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https://www.readbyqxmd.com/read/29667896/a-phase-1-study-to-assess-the-pharmacokinetics-safety-and-tolerability-of-fremanezumab-doses-225-mg-675-mg-and-900-mg-in-japanese-and-caucasian-healthy-subjects
#1
Orit Cohen-Barak, Sivan Weiss, Michele Rasamoelisolo, Nicola Faulhaber, Paul P Yeung, Pippa S Loupe, Esther Yoon, Mohit D Gandhi, Ofer Spiegelstein, Ernesto Aycardi
Objectives The primary and secondary objectives of this phase 1 study were to evaluate the pharmacokinetic profile, safety, and immunogenicity of fremanezumab subcutaneous (sc) doses tested in phase 2 and 3 trials (225 mg, 675 mg and 900 mg) following single administration in Japanese (n = 32) and Caucasian (n = 32) healthy subjects. Methods Japanese and matched Caucasian healthy subjects were enrolled into one of four cohorts and were randomly assigned to one of four treatments: 225, 675, or 900 mg fremanezumab, or placebo...
January 1, 2018: Cephalalgia: An International Journal of Headache
https://www.readbyqxmd.com/read/29667842/the-role-of-pcsk9-inhibitors-in-the-treatment-of-hypercholesterolemia
#2
Roshni S Patel, Emily M Scopelliti, Oludamilola Olugbile
OBJECTIVE: To evaluate the efficacy, safety, and cost-effectiveness of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors and describe its place in therapy for the treatment of hypercholesterolemia. DATA SOURCES: A search of MEDLINE, CINAHL, and Clinicaltrials.gov was performed from January 2012 to March 2018 to identify literature pertaining to PCSK9 inhibitors using pre-specified search terms. Additional references were identified from citations of the literature...
April 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29667769/targeting-the-phosphatidylinositol-3-kinase-akt-mechanistic-target-of-rapamycin-signaling-pathway-in-b-lineage-acute-lymphoblastic-leukemia-an-update
#3
REVIEW
Carolina Simioni, Alberto M Martelli, Giorgio Zauli, Marco Vitale, James A McCubrey, Silvano Capitani, Luca M Neri
Despite considerable progress in treatment protocols, B-lineage acute lymphoblastic leukemia (B-ALL) displays a poor prognosis in about 15-20% of pediatric cases and about 60% of adult patients. In addition, life-long irreversible late effects from chemo- and radiation therapy, including secondary malignancies, are a growing problem for leukemia survivors. Targeted therapy holds promising perspectives for cancer treatment as it may be more effective and have fewer side effects than conventional therapies. The phosphatidylinositol 3-phosphate kinase (PI3K)/Akt/mechanistic target of rapamycin (mTOR) signaling pathway is a key regulatory cascade which controls proliferation, survival and drug-resistance of cancer cells, and it is frequently upregulated in the different subtypes of B-ALL, where it plays important roles in the pathophysiology, maintenance and progression of the disease...
April 18, 2018: Journal of Cellular Physiology
https://www.readbyqxmd.com/read/29667584/pharmacist-interventions-during-patient-rounds-in-two-intensive-care-units-clinical-and-financial-impact
#4
B E Bosma, P M L A van den Bemt, P H G J Melief, J van Bommel, S S Tan, N G M Hunfeld
INTRODUCTION: The risk of prescribing errors and related adverse drug events (ADE) on the intensive care unit (ICU) is high. Based on studies carried out in North America or the UK, a clinical pharmacy service can reduce ADEs and lower overall costs. This study looks into the clinical and financial impact of interventions made by pharmacists during patient rounds in two ICU settings in the Netherlands. MATERIALS AND METHODS: A quality improvement study was performed in a general teaching hospital (GTH) and a university hospital (UH) in the Netherlands...
April 2018: Netherlands Journal of Medicine
https://www.readbyqxmd.com/read/29667438/the-tolerability-and-safety-profile-of-patiromer-a-novel-polymer-based-potassium-binder-for-the-treatment-of-hyperkalemia
#5
Bertram Pitt, Dahlia Garza
Hyperkalemia (HK) occurs often among patients with chronic kidney disease (CKD) and heart failure (HF) and those treated with renin-angiotensin-aldosterone system inhibitors (RAASI). Even small deviations from normal potassium levels carry increased risk of mortality. Patiromer is approved for treatment of HK and has been shown in clinical trials to reduce serum potassium among patients with HK and comorbid conditions. Areas covered: We review pooled data from two clinical trials of patiromer in patients with CKD and HK, safety of patiromer in special populations, drug-drug interaction (DDI) studies, and other studies in healthy volunteers...
April 18, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29667415/rectal-diclofenac-does-not-prevent-post-ercp-pancreatitis-in-consecutive-high-risk-and-low-risk-patients
#6
Lourdes Del Olmo Martínez, Benito Velayos Jiménez, Ana Almaraz Gómez
OBJECTIVE: rectal diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that is used to prevent pancreatitis in high-risk patients during endoscopic retrograde cholangiopancreatography (ERCP). The European Society of Gastrointestinal Endoscopy (ESGE) recommends the use of prophylaxis with indomethacin or diclofenac in all patients undergoing ERCP, including those at low or intermediate risk of pancreatitis. A study to investigate the efficacy of this recommendation was performed...
April 18, 2018: Revista Española de Enfermedades Digestivas
https://www.readbyqxmd.com/read/29667263/assumptions-made-when-preparing-drug-exposure-data-for-analysis-have-an-impact-on-results-an-unreported-step-in-pharmacoepidemiology-studies
#7
Stephen R Pye, Thérèse Sheppard, Rebecca M Joseph, Mark Lunt, Nadyne Girard, Jennifer S Haas, David W Bates, David L Buckeridge, Tjeerd P van Staa, Robyn Tamblyn, William G Dixon
PURPOSE: Real-world data for observational research commonly require formatting and cleaning prior to analysis. Data preparation steps are rarely reported adequately and are likely to vary between research groups. Variation in methodology could potentially affect study outcomes. This study aimed to develop a framework to define and document drug data preparation and to examine the impact of different assumptions on results. METHODS: An algorithm for processing prescription data was developed and tested using data from the Clinical Practice Research Datalink (CPRD)...
April 17, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29667175/first-line-drugs-for-hypertension
#8
REVIEW
James M Wright, Vijaya M Musini, Rupam Gill
BACKGROUND: This is the first update of a review published in 2009. Sustained moderate to severe elevations in resting blood pressure leads to a critically important clinical question: What class of drug to use first-line? This review attempted to answer that question. OBJECTIVES: To quantify the mortality and morbidity effects from different first-line antihypertensive drug classes: thiazides (low-dose and high-dose), beta-blockers, calcium channel blockers, ACE inhibitors, angiotensin II receptor blockers (ARB), and alpha-blockers, compared to placebo or no treatment...
April 18, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29666812/tumor-progression-the-neuronal-input
#9
REVIEW
Marco Arese, Federico Bussolino, Margherita Pergolizzi, Laura Bizzozero, Davide Pascal
One of the challenges of cancer is its heterogeneity and rapid capacity to adapt. Notwithstanding significant progress in the last decades in genomics and precision medicine, new molecular targets and therapies appear highly necessary. One way to approach this complex problem is to consider cancer in the context of its cellular and molecular microenvironment, which includes nerves. The peripheral nerves, the topic of this review, modulate the biological behavior of the cancer cells and influence tumor progression, including the events related to the metastatic spread of the disease...
March 2018: Annals of Translational Medicine
https://www.readbyqxmd.com/read/29666753/effect-of-metformin-monotherapy-on-serum-lipid-profile-in-statin-na%C3%A3-ve-individuals-with-newly-diagnosed-type-2-diabetes-mellitus-a-cohort-study
#10
Szu Han Lin, Po Chung Cheng, Shih Te Tu, Shang Ren Hsu, Yun Chung Cheng, Yu Hsiu Liu
Background: Cardiovascular disease is a major cause of mortality and morbidity in people with type 2 diabetes mellitus (T2DM). Studies have consistently identified dyslipidemia as an important risk factor for the development of macrovascular disease. The landmark United Kingdom Prospective Diabetes Study has shown that metformin therapy reduces cardiovascular events in overweight people with T2DM. This study investigates the effect of metformin monotherapy on serum lipid profile in statin-naïve individuals with newly diagnosed T2DM, and whether the effect, if any, is dosage-related...
2018: PeerJ
https://www.readbyqxmd.com/read/29666296/phase-ii-study-to-evaluate-the-efficacy-and-safety-of-rilotumumab-and-bevacizumab-in-subjects-with-recurrent-malignant-glioma
#11
Mary Lou Affronti, Jennifer Gamboa Jackman, Frances McSherry, James E Herndon, Elwood C Massey, Eric Lipp, Annick Desjardins, Henry S Friedman, Gordana Vlahovic, James Vredenburgh, Katherine B Peters
LESSONS LEARNED: Due to evolving imaging criteria in brain tumors and variation in magnetic resonance imaging evaluation, it is not ideal to use response rate as a primary objective. Future studies involving antiangiogenic agents should use overall survival.Disease-expected toxicities should be considered when defining the clinical significance of an adverse event. For example, vascular thromboembolic events are common in brain tumor patients and should not be attributed to the study drug in the safety analysis...
April 17, 2018: Oncologist
https://www.readbyqxmd.com/read/29666232/tunable-cytotoxic-aptamer-drug-conjugates-for-the-treatment-of-prostate-cancer
#12
Bethany Powell Gray, Linsley Kelly, Douglas P Ahrens, Ashley P Barry, Christina Kratschmer, Matthew Levy, Bruce A Sullenger
Therapies that can eliminate both local and metastatic prostate tumor lesions while sparing normal organ tissue are desperately needed. With the goal of developing an improved drug-targeting strategy, we turned to a new class of targeted anticancer therapeutics: aptamers conjugated to highly toxic chemotherapeutics. Cell selection for aptamers with prostate cancer specificity yielded the E3 aptamer, which internalizes into prostate cancer cells without targeting normal prostate cells. Chemical conjugation of E3 to the drugs monomethyl auristatin E (MMAE) and monomethyl auristatin F (MMAF) yields a potent cytotoxic agent that efficiently kills prostate cancer cells in vitro but does not affect normal prostate epithelial cells...
April 16, 2018: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/29666228/deep-learning-improves-prediction-of-drug-drug-and-drug-food-interactions
#13
Jae Yong Ryu, Hyun Uk Kim, Sang Yup Lee
Drug interactions, including drug-drug interactions (DDIs) and drug-food constituent interactions (DFIs), can trigger unexpected pharmacological effects, including adverse drug events (ADEs), with causal mechanisms often unknown. Several computational methods have been developed to better understand drug interactions, especially for DDIs. However, these methods do not provide sufficient details beyond the chance of DDI occurrence, or require detailed drug information often unavailable for DDI prediction. Here, we report development of a computational framework DeepDDI that uses names of drug-drug or drug-food constituent pairs and their structural information as inputs to accurately generate 86 important DDI types as outputs of human-readable sentences...
April 16, 2018: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/29665971/dissecting-the-signaling-features-of-the-multi-protein-complex-gpcr-%C3%AE-arrestin-erk1-2
#14
REVIEW
Gabriel Carmona-Rosas, Rocío Alcántara-Hernández, David Alejandro Hernández-Espinosa
G protein-coupled receptors (GPCRs) have emerged as key biological entities that regulate a plethora of physiological processes and participate in the onset and development of many diseases. Moreover, these receptors are important targets of almost 25% of the current therapeutic drugs in the market. Upon agonist binding, GPCRs activate a great number of signaling pathways, resulting in important cellular events like gene transcription, survival, proliferation and differentiation. In order to activate such events, GPCRs interact with a variety of scaffold and molecular entities, particularly with G proteins, but also with β-arrestins and the extracellular signal-regulated kinases 1 and 2 (ERK1/2) pathway, forming unique signaling modules...
April 4, 2018: European Journal of Cell Biology
https://www.readbyqxmd.com/read/29665906/-imatinib-as-second-line-treatment-drug-for-cml-patients-intolerant-to-nilotinib
#15
Jing Qi, You-Hai Xu, He-Sheng He
OBJECTIVE: To explore the individualized treatment for patient with chronic phase chronic myeloid leukemia(CML-CP). METHODS: The clinical data and treatment process of one CML-CP patient which intolerated to nilotinib were analyzed. RESULTS: Nilotinib was given to the patient once the diagnosis of CML-CP was set. Although major molecular remission (MMR) and complete cytogenetic remission (CCyR) were obtained during treatment for 3 months, a grade 3-4 hepatotoxicity appeared in the course of treatment...
April 2018: Zhongguo Shi Yan Xue Ye Xue za Zhi
https://www.readbyqxmd.com/read/29665901/-clinical-efficacy-of-nopho-aml-2004-regimen-for-treatment-of-children-with-acute-myelocytic-leukemia-non-m3
#16
Kun-Yin Qiu, Xiong-Yu Liao, Ke Huang, Yang Li, Wen-Jun Weng, Hong-Gui Xu, Jian-Pei Fang, Ruo-Hao Wu, Dun-Hua Zhou
OBJECTIVE: To investigate the efficacy and safety of NOPHO-AML 2004 chemotherapy regimen for treatment of children with acute myelocytic leukemia(non-M3). METHODS: Thirty-three patients aged 1-13 with acute myelocytic leukemia (non-M3) were diagnosed from January 2013 to June 2017. FAB typing showed that 1 case in M0, 4 cases in M1, 12 cases in M2, 5 cases in M4, 8 cases in M5, 1 case in M6, and 2 cases in M7; Risk stratification showed that: 19 cases in standard risk, and 14 cases in high risk...
April 2018: Zhongguo Shi Yan Xue Ye Xue za Zhi
https://www.readbyqxmd.com/read/29665860/the-use-of-cangrelor-with-heparin-for-left-ventricular-assist-device-implantation-in-a-patient-with-acute-heparin-induced-thrombocytopenia
#17
Yan K Gernhofer, Michael Ross, Swapnil Khoche, Victor Pretorius
BACKGROUND: Optimal anticoagulation strategy for cardiopulmonary bypass (CPB) in end-stage heart failure patients with heparin-induced thrombocytopenia (HIT) requiring left ventricular assist device (LVAD) implantation remains uncertain. Presently, there are no large-scale randomized studies comparing outcomes of alternative anticoagulation strategies for CPB in this patient population. A novel antiplatelet agent - cangrelor, which is a potent P2Y12 inhibitor with robust antiplatelet efficacy, rapid reversibility, and measurable drug effect, has become available since 2015...
April 17, 2018: Journal of Cardiothoracic Surgery
https://www.readbyqxmd.com/read/29665549/combination-of-cyp2c19-genotype-with-non-genetic-factors-evoking-phenoconversion-improves-phenotype-prediction
#18
Ádám Ferenc Kiss, Dorottya Vaskó, Máté Tamás Déri, Katalin Tóth, Katalin Monostory
BACKGROUND: CYP2C19 is an important drug-metabolizing enzyme, responsible for metabolism of approximately 10% of the drugs on the market. Large inter-individual differences exist in metabolic activities, which are primarily attributed to genetic polymorphism of CYP2C19 gene. Conflicting results have been published about the role of CYP2C19 polymorphisms in metabolism of CYP2C19 substrates and clinical outcomes; thus, we aimed to investigate CYP2C19 genotype-phenotype associations, and we sought to elicit potential causes of discrepancies in the genotype-based prediction by incorporating the liver donors' demographic data, drug administration events and pathological conditions...
December 5, 2017: Pharmacological Reports: PR
https://www.readbyqxmd.com/read/29665491/methamphetamine-use-and-future-risk-for-parkinson-s-disease-evidence-and-clinical-implications
#19
REVIEW
Julia M Lappin, Shane Darke, Michael Farrell
BACKGROUND: Methamphetamine use has been posited to be a risk factor for the development of Parkinson's disease (PD) and parkinsonism. The clinical implications of a potential association between methamphetamine use and PD are considered. METHODS: A review of methamphetamine and PD and parkinsonism was conducted, including evidence from animal models, clinical and population studies. RESULTS: There is biological plausibility to a link between methamphetamine use and PD...
April 10, 2018: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/29665445/acute-kidney-injury-during-treatment-with-high-dose-cloxacillin-a-report-of-23-cases-and-literature-review
#20
Aurélie Lavergne, Cécile Vigneau, Elisabeth Polard, Louise Triquet, Nathalie Rioux-Leclercq, Pierre Tattevin, Léonard Golbin
BACKGROUND: International guidelines recommend high-dose cloxacillin for endocarditis or osteoarticular infections due to meticillin-susceptible staphylococci. However, data on the tolerability of these regimens are scarce. METHODS: We used the computerized registry of suspected drug-related adverse events in our institution. Cases of acute kidney injury (AKI), as defined by KDIGO, in patients receiving high-dose cloxacillin, were retrospectively reviewed. Data were collected from medical charts on a standardized questionnaire...
April 14, 2018: International Journal of Antimicrobial Agents
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