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British Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28230269/antigenic-burden-and-serum-igg-concentrations-influence-rituximab-pharmacokinetics-in-rheumatoid-arthritis-patients
#1
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
#2
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
#3
I Aznar-Lou, A Fernández, M Gil-Girbau, M Fajó-Pascual, P Moreno-Peral, M T Peñarrubia-Maria, A Serrano-Blanco, A Sánchez-Niubó, M March-Pujol, A M Jové, M Rubio-Valera
INTRODUCTION: 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: Retrospective, register-based cohort study which linked 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
#4
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
https://www.readbyqxmd.com/read/28213957/a-bosentan-pharmacokinetic-study-to-investigate-dosing-regimens-in-paediatric-patients-with-pulmonary-arterial-hypertension-future-3
#5
R M F Berger, M Gehin, M Beghetti, D Ivy, A Kusic-Pajic, P Cornelisse, S Grill, D Bonnet
AIM: To investigate whether increasing bosentan dosing frequency from 2 mg/kg twice daily (b.i.d.) to 2 mg/kg three times daily (t.i.d.) in children with pulmonary arterial hypertension (PAH) (from ≥3 months to <12 years of age) would increase exposure. METHODS: An open-label, prospective, randomised, multicentre, multiple-dose, Phase 3 study was conducted. Patients (n = 64) were randomised 1:1 to receive oral doses of bosentan of 2 mg/kg b.i...
February 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28213941/population-pharmacokinetic-and-exposure-simulation-analysis-for-cediranib-azd2171-in-pooled-phase-i-ii-studies-in-patients-with-cancer
#6
Jianguo Li, Nidal Al-Huniti, Anja Henningsson, Weifeng Tang, Eric Masson
AIMS: A population pharmacokinetic (PPK) model was developed for cediranib to simulate cediranib exposure for different doses, including co-medication with strong UGT/Pgp inducers such as rifampicin, in cancer patients. METHODS: Plasma concentrations and covariates from 625 cancer patients after single or multiple oral cediranib administrations ranging from 0.5 to 90 mg in 19 Phase I and II studies were included in the analysis. Stepwise covariate modelling was used to develop the PPK model...
February 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28205318/risk-of-major-bleeding-and-stroke-associated-with-the-use-of-vkas-noacs-and-aspirin-in-patients-with-atrial-fibrillation-a-cohort-study
#7
Emilie Gieling, Hendrika A van den Ham, Hein van Onzenoort, Jacqueline Bos, Cornelis Kramers, Anthonius de Boer, Frank de Vries, Andrea M Burden
INTRODUCTION: Non-vitamin K antagonist oral anticoagulants (NOACs) are now available for the prevention of stroke in patients with atrial fibrillation (AF) as an alternative to vitamin K antagonists (VKA) and aspirin. The comparative effectiveness and safety in daily practice of these different drug classes is still unclear. The objective of this study was to evaluate the risk of major bleeding and stroke in AF patients using NOACs, VKAs or aspirin. METHODS: A retrospective cohort study was conducted among AF patients using the UK Clinical Practice Research Datalink (March 2008-October 2014)...
February 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28192629/the-effect-of-co-trimoxazole-on-serum-potassium-concentration-safety-evaluation-of-a-randomised-controlled-trial
#8
Wei Yee Chan, Allan B Clark, Andrew M Wilson, Yoon K Loke
AIMS: Co-trimoxazole maintains a well-established role in the treatment of Pneumocystis jirovecii and Toxoplasma gondii, as well as urinary tract infections. Observational studies report hyperkalemia associated with co-trimoxazole which may stem from an amiloride-like potassium sparing effect. Our study reports on changes in serum potassium on patients without acute infections, and the influence of concomitant anti-kaliuretic drugs on this effect. METHODS: Post-hoc analysis of a randomised controlled trial in patients with interstitial lung disease who were assigned to placebo or 960 mg twice daily co-trimoxazole...
February 13, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28186644/population-pharmacokinetics-and-pharmacodynamics-of-linezolid-induced-thrombocytopenia-in-hospitalized-patients
#9
Yasuhiro Tsuji, Nicholas H G Holford, Hidefumi Kasai, Chika Ogami, Young-A Heo, Yoshitsugu Higashi, Akiko Mizoguchi, Hideto To, Yoshihiro Yamamoto
AIMS: Thrombocytopenia is among the most important adverse effects of linezolid treatment. Linezolid-induced thrombocytopenia incidence varies considerably but has been associated with impaired renal function. We investigated the pharmacodynamic mechanism (myelosuppression or enhanced platelet destruction) and the role of impaired renal function in the development of thrombocytopenia. METHODS: The pharmacokinetics of linezolid were described with a two-compartment distribution model with first-order absorption and elimination...
February 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28185274/clarithromycin-trimethoprim-and-penicillin-and-oxidative-nucleic-acid-modifications-in-humans-randomised-controlled-trials
#10
Emil List Larsen, Vanja Cejvanovic, Laura Kofoed Kjaer, Morten Thorup Pedersen, Sara Daugaard Popik, Lina Kallehave Hansen, Jon Traerup Andersen, Espen Jimenez-Solem, Kasper Broedbaek, Morten Petersen, Allan Weimann, Trine Henriksen, Jens Lykkesfeldt, Christian Torp-Pedersen, Henrik Enghusen Poulsen
AIMS: In vitro studies have demonstrated that formation of reactive oxygen species (ROS) contributes to the effect of bactericidal antibiotics. The formation of ROS is not restricted to bacteria, but also occurs in mammalian cells. Oxidative stress is linked to several diseases. This study investigates whether antibiotic drugs induce oxidative stress in healthy humans as a possible mechanism for adverse reactions to the antibiotic drugs. METHODS: This study contains information from two randomised, controlled trials...
February 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28181291/comparing-intravenous-and-oral-proton-pump-inhibitor-therapy-for-bleeding-peptic-ulcers-following-endoscopic-management-a-systematic-review-and-meta-analysis
#11
A Tringali, R Manta, M Sica, G Bassotti, R Marmo, M Mutignani
BACKGROUND AND AIMS: The efficacy of proton pump inhibitors (PPI) has been demonstrated for bleeding peptic ulcers but the route of administration remains controversial. Several studies demonstrated that high dose oral PPI are as effective as intravenous PPI in reducing recurrent bleeding. However, current guidelines recommend intravenous PPI after endoscopic treatment. Previous data based on inadequate numbers to reach a firm conclusion suggested that oral and intravenous PPI had equivalent efficacy...
February 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28177137/hypoalbuminemia-and-decreased-midazolam-clearance-in-terminally-ill-adult-patients-an-inflammatory-effect
#12
L G Franken, A D Masman, B C M de Winter, F P M Baar, D Tibboel, T van Gelder, B C P Koch, R A A Mathot
BACKGROUND AND OBJECTIVE: Midazolam is the drug of choice for palliative sedation and is titrated to achieve the desired level of sedation. Because of large inter-individual variability (IIV), however, the time it takes to achieve adequate sedation varies widely. It would therefore greatly improve clinical care if an individualised dose could be determined beforehand. To find clinically relevant parameters for dose individualisation we performed a pharmacokinetic study on midazolam, 1OH-midazolam (1-OH-M) and 1OH-midazolam-glucuronide (1-OH-MG) in terminally ill patients...
February 8, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28177130/a-population-pharmacokinetic-model-of-at9283-in-adults-and-children-to-predict-the-maximum-tolerated-dose-in-children-with-leukaemia
#13
Janna K Duong, Melanie J Griffin, Darren Hargrave, Josef Vormoor, David Edwards, Alan V Boddy
AIMS: AT9283 is used to treat patients with solid tumors and patients with leukaemia. However, the maximum tolerated dose (MTD) for children with leukaemia remains unknown due to early termination of the Phase I trial. The aim of this study was to develop a population model of AT9283 to describe the pharmacokinetics in adults and children and to estimate the MTD in children with leukaemia. METHODS: Data from Phase I dose-escalation studies in adults and children were used to build a population pharmacokinetic model (NONMEM v7...
February 8, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28176362/interdisciplinary-pharmacometrics-linking-oseltamivir-pharmacology-influenza-epidemiology-and-health-economics-to-inform-antiviral-use-in-pandemics
#14
M A Kamal, P F Smith, N Chaiyakunapruk, D B C Wu, C Pratoomsoot, K K C Lee, H Y Chong, R E Nelson, K Nieforth, G Dall, S Toovey, D C M Kong, A Kamauu, C M Kirkpatrick, C R Rayner
AIM: A modular interdisciplinary platform was developed to investigate the economic impact of oseltamivir treatment by dosage regimen under simulated influenza pandemic scenarios. METHODS: The pharmacology module consisted of a pharmacokinetic distribution of oseltamivir carboxylate AUC0-24h at steady state (simulated for 75 mg and 150 mg BID regimens for 5 days) and a pharmacodynamic distribution of viral shedding duration (Tshed ) obtained from phase II influenza inoculation data...
February 8, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28168757/medication-induced-siadh-distribution-and-characterization-according-to-medication-class
#15
Shepshelovich Daniel, Schechter Amir, Calvarysky Bronislava, Diker-Cohen Talia, Rozen-Zvi Benaya, Gafter-Gvili Anat
AIMS: To determine the distribution of aetiologies for drug induced syndrome of inappropriate antidiuretic hormone secretion (SIADH) in hospitalized patients, and to characterize them according to the different drug groups. METHODS: A single centre retrospective study including all patients diagnosed with SIADH in a large community hospital and tertiary centre between 1.1.2007 and 1.1.2013 who were treated with drugs known to be associated with SIADH. Two physicians reviewed every patient's medical file for predetermined relevant clinical data...
February 7, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28168728/reponse-to-bodyweight-adjustments-introduce-significant-correlations-between-cyp3a-metrics-and-tacrolimus-clearance
#16
Thomas Vanhove, Pieter Annaert, Dirk R J Kuypers
No abstract text is available yet for this article.
February 6, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28166606/effect-of-ezetimibe-on-plasma-adipokines-a-systematic-review-and-meta-analysis
#17
Dolezelova E, Stein E, Derosa G, Maffioli P, Nachtigal P, Sahebkar A
AIMS: Statins are known to influence status of adipokines, which play a key role in the pathophysiology of cardiometabolic diseases. As the effect of ezetimibe add-on to statin therapy on the impact of statins on plasma adipokines levels is unclear yet, the aim of this study was to answer this question through meta-analysis of controlled trials. METHODS: A systematic review followed by a bibliographic search in PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases was performed...
February 6, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28160505/cytochrome-p450-mediated-interaction-between-perazine-and-risperidone-implications-for-antipsychotic-polypharmacy
#18
Michael Paulzen, Ekkehard Haen, Christoph Hiemke, Benedikt Stegmann, Sarah E Lammertz, Gerhard Gründer, Georgios Schoretsanitis
BACKGROUND: Although clinically very widespread, scientific evidence for antipsychotic polypharmacy is still limited. Combining different drugs increases the potential for drug-drug interactions enhancing the risk of adverse drug reactions. We aimed to unravel potential pharmacokinetic interactions between risperidone and perazine. METHODS: A therapeutic drug monitoring database contained plasma concentrations of risperidone (RIS) and its active metabolite (9-OH-RIS)...
February 4, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28156017/population-pharmacokinetics-and-site-of-action-exposures-of-veliparib-with-topotecan-plus-carboplatin-in-patients-with-hematological-malignancies
#19
Shailly Mehrotra, Mathangi Gopalakrishnan, Jogarao Gobburu, Jacqueline M Greer, Richard Piekarz, Judith E Karp, Keith Pratz, Michelle A Rudek
AIMS: Veliparib is a potent inhibitor of poly(ADP-ribose) polymerase (PARP) enzyme. The objectives of the analysis were to evaluate the effect of baseline covariates and co-administration of topotecan plus carboplatin (T + C) on pharmacokinetics of veliparib in patients with refractory acute leukemia, and compare veliparib concentration in various biological matrices. METHODS: A population pharmacokinetic model was developed and effect of age, body size indices, sex, creatinine clearance (CrCL), and co-administration of T + C on the pharmacokinetics of veliparib were evaluated...
February 3, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28156011/evaluation-of-single-and-multiple-doses-of-a-novel-mglu2-agonist-a-potential-antipsychotic-therapy-in-healthy-subjects
#20
J McColm, C Brittain, S Suriyapperuma, S Swanson, S Tauscher-Wisniewski, J Foster, D Soon, K Jackson
AIM: The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single and multiple doses of a novel mGlu2 agonist were assessed in healthy males. METHODS: In two, phase 1 investigator- and subject-blind, placebo-controlled studies, oral doses of prodrug LY2979165 were evaluated: single doses (20 to 150 mg, N = 30) and multiple once-daily (QD) doses (20 to 400 mg; N = 84), using a titration regimen. The plasma and urine PK of LY2979165 and active moiety, 2812223, were measured...
February 3, 2017: British Journal of Clinical Pharmacology
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