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Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/29330882/rate-of-cough-during-treatment-with-angiotensin-converting-enzyme-inhibitors-a-meta-analysis-of-randomized-placebo-controlled-trials
#1
Davor Vukadinović, Aleksandra Nikolovska Vukadinović, Daniel Lavall, Ulrich Laufs, Stefan Wagenpfeil, Michael Böhm
Use of protective angiotensin converting enzyme inhibitors (ACE-I) in patients with cardiovascular diseases (CVD) is sometimes limited by incident coughing. In clinical trials cough occurred also on placebo. We performed a meta-analysis including randomized, placebo-controlled trials reporting cough on ACE-I in patients with CVD. We evaluated the attributable fraction of cough on ACE-I accounting rate on placebo: placebo-adjusted ACE-I (%) = (ACE-I (%) - Placebo (%))/ACE-I (%). 65,054 patients from 22 included studies were analyzed...
January 13, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29330855/getting-innovative-therapies-faster-to-patients-at-the-right-dose-impact-of-quantitative-pharmacology-towards-first-registration-and-expanding-therapeutic-use
#2
Satyaprakash Nayak, Oliver Sander, Nidal Al-Huniti, Dinesh de Alwis, Anne Chain, Marylore Chenel, Soujanya Sunkaraneni, Shruti Agrawal, Neeraj Gupta, Sandra A G Visser
Quantitative pharmacology (QP) applications in translational medicine, drug-development, and therapeutic use were crowd-sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial-burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model-informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy...
January 13, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29330847/interchangeability-of-generic-drugs-a-non-parametric-pharmacokinetic-model-of-gabapentin-generic-drugs
#3
P J Glerum, Y Yu, W M Yamada, M N Neely, M Maliepaard, D M Burger, C Neef
Substitution by generic drugs is allowed when bioequivalence to the originator drug has been established. However, it is known that similarity in exposure may not be achieved at every occasion for all individual patients when switching between formulations. The ultimate aim of our research is to investigate if pharmacokinetic subpopulations exist when subjects are exposed to bioequivalent formulations. For that purpose, we developed a pharmacokinetic model for gabapentin, based on data from a previously conducted bioavailability study comparing gabapentin exposure following administration of the gabapentin originator and three generic gabapentin formulations in healthy subjects...
January 13, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29328506/underuse-of-vitamin-k-antagonist-and-direct-oral-anticoagulants-for-stroke-prevention-in-patients-with-atrial-fibrillation-a-contemporary-review
#4
REVIEW
Jonathan C Hsu, James V Freeman
No abstract text is available yet for this article.
January 12, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29328503/challenges-and-opportunities-with-oncology-drug-development-in-china
#5
REVIEW
Gaurav Bajaj, Manish Gupta, Hwei-Gene Heidi Wang, Jeffrey S Barrett, Matthew Tan, Katrin Rupalla, Richard Bertz, Jennifer Sheng
No abstract text is available yet for this article.
January 12, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29327356/gene-specific-variant-classifier-dpyd-varifier-to-identify-deleterious-alleles-of-dihydropyrimidine-dehydrogenase
#6
Shikshya Shrestha, Cheng Zhang, Calvin R Jerde, Qian Nie, Hu Li, Steven M Offer, Robert B Diasio
Deleterious variants in dihydropyrimidine dehydrogenase (DPD, DPYD gene) can be highly predictive of clinical toxicity to the widely prescribed chemotherapeutic 5-fluorouracil (5-FU). However, there is very limited data pertaining to the functional consequences of the >450 reported non-synonymous DPYD variants. We developed a DPYD-specific variant classifier (DPYD-Varifier) using machine learning and in vitro functional data for 156 missense DPYD variants. The developed model showed 85% accuracy and outperformed other in silico prediction tools...
January 12, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29322503/antiretroviral-therapy-with-efavirenz-in-hiv-infected-pregnant-women-understanding-the-possible-mechanisms-for-drug-drug-interaction
#7
LETTER
Nuggehally R Srinivas
No abstract text is available yet for this article.
January 11, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29322501/response-to-antiretroviral-therapy-with-efavirenz-in-hiv-infected-pregnant-women-understanding-the-possible-mechanisms-for-drug-drug-interaction
#8
LETTER
Prasanna Jagannathan, Richard Kajubi, Francesca T Aweeka
No abstract text is available yet for this article.
January 11, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29319159/leveraging-big-data-in-pediatric-development-programs-proceedings-from-the-2016-american-college-of-clinical-pharmacology-annual-meeting-symposium
#9
REVIEW
Lily Yeruk Mulugeta, Lynne Yao, Diane Mould, Brian Jacobs, Jeffrey Florian, Brian Smith, Vikram Sinha, Jeffrey S Barrett
This article discusses the use of big data in pediatric drug development. The article covers key topics discussed at the ACCP annual meeting symposium in 2016 including the extent to which big data or real-world data can inform clinical trial design and substitute for efficacy and safety data typically obtained in clinical trials. The current states of use, opportunities, and challenges with the use of big data in future pediatric drug development are discussed.
January 10, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29315510/developing-drugs-for-heart-failure-with-reduced-ejection-fraction-hfref-what-have-we-learned-from-clinical-trials
#10
REVIEW
Markus Hinder, B Alexander Yi, Thomas H Langenickel
No abstract text is available yet for this article.
January 9, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29315508/changing-prescribing-behavior-in-the-united-states-moving-upstream-in-opioid-prescription-education
#11
H Jean, C Wiese, Raven R Piercey, Claire D Clark
In the U.S., deaths from prescription opioids have quadrupled since 1999, prompting authorities to declare an "opioid abuse" crisis. Rising overdose deaths were attributed to trends in the over-prescription of opioids, specifically the strength and duration of the initial prescription. We describe educational interventions designed to control health care professionals' (HCP) opioid prescribing in the wake of this crisis. A review of relevant programs for practicing providers, medical residents, and medical students reveals a focus on educational interventions that we describe, borrowing from sociologist John McKinlay's metaphor for public health interventions, as "downstream...
January 9, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29315506/optimization-of-voriconazole-therapy-for-the-treatment-of-invasive-fungal-infections-in-adults
#12
Naveen Mangal, Issam Hamadeh, Meghan J Arwood, Larisa H Cavallari, Tanay S Samant, Kenneth P Klinker, Jurgen Bulitta, Stephan Schmidt
Therapeutic concentrations of voriconazole in invasive fungal infections (IFIs) are ensured using drug monitoring approach, which relies on attainment of steady state pharmacokinetics. For voriconazole, time to reach steady state can vary from 5-7 days, not optimal for critically ill patients. We developed a population pharmacokinetic/pharmacodynamic model-based approach to predict doses which can maximize the net benefit (probability of efficacy - probability of adverse events) and ensure therapeutic concentrations, early on during treatment...
January 9, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29315504/physiologically-based-pharmacokinetic-model-qualification-and-reporting-procedures-for-regulatory-submissions-a-consortium-perspective
#13
REVIEW
Mohamad Shebley, Punam Sandhu, Arian Emami Riedmaier, Masoud Jamei, Rangaraj Narayanan, Aarti Patel, Sheila Annie Peters, Venkatesh Pilla Reddy, Ming Zheng, Loeckie de Zwart, Maud Beneton, Francois Bouzom, Jun Chen, Yuan Chen, Yumi Cleary, Christiane Collins, Gemma L Dickinson, Nassim Djebli, Heidi J Einolf, Iain Gardner, Felix Huth, Faraz Kazmi, Feras Khalil, Jing Lin, Aleksandrs Odinecs, Chirag Patel, Haojing Rong, Edgar Schuck, Pradeep Sharma, Shu-Pei Wu, Yang Xu, Shinji Yamazaki, Kenta Yoshida, Malcolm Rowland
No abstract text is available yet for this article.
January 9, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29315502/a-genome-wide-association-study-identifies-a-candidate-gene-associated-with-atazanavir-exposure-measured-in-hair
#14
Bani Tamraz, Yong Huang, Audrey L French, Seble Kassaye, Kathryn Anastos, Marek J Nowicki, Stephen Gange, Deborah R Gustafson, Peter Bacchetti, Ruth M Greenblatt, Pirro G Hysi, Bradley E Aouizerat
Hair provides a direct measure of long-term exposure of atazanavir (ATV). We report the results of the first genome-wide association study (GWAS) of ATV exposure measured in hair in an observational cohort representative of U.S. women living with HIV; the Women's Interagency HIV Study. Approximately 14.1 million SNPs were analyzed in linear regression-based GWAS, with replication, adjusted for non-genetic predictors collected under conditions of actual use of ATV in 398 participants. Lastly, the PharmGKB database was used to identify pharmacogene associations with ATV exposure...
January 9, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29313952/how-to-consider-rare-genetic-variants-in-personalized-drug-therapy
#15
Volker M Lauschke, Magnus Ingelman-Sundberg
Personalized drug therapy aims to optimize the efficacy of pharmacological treatments by considering genetic, pathophysiological, dietary, and environmental factors as well as comedications and compliance. A multitude of associations between the specific genetic constitution of the patient and drug pharmacokinetics and pharmacodynamics has been identified in the last decades that encompass mainly common single nucleotide variants (SNVs) and gene copy number variations (CNVs) of importance for the function of genes encoding drug-metabolizing enzymes and transporters involved in drug absorption, distribution, metabolism, and excretion (ADME)...
January 5, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29285767/opioid-neonatal-abstinence-syndrome-an-overview
#16
Scott L Wexelblatt, Jennifer M McAllister, Amy T Nathan, Eric S Hall
Opioid neonatal abstinence syndrome (NAS) refers to signs of withdrawal observed in infants experiencing intrauterine opioid exposures. Early identification of at-risk infants allows for the prompt initiation of nonpharmacologic supportive care. When withdrawal symptoms are severe despite these interventions, pharmacologic therapy including opioid weaning is initiated. Consistency with standardized nonpharmacologic approaches as well as stringent weaning protocols are important in minimizing the length of stay and length of pharmacologic treatment for these vulnerable patients...
December 29, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29285753/biobanks-in-the-era-of-digital-medicine
#17
Gunnar Jacobs, Andreas Wolf, Michael Krawczak, Wolfgang Lieb
Digitalization is currently permeating virtually all sectors of modern societies, including biomedical research and medical care. At the same time, biobanks engaged in the long-term storage of biological samples that are fit for purpose have become key drivers in both fields. The present article highlights some of the challenges and opportunities that biobanking is facing in the current proverbial "era of digitalization."
December 29, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29285751/endogenous-metabolites-mediated-communication-between-oat1-oat3-and-oatp1b1-may-explain-the-association-between-slco1b1-snps-and-methotrexate-toxicity
#18
David Martinez, Kienana Muhrez, Jean-Baptiste Woillard, Aline Berthelot, Emmanuel Gyan, Sylvain Choquet, Christian R Andrès, Pierre Marquet, Chantal Barin-Le Guellec
Although OATP1B1 is not expressed in the kidney, polymorphisms in SLCO1B1 have been associated with methotrexate clearance or toxicity. This unexpected pharmacogenetic association may reflect remote communication between liver and kidney transporters. This study confirms the pharmacogenetic association with methotrexate toxicity in adult patients with hematological malignancies. Using a targeted urinary metabolomics approach, we identified 38 and 34 metabolites which were differentially excreted between wild-type and carriers of the c...
December 29, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29285750/the-use-of-stem-cell-therapy-to-reverse-opioid-tolerance
#19
Fei Li, LiPing Liu, Kathleen Cheng, Zhongbo Chen, Jianguo Cheng
Opioid tolerance (OT) and opioid-induced hyperalgesia (OIH) are major challenges in medicine. Here we report that transplantation of mesenchymal stem cells (MSCs) prevented and reversed OT and OIH in rats and mice. The preventive and therapeutic effects were long-lasting and consistent across different assessment schemes. Both intrathecal and intravenous transplantations were effective and safe. This emerging therapeutic strategy has thus shown promise to impact clinical practice and improve the efficacy and safety of opioid therapy...
December 29, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29285749/prognostic-circulating-microrna-biomarkers-in-early-stage-non-small-cell-lung-cancer-a-role-for-mir-150
#20
Erik A C Wiemer
Circulating microRNA biomarkers can be indicators of early-stage non-small cell lung cancer (NSCLC) but may also hold prognostic value. The ability to predict prognosis of early-stage NSCLC is important, as it may potentially impact patient outcome. Studies to define these prognostic microRNA biomarkers are urgently needed. Also, insight into the biological significance of the microRNA biomarker in the cancer cell-and within the tumor-may reveal novel and therapeutically interesting signaling networks.
December 29, 2017: Clinical Pharmacology and Therapeutics
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