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British Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/29139564/incident-diuretic-drug-use-and-adverse-respiratory-events-among-older-adults-with-copd
#1
Nicholas T Vozoris, Xuesong Wang, Peter C Austin, Denis E O'Donnell, Shawn D Aaron, Teresa M To, Andrea S Gershon
AIMS: Diuretic drugs may theoretically improve respiratory health outcomes in COPD through several possible mechanisms, but they might also lead to respiratory harm. We evaluated the association of incident oral diuretic drug use with respiratory-related morbidity and mortality among older adults with COPD. METHODS: This was a population-based, retrospective cohort study using health administrative data from Ontario, Canada, for the period 2008-2013. We identified adults aged 66 years and older with non-palliative COPD using a validated algorithm...
November 15, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29105853/measuring-the-impact-of-medicines-regulatory-interventions-systematic-review-and-methodological-considerations
#2
Thomas Goedecke, Daniel Morales, Alexandra Pacurariu, Xavier Kurz
AIM: Evaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research. METHODS: We searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non-European Union regulatory actions to safeguard public health published until March 2017...
November 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29105799/-microdialysis-as-a-tool-to-determine-the-local-tissue-concentration-of-dicloxacillin-in-man
#3
K K Hansen, F Nielsen, T B Stage, U Jørgensen, O Skov, L E Rasmussen
AIM: The most common pathogen in Denmark, to cause postoperative infections, is Staphylococcus (S.) aureus (1). Despite using prophylactic antibiotics, infections are still seen. Whether the tissue concentration is above the minimal inhibitory concentration (MIC) for the pathogen is unknown. Thus, the concentration of dicloxacillin in muscle and adipose tissue was measured after intravenous administration, in healthy men. METHODS: MIC for dicloxacillin against S...
November 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29105855/dicloxacillin-induces-cyp2c19-cyp2c9-and-cyp3a4-in-vivo-and-in-vitro
#4
Tore Bjerregaard Stage, Magnus Graff, Susan Wong, Louise Ladebo Rasmussen, Flemming Nielsen, Anton Pottegård, Kim Brøsen, Deanna L Kroetz, S Cyrus Khojasteh, Per Damkier
AIM: The aim of this study was to study potential cytochrome P450 induction by dicloxacillin. METHODS: We performed an open-label randomized two-phase 5-drug clinical pharmacokinetic cocktail crossover study in 12 healthy men with and without pretreatment with 1g dicloxacillin three times daily for 10 days. Plasma and urine was collected over 24 hours and the concentration of all five drugs and their primary metabolites was determined using a LC-MS/MS method. Cryopreserved primary human hepatocytes were exposed to dicloxacillin for 48h and changes in gene expression and enzyme activity of CYP3A4, CYP2C9, CYP2B6 and CYP1A2 was investigated...
November 4, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29098700/response-to-in-vitro-and-physiologically-based-pharmacokinetic-assessment-of-the-drug-drug-interaction-potential-of-canagliflozin
#5
LETTER
John O Miners, Attarat Pattanawongsa, Andrew Rowland
No abstract text is available yet for this article.
November 3, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29096426/results-and-evaluation-of-a-first-in-human-study-of-rg7342-a-mglu5-positive-allosteric-modulator-utilizing-bayesian-adaptive-methods
#6
Stefan Sturm, Marie-Laure Delporte, Salah Hadi, Scott Schobel, Lothar Lindemann, Robert Weikert, Georg Jaeschke, Michael Derks, Giuseppe Palermo
AIM: The objectives of this first-in-human study were to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, and to determine the maximum tolerated dose (MTD) of single ascending oral doses of RG7342, a positive allosteric modulator (PAM) of the metabotropic glutamate receptor 5 (mGlu5) for the treatment of schizophrenia, in healthy male subjects. METHODS: This was a single-centre, randomized, double-blind, adaptive study of 37 subjects receiving single ascending oral doses of RG7342 (ranging from 0...
November 2, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29077992/population-pharmacokinetics-of-exendin-9-39-and-clinical-dose-selection-in-patients-with-congenital-hyperinsulinism
#7
Chee M Ng, Fei Tang, Steven Seeholzer, Yixuan Zou, Diva D De León
AIMS: Congenital hyperinsulinism (HI) is the most common cause of persistent hypoglycaemia in infants and children. Exendin-(9-39), an inverse glucagon-like peptide 1 (GLP-1) agonist, is a novel therapeutic agent for HI that has demonstrated glucose-raising effect. We reported the first population pharmacokinetic (PopPK) model of the exendin-(9-39) in patients with HI and proposed the optimal dosing regimen for future clinical trials in neonates with HI. METHODS: 182 pharmacokinetic (PK) observations from 26 subjects in three clinical studies were included for constructing the PopPK model using FOCE with interaction method in NONMEM...
October 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29077230/risk-factors-contributing-to-a-low-darunavir-plasma-concentration
#8
A Daskapan, Y Stienstra, J G W Kosterink, W F W Bierman, T S van der Werf, D J Touw, J W C Alffenaar
Darunavir is an efficacious drug, however pharmacokinetic variability has been reported. The objective of this study was to find predisposing factors for low darunavir plasma concentrations in patients starting the once- or twice-daily dosage. Darunavir plasma concentrations from January 2010 till December 2014 of HIV-infected individuals treated in the outpatient clinic of the University Medical Center Groningen were retrospectively reviewed. The first darunavir plasma concentration of patients within 8 weeks after initiation of darunavir therapy was selected...
October 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29073329/comparative-risks-of-diabetes-related-complications-of-basal-insulins-a-longitudinal-population-based-cohort-of-type-1-diabetes-1999-2013-in-taiwan
#9
Huang-Tz Ou, Tsung-Ying Lee, Ye-Fong Du, Chung-Yi Li
AIM: We compared the effects of basal insulins: long-acting insulin analogues versus intermediate/long-acting human insulin, on diabetes-related complications in type 1 diabetes. METHODS: 1,188 type 1 diabetes newly on long-acting insulin analogues or intermediate/long-acting human insulin were identified in 2004-2008 and followed until death or 2013. Clinical outcomes included acute (i.e., hyperglycemia, hypoglycemia) and chronic (i.e., nephropathy, retinopathy, neuropathy, cardiovascular diseases) complications...
October 26, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29073323/urinalysis-of-mmx-mesalazine-as-a-tool-to-monitor-5-asa-adherence-in-daily-ibd-practice
#10
Tessa E H Römkens, Rene Te Morsche, Wilbert Peters, David M Burger, Frank Hoentjen, Joost P H Drenth
Adherence is pivotal but challenging in ulcerative colitis (UC) treatment. Many methods to assess adherence are subjective or have limitations. (Nac-)5-aminosalicylic acid (5-ASA) urinalysis by High-Performance Liquid Chromatography (HPLC) seems feasible and reproducible in healthy volunteers. We performed a prospective study in adult quiescent UC patients to evaluate the feasibility of spot (Nac-)5-ASA urinalysis by HPLC to assess adherence in daily IBD care. Twenty-nine patients (51.7% male, mean age 52 ± 11 yrs) were included (median FU 9 months) and collected weekly spot urine samples...
October 26, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29072785/predicting-cyp3a-mediated-midazolam-metabolism-in-critically-ill-neonates-infants-children-and-adults-with-inflammation-and-organ-failure
#11
J M Brussee, N J Vet, E H J Krekels, A J Valkenburg, E Jacqz-Aigrain, J M A van Gerven, E L Swart, J N van den Anker, D Tibboel, M de Hoog, S N de Wildt, C A J Knibbe
AIMS: Inflammation and organ failure have been reported to impact cytochrome P450 (CYP) 3A-mediated clearance of midazolam in critically ill children. Our aim was to evaluate a previously developed population pharmacokinetic model in both critically ill children and other populations in order to allow the model to be used to guide dosing in clinical practice. METHODS: The model was externally evaluated in 136 individuals, including (pre)term neonates, infants, children, and adults (body weight 0...
October 26, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29068066/parenteral-bilirubin-in-healthy-volunteers-a-reintroduction-in-translational-research
#12
Douwe Dekker, Mirrin J Dorresteijn, Marieke E B Welzen, Simone Timman, Peter Pickkers, David M Burger, Paul Smits, Frank A D T G Wagener, Frans G M Russel
AIM(S): Preclinical results suggest therapeutic potential of mild hyperbilirubinemia in T2DM and cardiovascular disease. Translational data are limited, because an appropriate bilirubin formulation for parenteral human use is lacking. Considering its use in both clinical practice and medical research in the past, we explored the feasibility to reintroduce parenteral bilirubin for translational experiments. METHODS: We developed a preparation method in accordance with good manufacturing practice and evaluated the parenteral applicability in healthy volunteers (n=8)...
October 25, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29057539/comparative-safety-of-systemic-and-low-bioavailability-steroids-in-inflammatory-bowel-disease-systematic-review-and-network-meta-analysis
#13
Stefanos Bonovas, Georgios K Nikolopoulos, Theodore Lytras, Gionata Fiorino, Laurent Peyrin-Biroulet, Silvio Danese
AIMS: Oral systemic corticosteroids have been used to induce remission in patients with active inflammatory bowel disease (IBD) for over 50 years; however, the wide array of adverse events (AEs) associated with these drugs prompted the development of steroid compounds with targeted delivery and low systemic bioavailability. This study assessed corticosteroids' comparative harm using network meta-analysis. METHODS: We searched PubMed, Scopus, Embase, the Cochrane Library, clinical trial registries, regulatory authorities' websites and major conference proceedings, through March 2017...
October 22, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29057492/qtc-prolongation-during-ciprofloxacin-and-fluconazole-combination-therapy-prevalence-and-associated-risk-factors
#14
Florine A Berger, Nico Monadian, Natasja M S de Groot, Bart Santbergen, Heleen van der Sijs, Matthijs L Becker, Annoek E C Broers, Teun van Gelder, Patricia M L A van den Bemt
AIM (S): Ciprofloxacin and fluconazole combination therapy is frequently used as prophylaxis for and treatment of infections in patients with haematological malignancies. However, both drugs are known to prolong the QTc-interval, which is a serious risk factor for Torsade de Pointes (TdP). Therefore, the aim of this study was to assess the prevalence of QTc-prolongation during ciprofloxacin and fluconazole use. The secondary objective was to determine associated risk factors of QTc-prolongation in these patients...
October 22, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29049872/optimal-dosing-and-delivery-of-pth-and-its-analogues-for-osteoporosis-and-hypoparathyroidism-translating-the-pharmacology
#15
REVIEW
D Tay, S Cremers, J P Bilezikian
In primary hyperparathyroidism (PHPT), bone loss results from the resorptive effects of excess parathyroid hormone (PTH). Under physiological conditions, PTH has actions that are more targeted to homeostasis and to bone accrual. The predominant action of PTH, either catabolic, anabolic, or homeostatic, can be understood in molecular and pharmacokinetic terms. When administered intermittently, PTH increases bone mass, but when present continuously and in excess (e.g., PHPT), bone loss ensues. This dual effect of PTH depends not only on the dosing regimen, continuous or intermittent, but also on how the PTH molecule interacts with various states of its receptor (PTH/PTHrP receptor) influencing downstream signaling pathways differentially...
October 19, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29044640/a-step-down-protocol-for-omalizumab-treatment-in-oral-corticosteroid-dependent-allergic-asthma-patients
#16
Christian Domingo, Xavier Pomares, Albert Navarro, María José Amengual, Concepción Montón, Ana Sogo, Rosa M Mirapeix
BACKGROUND: there are no specific criteria for a step-down or withdrawal dose of omalizumab. Our purpose was to evaluate the viability of a protocol for OMAlizumab DOse REduction (the OMADORE study) in severe allergic asthma (SAA). METHODS: the study population included 35 SAA patients treated during a minimum period of one year with oral corticosteroids (OC) equivalent to a mean daily dose of 4 mg of methyl-prednisolone. To qualify for the protocol, the patients had to have received treatment with OMA ≥ one year and a half, OC dose had to have reached the lowest tolerated dose and spirometry had to be ≥ at entry...
October 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29044597/short-and-long-term-complications-of-in-utero-exposure-to-lamotrigine
#17
Merav Cohen-Israel, Itai Berger, Einat Y Martonovich, Gil Klinger, Bracha Stahl, Nehama Linder
AIMS: The present study evaluates the effect of antenatal lamotrigine exposure, on short- and long-term paediatric outcome. METHODS: The study included the children of 83 epileptic women treated with lamotrigine during pregnancy, at a tertiary medical centre between 2004-2014. All newborns were monitored for vital signs, congenital malformations and Finnegan score. In addition, the parents completed a questionnaire regarding their child's development and health up to the age of 12 years...
October 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29028125/ledipasvir-and-tenofovir-drug-interaction-in-hiv-hcv-co-infected-patients-impact-on-tenofovir-ctrough-and-renal-safety
#18
Caroline Solas, Sylvie Bregigeon, Olivia Faucher-Zaegel, Sylvie Quaranta, Véronique Obry-Roguet, Catherine Tamalet, Bruno Lacarelle, Isabelle Poizot-Martin
We evaluate the impact of ledipasvir on both tenofovir plasma trough concentration (Ctrough ) and estimated glomerular renal function (eGFR) in HIV-HCV co-infected patients receiving a tenofovir(TDF)-based antiretroviral regimen and treated with ledipasvir/sofosbuvir. Twenty-six patients [81% male, median age: 51years; HCV genotype 1(75%)/4(15%)] were included. Tenofovir Ctrough (interquartile:IQR) increased from 78ng/mL (53-110) at baseline to 141ng/mL (72-176) at M1 (p=0.003). No significant difference on eGFR using both Cockroft-Gault and MDRD formula, respectively [median(IQR)] was observed between baseline [101...
October 13, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29027243/phenytoin-its-potential-as-neuroprotective-and-retinoprotective-drug
#19
LETTER
Flavia Chiosi, Jan Keppel Hesselink, Michele Rinaldi, Silvio Di Staso, Silvia Bartollino, Ciro Costagliola
No abstract text is available yet for this article.
October 12, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29023830/drug-management-in-acute-kidney-disease-report-of-the-adqi-xvi-meeting
#20
M Ostermann, L S Chawla, L G Forni, S L Kane-Gill, J A Kellum, J Koyner, P T Murray, C Ronco, S L Goldstein
AIMS: To summarize and extend the main conclusions and recommendations relevant to drug management during acute kidney disease (AKD) as agreed at the 16(th) Acute Disease Quality Initiative (ADQI) consensus conference. METHODS: Using a modified Delphi method to achieve consensus, experts attending the 16(th) ADQI consensus conference reviewed and appraised the existing literature on drug management during AKD and identified recommendations for clinical practice and future research...
October 11, 2017: British Journal of Clinical Pharmacology
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