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Drug event

Huan Zhang, Liurong Fang, Xinyu Zhu, Dang Wang, Shaobo Xiao
Protein lysine ubiquitination is a dynamic reversible post-translational modification that plays key roles in modulating different cellular processes. Porcine reproductive and respiratory syndrome virus (PRRSV) is a notorious pathogen, causing tremendous economic losses for the global swine industry. The possible involvement of ubiquitination in PRRSV infection is unclear. So anti-ubiquitination-based enrichment and LC-MS were performed to investigate the global ubiquitination events triggered by PRRSV infection in pulmonary alveolar macrophages...
June 18, 2018: Journal of Proteomics
Suryakant Niture, Malathi Ramalinga, Habib Kedir, Dorrelyn Patacsil, Samiksha S Niture, James Li, Haresh Mani, Simeng Suy, Sean Collins, Deepak Kumar
Tumor necrosis factor-α-inducible protein 8 (TNFAIP8) is a TNF-α inducible anti-apoptotic protein with multiple roles in tumor growth and survival. Mechanisms of cell survival by TNFAIP8 remain elusive. We investigated the role of TNFAIP8 in the regulation of the cell cycle, autophagy, cell survival and neuroendocrine differentiation in prostate cancer cells. We showed that TNFAIP8 dysregulates cell-cycle-related proteins, in PC3 cells. Oncogenic cell survival, drug resistance and dysregulation of cell cycle-related proteins are often associated with autophagy...
June 1, 2018: Oncotarget
He Huang, Qiyu Chen, Weijian Sun, Mingdong Lu, Yaojun Yu, Zhiqiang Zheng, Pihong Li
Although tamoxifen is the most frequently used drug for the treatment of estrogen receptor positive (ER+ )-breast cancer (BRCA), its efficacy varies between patients. In the present study, Cox multivariate regression of the relative mRNA expression levels in two microarray-based datasets (GSE17005 and GSE26971) was employed to develop a risk score model to evaluate the outcome of patients with BRCA in the GSE17005 dataset. A total of ten genes were used to develop the prediction model for the survival of tamoxifen-treated patients with breast cancer...
July 2018: Oncology Letters
Bo Zhang, Chenyan Fang, Dehou Deng, Liang Xia
As targeted drug therapy is increasingly applied in the treatment of colon cancer, understanding and managing the adverse reactions of patients is becoming increasingly important. The present review examines the mechanisms of and adverse reactions to the most commonly used targeted drugs for colon cancer, and discusses methods of coping with these adverse reactions. Approved targeted drugs for metastatic colon cancer include monoclonal antibodies targeting vascular endothelial growth factor (VEGF), including bevacizumab, ziv-aflibercept and regorafenib, and monoclonal antibodies targeting epithelial growth factor receptor (EGFR), including cetuximab and panitumumab...
July 2018: Oncology Letters
Vaishali K Patadia, Martijn J Schuemie, Preciosa M Coloma, Ron Herings, Johan van der Lei, Miriam Sturkenboom, Gianluca Trifirò
Background: Several initiatives have assessed if mining electronic health records (EHRs) may accelerate the process of drug safety signal detection. In Europe, Exploring and Understanding Adverse Drug Reactions (EU-ADR) Project Focused on utilizing clinical data from EHRs of over 30 million patients from several European countries. Rofecoxib is a prescription COX-2 selective Non-Steroidal Anti-Inflammatory Drugs (NSAID) approved in 1999. In September 2004, the manufacturer withdrew rofecoxib from the market because of safety concerns...
2018: Frontiers in Pharmacology
Sebastian Hoffmann, Mark Berneburg, Stephan Schreml
Bullous pemphigoid (BP) is a blistering autoimmune disease mainly observed in elderly patients. Several triggers are known for this autoimmune disease and some drugs are known to be a cause of BP. However, there are only few case reports on the induction of BP under adalimumab therapy. Other autoimmune diseases, such as lupus erythematosus, are also known to occur under TNF inhibition. Here, we report on an 81-year-old patient who received adalimumab for ulcerative colitis and subsequently developed BP. Other causes of BP (tumors, other drugs, viral or toxoplasma infections) were excluded...
May 2018: Case Reports in Dermatology
Evan C Chen, Amir T Fathi, Andrew M Brunner
Despite increasing understanding of the pathobiology of acute myeloid leukemia (AML), outcomes remain dismal particularly for patients over the age of 60 years, a population enriched for therapy-related AML (tAML) and secondary AML (sAML). For decades, the standard of care for AML has been the combination of cytarabine and daunorubicin, typically delivered in combination as "7 + 3" induction. In 2017, a liposomal-encapsulated combination of daunorubicin and cytarabine (CPX-351, Vyxeos) was approved by the US Food and Drug Administration (FDA) for use in the treatment of newly diagnosed tAML or AML with myelodysplasia-related changes (AML-MRCs)...
2018: OncoTargets and Therapy
Jung Sunwoo, Yu Kyong Kim, Yewon Choi, Kyung-Sang Yu, Heesook Nam, Young Lag Cho, Seonghae Yoon, Jae-Yong Chung
Background: LCB01-0371 is a novel oxazolidinone antibiotic that blocks protein production by binding to bacterial 23S ribosomes. This antibiotic is active against Gram-positive bacteria. This study aimed to evaluate the effect of food on the pharmacokinetics (PKs) of LCB01-0371 and evaluate its safety profile. Subjects and methods: A randomized, open-label, two-way crossover study was performed in 18 healthy Korean male subjects. All subjects received a single oral 800 mg dose of LCB01-0371 in each period under fed or fasting condition with a 7-day washout in between...
2018: Drug Design, Development and Therapy
Ariana Helena Ribeiro de Barros, João Paulo Fiadeiro Sequeira, Ary Severino Lopes de Sousa, Carlos Miguel Cheganças Capela, Rui Manuel Gomes Pedrosa, Manuel Alexandre Dos Santos Manita
OBJECTIVES: The aim of this study was to evaluate postmarketing fingolimod safety and effectiveness in a real-world clinical population. METHODS: This was a retrospective, single-center study with active multiple sclerosis patients treated with fingolimod with at least 12 months of follow-up. Demographic and clinical and imaging characteristics, including annualized relapse rate (ARR), Expanded Disability Status Score, previous treatment, adverse events, treatment duration, and reason for discontinuation, were analyzed...
June 20, 2018: Clinical Neuropharmacology
Tia Kostas, Randall Knoebel, Stacie Levine
Elderly, multi-morbid patients are at high risk for suffering adverse drug events. Safe medication management is a key process in preventing these adverse events, and requires interprofessional teamwork. We performed a needs assessment survey of graduating medical students and faculty to evaluate student training in medication management, in particular students' preparedness in the three minimum geriatrics competencies pertaining to medication management, interprofessional educational opportunities, and optimal learning methods...
June 21, 2018: Gerontology & Geriatrics Education
Mamitaro Ohtsuki, Hiroshi Morimoto, Hidemi Nakagawa
Atopic dermatitis (AD) requires long-term management, mainly with topical anti-inflammatory agents. Topical corticosteroids (TCS) and tacrolimus ointment (TAC-O) are recommended as first-line treatments for AD. However, the long-term use of TCS is limited by cutaneous adverse events such as skin atrophy. For TAC-O, Japanese and US labelings were updated in 2003 and 2006, respectively, to include a boxed warning about a theoretical risk of skin cancer and lymphoma in patients treated with topical calcineurin inhibitors...
June 21, 2018: Journal of Dermatology
Umesh Chandra Behera, Arshi Singh, Lubhani Jain, Alisha Desai
The early clinical manifestations of macular infarction secondary to subconjunctival gentamicin (Gentak; Akorn, Lake Forest, IL) use in an aphakic eye were documented sequentially on swept-source optical coherence tomography (OCT) and fundus fluorescein angiography. The first recorded event after drug toxicity was macular detachment, along with disorganization of outer retinal layers in about 12 hours. The changes in inner retinal layers occurred after 36 hours had elapsed. OCT-documented initial damage to outer retinal layers could be due to the susceptibility of first order retinal neurons, followed by subsequent inner retinal layer involvement and ischemia...
June 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
Z Chen, M Tang, D Huang, W Jiang, M Li, H Ji, J Park, B Xu, L J Atchison, G A Truskey, K W Leong
Human cell-based 3D tissue constructs play an increasing role in disease modeling and drug screening. Inflammation, atherosclerosis, and many autoimmune disorders involve the interactions between immune cells and blood vessels. However, it has been difficult to image and model these interactions under realistic conditions. In this study, we fabricated a perfusion and imaging chamber to allow the real-time visualization of leukocyte perfusion, adhesion, and migration inside a tissue-engineered blood vessel (TEBV)...
June 21, 2018: Lab on a Chip
Philip D Ambery, Sebastian Klammt, Maximillian G Posch, Marcella Petrone, Wenji Pu, Cristina Rondinone, Lutz Jermutus, Boaz Hirshberg
AIMS: MEDI0382 is a balanced glucagon-like peptide-1/glucagon receptor dual agonist under development for the treatment of type 2 diabetes mellitus and non-alcoholic steatohepatitis. The primary objective was to assess the safety of MEDI0382 in healthy subjects. METHODS: In this placebo-controlled, double-blind, phase 1 study, healthy subjects (aged 18-45 years) were randomised (3:1) to receive a single subcutaneous dose of MEDI0382 or placebo after ≥8 hours of fasting...
June 21, 2018: British Journal of Clinical Pharmacology
Hisamitsu Ishihara, Susumu Yamaguchi, Ikko Nakao, Taishi Sakatani
INTRODUCTION: Few data are available regarding ipragliflozin treatment in combination with glucagon-like peptide-1 (GLP-1) receptor agonists. The aim of this study was to evaluate the efficacy and safety of ipragliflozin in combination with GLP-1 receptor agonists in Japanese patients with inadequately controlled type 2 diabetes mellitus (T2DM). METHODS: This multicenter study (consisting of three periods: a 4-week washout period, a 6-week observation period, and a 52-week open-label treatment period) included patients aged ≥ 20 years who received a stable dose/regimen of a GLP-1 receptor agonist either solely or in combination therapy with a sulfonylurea for ≥ 6 weeks, with glycosylated hemoglobin (HbA1c) of ≥ 7...
June 20, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Rashid Kazerooni, Edward P Armstrong
INTRODUCTION: Published literature on overdoses related to botulinum toxin A (BtxA) agents is scarce. OBJECTIVE: The aim of this study was to assess the BtxA drug class' respective agents for associations with overdose. METHODS: United States Food and Drug Administration (FDA) adverse event reporting system (FAERS) database was utilized to search for overdoses. The analysis was conducted on data between second quarter 2014 and third quarter 2017...
June 20, 2018: Clinical Drug Investigation
Sezaneh Haghpanah, Tahereh Zarei, Peyman Eshghi, Omidreza Zekavat, Mohammadreza Bordbar, Mahmood Hoormand, Mehran Karimi
Recently, resveratrol showed induction of γ-globin mRNA synthesis in human erythroid precursors and reducing oxidative stress in red cells of thalassemia patients in many in vitro studies. We aimed to investigate the efficacy and safety of resveratrol, for the first time, in non-transfusion-dependent beta-thalassemia intermedia (B-TI) in Southern Iran. In this double-blind randomized clinical trial, 54 patients with B-TI were investigated during 6 months between October 2016 and March 2017. Patients were randomly allocated into three groups by simple randomization method...
June 21, 2018: Annals of Hematology
Eric S Daar, Edwin DeJesus, Peter Ruane, Gordon Crofoot, Godson Oguchi, Catherine Creticos, Jürgen K Rockstroh, Jean-Michel Molina, Ellen Koenig, Ya-Pei Liu, Joseph Custodio, Kristen Andreatta, Hiba Graham, Andrew Cheng, Hal Martin, Erin Quirk
BACKGROUND: Switching from therapy based on a boosted protease inhibitor to bictegravir, emtricitabine, and tenofovir alafenamide could avoid drug interactions and unwanted side-effects in virologically suppressed adults with HIV-1 infection, while maintaining a high barrier to resistance and providing a simplified once-daily, single-tablet regimen. Here, we report 48 week results of a phase 3 study investigating this switch. METHODS: In this multicentre, randomised, open-label, active-controlled, non-inferiority, phase 3 trial, adults with HIV-1 infection were enrolled at 121 outpatient centres in ten countries...
June 15, 2018: Lancet HIV
Jean-Michel Molina, Douglas Ward, Indira Brar, Anthony Mills, Hans-Jürgen Stellbrink, Luis López-Cortés, Peter Ruane, Daniel Podzamczer, Cynthia Brinson, Joseph Custodio, Hui Liu, Kristen Andreatta, Hal Martin, Andrew Cheng, Erin Quirk
BACKGROUND: Bictegravir, co-formulated with emtricitabine and tenofovir alafenamide, has shown good efficacy and tolerability, and similar bone, renal, and lipid profiles to dolutegravir, abacavir, and lamivudine, in treatment-naive adults with HIV-1 infection, without development of treatment-emergent resistance. Here, we report 48-week results of a phase 3 study investigating switching to bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir, abacavir, and lamivudine in virologically suppressed adults with HIV-1 infection...
June 15, 2018: Lancet HIV
Kenichi Inoue, Jun Ninomiya, Tsuyoshi Saito, Kei Kimizuka, Masafumi Kurosumi
BACKGROUND: To examine the efficacy and safety of induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin (ISMT) in Japanese patients with HER2-negative metastatic breast cancer (MBC). METHODS: Patients, who had previously undergone a maximum of 2 regimens of chemotherapy, received 3 cycles of induction therapy with paclitaxel (90 mg/m2 intravenously on days 1, 8, and 15 followed by 1-week drug holiday) and bevacizumab (10 mg/kg intravenously after the completion of paclitaxel administration on days 1 and 15)...
June 20, 2018: BMC Cancer
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