and metastatic urological cancers, clinical outcome may be improved by immune checkpoint inhibitors (ICIs). OBJECTIVE: To systematically review relevant literature on efficacy and safety of ICIs in patients with advanced and metastatic urothelial cell cancer (UCC), renal cell cancer (RCC), and prostate cancer. EVIDENCE ACQUISITION: Relevant databases, including Medline, Embase, and the Cochrane Library, were searched up to March 16, 2017...
June 20, 2017: European Urology
https://www.readbyqxmd.com/read/28645482/proton-pump-inhibitors-and-survival-outcomes-in-patients-with-metastatic-renal-cell-carcinoma
#16
Aly-Khan A Lalani, Rana R McKay, Xun Lin, Ronit Simantov, Marina D Kaymakcalan, Toni K Choueiri
INTRODUCTION: Proton pump inhibitors (PPIs) are potent inhibitors of gastric acid secretion and can affect the optimal absorption of concomitant oral medications, such as vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKIs). The purpose of this study was to investigate the effect of PPI use on survival in metastatic renal cell carcinoma (mRCC) patients treated in the targeted therapy era. MATERIALS AND METHODS: We conducted a pooled analysis of mRCC patients treated in phase II and III clinical trials...
May 31, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28645216/iglarlixi-a-fixed-ratio-combination-of-insulin-glargine-100-u-ml-and-lixisenatide-for-the-treatment-of-type-2-diabetes
#17
Jennifer Goldman, Jennifer M Trujillo
OBJECTIVE: To review the safety and efficacy of iGlarLixi, a titratable fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide, a glucagon-like peptide-1 receptor agonist. DATA SOURCES: A literature search of MEDLINE for all English-language primary articles through June 2016, using the terms LixiLan, iGlarLixi and insulin glargine and lixisenatide, and a search of abstracts presented at the 2016 Scientific Sessions of the American Diabetes Association were performed...
June 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28645018/take-over-performance-in-evasive-manoeuvres
#18
Riender Happee, Christian Gold, Jonas Radlmayr, Sebastian Hergeth, Klaus Bengler
We investigated after effects of automation in take-over scenarios in a high-end moving-base driving simulator. Drivers performed evasive manoeuvres encountering a blocked lane in highway driving. We compared the performance of drivers 1) during manual driving, 2) after automated driving with eyes on the road while performing the cognitively demanding n-back task, and 3) after automated driving with eyes off the road performing the visually demanding SuRT task. Both minimum time to collision (TTC) and minimum clearance towards the obstacle disclosed a substantial number of near miss events and are regarded as valuable surrogate safety metrics in evasive manoeuvres...
June 20, 2017: Accident; Analysis and Prevention
https://www.readbyqxmd.com/read/28644771/biomarker-based-phase-ii-trial-of-savolitinib-in-patients-with-advanced-papillary-renal-cell-cancer
#19
Toni K Choueiri, Elizabeth Plimack, Hendrik-Tobias Arkenau, Eric Jonasch, Daniel Y C Heng, Thomas Powles, Melanie M Frigault, Edwin A Clark, Amir A Handzel, Humphrey Gardner, Shethah Morgan, Laurence Albiges, Sumanta Kumar Pal
Purpose Patients with advanced papillary renal cell carcinoma (PRCC) have limited therapeutic options. PRCC may involve activation of the MET pathway, for example, through gene amplification or mutations. Savolitinib (AZD6094, HMPL-504, volitinib) is a highly selective MET tyrosine kinase inhibitor. We report results of a single-arm, multicenter, phase II study evaluating the safety and efficacy of savolitinib in patients with PRCC according to MET status. Patients and Methods Patients with histologically confirmed locally advanced or metastatic PRCC were enrolled and received savolitinib 600 mg orally once daily...
June 23, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28644733/trends-of-atv-use-and-associated-injury-on-saskatchewan-farms
#20
Lynne Clay, Stephan Milosavljevic, Niels Koehncke, James Dosman, Catherine Trask
PURPOSE: All-terrain vehicles (ATV's) are a hazardous source of injury in many contexts and geographical regions, but to date have not been investigated in Saskatchewan. METHODS: Baseline surveys from the Saskatchewan Farm Injury Project were examined at two time points in terms of: 1) rates and correlated characteristics of reported ATV use; and 2) qualitative content analysis of injury events involving ATVs. The sample of eligible farmers was 2972 in 2007 and 1702 in 2013...
June 23, 2017: Journal of Occupational and Environmental Hygiene
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