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British Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28317142/pharmacogenomic-screening-for-anthracycline-induced-cardiotoxicity-in-childhood-cancer
#1
LETTER
Folefac Aminkeng, Colin J D Ross, Shahrad R Rassekh, Michael J Rieder, Amit P Bhavsar, Shubhayan Sanatani, Daniel Bernstein, Michael R Hayden, Ursula Amstutz, Bruce C Carleton
No abstract text is available yet for this article.
March 19, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28299795/interruption-to-antiplatelet-therapy-early-after-acute-ischaemic-stroke-a-nested-case-control-study
#2
Wardati Mazlan-Kepli, Rachael L MacIsaac, Matthew Walters, Philip Michael William Bath, Jesse Dawson
AIMS: Antiplatelet drugs are often discontinued early after ischaemic stroke, either because of poor compliance, complications or withdrawal of care. It is unclear whether this places patients at increased risk of recurrence. We explored the association between cardiovascular event rate and persistence with prescribed antiplatelet drugs. METHODS: We used a matched case-control design using the Virtual International Stroke Trials Archive (VISTA). Cases were patients who had an acute coronary syndrome, recurrent stroke or transient ischaemic attack within 90 days post-stroke and were matched for age ±10 years and sex with up to four controls...
March 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28295451/ccl20-neutralisation-by-a-monoclonal-antibody-in-healthy-subjects-selectively-inhibits-recruitment-of-ccr6-cells-in-an-experimental-suction-blister
#3
Gerben Bouma, Stefano Zamuner, Kirsty Hicks, Andrew Want, João Oliveira, Arpita Choudhury, Sara Brett, Darren Robertson, Leigh Felton, Virginia Norris, Disala Fernando, Michael Herdman, Ruth Tarzi
AIMS: GSK3050002, a humanized IgG1κ antibody with high binding affinity to human CCL20, was administered in a first-in-human study to evaluate safety, pharmacokinetics (PK) and pharmacodynamics (PD). An experimental skin suction blister model was employed to assess target engagement and the ability of the compound to inhibit recruitment of inflammatory CCR6 expressing cells. METHODS: This study was a randomized, double-blind (sponsor open), placebo-controlled, single-centre, single ascending intravenous dose escalation trial in 48 healthy male volunteers...
March 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28294391/a-population-pharmacokinetic-meta-analysis-of-custirsen-an-antisense-oligonucleotide-in-oncology-patients-and-healthy-subjects
#4
Alena Y Edwards, Anna Elgart, Colm Farrell, Ofra Barnett-Griness, Laura Rabinovich-Guilatt, Ofer Spiegelstein
AIMS: Custirsen (OGX-011/TV-1011), a second-generation antisense oligonucleotide that reduces clusterin production, is under investigation with chemotherapy in prostate and lung cancer. This meta-analysis evaluated the population pharmacokinetics (PK) of custirsen in cancer patients and healthy subjects. METHODS: The population PK analysis used custirsen plasma concentrations from five phase 1 studies, one phase 1/2 study, and one phase 3 study in two stages. Cancer patients received multiple doses of custirsen (40-640 mg intravenously over 120 minutes) with chemotherapy; healthy subjects received single or multiple doses (320-640 mg)...
March 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28294379/use-of-oral-antidiabetic-agents-and-risk-of-community-acquired-pneumonia-a-nested-case-control-study
#5
J Gorricho, J Garjón, A Alonso, M C Celaya, L C Saiz, J Erviti, A López
AIM: To evaluate the association between use of different oral antidiabetic agents (OAD) and the risk of community-acquired pneumonia (CAP) in patients with type-2 diabetes (T2DM). METHODS: Case-control study nested in a cohort of patients with T2DM and use of OAD between 2002-2013, based in a Spanish general practice research database. Cases were people diagnosed of T2DM, aged >18 years and with a validated diagnosis of CAP between 2002-2013. Ten controls were matched on age, sex and calendar year...
March 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28295508/pharmacological-treatment-for-copd-gold-2017-changes-direction
#6
EDITORIAL
Dave Singh
No abstract text is available yet for this article.
March 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28276585/electronic-case-report-forms-and-electronic-data-capture-within-clinical-trials-and-pharmacoepidemiology
#7
REVIEW
David A Rorie, Robert W V Flynn, Kerr Grieve, Alexander Doney, Isla Mackenzie, Thomas M MacDonald, Amy Rogers
AIMS: Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underutilised despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research. METHODS: The review used PubMed and the Institute of Electrical and Electronic Engineers library (IEEE). Search terms used were agreed by the authors and documented...
March 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28268245/psychotropics-and-weak-opioid-analgesics-in-plasma-samples-of-older-hip-fracture-patients-detection-frequencies-and-consistency-with-drug-records
#8
Ragnhild Birkeland Waade, Espen Molden, Mette Irene Martinsen, Monica Hermann, Anette Hylen Ranhoff
AIM: To determine use of psychotropic drugs and weak opioids in hip fracture patients by analysing plasma samples at admission, and compare detected drug frequencies with prescription registry data and drug records. METHODS: Plasma from 250 hip fracture patients ≥65 years sampled at hospital admission were analysed by ultra-performance liquid chromatography - tandem mass spectrometry methods for detection of psychotropic drugs and weak opioid analgesics (alcohol also determined)...
March 7, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28257154/microrna-122-can-be-measured-in-capillary-blood-which-facilitates-point-of-care-testing-for-drug-induced-liver-injury
#9
A D Bastiaan Vliegenthart, Cécile Berends, Carmelita M J Potter, Maiwenn Kersaudy-Kerhoas, James W Dear
AIM: Liver-enriched microRNA-122 (miR-122) is a novel circulating biomarker for drug-induced liver injury (DILI). To date, miR-122 has been measured in serum or plasma venous samples. If miR-122 could be measured in capillary blood obtained from a finger prick it would facilitate point-of-care testing, such as in resource-limited settings that have a high burden of DILI. METHODS: In this study, in healthy subjects, miR-122 was measured by PCR in 3 capillary blood drops taken from different fingers and in venous blood and plasma (N = 20)...
March 3, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28256012/a-licence-to-prescribe
#10
LETTER
Cornelis Kramers, Ben J Janssen, Wilma Knol, Marleen H M Hessel, Wilhelmina M Mulder, Glenn Dumont, Antoinette Maassen van den Brink, Jelle Tichelaar
No abstract text is available yet for this article.
March 2, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28252213/defining-the-non-inferiority-margin-and-analyzing-non-inferiority-an-overview
#11
Turki A Althunian, Anthonius de Boer, Rolf H H Groenwold, Olaf H Klungel
Non-inferiority trials are used to assess whether the effect of a new drug is not worse than an active comparator by more than a non-inferiority margin. If the difference between the new drug and the active comparator does not exceed this pre-specified margin, non-inferiority can be concluded. This margin must be specified based on clinical and statistical reasoning; however, it is considered as one the most challenging step in the design of non-inferiority trials. Regulators recommend that the margin should be defined based on the historical evidence of the active comparator (the latter is often the well-established standard treatment of the disease), which can be performed by different approaches...
March 2, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28252212/should-we-treat-very-large-paracetamol-overdose-differently
#12
D Nicholas Bateman, James W Dear
No abstract text is available yet for this article.
March 2, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28245519/pharmacokinetics-of-tranexamic-acid-in-neonates-and-infants-undergoing-cardiac-surgery
#13
Ralph Gertler, Michael Gruber, Stanislas Grassin-Delyle, Saïk Urien, Klaus Martin, Peter Tassani-Prell, Siegmund Braun, Simon Burg, Gunther Wiesner
AIM: Tranexamic acid (TXA) continues to be one of the antifibrinolytics of choice during paediatric cardiac surgery. However, in infants less than one year of age, the optimal dosing based on pharmacokinetic (PK) considerations is still under discussion. METHODS: 43 children less than one year of age were enrolled. 37 required the use of cardiopulmonary bypass (CPB) while 6 were operated on without CPB. 50 mg kg(-1) TXA i.v. at the induction of anaesthesia was followed by 50 mg kg(-1) into the CPB prime in the CPB group...
February 28, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28244609/preparedness-of-newly-qualified-doctors-in-ireland-for-prescribing-in-clinical-practice
#14
S E Geoghegan, E Clarke, D Byrne, D Power, D Moneley, J Strawbridge, D J P Williams
AIM: To investigate the level of preparedness of newly qualified Irish trained doctors for prescribing, and to investigate their attitudes towards prescribing and prescribing education, through a national survey. METHODS: A 29 item online survey was distributed to 686 newly qualified doctors one month prior to the completion of their first year of clinical practice (internship). Only graduates from Irish medical schools were included. RESULTS: The response rate was 20...
February 28, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28239898/early-signal-of-diverted-use-of-tropicamide-eye-drops-in-france
#15
Camille Ponté, Christian Pi, Aurore Palmaro, Emilie Jouanjus, Maryse Lapeyre-Mestre
BACKGROUND: Tropicamide is a mydriatic drug used as eye-drops for diagnostic or therapeutic purposes. From 2013, a diverted use by intravenous route has been suspected in Eastern Europe in opioids users. To recent date, no signal of a misuse has been identified in France. PURPOSE: To investigate an early signal of a diverted use of tropicamide eye drops and to collect information regarding motives of misusing and tropicamide-induced effects. METHODS: Information was obtained at 1/ regional level (Midi-Pyrénées area): reimbursement data and pharmacists' reports on suspicious requests, 2/ national level: reimbursement data and prescriptions suggesting possible abuse from the OSIAP (Ordonnances Suspectes, Indicateur d'Abus Possible) survey and 3/ international level: VigiBase® reports and Web sources...
February 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28239897/population-pharmacokinetics-of-rituximab-in-patients-with-diffuse-large-b-cell-lymphoma-and-association-with-clinical-outcome
#16
S Rozman, I Grabnar, S Novaković, A Mrhar, B J Novaković
AIMS: Pharmacokinetic (PK) studies suggest that there is a room for improvement in clinical use of rituximab through more individualized treatment. The objective of this study was to characterize rituximab PK in 29 newly diagnosed patients with diffuse large B-cell lymphoma treated with rituximab in combination with cyclophosphamide, doxorubicin, vincristine and methylprednisolone every three weeks. We also evaluated the association of rituximab PK with clinical outcome. METHODS: Rituximab serum levels were determined by enzyme-linked immunosorbent assay and evaluated by a population PK analysis applying non-linear mixed effects modelling...
February 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28230269/antigenic-burden-and-serum-igg-concentrations-influence-rituximab-pharmacokinetics-in-rheumatoid-arthritis-patients
#17
Bertrand Lioger, Soujanya Ratna Edupuganti, Denis Mulleman, Christophe Passot, Céline Desvignes, Théodora Bejan-Angoulvant, Gilles Thibault, Valérie Gouilleux-Gruart, Julien Mélet, Gilles Paintaud, David Ternant
AIMS: Rituximab is a monoclonal antibody directed against CD20, which is approved in rheumatoid arthritis (RA). This study aimed at assessing the influence of CD19+ cell counts as target-antigen amount, and of immunoglobulin G (IgG) serum concentrations on rituximab pharmacokinetics in RA patients. METHODS: In a cohort of 64 RA patients who had received repetitive courses of rituximab, the influence of CD19+ cell count, IgG serum concentration, body surface area (BSA), sex, and disease activity score in 28 joints (DAS28) on rituximab pharmacokinetic parameters was assessed using a population pharmacokinetic analysis...
February 23, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28230262/evaluation-of-the-immunogenicity-of-the-dabigatran-reversal-agent-idarucizumab-during-phase-i-studies
#18
Stephen Norris, Steven Ramael, Ippei Ikushima, Wouter Haazen, Akiko Harada, Viktoria Moschetti, Susumu Imazu, Paul A Reilly, Benjamin Lang, Joachim Stangier, Stephan Glund
AIMS: Idarucizumab, a humanized monoclonal anti-dabigatran antibody fragment, is effective in emergency reversal of dabigatran anticoagulation. Pre-existing and treatment-emergent anti-idarucizumab antibodies (antidrug antibodies; ADA) may affect the safety and efficacy of idarucizumab. This analysis characterized the pre-existing and treatment-emergent ADA and assessed their impact on the pharmacokinetics and pharmacodynamics (PK/PD) of idarucizumab. METHODS: Data were pooled from three phase I, randomized, double-blind idarucizumab studies in healthy Caucasian; elderly, renally impaired subjects; and healthy Japanese subjects...
February 23, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28229476/initial-medication-non-adherence-prevalence-and-predictive-factors-in-a-cohort-of-1-6-million-primary-care-patients
#19
Ignacio Aznar-Lou, Ana Fernández, Montserrat Gil-Girbau, Marta Fajó-Pascual, Patricia Moreno-Peral, María Teresa Peñarrubia-Teresa, Antoni Serrano-Blanco, Albert Sánchez-Niubó, María Antonia March-Pujol, Anna Maria Jové, Maria Rubio-Valera
AIMS: Adherence to medicines is vital in treating diseases. Initial medication non-adherence (IMNA) - defined as not obtaining a medication the first time it is prescribed - has been poorly explored. Previous studies show IMNA rates between 6 and 28% in primary care (PC). The aims of this study were to determine prevalence and predictive factors of IMNA in the most prescribed and expensive pharmacotherapeutic groups in the Catalan health system. METHODS: This is a retrospective, register-based cohort study which linked the Catalan PC System (Spain) prescription and invoicing databases...
February 23, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28217868/an-anti-nicotinic-cognitive-challenge-model-using-mecamylamine-in-comparison-with-the-anti-muscarinic-cognitive-challenge-using-scopolamine
#20
A C Baakman, R Alvarez-Jimenez, R Rissmann, E S Klaassen, J Stevens, S C Goulooze, J Burger, E L Swart, J M A van Gerven, G J Groeneveld
INTRODUCTION: The muscarinic acetylcholine receptor antagonist scopolamine is often used for proof-of-pharmacology studies with pro-cognitive compounds. From a pharmacological point of view, it would seem more rational to use a nicotinic rather than a muscarinic anticholinergic challenge to prove pharmacology of a nicotinic acetylcholine receptor agonist. This study aims to characterize a nicotinic anticholinergic challenge model using mecamylamine and to compare it to the scopolamine model...
February 20, 2017: British Journal of Clinical Pharmacology
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