Disproportionality analysis of upadacitinib-related adverse events in inflammatory bowel disease using the FDA adverse event reporting system by Shiyi Wang, Xiaojian Wang, Jing Ding, Xudong Zhang, Hongmei Zhu, Yihong Fan, Changbo Sun

“…This study evaluates upadacitinib-related adverse events (AEs) utilizing data from the US Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsWe employed disproportionality analyses, including the proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) algorithms to identify signals of upadacitinib-associated AEs for treating inflammatory bowel disease (IBD).ResultsFrom a total of 7,037,004 adverse event reports sourced from the FAERS database, 37,822 identified upadacitinib as the primary suspect drug in adverse drug events (ADEs), including 1,917 reports specifically related to the treatment of inflammatory bowel disease (IBD). …”
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A novel model-based meta-analysis to indirectly estimate the comparative efficacy of two medications: an example using DPP-4 inhibitors, sitagliptin and linagliptin, in treatment o... by Yan Gong, James Rogers, Christian Friedrich, Sanjay Patel, Alexander Staab, Jorge Luiz Gross, Daniel Polhamus, William Gillespie, Brigitta Ursula Monz, Silke Retlich

“…Comparison of two oral dipeptidyl peptidase (DPP)-4 inhibitors, sitagliptin and linagliptin, for type 2 diabetes mellitus (T2DM) treatment was used as an example.Design Systematic review with MBMA.Data sources MEDLINE, EMBASE, http://www.ClinicalTrials.gov, Cochrane review of DPP-4 inhibitors for T2DM, sitagliptin trials on Food and Drug Administration website to December 2011 and linagliptin data from the manufacturer.Eligibility criteria for selecting studies Double-blind, randomised controlled clinical trials, ≥12 weeks’ duration, that analysed sitagliptin or linagliptin efficacies as changes in glycated haemoglobin (HbA1c) levels, in adults with T2DM and HbA1c >7%, irrespective of background medication.Model development and application A Bayesian model was fitted (Markov Chain Monte Carlo method). …”
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Dihydrotanshinone I enhanced BRAF mutant melanoma treatment efficacy by inhibiting the STAT3/SOX2 signaling pathway by Xing Luo, Yi Duan, Jinwei He, CongGai Huang, Jun Liu, Yifan Liu, Mengdei Xu, Qiong Dai, Zhihui Yang

“…BackgroundThe Food and Drug Administration has approved the Serine/threonine-protein kinase B-raf (BRAF) inhibitor and Mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor combo as the first-line treatment for individuals with metastatic melanoma, although the majority of these patients exhibit primary or secondary drug resistance in the clinic. …”
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Development, opportunities, and challenges of siRNA nucleic acid drugs by Bowen Xiao, Shaopeng Wang, Yu Pan, Wenjun Zhi, Chensheng Gu, Tao Guo, Jiaqi Zhai, Chenxu Li, Yong Q. Chen, Rong Wang

“…They have reached the market for administration to patients after more than 20 years of development. The US Food and Drug Administration has approved six siRNA drugs in recent years: patisiran, givosiran, lumasiran, vutrisiran, inclisiran, and nedosiran. siRNA drugs are based on the post-transcriptional gene regulation mechanism of RNA interference. …”
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A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases by Siyu Lou, Zhiwei Cui, Yingyong Ou, Junyou Chen, Linmei Zhou, Ruizhen Zhao, Chengyu Zhu, Li Wang, Zhu Wu, Fan Zou

“…As such, this study aimed to comprehensively evaluate real-world adverse drug events (ADEs) linked to paliperidone palmitate by employing data mining techniques on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database. …”
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Associated adverse outcomes with tumor treating fields when combined to temozolomide versus temozolomide alone for the treatment of glioblastoma: a meta-analysis of randomized tria... by Yuanyuan Chen, Yan Chen, Hong Zhen, Danhua Lou

“…Recently, the Food and Drug Administration (FDA) has approved tumor treating fields (TTF) for the treatment of glioblastoma. …”
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Computer-guided identification of novel inhibitors of apoptosis-signaling kinase 1 from Spondia mombim bioactive compounds against colorectal cancer by Olusola Olalekan Elekofehinti, Hannah Oluwaseun Popoola, Adedotun Olayemi Oluwatuyi, Opeyemi Iwaloye, Moses Orimoloye Akinjiyan, Oluwamodupe Cecilia, Frank Abimbola Ogundolie, Olalekan Isaac Olatunde, Oussama Abchir, Samir Chtita, Joao Batista Texeira Rocha

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Private, public, and bottled drinking water: Shared contaminant-mixture exposures and effects challenge by Paul M. Bradley, Kristin M. Romanok, Kelly L. Smalling, Stephanie E. Gordon, Bradley J. Huffman, Katie Paul Friedman, Daniel L. Villeneuve, Brett R. Blackwell, Suzanne C. Fitzpatrick, Michael J. Focazio, Elizabeth Medlock-Kakaley, Shannon M. Meppelink, Ana Navas–Acien, Anne E. Nigra, Molly L. Schreiner

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Safety profiles of IDH inhibitors: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database by Ximu Sun, Han Zhou, Yanming Li, Yanhui Luo, Qixiang Guo, Yixin Sun, Chenguang Jia, Bin Wang, Maoquan Qin, Peng Guo

“…This study aimed to evaluate the adverse events (AEs) of IDH inhibitors based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database. …”
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Dual targeting of breast cancer by chitosan/poly lactic-co-glycolic acid nanodelivery systems: Surface activation with folic acid/aptamers, and co-encapsulated with Sorafenib and q... by Asghar Narmani, Saeid Ganji, Maryam Amirishoar, Fatemeh Hajikarimi, Aynaz Mazandarani, Mahya Karimi, Ali Mohammadinejad, Azin Azadpour, Roghayyeh Jahedi, Elham Assadpour, Seid Mahdi Jafari

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Adverse events of hepatic anti-fibrotic agents in phase 3 and above clinical trials: a descriptive analysis of the WHO-VigiAccess database by Yuwei Liu, Yuwei Liu, Xu Zhao, Xu Zhao, Xinrui Wang, Xinrui Wang, Qiang Zhou, Qiang Zhou

“…Currently, there is no Food and Drug Administration (FDA) approved pharmacotherapy for liver fibrosis. …”
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Impact of warning pictorials and size on perceived effectiveness of cigar warning labels in a nationally representative between-subjects experiment by James F Thrasher, Tara L Queen, Jennifer Cornacchione Ross, Sarah D Kowitt, Leah M Ranney, Adam O Goldstein, Chineme Enyioha, Desmond Jenson, Paschal Sheeran, Sonia A Clark, Kristen L Jarman, Michelle Z Yang

“…Our findings provide important insights for the US Food and Drug Administration and international regulatory agencies in designing new HWLs for cigars that can more effectively communicate smoking risks, address misinformation and potentially reduce cigar smoking.…”
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E-Cigarette Use and Use of Evidence-Based Smoking Cessation Methods Among American Indian Cigarette Smokers: A Cross-Sectional Analysis by Ashley L. Comiford, DrPH, Dorothy A. Rhoades, MD, MPH, Justin D. Dvorak, PhD, Kai Ding, PhD, Noah Collins, Alexandra L. Blair, Mark P. Doescher, MD, MSPH

“…Although the U.S. Food and Drug Administration–approved products and evidence-based methods exist for smoking cessation, people who smoke might use E-cigarettes as cessation aids. …”
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Intravenous nicardipine and labetalol use in hypertensive patients with signs or symptoms suggestive of end-organ damage in the emergency department: a subgroup analysis of the CLU... by Brian Hiestand, Phillip Levy, W Frank Peacock, Brigitte M Baumann, Richard M Nowak, Amy Hsu, Joseph Varon, Chad M Cannon, David M Cline, Pierre Borczuk, Abhinav Chandra, Deborah B Diercks, Preeti Jois, Brian Kaminski, Jon W Schrock

“…Objective To compare the efficacy of Food and Drug Administration recommended dosing of nicardipine versus labetalol for the management of hypertensive patients with signs and/or symptoms (S/S) suggestive of end-organ damage (EOD).Design Secondary analysis of the multicentre prospective, randomised CLUE trial.Setting 13 academic emergency departments in the USA.Participants Eligible patients had two systolic blood pressure (SBP) measures ≥180 mm Hg at least 10 min apart, no contraindications to nicardipine or labetalol and predefined S/S suggestive of EOD on arrival.Interventions Medications were administered by continuous infusion (nicardipine) or repeat intravenous bolus (labetalol) for a study period of 30 min or until a specified target SBP ±20 mm Hg was achieved.Primary outcome measure Percentage of participants achieving a predefined target SBP range (TR) defined as an SBP within ±20 mm Hg as established by the treating physician.Results Of the 141 eligible patients, 49.6% received nicardipine, 51.7% were women and 81.6% were black. …”
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Geographically widespread and novel hemotropic mycoplasmas and bartonellae in Mexican free-tailed bats and sympatric North American bat species by Daniel J. Becker, Kristin E. Dyer, Lauren R. Lock, Beckett L. Olbrys, Shawn A. Pladas, Anushka A. Sukhadia, Bret Demory, Juliana Maria Nunes Batista, Micaela Pineda, Nancy B. Simmons, Amanda M. Adams, Winifred F. Frick, M. Teague O'Mara, Dmitriy V. Volokhov

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Bringing MDMA-assisted therapy for PTSD to traditional healthcare systems: tending to set and setting by Dimitri Perivoliotis, Dimitri Perivoliotis, Kayla Knopp, Kayla Knopp, Shannon Remick, Allie Kaigle, Allie Kaigle, Christopher S. Stauffer, Christopher S. Stauffer, Chandra Khalifian, Chandra Khalifian, Tamara R. Wachsman, Bettye E. Chargin, Andrew W. Bismark, Andrew W. Bismark, Al Alam, Al Alam, Leslie Morland, Leslie Morland, Leslie Morland

“…MDMA-assisted therapy (MDMA-AT) for PTSD is a promising intervention currently being evaluated in numerous studies worldwide, including investigation for potential Food and Drug Administration (FDA) approval in the United States. …”
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Relieving Sore Throat Formula Exerts a Therapeutic Effect on Pharyngitis through Immunoregulation and NF-κB Pathway by Yushi Ding, Suyun Yu, Zhonghong Wei, Rui Deng, Peng Chen, Yifan Sun, Qi Jia, Xiaoman Li, Yuanyuan Wu, Wenxing Chen, Kurt S. Zanker, Aiyun Wang, Yin Lu

“…Relieving Sore Throat Formula (RSTF) is a formula approved by the China Food and Drug Administration and has been used for the treatment of pharyngitis in clinic for many years. …”
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Sentiments of Individuals with Interstitial Cystitis/Bladder Pain Syndrome Toward Pentosan Polysulfate Sodium: Infodemiology Study by Yulin Hswen, Qiuyuan Qin, Pressley Smith, Alison Swierczynski, Stuart Bauer, Erika Ladson, Amanda Leigh Garrett, Catherine A Brownstein

“…The only US Food and Drug Administration–approved medication to treat IC/BPS is pentosan polysulfate sodium (PPS). …”
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Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types by Jeffrey S Ross, Richard S P Huang, Jake G Maule, Lani K Clinton, Ryon P Graf, Jinpeng Xiao, Geoffrey R Oxnard

“…Background Multiple PD-L1 immunohistochemistry (IHC) assays, including DAKO 22C3, DAKO 28-8, and Ventana SP142 PD-L1 IHC assays, have been approved by the Food and Drug Administration as a companion diagnostic (CDx) for various antiprogrammed death-1 and antiprogrammed death ligand 1 (PD-L1) based cancer immunotherapies. …”
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Exploring the ability of plasma pTau217, pTau181 and beta-amyloid in mirroring cerebrospinal fluid biomarker profile of Mild Cognitive Impairment by the fully automated Lumipulse®... by Marcella Catania, Claudia Battipaglia, Alberto Perego, Erika Salvi, Emanuela Maderna, Federico Angelo Cazzaniga, Paolo M. Rossini, Camillo Marra, Nicola Vanacore, Alberto Redolfi, Daniela Perani, Patrizia Spadin, Maria Cotelli, Stefano Cappa, Naike Caraglia, Pietro Tiraboschi, Fabrizio Tagliavini, Giuseppe Di Fede

“…Abstract Background The approval of new disease-modifying therapies by the U.S. Food and Drug Administration and the European Medicine Agency makes it necessary to optimize non-invasive and cost-effective tools for the identification of subjects at-risk of developing Alzheimer’s Disease (AD). …”
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