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British Journal of Clinical Pharmacology

Cheryl Li, Satoshi Shoji, Jean Beebe
AIMS: The purpose of this study was to characterize pharmacokinetics (PK) of PF-04236921, a novel anti-IL-6 monoclonal antibody, and its pharmacokinetics/pharmacodynamics (PK/PD) relationship on serum C-Reactive Protein (CRP) in healthy volunteers and patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Crohn's disease (CD) METHODS: Population modelling analyses were conducted using nonlinear mixed effects modelling. Data from 2 phase 1 healthy volunteer studies, a phase 1 RA study, a Phase 2 CD study, and a Phase 2 SLE study were included...
May 18, 2018: British Journal of Clinical Pharmacology
Heini Kari, Hanna Kortejärvi, Marja Airaksinen, Raisa Laaksonen
AIMS: The aim of this study is to evaluate how critical patient involvement is in pharmacist-led clinical medication reviews (CMRs) and in identifying the most significant clinical drug-related problems (DRPs). METHODS: Pharmacist-led CMRs were conducted with 161 consenting patients aged >75 years with 7+ prescribed medicines, living independently at home in Finland. A pharmacist, a nurse and a physician evaluated the clinical significance of the DRPs identified during the patient interview at an interprofessional case conference...
May 18, 2018: British Journal of Clinical Pharmacology
Alessandra Bettiol, Niccolò Lombardi, Ettore Marconi, Giada Crescioli, Roberto Bonaiuti, Valentina Maggini, Eugenia Gallo, Alessandro Mugelli, Fabio Firenzuoli, Claudia Ravaldi, Alfredo Vannacci
AIMS: Use of complementary and alternative medicines (CAMs) during breastfeeding is commonly increasing, mainly due to their presumed higher safety compared to conventional medications. Indeed, CAMs can cause serious adverse effects, and high-quality evidence supporting their use during lactation is limited. In Italy, specific investigations on the attitude of lactating women towards CAMs are lacking. The Herbal supplements in Breastfeeding InvesTigation (HaBIT) aimed to explore the attitudes and knowledge on CAMs among lactating women...
May 16, 2018: British Journal of Clinical Pharmacology
Wen-Hsuan Hou, Kai-Cheng Chang, Chung-Yi Li, Huang-Tz Ou
AIMS: To investigate the putative link between dipeptidyl peptidase-4 inhibitor (DPP-4i) use and the risk of fracture in patients with type 2 diabetes. METHODS: This propensity-score-matched population-based cohort study was performed between 2009 and 2013 on patients with type 2 diabetes who were stable metformin users. A total of 3,996 patients with type 2 diabetes used DPP-4i as a second-line antidiabetic drug. The same number of matched non-DPP-4i users were followed up until fracture occurrence, health insurance policy termination, or the end of 2013...
May 16, 2018: British Journal of Clinical Pharmacology
Zheng Liu, Jennifer H Martin
AIM: Model-based prediction on clinical doses for cannabinoids therapy is beneficial in the clinical setting, especially for seriously ill patients with both altered pharmacokinetics and pharmacodynamic responses. The objective of this article is to review the currently available PK and/or PD models of Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to highlight the major issues for modelling this complex therapeutic area. METHODS: A systematic search was conducted in the electronic databases PubMed and EMBASE using the key words "cannabis", "cannabinoid", "tetrahydrocannabinol", "THC", "cannabidiol", "CBD", "pharmacokinetic model", "pharmacodynamics model" and their combinations...
May 16, 2018: British Journal of Clinical Pharmacology
R Gertler, M Gruber, G Wiesner, S Grassin-Delyle, S Urien, P Tassani-Prell, K Martin
AIM: Very little data exist regarding the effect of cardiopulmonary bypass (CPB) on cefuroxime (CXM) pharmacokinetics in children less than one year of age. METHODS: 50 mg kg-1 CXM iv after induction were followed by 75 mg kg-1 into the CPB circuit. In 42 patients undergoing cardiac surgery 15 to 20 samples were obtained between 5 and 360 min after each dose. Total CXM concentrations were measured by high-performance liquid chromatography and a PK/PD modelling was performed...
May 14, 2018: British Journal of Clinical Pharmacology
Caroline Gjestad, Tore Haslemo, Ole A Andreassen, Espen Molden
No abstract text is available yet for this article.
May 10, 2018: British Journal of Clinical Pharmacology
Carlotta Franchi, Stefania Antoniazzi, Marco Proietti, Alessandro Nobili, Pier Mannuccio Mannucci
BACKGROUND: Oral anticoagulants (OACs) are effective in preventing stroke in older people with atrial fibrillation (AF). Despite this, they are often underused in this at particularly high risk population. OBJECTIVES: To assess the appropriateness of OAC prescription and its associated factors in hospitalized patients aged 65 years or older. METHODS: Data were obtained from the retrospective phase of SIM-AF study, held in 32 Italian internal medicine and geriatric wards...
May 10, 2018: British Journal of Clinical Pharmacology
Shin-Chia Tsai, Shiow-Yunn Sheu, Li-Nien Chien, Hsin-Chien Lee, Eunice Jia-Shiow Yuan, Rey-Yue Yuan
AIMS: We conducted a cohort study utilizing a nationwide health insurance database to assess European Medicines Agency's restrictions on using metoclopramide and its association with risk of parkinsonism. METHODS: New oral metoclopramide users aged ≥20 years, and age-, gender-matched non-users were recruited in 2001-2011. Users were divided into high-exposure (dose >30 mg/day and/or duration >5 days) and standard-exposure (dose ≤30 mg/day and duration ≤5 days) groups...
May 10, 2018: British Journal of Clinical Pharmacology
S Leroux, E Jacqz Aigrain, V Elie, F Legrand, C Barin-Le Guellec, B Aurich, V Biran, B Dusang, S Goudjil, S Coopman, R Garcia Sanchez, W Zhao, P Manzoni
AIMS: Pharmacokinetics (PK) of fluconazole and micafungin differ in neonates compared with children and adults. Dosing instructions in product labels appear inconsistent with the emerging scientific evidence. Limited information is available on their safety profile in neonates. Our objective was to study population PK and safety of both drugs, randomly administered in neonates with suspected or confirmed systemic candidiasis. METHODS: Neonates were randomized 1:1 to fluconazole (loading dose 25mg/kg; maintenance dose 12 or 20mg/kg/day for infants <30 or ≥ 30 weeks corrected gestational age) or micafungin (loading dose 15mg/kg/day; maintenance dose 10mg/kg/day)...
May 10, 2018: British Journal of Clinical Pharmacology
David Counter, James W T Millar, James S McLay
AIMS: Applying version 2 of the STOPP/START criteria to discharge prescriptions of older adults discharged from a general medical unit, assess potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs)and their association with hospital readmission and mortality. METHODS: Discharge medications, co-morbidities and patient demographics were recorded over an 8 month period for consecutive emergency admissions aged ≥ 65 years. PIMs and PPOs were identified using version 2 of the STOPP/START criteria...
May 9, 2018: British Journal of Clinical Pharmacology
Bas Vreugdenhil, Walter J F M van der Velden, Ton Feuth, Matthijs Kox, Peter Pickkers, Frank L van de Veerdonk, Nicole M A Blijlevens, Roger J M Brüggemann
BACKGROUND: Voriconazole (VCZ) exhibits a wide intra-patient pharmacokinetic variability, which is disadvantageous because of the narrow-therapeutic range of VCZ. A considerable part of this variation remains unexplainable despite extensive knowledge of this drug. It is hypothesized that inflammation has an impact on voriconazole pharmacokinetics. In this study we investigated the correlation between voriconazole trough concentrations and various cytokines. METHODS: A prospective single center analysis was performed in adult hematology patients receiving voriconazole for possible, probable or proven IFD...
May 9, 2018: British Journal of Clinical Pharmacology
Aurel Iuga, Ash Genaidy
No abstract text is available yet for this article.
May 7, 2018: British Journal of Clinical Pharmacology
Jules A A C Heuberger, Sven C van Dijkman, Adam F Cohen
AIM: Salbutamol is used in the management of obstructive bronchospasm, including that of some elite athletes. It is claimed that high salbutamol (oral) doses may also have an anabolic effect. Therefore, inhalation of salbutamol is restricted by the World Anti-Doping Agency (WADA) to a maximal daily dose. Urine is tested for violations, but recent cases have resulted in a debate regarding the validity of this approach. It was our aim to determine whether current approaches are sufficiently able to differentiate approved usage from violations...
May 3, 2018: British Journal of Clinical Pharmacology
Katherine Kay, Dhaval K Shah, Lisa Rohan, Robert Bies
AIMS: A physiologically-based pharmacokinetic (PBPK) model of the vaginal space was developed with the aim of predicting concentrations in the vaginal and cervical space. These predictions can be used to optimize the probability of success of vaginally administered dapivirine (DPV) for HIV prevention. We focus on vaginal delivery using either a ring [1] or film [2]. METHODS: A PBPK model describing the physiological structure of the vaginal tissue and fluid was defined mathematically and implemented in MATLAB...
May 1, 2018: British Journal of Clinical Pharmacology
Hung-Wei Lin, Yunn-Fang Ho, Fang-Ju Lin
AIMS: To examine the association between statin use before and after intracranial hemorrhage (ICH) and the risk of post-stroke epilepsy (PSE). METHODS: Patients with new-onset ICH between 2004 and 2012 were identified from the Taiwan National Health Insurance Research Database. The main outcome was the occurrence of epilepsy after stroke. Multivariable Cox regression modeling was used to estimate the association between statin use and the risk of PSE, with post-stroke medication exposures being treated as time-dependent variables...
May 1, 2018: British Journal of Clinical Pharmacology
Myriam Gagné, Louis-Philippe Boulet, Norma Pérez, Jocelyne Moisan
AIM: To systematically identify the measurement properties of patient-reported outcome instruments (PROs) that evaluate adherence to inhaled maintenance medication in adults with asthma. METHODS: We conducted a systematic review of six databases. Two reviewers independently included studies on the measurement properties of PROs that evaluated adherence in asthmatic participants aged ≥18 years. Based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), the reviewers (1) extracted data on internal consistency, reliability, measurement error, content validity, structural validity, hypotheses testing, cross-cultural validity, criterion validity, and responsiveness; (2) assessed the methodological quality of the included studies; (3) assessed the quality of the measurement properties (positive or negative); and (4) summarised the level of evidence (limited, moderate, or strong)...
April 30, 2018: British Journal of Clinical Pharmacology
Oliver Pohl, Line Marchand, Jean-Pierre Gotteland, Simon Coates, Jörg Täubel, Ulrike Lorch
AIMS: Preterm birth remains a significant risk for later disability. The selective inhibition of the prostaglandin F2α receptor (FP) has significant advantages for a tocolytic. The pro-drug OBE022 and its metabolite OBE002 are novel FP antagonists under development for treating preterm labour. METHODS: We performed a prospective, first in human, Phase I, dose escalation, placebo-controlled, randomised trial at a clinical trial site in the UK. Placebo, single ascending doses (SAD) of 10, 30, 100, 300, 1000 or 1300 mg, and multiple ascending doses (MAD) over seven days of 100, 300 or 1000 mg per day; were administered to post-menopausal female volunteers...
April 30, 2018: British Journal of Clinical Pharmacology
Christine Gispen-de Wied, Anthonius de Boer
No abstract text is available yet for this article.
April 28, 2018: British Journal of Clinical Pharmacology
Gary Tse, Mengqi Gong, Guangping Li, Sunny Hei Wong, William K K Wu, Wing Tak Wong, Leonardo Roever, Alex Pui Wai Lee, Gregory Y H Lip, Martin C S Wong, Tong Liu
BACKGROUND: Previous trials on the effectiveness of genotype-guided warfarin dosing versus conventional dosing have been inconclusive. We conducted a systematic review and meta-analysis of randomized trials comparing genotype-guided to conventional dosing strategies. METHODS: PubMed and Cochrane Library were searched until 23rd October 2017. RESULTS: A total of 76 and 94 entries were retrieved. A total of 2626 subjects in the genotype-guided dosing (mean age: 63...
April 28, 2018: British Journal of Clinical Pharmacology
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