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European Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/27913837/hospitalizations-due-to-preventable-adverse-reactions-a-systematic-review
#1
REVIEW
Nidhi S Patel, Tejas K Patel, Parvati B Patel, Viren N Naik, C B Tripathi
PURPOSE: The study aimed to measure the percentage of preventable adverse drug reactions that lead to the hospitalization (PADRAd) and to explore the heterogeneity in its estimation through subgroup analysis of study characteristics. METHODS: Two investigators independently searched in electronic databases and related bibliography for prospective studies involving PADRAd. We excluded studies investigating medication errors and spontaneous and retrospective reporting...
December 2, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27909740/clinical-pharmacokinetics-of-magnesium-sulfate-in-the-treatment-of-children-with-severe-acute-asthma
#2
Joseph E Rower, Xiaoxi Liu, Tian Yu, Michael Mundorff, Catherine M T Sherwin, Michael D Johnson
PURPOSE: Intravenous (IV) magnesium sulfate (MgSO4) is used as adjunct therapy to treat acute asthma exacerbations. Despite its clinical use, there is a limited understanding of the disposition of magnesium in children. METHODS: To explore the pharmacokinetics (PK) of IV MgSO4 in this population, we collected retrospective data from 54 children who received IV MgSO4 for treatment of an acute asthma exacerbation at Primary Children's Hospital in Salt Lake City, UT...
December 2, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27909739/quantification-of-anticholinergic-and-sedative-drug-load-with-the-drug-burden-index-a-review-of-outcomes-and-methodological-quality-of-studies
#3
REVIEW
Hans Wouters, Helene van der Meer, Katja Taxis
PURPOSE: The Drug Burden Index (DBI) is a non-invasive method to quantify patients' anticholinergic and sedative drug burden from their prescriptions. This systematic review aimed to summarise the evidence on the associations between the DBI and clinical outcomes and methodological quality of studies. METHODS: A search in PubMed and Embase (search terms: 'drug', 'burden', and 'index') was performed and experts were contacted. We excluded publications that did not report empirical results or clinical outcomes...
December 1, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27900402/effects-of-ugt1a9-genetic-polymorphisms-on-monohydroxylated-derivative-of-oxcarbazepine-concentrations-and-oxcarbazepine-monotherapeutic-efficacy-in-chinese-patients-with-epilepsy
#4
Yao Lu, Youxin Fang, Xunyi Wu, Chunlai Ma, Yue Wang, Lan Xu
AIM: The human UDP-glucuronosyltransferase which is genetically polymorphic catalyzes glucuronidations of various drugs. The interactions among UGT1A4, UGT1A6, UGT1A9, and UGT2B15 genetic polymorphisms, monohydroxylated derivative (MHD) of oxcarbazepine (OXC) plasma concentrations, and OXC monotherapeutic efficacy were explored in 124 Chinese patients with epilepsy receiving OXC monotherapy. METHOD: MHD is the major active metabolite of OXC, and its plasma concentration was measured using high-performance liquid chromatography when patients reached their maintenance dose of OXC...
November 29, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27896379/seizure-and-tetany-secondary-to-hypomagnesaemic-hypoparathyroidism-induced-by-a-proton-pump-inhibitor
#5
LETTER
Luca Pasina, Danilo Zanotta, Silvana Puricelli, Guido Bonoldi
No abstract text is available yet for this article.
November 28, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27889835/valproic-acid-reduces-hair-loss-and-improves-survival-in-patients-receiving-temozolomide-based-radiation-therapy-for-high-grade-glioma
#6
Shinichi Watanabe, Yui Kuwabara, Satoshi Suehiro, Daisuke Yamashita, Mamoru Tanaka, Akihiro Tanaka, Shiro Ohue, Hiroaki Araki
PURPOSE: Valproic acid (VPA), a histone deacetylase (HDAC) inhibitor, is also used to manage seizures in glioblastoma patients. HDAC inhibitors can protect normal cells and tissues from the deleterious effects of radiotherapy, and VPA is reported to improve the survival of glioblastoma patients receiving chemoradiation therapy. VPA also promotes hair growth, and thus has the potential to reduce the radiotherapy side effect of hair loss while improving the survival of patients with glioblastoma...
November 26, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27889834/antiepileptic-drug-use-in-italian-children-over-a-decade
#7
Daria Putignano, Antonio Clavenna, Rita Campi, Angela Bortolotti, Ida Fortino, Luca Merlino, Aglaia Vignoli, Maria Paola Canevini, Maurizio Bonati
PURPOSE: The aim of the study was to evaluate prescription profiles of antiepileptic drugs (AEDs) and to assess hospitalizations and specialist visits in pediatric patients with epilepsy. METHODS: The data sources were administrative health databases of Italy's Lombardy Region, which collect prescriptions for drugs, diagnostic tests, specialist visits, and hospital discharge forms. All patients aged 0-16 years with at least seven AED (group N03A of the International Anatomical Therapeutic Chemical Classification) prescriptions over two consecutive years between 2003 and 2010 were identified and classified as prevalent or incident cases (no prescriptions in two previous years)...
November 26, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27889833/factors-associated-with-expression-of-extrapyramidal-symptoms-in-users-of-atypical-antipsychotics
#8
Susana Barbosa Ribeiro, Aurigena Antunes de Araújo, Caroline Addison Xavier Medeiros, Katarina Melo Chaves, Maria do Socorro Costa Feitosa Alves, Antonio Gouveia Oliveira, Rand Randall Martins
PURPOSE: The aim of this study was to investigate factors associated with the occurrence of extrapyramidal symptoms (EPS) in users of second-generation antipsychotics (SGA). METHODS: Observational cross-sectional study based on a random sample of subjects from three outpatient clinics. Inclusion criteria were age between 18 and 65 years, of both genders, with a diagnosis of schizophrenia and under the use of a single SGA agent. Subjects who had received i.m. long-acting antipsychotics in the past were excluded...
November 26, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27889832/effects-of-cytochrome-p450-cyp3a4-and-cyp2c19-inhibition-and-induction-on-the-exposure-of-selumetinib-a-mek1-2-inhibitor-in-healthy-subjects-results-from-two-clinical-trials
#9
Angela W Dymond, Karen So, Paul Martin, Yifan Huang, Paul Severin, David Mathews, Eleanor Lisbon, Gabriella Mariani
PURPOSE: Two phase I, open-label trials in healthy subjects assessed whether co-administration with CYP3A4/CYP2C19 inhibitors, itraconazole/fluconazole (study A), or CYP3A4 inducer, rifampicin (study B), affects the exposure, safety/tolerability and pharmacokinetics of selumetinib and its metabolite N-desmethyl selumetinib. METHODS: In study A (n = 26), subjects received a single dose of selumetinib 25 mg and, after 4 days of washout, were randomized to treatment 1 (itraconazole 200 mg twice daily on days 1-11) or treatment 2 (fluconazole 400 mg on day 1 then 200 mg/day on days 2-11) plus co-administration of single-dose selumetinib 25 mg on day 8 (selumetinib staggered 4 h after itraconazole/fluconazole dose); Twenty-one days after discharge/washout, subjects received the alternate treatment...
November 26, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27885399/absolute-oral-bioavailability-of-selexipag-a-novel-oral-prostacyclin-ip-receptor-agonist
#10
Priska Kaufmann, Noémie Hurst, Béatrice Astruc, Jasper Dingemanse
PURPOSE: The aim of this single-center, open-label study was to assess the absolute bioavailability of an oral (tablet) versus intravenous (i.v.) formulation of selexipag in healthy subjects. METHODS: A pilot phase in three healthy male subjects, which preceded the main study, consisted of a single 20-minute i.v. infusion of 50 μg selexipag. Its objectives were to ensure the safety of the i.v. formulation and to select the i.v. dose for the main study. The main study had a randomized, two-way crossover design in 16 healthy male subjects...
November 24, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27885398/real-world-risk-of-diabetes-with-antipsychotic-use-in-older-new-zealanders-a-case-crossover-study
#11
Prasad S Nishtala, Te-Yuan Chyou
PURPOSE: The primary aim was to examine and compare the increased risk of incident diabetes associated with second-generation antipsychotics (SGAs) and first-generation antipsychotics (FGAs), with and without adjusting for potential confounding factors. The secondary aim was to recalculate the relative risks of diabetes onset using a semi-symmetric bidirectional case-crossover (SSBC) design to adjust for time-trend bias. METHOD: Prescription records (2005-2015) of antipsychotics were sourced from New Zealand Pharmaceutical Collections...
November 24, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27866243/monitoring-of-adherence-to-headache-treatments-by-means-of-hair-analysis
#12
Anna Ferrari, Manuela Licata, Cecilia Rustichelli, Carlo Baraldi, Daniele Vandelli, Filippo Marchesi, Federica Palazzoli, Patrizia Verri, Enrico Silingardi
PURPOSE: The aim of this study was to evaluate the potential of hair analysis to monitor medication adherence in headache patients undergoing chronic therapy. For this purpose, the following parameters were analyzed: the detection rate of 23 therapeutic drugs in headache patients' hair, the degree of agreement between the self-reported drug and the drug found in hair, and whether the levels found in hair reflected the drug intake reported by the patients. METHODS: The study included 93 patients suffering from primary headaches declaring their daily intake of at least one of the following drugs during the 3 months before the hair sampling: alprazolam, amitriptyline, citalopram, clomipramine, clonazepam, delorazepam, diazepam, duloxetine, fluoxetine, flurazepam, levomepromazine, levosulpiride, lorazepam, lormetazepam, mirtazapine, paroxetine, quetiapine, sertraline, topiramate, trazodone, triazolam, venlafaxine, and zolpidem...
November 20, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27864592/evaluation-of-5-fluorouracil-degradation-rate-and-pharmacogenetic-profiling-to-predict-toxicity-following-adjuvant-capecitabine
#13
Michela Roberto, Adriana Romiti, Andrea Botticelli, Federica Mazzuca, Luana Lionetto, Giovanna Gentile, Ida Paris, Rosa Falcone, Maria Bassanelli, Francesca Romana Di Pietro, Concetta Elisa Onesti, Elisabetta Anselmi, Serena Macrini, Maurizio Simmaco, Paolo Marchetti
BACKGROUND: On account of the lack of predictive biomarkers of toxicity, we investigated whether polymorphisms of genes involved in fluoropyrimidine metabolism and 5-fluorouracil (5-FU) degradation rate were associated with outcomes of adjuvant capecitabine in patients with early stage gastrointestinal cancers. METHODS: Genotyping of DPYD GIVS14A, MTHFR C677T and A1298C SNPs were performed by pyro-sequencing technology. PCR analysis was used for genotyping TYMS-TSER...
November 18, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27858108/effects-of-ranitidine-antacid-food-and-formulation-on-the-pharmacokinetics-of-fostamatinib-results-from-five-phase-i-clinical-studies
#14
Talia Flanagan, Paul Martin, Michael Gillen, David Mathews, Eleanor Lisbon, Martin Kruusmägi
PURPOSE: Fostamatinib is an orally dosed phosphate prodrug that is cleaved by intestinal alkaline phosphatase to the active metabolite R406. Clinical studies were performed to assess the effect of food and ranitidine on exposure, to support in vitro-in vivo relationships (IVIVR) understanding and formulation transitions and to investigate absolute oral bioavailability. METHODS: A series of in vitro dissolution and clinical pharmacokinetic studies were performed to support the design and introduction of a new formulation, understand the impact of changes in in vitro dissolution on in vivo performance for two fostamatinib formulations, to characterize the effects of food and ranitidine on exposure, and determine the absolute oral bioavailability...
November 17, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27853825/clindamycin-hydrochloride-and-clindamycin-phosphate-two-drugs-or-one-a-retrospective-analysis-of-a-spontaneous-reporting-system
#15
LETTER
Haona Li, Jianxiong Deng, Zhihua Yue, Yiexiang Zhang, He Sun, Xuequn Ren
No abstract text is available yet for this article.
November 16, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27838760/improved-participants-understanding-of-research-information-in-real-settings-using-the-sidcer-informed-consent-form-a-randomized-controlled-informed-consent-study-nested-with-eight-clinical-trials
#16
Nut Koonrungsesomboon, Thipaporn Tharavanij, Kittichet Phiphatpatthamaamphan, Ratha-Korn Vilaichone, Sudsayam Manuwong, Parichat Curry, Sith Siramolpiwat, Thanachai Punchaipornpon, Supakit Kanitnate, Nattapol Tammachote, Rodsarin Yamprasert, Waipoj Chanvimalueng, Ruchirat Kaewkumpai, Soiphet Netanong, Peerapong Kitipawong, Paskorn Sritipsukho, Juntra Karbwang
PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial...
November 12, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27837337/public-confidence-in-adr-identification-and-their-views-on-adrreporting-mixed-methods-study
#17
Narumol Jarernsiripornkul, Arunrot Patsuree, Janet Krska
PURPOSE: The value of patients as potential reporters into pharmacovigilance systems is acknowledged worldwide and allowed in Thailand. However, nothing is known about the Thai public's awareness of direct patient reporting facility or their views concerning it. This study aimed to determine confidence among members of the public in identifying suspected adverse drug reactions (ADRs), information sources they use and their views towards direct ADR reporting. METHODS: Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with members of the public recruited in primary care centres, pharmacies and public places during October 2013 to February 2015...
November 11, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27826643/association-between-antithrombotic-treatment-and-hemorrhagic-stroke-in-patients-with-atrial-fibrillation-a-cohort-study-in-primary-care
#18
Per Wändell, Axel C Carlsson, Martin Holzmann, Johan Ärnlöv, Sven-Erik Johansson, Jan Sundquist, Kristina Sundquist
OBJECTIVE: The objective of this study was to study the association between antithrombotic treatment and risk of hemorrhagic stroke (HS) in patients with atrial fibrillation (AF) treated in primary health care. METHODS: Study population included all adults (n = 12,215) 45 years and older diagnosed with AF at 75 primary care centers in Sweden 2001-2007. Outcome was defined as a first hospital episode with a discharge episode of HS after the AF diagnosis. Association between HS and persistent treatment with antithrombotic agents (warfarin, acetylsalicylic acid (ASA), clopidogrel) was explored using Cox regression analysis, with hazard ratios (HRs) and 95 % CIs...
November 8, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27819122/erratum-to-carriers-of-genetic-variants-in-the-hnf1a-gene-are-more-common-among-dead-opioid-addicts-than-among-living-addicts
#19
Anh Nguyen, Tore B Stage, Søren Feddersen, Dorte J Christoffersen, Mette Marie H Christensen, Per Damkier, Jørgen L Thomsen, Kim Brøsen
No abstract text is available yet for this article.
November 7, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27796467/an-evaluation-of-the-completeness-of-drug-drug-interaction-related-information-in-package-inserts
#20
Giok Qin Ng, Grant Edward Sklar, Hui Ting Chng
PURPOSE: The project aimed to evaluate the completeness of drug-drug interaction (DDI)-related information in package inserts (PIs) and develop a systematic approach to conduct the evaluation. METHODS: DDI-related information in the branded PIs of statins, macrolides, protease inhibitors and selected drugs of narrow therapeutic index (DNTI) were evaluated against the criteria distilled from the Food and Drug Administration (FDA) labelling recommendation guidance document...
October 29, 2016: European Journal of Clinical Pharmacology
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