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https://www.readbyqxmd.com/read/29346833/phase-1b-trial-of-ficlatuzumab-a-humanized-hepatocyte-growth-factor-inhibitory-monoclonal-antibody-in-combination-with-gefitinib-in-asian-patients-with-nsclc
#1
Eng-Huat Tan, Wan-Teck Lim, Myung-Ju Ahn, Quan-Sing Ng, Jin Seok Ahn, Daniel Shao-Weng Tan, Jong-Mu Sun, May Han, Francis C Payumo, Krista McKee, Wei Yin, Marc Credi, Shefali Agarwal, Jaroslaw Jac, Keunchil Park
Hepatocyte growth factor (HGF)/c-Met pathway dysregulation is a mechanism for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Ficlatuzumab (AV-299; SCH 900105), a humanized IgG1 κ HGF inhibitory monoclonal antibody, prevents HGF/c-Met pathway ligand-mediated activation. This phase 1b study assessed the safety/tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of ficlatuzumab plus gefitinib in Asian patients with previously treated advanced non-small cell lung cancer (NSCLC)...
January 18, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29346485/adverse-events-in-facial-implant-surgery-and-associated-malpractice-litigation
#2
Hani M Rayess, Peter Svider, Curtis Hanba, Vivek Sagar Patel, Michael Carron, Giancarlo Zuliani
Importance: Facial implants represent an important strategy for providing instant and long-lasting volume enhancement to address both aging and posttraumatic defects. Objective: To better understand risks of facial implants by examining national resources encompassing adverse events and considerations facilitating associated litigation. Design, Setting, and Participants: A cross-sectional study reviewed complications following facial implants...
January 18, 2018: JAMA Facial Plastic Surgery
https://www.readbyqxmd.com/read/29346478/differentiation-syndrome-associated-with-enasidenib-a-selective-inhibitor-of-mutant-isocitrate-dehydrogenase-2-analysis-of-a-phase-1-2-study
#3
Amir T Fathi, Courtney D DiNardo, Irina Kline, Laurie Kenvin, Ira Gupta, Eyal C Attar, Eytan M Stein, Stephane de Botton
Importance: Enasidenib mesylate, a mutant isocitrate dehydrogenase 2 (IDH2) protein inhibitor that promotes differentiation of leukemic myeloblasts, was recently approved by the US Food and Drug Administration for use in relapsed/refractory (R/R) mutant IDH2 acute myeloid leukemia (AML). During the first study of enasidenib in humans, a minority of patients with advanced myeloid neoplasms experienced unexpected signs/symptoms of a differentiation syndrome (DS), a potentially lethal entity...
January 18, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29346119/the-role-of-tedizolid-in-skin-and-soft-tissue-infections
#4
Emilio Bouza, Patricia Muñoz, Almudena Burillo
PURPOSE OF REVIEW: Tedizolid is a second-generation oxazolidinone with activity against Gram-positive bacteria, including MRSA isolates resistant to linezolid. Pivotal clinical trials showed that tedizolid at 200 mg once-daily for 6 days is not inferior to linezolid 600 mg twice daily for 10 days in patients with SSTI. The comparison of adverse events is favorable to tedizolid under the circumstances of the clinical trials. This is a review of recent literature on tedizolid, its use in special populations and potential adverse effects...
January 15, 2018: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/29345798/clinical-impact-of-pharmacokinetic-interactions-between-the-hcv-protease-inhibitor-simeprevir-and-frequently-used-concomitant-medications
#5
Fiona Marra, Christoph Höner Zu Siederdissen, Saye Khoo, David Back, Michael Schlag, Sivi Ouwerkerk-Mahadevan, Ceyhun Bicer, Isabelle Lonjon-Domanec, Wolfgang Jessner, Maria Beumont-Mauviel, Ronald Kalmeijer, Markus Cornberg
AIMS: Direct-acting antivirals (DAAs) for the treatment of hepatitis C (HCV) can be associated with drug-drug interactions (DDIs) with concomitant medications. The practical clinical implications of such DDIs are poorly understood. We assessed the clinical impact of possible pharmacokinetic (PK) interactions between simeprevir and frequently prescribed concomitant medications. METHODS: This post-hoc analysis pooled data from 9 studies which evaluated simeprevir (SMV)-based interferon-free HCV treatment...
January 18, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29345598/dolutegravir-related-neurological-adverse-events-a-case-report-of-successful-management-with-therapeutic-drug-monitoring
#6
Francois Parant, Patrick Miailhes, Florence Brunel, Marie-Claude Gagnieu
Dolutegravir (DTG), a highly effective second-generation HIV integrase inhibitor with high genetic barrier to resistance, has shown excellent tolerability and safety profiles in clinical trials. However, some patients may experience neurological or psychiatric adverse effects leading to DTG discontinuation. This report describes a case of 29-year-old woman who developed neurological adverse events after starting the DTG-based antiretroviral therapy. Serum DTG concentrations were supra-therapeutic which has required a dosing interval adjustment...
January 16, 2018: Current Drug Safety
https://www.readbyqxmd.com/read/29345153/selective-serotonin-reuptake-inhibitor-use-in-pregnant-women-pharmacogenetics-drug-drug-interactions-and-adverse-effects
#7
Asher Ornoy, Gideon Koren
Possible negative effects of selective serotonin reuptake inhibitors (SSRIs) in pregnancy relate to congenital anomalies, negative perinatal events and neurodevelopmental outcome. Many studies are confounded by the underlying maternal disease and by pharmacogenetic and pharmacokinetic differences of these drugs. Areas covered: The possible interactions of SSRIs and serotonin and norepinephrine reuptake inhibitors with other drugs and the known effects of SSRIs on congenital anomalies, perinatal and neurodevelopmental outcome...
January 18, 2018: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/29344756/the-current-state-of-left-main-percutaneous-coronary-intervention
#8
REVIEW
Harshith R Avula, Andrew N Rassi
PURPOSE OF REVIEW: While coronary artery bypass grafting (CABG) remains the standard of care, advances in stenting technology and procedural technique are changing the role of percutaneous coronary intervention (PCI) in the treatment of severe left main coronary artery (LMCA) disease. We review contemporary evidence comparing PCI and CABG for the treatment of severe LMCA disease, discuss optimal techniques during left main PCI, and provide guidance on studied revascularization strategies within specific patient subgroups...
January 17, 2018: Current Atherosclerosis Reports
https://www.readbyqxmd.com/read/29344680/acute-and-long-term-outcome-of-focal-atrial-tachycardia-ablation-in-the-real-world-results-of-the-german-ablation-registry
#9
Sonia Busch, Mathias Forkmann, Karl-Heinz Kuck, Thorsten Lewalter, Hüseyin Ince, Florian Straube, Heinrich Wieneke, K R Julian Chun, Lars Eckardt, Claus Schmitt, Matthias Hochadel, Jochen Senges, Johannes Brachmann
INTRODUCTION: Catheter ablation of focal atrial tachycardia (FAT) can be a challenging procedure and results have been rarely described. The purpose of this study was to determine the characteristics and results of FAT ablation in the large cohort of the German Ablation Registry. METHODS: The German Ablation Registry is a nationwide prospective multicenter database including 12566 patients who underwent an ablation procedure between 2007 and 2010. Among them 431 (3...
January 17, 2018: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
https://www.readbyqxmd.com/read/29344404/unleashing-the-tiger-iatrogenic-autoimmunity-from-cancer-immunotherapy-drugs
#10
Queenie Luu, Gabor Major
Immune checkpoint inhibitors can lead to the development of organ and non-organ specific immune related adverse events.
January 2018: JRSM Open
https://www.readbyqxmd.com/read/29344329/major-adverse-cardiovascular-event-reduction-with-glp-1-and-sglt2-agents-evidence-and-clinical-potential
#11
REVIEW
Michael E Røder
Treatment of patients with type 2 diabetes is directed against treating symptoms of hyperglycemia, minimizing the risk of hypoglycemia, and the risk of microvascular and macrovascular complications. The majority of patients with type 2 diabetes die from cardiovascular or cerebrovascular disease. Future therapies should therefore focus on reducing cardiovascular morbidity in this high-risk population. Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose co-transporter 2 inhibitors (SGLT2-i) are two drug classes with proven antihyperglycemic effect in type 2 diabetes...
January 2018: Therapeutic Advances in Chronic Disease
https://www.readbyqxmd.com/read/29344327/secukinumab-a-review-of-the-anti-il-17a-biologic-for-the-treatment-of-psoriasis
#12
REVIEW
Jillian Frieder, Dario Kivelevitch, Alan Menter
Psoriasis is a systemic inflammatory disease associated with numerous comorbidities and a profound impact on patients' quality of life. While its complex immune pathogenesis is still not fully delineated, current evidence supports a fundamental role of the T-helper-17 (TH-17) pathway and its related interleukin-17 (IL-17) cytokine. Thus, new antipsoriatic therapies have been developed to block this key cytokine and its downstream effects. Secukinumab is a fully humanized, monoclonal anti-IL-17A antibody, and the first in its class to be approved by the US Food and Drug Administration for the treatment of moderate to severe plaque psoriasis...
January 2018: Therapeutic Advances in Chronic Disease
https://www.readbyqxmd.com/read/29344270/lenvatinib-in-advanced-radioiodine-refractory-thyroid-cancer-a-retrospective-analysis-of-the-swiss-lenvatinib-named-patient-program
#13
Catharina Balmelli, Nikola Railic, Marco Siano, Kristin Feuerlein, Richard Cathomas, Valerie Cristina, Christiane Güthner, Stefan Zimmermann, Sabine Weidner, Miklos Pless, Frank Stenner, Sacha I Rothschild
Purpose: Differentiated thyroid cancer (DTC) accounts for approximately 95% of thyroid carcinomas. In the metastatic RAI-refractory disease, chemotherapy has very limited efficacy and is associated with substantial toxicity. With increasing knowledge of the molecular pathogenesis of DTC, novel targeted therapies have been developed. Lenvatinib is a tyrosine kinase inhibitor (TKI) with promising clinical activity based on the randomized phase III SELECT trial. In Switzerland, a Named Patient Program (NPP) was installed to bridge the time gap to Swissmedic approval...
2018: Journal of Cancer
https://www.readbyqxmd.com/read/29343977/cost-effectiveness-analysis-of-six-therapies-for-the-treatment-of-lower-urinary-tract-symptoms-due-to-benign-prostatic-hyperplasia
#14
James C Ulchaker, Melissa S Martinson
Objective: To conduct a cost-effectiveness analysis from payers' perspectives of six treatments for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and to examine positioning of these modalities in the marketplace for the best use of health care funds and quality-of-life benefits for patients. Methods: The economic analysis was conducted with a Markov model to compare combination prescription drug therapy (ComboRx), minimally invasive therapies (MITs) including convective radiofrequency (RF) water vapor thermal therapy (Rezūm®), conductive RF thermal therapy (Prostiva®), and prostatic urethral lift (UroLift®), and invasive surgical procedures including photovaporization of the prostate (Greenlight® PVP) and transurethral resection of the prostate (TURP)...
2018: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29343945/the-impact-of-pharmaceutical-interventions-on-the-rational-use-of-proton-pump-inhibitors-in-a-chinese-hospital
#15
Chuanwei Xin, Zhu Dong, Mengmeng Lin, Gong-Hua Li
Background: The prescriptions of proton pump inhibitors (PPIs) have raised concern due to both huge increase in medical expenditure and the possible long-term adverse events caused by them; therefore, an approach to taper off the irrational use of PPIs by patients is clinically warranted. The aim of this study was to evaluate the impact of pharmaceutical interventions on the rational use of PPIs. Patients and methods: A single-center, pre- to post-intervention study (pharmaceutical interventions group and control group) was performed in a Chinese hospital...
2018: Patient Preference and Adherence
https://www.readbyqxmd.com/read/29343867/improving-survival-of-acute-on-chronic-liver-failure-patients-complicated-with-invasive-pulmonary-aspergillosis
#16
Jie Gao, Qing Zhang, Yuankui Wu, Ying Li, Tingting Qi, Congyan Zhu, Sijia Liu, Ruoxi Yu, Qinjun He, Weiqun Wen, Fuyuan Zhou, Yongpeng Chen, Jinjun Chen, Jinlin Hou
The mortality of acute-on-chronic liver failure (ACLF) patients complicated with invasive pulmonary aspergillosis (IPA) was extremely high. We aimed to explore prognostic value of the Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) lung score and to establish an optimal voriconazole regimen for ACLF patients complicated with IPA. We retrospectively screened hospitalized ACLF patients in our hospital from July 2011 to April 2016, from which 20 probable IPA cases were diagnosed. Along with onsets of IPA, deteriorated diseases severity, especially lung conditions were found in those 20 ACLF patients...
January 17, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29343586/a-case-of-cardiomyopathy-due-to-premature-ductus-arteriosus-closure-the-flip-side-of-paracetamol
#17
Ingrid Anne Mandy Schierz, Mario Giuffrè, Ettore Piro, Simona La Placa, Giovanni Corsello
Paracetamol (acetaminophen or N-acetyl-p-aminophenol) is considered a safe analgesic and antipyretic nonsteroidal antiinflammatory drug commonly used during pediatric ages and during pregnancy. We report on a term neonate with closed ductus arteriosus, severe cardiomyopathy, right ventricular dysfunction, and functional stenosis of pulmonary arteries at birth after maternal self-medication with paracetamol and consumption of polyphenol-rich foods in late pregnancy. This drug, especially when associated with other vasoconstrictors (such as polyphenols), interferes with prostaglandin metabolism, which seriously accentuates the intrauterine ductus arteriosus constriction and leads to pharmacologic adverse events...
January 17, 2018: Pediatrics
https://www.readbyqxmd.com/read/29343131/safety-and-tolerability-of-plecanatide-in-patients-with-chronic-idiopathic-constipation-long-term-evidence-from-an-open-label-study
#18
Charles F Barish, Patrick Griffin
OBJECTIVE: This multicenter, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC). METHODS: Eligible patients completed a phase 2b or phase 3 double-blind study of plecanatide, or had not previously been treated with plecanatide. Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks. Safety and tolerability were assessed by the incidence, nature, and severity of spontaneously reported treatment-emergent adverse events (TEAEs)...
January 17, 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29342497/non-antipsychotic-catecholaminergic-drugs-for-antipsychotic-induced-tardive-dyskinesia
#19
REVIEW
Hany G El-Sayeh, John Rathbone, Karla Soares-Weiser, Hanna Bergman
BACKGROUND: Tardive dyskinesia (TD) is a disabling movement disorder associated with the prolonged use of antipsychotic medication. Several strategies have been examined in the treatment of TD. Currently, however, there is no clear evidence of the effectiveness of these drugs in TD and they have been associated with many side effects. One particular strategy would be to use pharmaceutical agents which are known to influence the catecholaminergic system at various junctures. OBJECTIVES: 1...
January 18, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29342267/safety-of-single-dose-primaquine-in-g6pd-deficient-and-g6pd-normal-males-in-mali-without-malaria-an-open-label-phase-1-dose-adjustment-trial
#20
Ingrid Chen, Halimatou Diawara, Almahamoudou Mahamar, Koualy Sanogo, Sekouba Keita, Daouda Kone, Kalifa Diarra, Moussa Djimde, Mohamed Keita, Joelle Brown, Michelle E Roh, Jimee Hwang, Helmi Pett, Maxwell Murphy, Mikko Niemi, Bryan Greenhouse, Teun Bousema, Roly Gosling, Alassane Dicko
Background: The World Health Organization recommendation on the use of single low-dose primaquine (SLD-PQ) to reduce Plasmodium falciparum malaria transmission requires more safety data. Methods: We conducted an open-label, non-randomized, dose-adjustment trial of the safety of three single doses of primaquine in glucose-6-phosphate dehydrogenase (G6PD)-deficient adult males in Mali, followed by an assessment of safety in G6PD-deficient boys ages 11-17 years, and 5-10 years, including G6PD-normal control groups...
January 12, 2018: Journal of Infectious Diseases
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