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European Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28108782/contextualizing-patient-care-opportunities-for-pharmacotherapy-education
#1
LETTER
David J Brinkman, Jelle Tichelaar, Michiel A van Agtmael
No abstract text is available yet for this article.
January 20, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28108781/potentially-inappropriate-medications-predictor-for-mortality-in-a-cohort-of-community-dwelling-older-adults
#2
Mariana Martins Gonzaga do Nascimento, Juliana Vaz de Melo Mambrini, Maria Fernanda Lima-Costa, Josélia Oliveira Araújo Firmo, Sérgio William Viana Peixoto, Antônio Ignácio de Loyola Filho
PURPOSE: The objective of this study was to investigate whether the potentially inappropriate medication (PIM) use is a predictor for mortality in a community-based population of older adults. METHODS: A cohort study was performed between January 1, 1997, and December 31, 2011, based on data from a representative sample of the population aged 60 years or older living in Bambuí, Brazil. Univariate and multivariate analyses of the association between the variable of interest (use of PIM or pharmacological groups of PIM) and mortality were based on the extended Cox model for proportional hazards...
January 20, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28105514/%C3%A1
#3
(no author information available yet)
No abstract text is available yet for this article.
January 20, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28105513/pharmacokinetics-of-ginkgolides-a-b-and-k-after-single-and-multiple-intravenous-infusions-and-their-interactions-with-midazolam-in-healthy-chinese-male-subjects
#4
Feng Shao, Hongwen Zhang, Lijun Xie, Juan Chen, Sufeng Zhou, Jinsong Zhang, Jinru Lv, Weiwen Hao, Yunsu Ma, Yun Liu, Ning Ou, Wei Xiao
PURPOSE: Ginkgo terpene lactones meglumine injection (GMI) is a novel preparation of traditional Chinese medicine that contains ginkgolides A, B and K (GA, GB, GK, respectively) as its primary components. In this study we evaluated the safety, tolerability and pharmacokinetics of these three ginkgolides after single and multiple intravenous infusions of GMI. We also investigated the effect of GMI on cytochrome P450 3A4 (CYP3A4) in healthy Chinese volunteers. METHODS: In this open-label, placebo-controlled study 15 subjects were randomly assigned to receive GMI or matched placebo (4:1 ratio)...
January 20, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28101657/levodopa-carbidopa-microtablets-in-parkinson-s-disease-a-study-of-pharmacokinetics-and-blinded-motor-assessment
#5
Marina Senek, Sten-Magnus Aquilonius, Håkan Askmark, Filip Bergquist, Radu Constantinescu, Anders Ericsson, Sara Lycke, Alexander Medvedev, Mevludin Memedi, Fredrik Ohlsson, Jack Spira, Jerker Westin, Dag Nyholm
BACKGROUND: Motor function assessments with rating scales in relation to the pharmacokinetics of levodopa may increase the understanding of how to individualize and fine-tune treatments. OBJECTIVES: This study aimed to investigate the pharmacokinetic profiles of levodopa-carbidopa and the motor function following a single-dose microtablet administration in Parkinson's disease. METHODS: This was a single-center, open-label, single-dose study in 19 patients experiencing motor fluctuations...
January 18, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28101656/off-label-use-of-antimicrobials-in-neonates-in-a-tertiary-children-s-hospital
#6
Niina Laine, Ann Marie Kaukonen, Kalle Hoppu, Marja Airaksinen, Harri Saxen
PURPOSE: Off-label (OL) use of drugs for hospitalized children is very common. OL use occurs especially in the youngest patients, neonates. This study focused on the OL use of antimicrobials in neonates. To our knowledge, only few studies have focused on the prevalence of OL use of antimicrobials in neonates. METHODS: We investigated the OL use of antimicrobials in neonates in a tertiary children's hospital. First, we investigated what were the most consumed OL antimicrobials in defined daily doses according to hospital's registry data from neonatal intensive care unit (NICU) during 2009-2014...
January 18, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28093640/polypharmacy-and-potentially-inappropriate-medications-a-cross-sectional-analysis-among-451-nursing-homes-in-france
#7
Marie Herr, Helene Grondin, Stéphane Sanchez, Didier Armaingaud, Caroline Blochet, Antoine Vial, Philippe Denormandie, Joël Ankri
PURPOSE: The quality of drug therapy is an important issue for nursing homes. This study aimed to assess the prevalence of polypharmacy and potentially inappropriate medications (PIMs) in a large sample of nursing home residents by using the data recorded during the preparation of pill dispensers. METHODS: This is a cross-sectional study that included 451 nursing homes across France. Information about the medications received by the 30,702 residents (73.8% women) living in these nursing homes was extracted from the system that assists in the preparation of pill dispensers in pharmacies...
January 16, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28091704/medical-students-medication-communication-skills-regarding-drug-prescription-a-qualitative-analysis-of-simulated-physician-patient-consultations
#8
Katarina Hauser, Jan Matthes
PURPOSE: Poor medication communication of physicians to patients is detrimental, e.g. for medication adherence. Reasons for physicians' deficits in medication communication may be unfavourable conditions in daily practice or already insufficient training during their (undergraduate) medical studies. We explored medical students' communication on new medications in simulated physician-patient conversations to identify actual deficits indicating apparent educational needs. METHODS: Fifth year medical students attending a mandatory course at the University of Cologne had simulated physician-patient consultations aiming at drug prescription...
January 14, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28091703/bolus-application-of-landiolol-and-esmolol-comparison-of-the-pharmacokinetic-and-pharmacodynamic-profiles-in-a-healthy-caucasian-group
#9
Günther Krumpl, Ivan Ulc, Michaela Trebs, Pavla Kadlecová, Juri Hodisch
PURPOSE: The aim of this prospective study was to compare in non-Asian subjects the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of two short-acting cardioselective β1-adrenergic antagonists, landiolol and esmolol, after administration of three different bolus dosages. MATERIALS AND METHODS: We conducted a single-center, prospective, double-blinded, randomized study in three cross-over periods with 12 healthy subjects (7 women and 5 men, mean age of 24...
January 13, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28091702/platelet-receptor-gene-p2y12-p2y1-and-platelet-glycoprotein-gene-gpiiia-polymorphisms-are-associated-with-antiplatelet-drug-responsiveness-and-clinical-outcomes-after-acute-minor-ischemic-stroke
#10
Xingyang Yi, Qiang Zhou, Chun Wang, Jing Lin, Ping Liu, Cheng Fu
PURPOSE: Patients with minor ischemic stroke (MIS) are at high risk of recurrent ischemic stroke (RIS). The aim of this study was to evaluate the effects of platelet receptor gene (P2Y12, P2Y1) and glycoprotein gene (GPIIIa) polymorphisms, as well as their interactions, on antiplatelet drug responsiveness and clinical outcomes in patients with acute MIS. METHODS: We prospectively enrolled 426 patients with acute MIS who had been receiving combined aspirin and clopidogrel treatment for at least 3 months...
January 13, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28083650/association-between-n-desethylamiodarone-amiodarone-ratio-and-amiodarone-induced-thyroid-dysfunction
#11
Mikie Yamato, Kyoichi Wada, Mai Fujimoto, Kouichi Hosomi, Tomohiro Hayashi, Akira Oita, Mitsutaka Takada
PURPOSE: We used a retrospective data mining approach to explore the association between serum amiodarone (AMD) and N-desethylamiodarone (DEA) concentrations and thyroid-related hormone levels. METHODS: Laboratory data sets from January 2012 to April 2016 were extracted from the computerized hospital information system database at the National Cerebral and Cardiovascular Center (NCVC). Data sets that contained serum AMD and DEA concentrations and thyroid function tests, including thyroid-stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3), were analyzed...
January 12, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28070601/use-of-antidepressants-and-the-risk-of-cardiovascular-and-cerebrovascular-disease-a-meta-analysis-of-observational-studies
#12
A Biffi, L Scotti, G Corrao
PURPOSE: This study aims to systematically review studies quantifying the associations between antidepressants (ADs) use and the risk of cardiovascular (CV) outcomes. METHODS: Medline was searched to October 2015 for full text articles in English. Prospective cohort and case-control studies were admitted if they investigated the relationship between current use of ADs as a whole, tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs), and the onset CV events...
January 9, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28064355/population-pharmacokinetic-models-of-lamotrigine-in-different-age-groups-of-chinese-children-with-epilepsy
#13
Zhong-Bin Zhang, Shuang-Min Ji, Ying Han, Li-Li Zang, Ying-Hui Wang, Wei Lu, Li Wang, Ye Wu
PURPOSE: The study aims to establish population pharmacokinetic (PPK) models of lamotrigine (LTG) in different age groups of epileptic children by nonlinear mixed effect modelling(NONMEM), and provide essential tools and theoretical basis for individualised optimal drug dose. METHODS: Cases of 473 epileptic children were divided into infant, toddler and preschool age (≤6 years) (n = 211), school age (6-12 years) (n = 171) and adolescence age (>12 years) (n = 81)...
January 7, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28064354/can-systematic-reviews-contribute-to-regulatory-decisions
#14
REVIEW
Corrado Barbui, Antonio Addis, Laura Amato, Giuseppe Traversa, Silvio Garattini
INTRODUCTION: The new call on independent research on drugs issued in October 2016 by the Italian Medicines Agency (AIFA) explicitly reported that proposals based on systematic reviews were not admissible, and no justification or explanation for this choice was given. Prompted by this policy decision, here, we briefly discuss the potential usefulness of systematic reviews in responding to regulatory needs. First, systematic reviews, by collecting, analysing and critically appraising all relevant studies on a specific topic, may be used by different stakeholders as a basis for making clinical and policy recommendations, including regulatory recommendations...
January 7, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28064353/who-is-a-healthy-subject-consensus-results-on-pivotal-eligibility-criteria-for-clinical-trials
#15
REVIEW
Kerstin Breithaupt-Groegler, Christoph Coch, Martin Coenen, Frank Donath, Katharina Erb-Zohar, Klaus Francke, Karin Goehler, Mario Iovino, Klaus Peter Kammerer, Gerd Mikus, Jens Rengelshausen, Hildegard Sourgens, Reinhard Schinzel, Thomas Sudhop, Georg Wensing
INTRODUCTION/METHODS: A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolling stakeholders from the pharmaceutical industry, contract research organisations, academia, ethics committees and competent authority. RESULTS: Pivotal eligibility criteria were defined for trials with new investigational medicinal products (IMPs) or with clinically established IMPs...
January 7, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28050623/clinical-relevance-of-the-stopp-start-criteria-in-hip-fracture-patients
#16
Johan Lönnbro, Susanna M Wallerstedt
PURPOSE: The aim of this study was to investigate the clinical relevance of potentially inappropriate medications (PIMs), identified by the STOPP criteria, and potential prescribing omissions (PPOs), identified by the START criteria, and to identify predictors for clinically relevant PIMs and PPOs. METHODS: The STOPP and START criteria were applied on the medication lists of 200 older hip fracture patients, consecutively recruited to a randomized controlled study in 2009...
January 3, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28035437/does-substitution-of-brand-name-medications-by-generics-differ-between-pharmacotherapeutic-classes-a-population-based-cohort-study-in-france
#17
Alicia Molinier, Aurore Palmaro, Vanessa Rousseau, Agnès Sommet, Robert Bourrel, Jean-Louis Montastruc, Haleh Bagheri
PURPOSE: The purpose of this study was to measure the rate of substitution failure to generic antiepileptic drugs (AEDs) compared to two other pharmacotherapeutic classes (neuroleptics, beta-blockers). METHODS: We conducted a cohort study involving beneficiaries of the French health insurance system from January 2009 to November 2012. Substitution failure to generic drugs was estimated by the rate of switchback (i.e. from generic drug back to its branded drug). We selected the patients who had a dispensation of a branded AED for 60 days or more during the 90 days preceding the generic substitution...
December 29, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28035436/six-year-activity-on-approval-of-compassionate-use-of-medicines-by-the-ethics-committee-of-the-university-hospital-of-bologna-italy-time-to-update-rules-and-recommendations
#18
Nicola Montanaro, Mauro Melis, Stefania Proni, Giacomo Chiabrando, Domenico Motola
PURPOSE: Compassionate use of forthcoming drugs has become an increasing pathway through which patients can take advantage of promising medicines. We aimed to analyse the main features of the requests of compassionate use submitted to the Independent Ethics Committee (IEC) of the University Hospital of Bologna in the period 2010-2015. METHODS: The present analysis concerns the requests of compassionate use received by the IEC in the period 2010-2015. For each requested drug, we paired the date of the first request to our IEC with the date(s) of (a) submission to EMA, (b) CHMP positive opinion, and (c) European marketing authorization (if issued)...
December 29, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28028587/safety-of-zidovudine-lamivudine-scored-tablets-in-children-with-hiv-infection-in-europe-and-thailand
#19
Ali Judd
BACKGROUND: Zidovudine (ZDV) has been associated with risk of haematological toxicity. Safety data from clinical trials is generally limited to 48 weeks. We assessed the short- and mid-term toxicity of ZDV/lamivudine (3TC) fixed-dose combination scored tablets in HIV-infected children followed in the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) network. METHODS: Fourteen cohorts provided data on patients <18 years of age taking ZDV/3TC scored tablets between 2008 and 2012...
December 27, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28028586/role-of-mirna-and-its-potential-as-a-novel-diagnostic-biomarker-in-drug-induced-liver-injury
#20
REVIEW
Sukumaran Sanjay, Chandrashekaran Girish
PURPOSE: MicroRNAs (miRNA or miR) are the most abundant and stable class of small RNA. Unlike the typical RNA molecules present in the cell, they do not encode proteins but can control translation. and Hhence, they are found to play a major role in the regulation of cellular processes. miRNAs have been shown to differentially regulate various genes, and the expression levels of some miRNAs changes several fold in liver and serum, during drug- induced toxicity. This review summarises some of the latest findings about the biological functions of miRNA and its potential use as diagnostic biomarkers in drug- induced liver injury...
December 27, 2016: European Journal of Clinical Pharmacology
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