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British Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28449367/metoprolol-pridopidine-drug-drug-interaction-and-food-effect-assessments-of-pridopidine-a-new-drug-for-treatment-of-huntington-disease
#1
Laura Rabinovich-Guilatt, Lilach Steiner, Hussein Hallak, Gina Pastino, Pierandrea Muglia, Ofer Spiegelstein
AIM: Pridopidine is an oral drug in clinical development for treatment of patients with Huntington disease. This study examined the interactions of pridopidine with in vitro cytochrome P450 activity and characterized the effects of pridopidine on CYP2D6 activity in healthy volunteers using metoprolol as a probe substrate. The effect of food on pridopidine exposure was assessed. METHODS: The ability of pridopidine to inhibit and/or induce in vitro activity of drug metabolising enzymes was examined in human liver microsomes and fresh hepatocytes...
April 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28449302/prescribing-safety-assessment-2016-delivery-of-a-national-prescribing-assessment-to-7-343-uk-final-year-medical-students
#2
Simon R J Maxwell, Jamie J Coleman, Lynne Bollington, Celia Taylor, David J Webb
AIM(S): Newly graduated doctors write a large proportion of prescriptions in UK hospitals but recent studies have shown that they frequently make prescribing errors. The Prescribing Safety Assessment (PSA) has been developed as an assessment of competence in relation to prescribing and supervising the use of medicines. This report describes the delivery of the PSA to all UK final-year medical students in 2016 (PSA2016). METHODS: The PSA is a 2-hour online assessment comprising eight sections which cover various aspects of prescribing defined within the outcomes of undergraduate education identified by the UK General Medical Council...
April 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28449232/safety-pharmacokinetics-and-pharmacologic-effects-of-the-selective-androgen-receptor-modulator-gsk2881078-in-healthy-men-and-postmenopausal-women
#3
Richard V Clark, Ann C Walker, Susan Andrews, Philip Turnbull, Jeffrey A Wald, Mindy H Magee
AIM: Selective androgen receptor modulators (SARMs) induce anabolic effects on muscle without the adverse effects of androgenic steroids. In this first-in-human study, we report safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of the SARM GSK2881078. METHODS: In Part A, healthy young men (n = 10) received a single dose of study drug (0 mg, 0.05 mg, 0.1 mg, 0.2 mg GSK2881078 or matching-placebo). In Part B, repeat-dose cohorts in men (n = 65) were 0...
April 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28432691/tenapanor-administration-and-the-activity-of-the-h-coupled-transporter-pept1-in-healthy-volunteers
#4
Susanne Johansson, David P Rosenbaum, Johan Palm, Bergur Stefansson, Mikael Knutsson, Eleanor A Lisbon, Constanze Hilgendorf
AIM: Tenapanor (RDX5791/AZD1722), an inhibitor of gastrointestinal Na(+) /H(+) exchanger NHE3, is being evaluated for the treatment of patients with constipation-predominant irritable bowel syndrome and the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis. By reducing intestinal H(+) secretion, inhibition of NHE3 by tenapanor could indirectly affect H(+) -coupled transporter activity, leading to drug-drug interactions. We investigated the effect of tenapanor on the activity of the H(+) -coupled peptide transporter PepT1 via assessment of the pharmacokinetics of cefadroxil - a compound transported by PepT1 - in healthy volunteers...
April 22, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28429533/impact-of-adverse-drug-events-and-treatment-satisfaction-on-patient-adherence-with-antihypertensive-medication-a-study-in-ambulatory-patients
#5
Derbew Fikadu Berhe, Katja Taxis, Flora M Haaijer-Ruskamp, Afework Mulugeta, Yewondwossen Tadesse Mengistu, Johannes G M Burgerhof, Peter G M Mol
OBJECTIVE: To evaluate the impact of adverse drug events (ADEs) and treatment satisfaction on antihypertensive medication adherence. METHODS: A cross-sectional study was conducted in six public hospitals in Ethiopia. We included adult ambulatory patients on antihypertensive medication. Adherence was measured with the 8-point Morisky Medication Adherence Scale (MMAS-8), categorized in low (0-5), medium (6-7), and high (=8) adherence. Treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1...
April 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28429492/body-weight-gender-and-pregnancy-affect-enantiomer-specific-ketorolac-pharmacokinetics
#6
Pyry A Välitalo, Heidi Kemppainen, Aida Kulo, Anne Smits, Kristel van Calsteren, Klaus T Olkkola, Jan de Hoon, Catherijne A J Knibbe, Karel Allegaert
AIMS: Although ketorolac analgesia is linked only to the S-enantiomer, there is limited information on the stereo-selective pharmacokinetics of ketorolac. We studied the stereo-selective pharmacokinetics of ketorolac in a pooled dataset of two studies, with women at delivery and 4-5 months postpartum, and males and non-pregnant females. METHODS: Non-linear mixed effect modeling was used to evaluate stereo-selective pharmacokinetics of ketorolac tromethamine after single intravenous injection immediately after delivery (n = 41), 4-5 months postpartum (n = 8, paired), and in non-pregnant female (n = 14) and male (n = 12) subjects...
April 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28418224/commentary-a-new-drug-nomenclature-for-psychiatry-prospects-and-hazards
#7
S Nassir Ghaemi
No abstract text is available yet for this article.
April 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28417592/individualising-the-dose-of-allopurinol-in-patients-with-gout
#8
Diluk R W Kannangara, Garry G Graham, Daniel F B Wright, Sophie L Stocker, Ian Portek, Kevin D Pile, Murray L Barclay, Kenneth M Williams, Lisa K Stamp, Richard O Day
AIMS: The aims of the study were to 1) determine if a plasma oxypurinol concentration-response relationship or an allopurinol dose-response relationship best predicts the dose requirements of allopurinol in the treatment of gout; and, 2) to construct a nomogram for calculating the optimum maintenance dose of allopurinol to achieve target serum urate (SU) concentrations. METHODS: A non-linear regression analysis was used to examine the plasma oxypurinol concentration- and allopurinol dose-response relationships with serum urate...
April 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419522/a-general-empirical-model-for-renal-drug-handling-in-pharmacokinetic-analyses
#9
Daniel F B Wright, Stephen B Duffull
Dose adjustment in renal insufficiency is generally based on the assumption that renal drug clearance is related linearly to glomerular filtration rate. The theory underpinning this model is the Intact Nephron Hypothesis, where impaired renal function is said to be caused by a reduction in the number of complete (intact) nephrons. The purpose of this commentary is to propose a general empirical model for renal drug handling. We will explore models for renal function under two scenarios; one that aligns with the intact nephron hypothesis, and one that relaxes the assumptions of this hypothesis...
April 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419518/public-preferences-on-written-informed-consent-for-low-risk-pragmatic-clinical-trials-in-spain
#10
Rafael Dal-Ré, Antonio J Carcas, Xavier Carné, David Wendler
AIMS: Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to significantly improve medical care. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the U.S. public endorses written consent for low risk pRCTs. This study was designed to assess whether this view is specific to the US. METHODS: Cross-sectional, probability-based survey, with a 2x2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night...
April 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28407449/drug-interactions-and-safety-profiles-with-concomitant-use-of-caspofungin-and-calcineurin-inhibitors-in-allogeneic-hematopoietic-cell-transplantation
#11
Mitsutaka Nishimoto, Hideo Koh, Atsushi Tokuwame, Yousuke Makuuchi, Masatomo Kuno, Teruhito Takakuwa, Hiroshi Okamura, Shiro Koh, Takuro Yoshimura, Satoru Nanno, Mika Nakamae, Asao Hirose, Yasuhiro Nakashima, Takahiko Nakane, Masayuki Hino, Hirohisa Nakamae
AIM: Small-scale clinical studies have reported on drug interactions between caspofungin (CPFG) and calcineurin inhibitors in healthy subjects; however, little is known about these interactions in allogeneic hematopoietic cell transplantation (allo-HCT) patients. METHODS: We retrospectively assessed the drug interactions and safety profiles in allo-HCT recipients treated concomitantly with CPFG and calcineurin inhibitors. RESULTS: Ninety-one consecutive cases were evaluated...
April 13, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28406539/mechanisms-of-drug-drug-interaction-between-rifampicin-and-fusidic-acid
#12
LETTER
Florianne Bel, Laurent Bourguignon, Michel Tod, Tristan Ferry, Sylvain Goutelle
No abstract text is available yet for this article.
April 12, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28401576/a-new-nomenclature-for-classifying-psychotropic-drugs
#13
Filippo Caraci, S J Enna, Joseph Zohar, Giorgio Racagni, Gil Zalsman, Wim van den Brink, Siegfried Kasper, George F Koob, Carmine M Pariante, Pier Vincenzo Piazza, Kiyofumi Yamada, Michael Spedding, Filippo Drago
The Neuroscience-based Nomenclature (NbN) for psychotropic drugs was developed as an alternative to the current Anatomical Therapeutic Chemical (ATC) indication-based classification in order to provide more precise designations for this drug class. The ATC nomenclature for psychotherapeutics is limited in that it fails to specify neither pharmacological domains nor mechanism of action and also does not describe all the potential uses of a particular agent. The disconnect between the drug classification and its clinical use is not very useful for scientific purposes and is confusing for patients and caregivers, often leading to a misunderstanding of the intended effects of the prescribed medication and, most importantly, to low treatment adherence...
April 12, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28401570/effect-of-p-glycoprotein-inhibition-at-the-blood-brain-barrier-on-brain-distribution-of-r-11-c-verapamil-in-elderly-versus-young-subjects
#14
Martin Bauer, Beatrix Wulkersdorfer, Rudolf Karch, Cécile Philippe, Walter Jäger, Johann Stanek, Wolfgang Wadsak, Marcus Hacker, Markus Zeitlinger, Oliver Langer
AIMS: The efflux transporter P-glycoprotein (ABCB1) restricts at the blood-brain barrier (BBB) distribution of many different drugs from blood to the brain. Previous data suggest an age-associated decrease in the expression and function of ABCB1 at the BBB. In this study we investigated the influence of age on the magnitude of an ABCB1-mediated drug-drug interaction (DDI) at the BBB. METHODS: We performed positron emission tomography (PET) scans with the model ABCB1 substrate (R)-[(11) C]verapamil in five young (26 ± 1 years, [mean ± standard deviation]) and five elderly (68 ± 6 years) healthy male volunteers before and after intravenous administration of a low dose of the ABCB1 inhibitor tariquidar (3 mg kg(-1) )...
April 12, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28390065/trends-in-the-prescription-of-novel-oral-anticoagulants-in-uk-primary-care
#15
S Y Loo, S Dell'Aniello, L Huiart, C Renoux
AIMS: Novel oral anticoagulants (NOAC) are alternatives to vitamin-K antagonists (VKA) for the prevention of thromboembolism. It is unclear how NOAC have been adopted in the UK since first introduced in 2008. This study was conducted to describe the trends in the prescription of NOAC, including dabigatran, rivaroxaban, and apixaban. METHODS: Using the UK's Clinical Practice Research Datalink, the rates of new users of NOAC and VKA from 2009 to 2015 were calculated with Poisson regression...
April 7, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28387051/when-less-is-more-efficacy-with-less-toxicity-at-the-ed50
#16
EDITORIAL
Simon Dimmitt, Hans Stampfer, Jennifer H Martin
No abstract text is available yet for this article.
April 6, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28378403/dose-sparing-and-lack-of-dose-response-relationship-with-an-influenza-vaccine-in-adult-and-elderly-patients-a-randomised-double-blind-clinical-trial
#17
Zoltan Vajo, Gergely Balaton, Peter Vajo, Laszlo Kalabay, Adam Erdman, Peter Torzsa
AIMS: The currently licensed seasonal trivalent influenza vaccines contain 15 micrograms of hemagglutinin per strain for adult, and up to 60 micrograms for elderly patients. However, due to recent shortages, dose sparing to increase production capacity would be highly desirable. In the present study, we attempted to find a dose-response relationship for immunogenicity and thus, the optimal dose for seasonal influenza vaccines in adult and elderly patients. METHODS: A total of 256 subjects, including adult (ages 18-60 years) and elderly (age over 60 years) were enrolled...
April 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28374426/response-to-response-to-bodyweight-adjustments-introduce-significant-correlations-between-cyp3a-metrics-and-tacrolimus-clearance
#18
LETTER
Elisabet Størset, Kristine Hole, Karsten Midtvedt, Stein Bergan, Espen Molden, Anders Åsberg
No abstract text is available yet for this article.
April 3, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28370351/statins-and-polyneuropathy-revisited-case-control-study-in-denmark-1999-2013
#19
Toke de Koning Svendsen, Peter Nørregaard Hansen, Luis Alberto García Rodríguez, Lene Andersen, Jesper Hallas, Søren Hein Sindrup, David Gaist
AIM: In a previous study, we found a positive association between statin use and polyneuropathy risk. Other studies reported equivocal results. The present study aimed to confirm our findings with a design similar to our previous study, but with a larger data set. METHODS: We searched medical registry data to identify patients diagnosed with incident polyneuropathy of no known cause (idiopathic polyneuropathy) in 1999-2013; we verified the diagnosis through medical records...
April 1, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28370224/do-antiepileptic-drugs-increase-the-risk-of-infectious-diseases-a-meta-analysis-of-placebo-controlled-studies
#20
Gaetano Zaccara, Fabio Giovannelli, Filippo Sean Giorgi, Valentina Franco, Sara Gasparini, Francesco Mandò Tacconi
AIMS: Experimental studies show that some antiepileptic drugs (AEDs) may modify natural immune defenses, thus influencing the risk of developing infectious diseases. The aim of this meta-analysis was to explore whether AEDs as a class of drugs or singularly may increase risk of infectious diseases. METHODS: A meta-analysis of all randomized, double-blind, placebo-controlled trials (RCTs) investigating any AED in any condition was performed. All terms which could be coded in the System Organ Classes (SOCs) of "infections and infestations" using the Medical Dictionary for Regulatory Activities (MedDRA) were recorded...
March 31, 2017: British Journal of Clinical Pharmacology
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