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European Journal of Clinical Pharmacology

Clara Blanchard, Denis Pouchain, Paul Vanderkam, Marie-Christine Perault-Pochat, Rémy Boussageon, Hélène Vaillant-Roussel
AIM: Phloroglucinol is a musculotropic anti-spasmodic drug. It is frequently prescribed in many European countries with a considerable cost for health services. The purpose of this study was to review the existing randomised controlled trials (RCT) comparing the efficacy of phloroglucinol treating abdominal pain versus placebo. METHODS: A literature search was carried out up to May 2017 to select RCT comparing the effect of phloroglucinol versus placebo with intensity of abdominal pain as an endpoint...
January 19, 2018: European Journal of Clinical Pharmacology
Shansen Xu, Limin Liu, Yanan Chen, Mei Liu, Tong Lu, Huanxin Wang, Shihao Liu, Mingming Zhao, Limei Zhao
PURPOSE: The aims of this study were to develop a population pharmacokinetic (PPK) model of lamotrigine (LTG) in Chinese epileptic children by using nonlinear mixed effects modeling (NONMEM) and to investigate the effects of valproic acid (VPA) and genetic polymorphisms of the major metabolizing enzymes (UGT1A4, UGT2B7) on the pharmacokinetics of LTG. METHODS: A total of 182 epileptic children who were treated with LTG as monotherapy or as part of combination therapy were included in this study as the model group, and 61 patients were included as the validation group...
January 16, 2018: European Journal of Clinical Pharmacology
Sharmin S Bala, Sujita W Narayan, Prasad S Nishtala
PURPOSE: The prescription of potentially inappropriate medications (PIMs) is associated with an increase in adverse events, prescribing cascades, high health-care costs, morbidity, and mortality in the elderly. The overarching objective of this study is to examine the prevalence of PIMs in the elderly, applying the 2012 American Geriatrics Society Beers criteria for the study period 2012-2014, and the updated 2015 Beers criteria for 2015. METHODS: The study population (N = 70,479) included a continuously recruited national cohort of community-dwelling older (aged ≥ 65 years) New Zealanders who had undertaken the International Resident Assessment Instrument-Home Care (interRAI-HC) assessments between September 2012 and October 2015...
January 12, 2018: European Journal of Clinical Pharmacology
Günther Krumpl
No abstract text is available yet for this article.
January 10, 2018: European Journal of Clinical Pharmacology
Guenther Frank, Robert Denham Fitzgerald
No abstract text is available yet for this article.
January 8, 2018: European Journal of Clinical Pharmacology
François Montastruc, Anne Bénard-Laribière, Pernelle Noize, Elodie Pambrun, Fabienne Diaz-Bazin, Marie Tournier, Bernard Bégaud, Antoine Pariente
PURPOSE: The present study was conducted to describe antipsychotic (AP) prevalent and incident use, characteristics of AP users, and their trends in the French population. METHODS: A cross-sectional study was repeated yearly from January 1, 2007 to December 31, 2013 (for prevalence analysis) or to December 31, 2012 (for incidence analysis) using the French Health Insurance reimbursement database (Echantillon Généraliste de Bénéficiaires, EGB). For each year studied, prevalent and incident AP users were described in terms of age and gender overall, and according to the type of AP (FGAPs or SGAPs) used at index date...
January 6, 2018: European Journal of Clinical Pharmacology
Kevin J Freise, Beibei Hu, Ahmed Hamed Salem
PURPOSE: Venetoclax is a selective BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). It is predominately metabolized by cytochrome P450 (CYP) 3A. The study objective was to determine the effect of different dosage regimens of ritonavir, a strong CYP3A inhibitor, on the pharmacokinetics of venetoclax in 20 healthy subjects. METHODS: In cohorts 1 and 2, subjects received single 10 mg doses of venetoclax in periods 1 and 2 and a single 50- or 100-mg dose of ritonavir in period 2...
January 4, 2018: European Journal of Clinical Pharmacology
Kristian Svendsen, Mollie Wood, Erika Olsson, Hedvig Nordeng
PURPOSE: Despite FDA and EMA warnings of long-term use, little is known regarding the time to onset (TTO) of neurological adverse drug reactions (ADR) for metoclopramide. The aims of this study were, first, to evaluate whether neurological ADRs are more commonly reported for metoclopramide than for other medications, and second, to describe how time to onset of neurological ADRs differs by age and gender. METHODS: All ADR reports with metoclopramide as the suspected/interacting drug were extracted from the WHOs Global ADR database Vigibase® between 1967 and May 2016...
December 30, 2017: European Journal of Clinical Pharmacology
Yi Jin, Hubert Borell, Anne Gardin, Mike Ufer, Felix Huth, Gian Camenisch
PURPOSE: The purpose of the study is to investigate the enzyme(s) responsible for siponimod metabolism and to predict the inhibitory effects of fluconazole as well as the impact of cytochrome P450 (CYP) 2C9 genetic polymorphism on siponimod pharmacokinetics (PK) and metabolism. METHODS: In vitro metabolism studies were conducted using human liver microsomes (HLM), and enzyme phenotyping was assessed using a correlation analysis method. SimCYP, a physiologically based PK model, was developed and used to predict the effects of fluconazole and CYP2C9 genetic polymorphism on siponimod metabolism...
December 22, 2017: European Journal of Clinical Pharmacology
Emelie Wolgast, Ann Josefsson, Martin Josefsson, Caroline Lilliecreutz, Margareta Reis
PURPOSE: In Sweden, information on drug use during pregnancy is obtained through an interview and recorded in a standardized medical record at every visit to the antenatal care clinic throughout the pregnancy. Antenatal, delivery, and neonatal records constitute the basis for the Swedish Medical Birth Register (MBR). The purpose of this exploratory study was to investigate the reliability of reported drug use by simultaneous screening for drug substances in the blood stream of the pregnant woman and thereby validate self-reported data in the MBR...
December 20, 2017: European Journal of Clinical Pharmacology
Eva-Stina Hemmingsson, Maria Gustafsson, Ulf Isaksson, Stig Karlsson, Yngve Gustafson, Per-Olof Sandman, Hugo Lövheim
PURPOSE: Many elderly people living in nursing homes experience pain and take analgesic medication. The aim of this study was to analyze the prevalence of pain and pharmacological pain treatment among people living in nursing homes in Sweden, in two large, comparable, samples from 2007 to 2013. METHODS: Cross-sectional surveys were performed in 2007 and 2013, including all residents in nursing homes in the county of Västerbotten, Sweden. A total of 4933 residents (2814 and 2119 respectively) with a mean age of 84...
December 20, 2017: European Journal of Clinical Pharmacology
Novkovic Mirjana, Matic Dragan, Kusic-Tisma Jelena, Antonijevic Nebojsa, Radojkovic Dragica, Rakicevic Ljiljana
PURPOSE: Bleeding is one of the possible adverse events during clopidogrel therapy. The CYP2C19 gene is the most significant genetic factor which influences response to clopidogrel treatment. We aimed to examine the contribution of the CYP2C19 gene to bleeding occurrence during clopidogrel therapy in Serbian patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). METHODS: This case-control study included 53 patients who experienced bleeding and 55 patients without bleeding...
December 19, 2017: European Journal of Clinical Pharmacology
Camille Morival, Richard Westerlynck, Guillaume Bouzillé, Marc Cuggia, Pascal Le Corre
AIM: Our aim was to describe prevalence, nature, and level of severity of potential statin drug-drug interactions in a university hospital. METHODS: In a cross-sectional study, statin drug-drug interactions were screened from medical record of 10,506 in-patients treated stored in the clinical data warehouse "eHOP." We screened drug-drug interactions using Theriaque and Micromedex drug databases. RESULTS: A total of 22.5% of patients were exposed to at least one statin drug-drug interaction...
December 18, 2017: European Journal of Clinical Pharmacology
Kristian Svendsen, Kjell H Halvorsen, Solveig Vorren, Hilde Samdal, Beate Garcia
PURPOSE: Spontaneous reporting of adverse drug reactions (ADRs) is a cornerstone in pharmacovigilance. However, information about the underlying consumption of drugs is rarely used when analysing spontaneous reports. The purpose of this study was to combine ADR reports with drug consumption data to demonstrate the additional information this gives in various scenarios, comparing different drugs, gender-stratified sub-populations and changes in reporting over time. METHODS: We combined all Norwegian ADR reports in 2004-2013 from the EudraVigilance database (n = 14...
December 18, 2017: European Journal of Clinical Pharmacology
Lucía Jiménez-Pichardo, Rocío Gázquez-Pérez, Jesús Francisco Sierra-Sánchez
PURPOSE: The purpose of the study is to analyse the degree of prescribers' knowledge about the regulation and variability in manufacturing processes (MP) in bio-drugs "innovators" (BI). METHODS: For each selected drugs, the date of authorization by the European Medicines Agency, time elapsed until the first change, total number of changes and annual rate of change (ARC) were recorded. A survey was designed with 4 parts: (a) identifying the BI prescribed; (b) knowledge of the number and ARC of each BI during its MP; (c) knowledge of comparability requirement of BI before or after the MP; (d) evaluating the utility of the information in the survey...
December 15, 2017: European Journal of Clinical Pharmacology
Zhixiong Zhong, Jingyuan Hou, Qifeng Zhang, Bin Li, Cunren Li, Zhidong Liu, Min Yang, Wei Zhong, Xuebo He, Hesen Wu, Miaocai Zhong, Pingsen Zhao
BACKGROUND AND OBJECTIVES: The objective of this study is to evaluate the effects of cytochrome P450 2C19 (CYP2C19) polymorphism on adverse cardiovascular events (MACE) in Hakka patients with acute coronary syndrome (ACS) receiving clopidogrel who had undergone coronary drug-eluting stent placement after percutaneous coronary intervention (PCI) in southern China. METHODS: Genotyping of CYP2C19 and MACE of 934 ACS patients with PCI on clopidogrel maintenance therapy were analyzed...
December 14, 2017: European Journal of Clinical Pharmacology
Ping Wang, Xiao-Qian Lin, Wen-Ke Cai, Gui-Li Xu, Meng-Di Zhou, Mei Yang, Gong-Hao He
PURPOSE: Valproic acid (VPA) is one of the most widely used antiepileptic drugs. Recently, increasing evidence suggested that polymorphisms in UGT2B7 gene were associated with VPA pharmacokinetics, but results remained controversial. Therefore, a meta-analysis was performed to derive a more precise evaluation between C802T, C161T, and G211T polymorphisms and plasma concentration of VPA. METHODS: The PubMed, EMBASE, and the Cochrane library databases were searched for eligible studies...
December 14, 2017: European Journal of Clinical Pharmacology
R A Charlton, V Bettoli, H J Bos, A Engeland, E Garne, R Gini, A V Hansen, L T W de Jong-van den Berg, S Jordan, K Klungsøyr, A J Neville, A Pierini, A Puccini, M Sinclair, D Thayer, H Dolk
PURPOSE: Pregnancy prevention programmes (PPPs) exist for some medicines known to be highly teratogenic. It is increasingly recognised that the impact of these risk minimisation measures requires periodic evaluation. This study aimed to assess the extent to which some of the data needed to monitor the effectiveness of PPPs may be present in European healthcare databases. METHODS: An inventory was completed for databases contributing to EUROmediCAT capturing pregnancy and prescription data in Denmark, Norway, the Netherlands, Italy (Tuscany/Emilia Romagna), Wales and the rest of the UK, to determine the extent of data collected that could be used to evaluate the impact of PPPs...
December 11, 2017: European Journal of Clinical Pharmacology
A E C A B Willemsen, L M Knapen, Y M de Beer, R J M Brüggemann, S Croes, C M L van Herpen, N P van Erp
PURPOSE: Everolimus treatment is seriously hampered by its toxicity profile. As a relationship between everolimus exposure and effectiveness and toxicity has been established, early and ongoing concentration measurement can be key to individualize the dose and optimize treatment outcomes. Dried blood spot (DBS) facilitates sampling at a patients' home and thereby eases dose individualization. The aim of this study is to determine the agreement and predictive performance of DBS compared to whole blood (WB) to measure everolimus concentrations in cancer patients...
December 8, 2017: European Journal of Clinical Pharmacology
Michael Mcfarlane, B Liu, C Nwokolo
PURPOSE: Domperidone is thought to accelerate gastric emptying via D2 receptor antagonism at the gastro-oesophageal and gastro-duodenal junctions. Listed in the BNF as a prokinetic anti-emetic, it has been used in video capsule endoscopy (VCE) to accelerate capsule delivery to the small intestine. We audited VCEs performed at UHCW from 2011, when as standard practice, domperidone was given pre-VCE, to 2012, after its discontinuation due to doubts about its effectiveness. METHODS: Thirty-one patients received oral domperidone 20 mg pre-VCE...
December 8, 2017: European Journal of Clinical Pharmacology
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