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European Journal of Clinical Pharmacology

Tatjana Welzel, Victoria C Ziesenitz, Salome Waldvogel, Sabrina Scheidegger, Peter Weber, Johannes N van den Anker, Verena Gotta
No abstract text is available yet for this article.
January 15, 2019: European Journal of Clinical Pharmacology
Wen-Bin Rui, Hui-Min An, Kun Shao, Xiao-Hui Zhai, Jia-Qian Lu, Shan-Shan Hu, Bing Chen, Pei-Jun Zhou
OBJECTIVES: Valganciclovir (VGCV) treatment is recommended for the prevention of cytomegalovirus (CMV) infection in renal allograft recipients. The aim of the present study is to investigate the pharmacokinetic characteristics of ganciclovir (GCV) after administration of VGCV in Chinese adult renal allograft recipients and estimate the exposure to GCV using limited sampling strategy (LSS). METHODS: Forty Chinese renal allograft recipients were given 450 mg or 900 mg VGCV daily...
January 14, 2019: European Journal of Clinical Pharmacology
Dario Cattaneo, Stefania Cheli, Marta Fusi, Emilio Clementi, Cristina Gervasoni
No abstract text is available yet for this article.
January 9, 2019: European Journal of Clinical Pharmacology
Ruggero Lasala, Fiorenzo Santoleri, Alessia Romagnoli, Felice Musicco, Alberto Costantini
PURPOSE: The aim of this study was to evaluate in what measure is dosage adjustment particularly prevalent in pivotal clinical trials of oral targeted therapy drugs approved by the European Medicine Agency as of July 31, 2018, for the treatment of solid tumors. METHODS: We performed a search on the official EMA site on human medicines, using as Keyword Search the ATC Code L01X (other antineoplastic agents); from the list of drugs results, we subsequently excluded antineoplastic drugs for hematological diseases, as well as refused and withdrawn drugs...
January 8, 2019: European Journal of Clinical Pharmacology
Paul Vanderkam, Clara Blanchard, Florian Naudet, Denis Pouchain, Helene Vaillant Roussel, Marie Christine Perault-Pochat, Nematollah Jaafari, Rémy Boussageon
PURPOSE: To assess the efficacy of acetylleucine to improve or stop an attack of vertigo and dizziness (vertigo/dizziness). METHODS: Systematic review by 2 independent reviewers. Consultation of the Medline, Cochrane and databases until September 2018. Keywords used: Acetylleucine, Tanganil®, Acetyl-DL-leucine, Acetyl-leucine. Trial selection: randomised controlled trials (RCTs) comparing acetylleucine against placebo. RESULTS: Up until 2018, no RCTs have been published on the efficacy of acetylleucine in vertigo/dizziness...
January 6, 2019: European Journal of Clinical Pharmacology
Ningyuan Zhang, Yinghua Lv, Huafang Li, Junchao Chen, Yunfei Li, Fang Yin, Lujin Li, Qingshan Zheng
PURPOSE: This study aimed to establish a non-linear mixed effects model to quantitatively analyze the placebo responses of neuropsychiatric symptoms (NPS) in Alzheimer's disease (AD). METHODS: A comprehensive literature search was conducted in public databases. Placebo-controlled randomized AD clinical trials using the neuropsychiatric inventory (NPI) score as the primary or secondary outcome were included. Non-linear mixed effects model was used to describe the time course of the placebo responses of NPS in AD clinical trials...
January 5, 2019: European Journal of Clinical Pharmacology
Sven Frick, Daniel Müller, Gerd A Kullak-Ublick, Alexander Jetter
PURPOSE: The thiopurines azathioprine and 6-mercaptopurine are frequently used for remission maintenance in patients with inflammatory bowel diseases. However, there are therapy failures, and it is unclear whether clinical and laboratory parameters can be used to predict thiopurine metabolite concentrations (as a surrogate for adequate remission maintenance therapy) and clinical outcome in these patients. METHODS: In this retrospective analysis of clinical routine patient data, multivariate statistical models based on Linear Mixed Models regression and Generalized Estimating Equations logistic regression were developed...
January 4, 2019: European Journal of Clinical Pharmacology
Daniela Fialová, Blanca Laffon, Valentina Marinković, Ljiljana Tasić, Peter Doro, Gyӧngyver Sόos, Jorge Mota, Soner Dogan, Jovana Brkić, João Paulo Teixeira, Vanessa Valdiglesias, Solange Costa
INTRODUCTION: The importance of rational drug therapy is increasing with the aging of the population. Since one of the main reasons for inappropriate drug prescribing is also the "age-blind" approach, which results in ageist practices, this narrative literature review focuses on the description of the main barriers related to insufficient individualization of drug regimens associated with such age-blind approaches. METHODOLOGY: A narrative literature review using the PubMed, WoS, Embase, and Scopus databases was conducted by the EU COST Action IS1402...
January 4, 2019: European Journal of Clinical Pharmacology
Pâmela C Lukasewicz Ferreira, Flavia Valladao Thiesen, Thaina Tavares de Araujo, Domingos Otávio D'Ávila, Giovani Gadonski, Carmem Silvana A de Oliveira, Aline Rigon Zimmer, Pedro Eduardo Fröehlich
PURPOSE: Mycophenolic acid is one of the most used immunosuppressive drugs in solid organ transplant treatments in the world. Developing a highly sensitive analytical method to analyse the drug and its metabolites in oral fluid and plasma is important to evaluate the possibility of using oral fluid as a biological matrix in therapeutic drug monitoring, instead of plasma. METHOD: The liquid chromatography coupled to mass spectrometry (LC-MS) method was developed and validated for determining mycophenolic acid (MPA) and its glucuronide metabolite (MPAG) in oral fluid and plasma, with both matrices presenting a detection limit of 1 ng/mL for MPA and 5 ng/mL for MPAG...
January 4, 2019: European Journal of Clinical Pharmacology
Deborah Hukins, Una Macleod, Jason W Boland
PURPOSE: Older people with dementia are at risk of adverse events associated with potentially inappropriate prescribing. AIM: to describe (1) how international tools designed to identify potentially inappropriate prescribing have been used in studies of older people with dementia, (2) the prevalence of potentially inappropriate prescribing in this cohort and (3) advantages/disadvantages of tools METHODS: Systematic literature review, designed and reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P)...
January 4, 2019: European Journal of Clinical Pharmacology
Esther Oyaga-Iriarte, Asier Insausti, Onintza Sayar, Azucena Aldaz
PURPOSE: Irinotecan (CPT-11) is a drug used against a wide range of tumor types. The individualized dosing of CPT-11 is essential to ensure optimal pharmacotherapy in cancer patients, given the wide interindividual pharmacokinetic variability of this drug and its active metabolite SN-38. Moreover, the reabsorption from SN-38-G to SN-38, by enterohepatic recirculation, is critical due to its influence in the treatment tolerance. The aim of this research was to build a joint population pharmacokinetic model for CPT-11 and its metabolites (SN-38, and its glucuronide, SN-38-G) that enabled an individualized posology adjustment...
January 4, 2019: European Journal of Clinical Pharmacology
Aarthi Manoharan, Ajay Sam Kumar, Ambujam Sreedevi, Aruna Devi Sathishkannan, Bhargav Kiran Gaddam
No abstract text is available yet for this article.
January 4, 2019: European Journal of Clinical Pharmacology
Harald Chr Langaas, Eimir Hurley, Roar Dyrkorn, Olav Spigset
PURPOSE: The objective of this study was to examine the impact of an academic detailing programme in primary care in Norway on the prescribing rate of diclofenac, naproxen and non-steroidal anti-inflammatory drugs (NSAIDs) in total. METHODS: An academic detailing programme was delivered to general practitioners (GPs) in two Norwegian cities. The key message was to avoid diclofenac and COX-2 inhibitors and to use naproxen as the NSAID of choice. We analysed prescription data for 12 months before and after the programme to estimate its impact, using interrupted time series to control for underlying trends, and using the rest of Norway as a comparator...
December 31, 2018: European Journal of Clinical Pharmacology
Simon Coates, Jörg Täubel, Ulrike Lorch
PURPOSE: Stopping rules are an essential part of risk management in early phase clinical trials. As well as being necessary for ensuring the safety of participants on clinical trials, they are also a requirement under the revision to the European Medicine Agency's first-in-human and early clinical trial guideline. The increasing complexity and size of modern trial designs (e.g. integrated trials) raise potential issues with risk management, which, if also too complex, presents challenges for both regulators and investigators to implement...
December 19, 2018: European Journal of Clinical Pharmacology
Guo Yu, Hong-Hao Zhou, Qing-Shan Zheng, Guo-Fu Li
PURPOSE: Prospective prediction of pharmacokinetic properties for individuals of different ethnic groups could provide useful information for the design of multiregional clinical trials. The accuracy of interethnic scaling of fraction unbound (fu ) of a drug could determine in large part the predictive capability of volume of distribution as well as renal clearance. As such, exploring the interethnic extrapolation of fu from healthy Caucasian to Chinese subjects and associated effect on the scaling of volume of distribution is highly warranted...
December 19, 2018: European Journal of Clinical Pharmacology
Alice Holton, Fiona Boland, Paul Gallagher, Tom Fahey, Rose Anne Kenny, Gráinne Cousins
PURPOSE: This study aims to estimate (i) the prevalence of potentially serious alcohol-medication interactions in a nationally representative sample of older adults using the Potentially Serious Alcohol-Medication Interactions in Older adults (POSAMINO) criteria, and (ii) whether POSAMINO prevalence changes over time. METHODS: A prospective cohort study of adults aged ≥ 65 years, using data from the first three waves of The Irish Longitudinal Study on Ageing (TILDA)...
December 19, 2018: European Journal of Clinical Pharmacology
C Couffignal, J Bertrand, S Sportiche, Marine Jarroir, S El Balkhi, N Djebrani-Oussedik, J Poupon, X Declèves, F Mentré, F Bellivier
PURPOSE: Lithium (Li), the first-line treatment of bipolar disorder, was first developed as an immediate-release form with a routine therapeutic drug monitoring 12 h after the last dose. In Europe, the most commonly prescribed form is a sustained release (srLi). Yet no pharmacokinetics (PK) study has been published of srLi, administered once a day, in adults. The present study describes srLi PK in the serum and erythrocytes of bipolar patients. METHODS: To assess srLi PK, we studied prospectively 17 French bipolar patients on a median dose of 1000 mg (600-1600) for at least 2 years...
December 15, 2018: European Journal of Clinical Pharmacology
Hongzhou Xu, Lingti Kong, Chenchen Wu, Bo Xu, Xiaofei Wu
No abstract text is available yet for this article.
December 15, 2018: European Journal of Clinical Pharmacology
Ophélie Maison, Cléa Tardy, Delphine Cabelguenne, Stéphanie Parat, Sophie Ducastelle, Vincent Piriou, Alain Lepape, Laure Lalande
PURPOSE: Physicochemical incompatibility (PCI) between drugs infused together is frequent, but under-recognized. PCI can lead to drug inactivity, catheter occlusion, embolism or inflammatory reactions. The aims of this work were to identify most frequent and relevant drug incompatibilities and to review and develop strategies for their prevention. METHOD: This was an observational prospective survey conducted between January and March 2015 in an intensive care unit (ICU) and in September 2014 in a hematology sterile unit (HSU)...
December 12, 2018: European Journal of Clinical Pharmacology
Jonathan Chambers, Madhu Page-Sharp, Sam Salman, John Dyer, Timothy M E Davis, Kevin T Batty, Laurens Manning
PURPOSE: Ertapenem is used off-label to treat osteoarticular infections but there are few pharmacokinetic (PK) data to guide optimal dosing strategies in patients who may be obese with multiple co-morbidities including diabetes and peripheral vascular disease. METHODS: Participants undergoing lower limb amputation or elective joint arthroplasty received a dose of intravenous ertapenem prior to surgery. Eight plasma samples were collected over 24 h, together with at least one bone sample per patient...
December 4, 2018: European Journal of Clinical Pharmacology
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