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British Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/27922194/pharmacodynamic-response-profiles-of-anxiolytic-and-sedative-drugs
#1
Xia Chen, Freerk Broeyer, Marieke de Kam, Joke Baas, Adam Cohen, Joop van Gerven
INTRODUCTION: Centrally-acting acutely anxiolytic drugs, like benzodiazepines, barbiturates and gabapentinoids, affect various central nervous system (CNS) functions, which reflect not only their anxiolytic effects but also neuropsychological side-effects. To validate the pharmacodynamic biomarkers for GABA-ergic anxiolytics, this study determined the pharmacodynamics of two anxiolytics and a non-anxiolytic control and linked them to their anxiolytic and sedative effects, during an anxiety-challenge study day...
December 6, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27921324/statins-and-mortality-the-untold-story
#2
Michael S Kostapanos, Moses S Elisaf
Statins are first-line evidence-based drugs for the management of dyslipidaemias and to reduce the risk of cardiovascular events. However, statin clinical trials have shown marginally significant benefits on mortality, especially in the primary prevention setting. A major limitation of those trials is their relatively short follow-up. A reduced number of fatal events within a 5-year follow-up make mortality benefits unlikely to arise. This is particularly relevant for the primary prevention trials, whereby the risk of cardiovascular death is low...
December 6, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27921320/cardiac-effects-of-amiselimod-compared-with-fingolimod-and-placebo-results-of-a-randomised-parallel-group-phase-i-study-in-healthy-subjects
#3
Tomohiko Harada, Darren Wilbraham, Guillemette de La Borderie, Shinsuke Inoue, Jim Bush, A John Camm
AIM: Amiselimod (MT-1303) is a selective sphingosine 1-phosphate 1 (S1P1 ) receptor modulator which is currently being developed for the treatment of various autoimmune diseases. Unlike some other S1P receptor modulators, amiselimod seemed to show a favourable cardiac safety profile in pre-clinical, phase I and II studies. The aim of this study was to characterise the cardiac effects of amiselimod by directly comparing it with fingolimod and placebo. METHODS: Eighty-one (81) healthy subjects aged 18-55 years were equally randomised to receive amiselimod 0...
December 6, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27918623/the-effect-of-prescriber-education-on-medication-related-patient-harm-in-the-hospital-a-systematic-review
#4
J M Bos, P M L A van den Bemt, P A G M De Smet, C Kramers
INTRODUCTION: Educating prescribers is a strategy to reduce prescription errors in hospitals. This systematic review gives an overview of original research papers on education of prescribers, reporting outcomes on (potential) patient harm. METHODS: A search of the databases Embase and Medline using the Ovid interface was performed. Research on the effect of education of physicians in order to prevent medication related problems of inpatients, reporting original data and outcomes on prescribing errors and/or (potential) patient harm, was included...
December 5, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27905143/characterization-of-adverse-drug-reactions-causing-admission-to-an-intensive-care-unit
#5
Camilo Rojas-Velandia, Jair Ruiz-Garzón, Juan-Carlos Moscoso-Alcina, Álvaro Vallejos-Narvaéz, Jenny Castro-Canoa, Yuri Bustos-Martínez, Max Flórez-Cutiva, Mabel Contreras-Muñoz, Jully-Carolina Gómez-Gil, Carlos-Alberto Calderón-Ospina
AIM: This study aimed to determine the occurrence of adverse drug reactions (ADRs) that caused admission to the intensive care unit (ICU) of a university hospital. METHODS: Clinical records were reviewed for patients meeting the inclusion criteria who were admitted to the ICU between September and December 2012. Suspected cases of adverse drug reactions (ADR) were documented. Nine researchers later evaluated causality using the Naranjo Algorithm, preventability using the Schumock and Thornton criteria, and clinical classification based on the dose-time-susceptibility (DoTS) system...
December 1, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27896848/composite-endpoints-and-the-distortion-of-risk-benefit-analysis
#6
EDITORIAL
John B Warren
No abstract text is available yet for this article.
November 28, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27891666/a-systematic-review-of-the-outcomes-reported-in-trials-of-medication-review-in-older-patients-the-need-for-a-core-outcome-set
#7
Jean-Baptiste Beuscart, Lisa G Pont, Stefanie Thevelin, Benoit Boland, Olivia Dalleur, Anne Rutjes, Johanna I Westbrook, Anne Spinewine
AIM: Medication review has been advocated as one of the measures to tackle the challenge of polypharmacy in older patients, yet there is no consensus on how best to evaluate its efficacy. This study aimed to assess outcome reporting in trials of medication review in older patients. METHODS: Randomized controlled trials (RCTs), prospective studies and RCT protocols involving medication review performed in patients aged 65 years or older in any setting of care were identified from: (1) a recent systematic review; (2) RCT registries of ongoing studies; (3) the Cochrane library...
November 27, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27891663/extended-release-niacin-increases-anti-apoa-i-antibodies-that-block-the-anti-oxidant-effect-of-hdl-c-the-explore-clinical-trial
#8
J R Batuca, M C Amaral, C Favas, F S Paula, P R J Ames, A L Papoila, J Delgado Alves
AIMS: Extended Release-Niacin (ERN) is the most effective agent for increasing high-density lipoprotein-cholesterol (HDL-C). Having previously identified anti-HDL antibodies, we investigated whether ERN affected the antioxidant capacity of HDL and whether ERN was associated with the production of antibodies against HDL (aHDL) and apolipoprotein A-I (aApoA-I). METHODS: Twenty-one patients older than 18 years, with HDL-C ≤ 40 mg/dL (men) or ≤ 50 mg/dL (women) were randomly assigned to receive daily ERN (n = 10) or placebo (n = 11) for two sequential 12-week periods, with 4 weeks of wash-out before cross-over...
November 27, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27874994/ssri-and-snri-use-during-pregnancy-and-the-risk-of-persistent-pulmonary-hypertension-of-the-newborn
#9
Anick Bérard, Odile Sheehy, Jin-Ping Zhao, Évelyne Vinet, Sasha Bernatsky, Michal Abrahamowicz
AIM: Use of selective serotonin reuptake inhibitors (SSRIs) in late pregnancy may be associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN). Limited data are available on the risk of PPHN associated with serotonin norepinephrine reuptake inhibitors (SNRIs). We aimed to quantify both associations. METHODS: Using data from the Quebec Pregnancy Cohort between 1998 and 2009, we included women covered by the provincial drug plan who had a singleton live birth...
November 22, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27868226/factors-affecting-patient-reporting-of-adverse-drug-reactions-a-systematic-review
#10
Rania Al Dweik, Dawn Stacey, Dafna Kohen, Sanni Yaya
AIM: The aim of the present study was to determine the barriers and motives influencing consumer reporting of adverse drug reactions (ADRs). METHODS: A systematic review, guided by the Cochrane Handbook, was conducted. Electronic searches included MEDLINE, EMBASE, PsycINFO, CINAHL, PubMed and the Cochrane Database of Systematic Reviews from 1964 to December 2014. Eligible studies addressed patients' perceptions and factors influencing ADR reporting. Studies about healthcare professional (HCP) reporting of ADRs were excluded...
November 21, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27868231/aprepitant-in-pediatric-patients-using-moderate-and-highly-emetogenic-protocols-a-systematic-review-and-meta-analyses-of-randomized-controlled-trials
#11
Lucas Miyake Okumura, Fernanda D' Athayde Rodrigues, Maria Angelica Pires Ferreira, Leila Beltrami Moreira
AIMS: To review the efficacy and safety of aprepitant in combination with ondansetron and dexamethasone (triple therapy) in children and adolescents on moderate to highly emetogenic chemotherapy. METHODS: Medline, Embase, Scielo, Lilacs, Cochrane and congress abstracts published until September 2016 were used as data sources. Two reviewers independently selected manuscripts and extracted data. A third reviewer solved discrepancies in study's selection and data extraction...
November 20, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27868228/pharmacokinetic-interaction-between-taxanes-and-amiodarone-leading-to-severe-toxicity
#12
LETTER
Felix Hammann, Verena Gotta, Katrin Conen, Michael Medinger, Philipp Cesana, Christoph Rochlitz, Anne B Taegtmeyer
ADVERSE EVENT: A drug interaction leading to severe skin and mucosal toxicity. DRUGS IMPLICATED: Paclitaxel, docetaxel and amiodarone. THE PATIENT: A 77-year-old woman with a history of hypertension, hyperlipidemia, and palpitations, managed with amiodarone, was treated for HER2-positive invasive ductal breast cancer with paclitaxel and trastuzumab as an adjunct to surgery. EVIDENCE THAT LINKS THE DRUG TO THE EVENT: There was a strong temporal relationship between the taxane therapy and the development of severe skin and mucosal toxicity due to an unexpected reduction in taxane clearance...
November 20, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27859495/drug-specific-hypophosphatemia-and-hypersensitivity-reactions-following-different-intravenous-iron-infusions
#13
Palle Bager, Christian L Hvas, Jens F Dahlerup
AIMS: Intravenous (IV) iron infusions have been associated with hypophosphatemia (HP) and hypersensitivity reactions (HSRs). No studies have compared the side effects of ferric carboxymaltose (FCM) with those of isomaltoside 1000 (ISM). This study aimed to describe the occurrence of HP and HSRs following the administration of either FCM or ISM. METHODS: Data on 231outpatients treated with IV iron infusions, between November 2011 and April 2014, were collected. During that period, the department made a switch from FCM to ISM and then back to FCM...
November 17, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27859546/first-in-human-randomised-study-of-bimekizumab-a-humanised-monoclonal-antibody-and-selective-dual-inhibitor-of-il-17a-and-il-17%C3%A2-f-in-mild-psoriasis
#14
S Glatt, E Helmer, B Haier, F Strimenopoulou, G Price, P Vajjah, O A Harari, J Lambert, S Shaw
AIMS: Assess safety, pharmacokinetics (PK) and clinical efficacy of bimekizumab, (formerly UCB4940), a novel humanised monoclonal antibody and dual inhibitor of interleukin (IL)-17A and IL-17 F, in subjects with mild plaque psoriasis. METHODS: Randomised, double-blind, first-in-human study of bimekizumab in 39 subjects who received single-dose intravenous (iv) bimekizumab (8-640 mg) or placebo (NCT02529956). RESULTS: Bimekizumab demonstrated dose-proportional linear PK and was tolerated across the dose range assessed...
November 13, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27862160/in-vitro-and-pbpk-based-assessment-of-drug-drug-interaction-potential-of-canagliflozin
#15
Rao N V S Mamidi, Shannon Dallas, Carlo Sensenhauser, Heng Keang Lim, Ellen Scheers, Peter Verboven, Filip Cuyckens, Laurent Leclercq, David C Evans, Michael F Kelley, Mark D Johnson, Jan Snoeys
AIMS: Canagliflozin is a recently approved drug for use in the treatment of type 2 diabetes. The potential for canagliflozin to cause clinical drug-drug interactions (DDIs) was assessed. METHODS: DDI potential of canagliflozin was investigated using in vitro test systems containing drug metabolizing enzymes or transporters. Basic predictive approaches were applied to determine potential interaction in vivo. A physiologically-based pharmacokinetic (PBPK) model was developed and clinical DDI simulations were performed to determine the likelihood of CYP inhibition by canagliflozin...
November 11, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27862179/the-use-of-a-battery-of-pain-models-to-detect-analgesic-properties-of-compounds-a-two-part-four-way-crossover-study
#16
P Okkerse, G van Amerongen, M L de Kam, J Stevens, R P Butt, R Gurrell, A Dahan, J M van Gerven, J L Hay, G J Groeneveld
AIM: The aim was to investigate the ability of a battery of pain models to detect analgesic properties of commonly used analgesics in healthy subjects. METHODS: The battery consisted of tests eliciting electrical, mechanical and thermal (contact heat and cold pressor)-pain and included a UVB model, the thermal grill illusion and a paradigm of conditioned pain modulation. Subjects were administered fentanyl 3 µg/kg, phenytoin 300 mg, (S)-ketamine 10 mg and placebo (part I), or imipramine 100 mg, pregabalin 300 mg, ibuprofen 600 mg and placebo (part II)...
November 9, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27862167/the-effect-of-inflammation-on-voriconazole-trough-concentrations-in-children
#17
LETTER
Mendy Ter Avest, Anette Veringa, Edwin R van den Heuvel, Jos G W Kosterink, Elisabeth H Schölvinck, Wim J E Tissing, Jan-Willem C Alffenaar
No abstract text is available yet for this article.
November 9, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27862178/tolerability-pharmacokinetics-and-antiviral-activity-of-rhsa-ifn%C3%AE-2a-for-the-treatment-of-chronic-hepatitis-b-infection
#18
Yanhua Ding, Jinfeng Lou, Hong Cheng, Xiaojiao Li, Min Wu, Cuiyun Li, Jingrui Liu, Chengjiao Liu, Qingmei Li, Hong Zhang, Junqi Niu
BACKGROUND AND AIMS: A recombinant human serum albumin-interferon alpha2a fusion protein (rHSA/IFNα2a) is expected to extend the half-life of IFNα2a. This study aims to evaluate the tolerability, safety and efficacy of rHSA/IFNα2a. METHODS: This is an open, randomized, positive control, multiple-dose ascending phase Ib study. A panel of 32 treatment naïve and non-cirrhotic chronic hepatitis B patients were divided into four cohorts, and each received 600, 750 or 900 µg of rHSA/IFNα2a or 180 µg of PEG-IFNα2a for three months...
November 8, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27813241/population-pharmacokinetics-of-rifampicin-in-adult-patients-with-osteoarticular-infections-interaction-with-fusidic-acid
#19
A Marsot, A Ménard, J Dupouey, C Muziotti, R Guilhaumou, O Blin
AIMS: Rifampicin represents the key antibiotic for management of osteoarticular infections. An important pharmacokinetic variability has already been described, incriminating notably absorption and metabolism. All previous pharmacokinetic studies were only focused on patient treated for tuberculosis. The objective of this study was to describe a population pharmacokinetic model of rifampicin in patients with staphylococcal osteoarticular infections, data which have not been investigated to date...
November 4, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27808426/venlafaxine-and-oxycodone-have-different-effects-on-spinal-and-supra-spinal-activity-in-man-a-somatosensory-evoked-potential-study
#20
Dina Lelic, Massimiliano Valeriani, Iben W D Fischer, Albert Dahan, Asbjørn M Drewes
INTRODUCTION: Opioids and antidepressants that inhibit serotonin and norepinephrine reuptake (SNRI) are recognized as analgesics to treat severe and moderate pain, but for both of them the mechanisms in humans remain unclear. This study aimed to explore how oxycodone (opioid) and venlafaxine (SNRI) modulate spinal and supraspinal sensory processing. METHODS: Twenty volunteers were included in this randomized, double blinded, three-way (placebo, oxycodone, venlafaxine), cross-over study...
November 3, 2016: British Journal of Clinical Pharmacology
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