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British Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28098949/identification-of-cellular-targets-involved-in-cardiac-failure-caused-by-pki-in-oncology-an-approach-combining-pharmacovigilance-and-pharmacodynamics
#1
E Patras de Campaigno, E Bondon-Guitton, G Laurent, F Montastruc, J L Montastruc, M Lapeyre-Mestre, F Despas
AIMS: To evaluate the risk of cardiac failure (CF) of 15 anticancer protein kinase inhibitors (PKIs) through a case/non-case analysis and to identify which PK(s) and pathways are involved in PKI-induced CF. METHODS: To evaluate the risk of CF, adjusted reporting odds ratios (aRORs) were calculated for the 15 anticancer PKIs in the WHO safety report database (VigiBase®). We realised a literature review to identify 21 PK possibly involved in CF caused by PKIs. Pearson's correlation coefficients (r) between aROR and affinity data of the 15 PKIs for the 21 PKs were calculated to identify the cellular target most likely involved in PKI-induced CF...
January 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28097677/pharmacokinetics-of-first-line-antitubercular-drugs-in-plasma-and-pbmcs
#2
LETTER
Ilaria Motta, Andrea Calcagno, Lorena Baietto, Paolo Bigliano, Cecilia Costa, Katia Baruffi, Giovanna Fatiguso, Antonio D'Avolio, Giovanni Di Perri, Stefano Bonora
No abstract text is available yet for this article.
January 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28093797/adverse-reactions-to-dietary-supplements-containing-red-yeast-rice-assessment-of-cases-from-the-italian-surveillance-system
#3
Gabriela Mazzanti, Paola Angela Moro, Emanuel Raschi, Roberto Da Cas, Francesca Menniti-Ippolito
AIMS: Red yeast rice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs). METHODS: Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions...
January 17, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28087982/the-impact-of-ces1-genotypes-on-the-pharmacokinetics-of-methylphenidate-in-healthy-danish-subjects
#4
Claus Stage, Gesche Jürgens, Louise Schow Guski, Ragnar Thomsen, Ditte Bjerre, Laura Ferrero-Miliani, Yassine Kamal Lyauk, Henrik Berg Rasmussen, Kim Dalhoff
AIM: This study investigated the influence of CES1 variations, including the SNP rs71647871 (G143E) and variation in copy number, on the pharmacokinetics of a single oral dose of 10 mg methylphenidate. METHODS: CES1 genotype was obtained from 200 healthy Danish Caucasian volunteers. Based on the genotype, 44 (19 males and 25 females) were invited to participate in an open, prospective trial involving six predefined genotypes: three groups with two, three, and four CES1 copies, respectively; a group of carriers of the CES1 143E allele; a group of individuals homozygous for CES1A1c (CES1VAR); and a group having three CES1 copies, in which the duplication, CES1A2, had increased transcriptional activity...
January 14, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28087972/lack-of-effect-of-oral-cabotegravir-on-the-pharmacokinetics-of-a-levonorgestrel-ethinyl-estradiol-containing-oral-contraceptive-in-healthy-adult-females
#5
C Trezza, S L Ford, E Gould, Y Lou, C Huang, J M Ritter, A M Buchanan, W Spreen, P Patel
AIM(S): This study aimed to investigate whether cabotegravir (CAB), an integrase inhibitor in development for treatment and prevention of HIV-1, influences the pharmacokinetics (PK) of a levonorgestrel (LNG) and ethinyl estradiol (EE)-containing oral contraceptive (OC) in healthy women. METHODS: In this open-label, fixed-sequence crossover study, healthy female subjects received LNG 0.15 mg/EE 0.03 mg tablet once daily Days 1-10 alone and with oral CAB 30 mg once daily Days 11-21...
January 14, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28079918/dose-evaluation-of-lamivudine-in-hiv-infected-children-aged-5%C3%A2-months-18%C3%A2-years-based-on-a-population-pharmacokinetic-analysis
#6
Esther J H Janssen, Diane E T Bastiaans, Pyry A J Välitalo, Annemarie M C van Rossum, Evelyne Jacqz-Aigrain, Hermione Lyall, Catherijne A J Knibbe, David M Burger
AIM: The objectives of this study were to characterise age-related changes in lamivudine pharmacokinetics in children and evaluate lamivudine exposure, followed by dose recommendations for subgroups in which target steady state AUC0-24h is not reached. METHODS: Population pharmacokinetic modelling was performed in NONMEM using data from two model building datasets and two external datasets (n = 180 (age 0.4-18 years, bodyweight 3.4-60.5 kg); 2,061 samples (median 12 per child); daily oral dose 60-300 mg (3...
January 12, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28078682/population-pharmacokinetics-of-intravenous-clonidine-for-sedation-during-pediatric-extracorporeal-membrane-oxygenation-ecmo-and-continuous-veno-venous-hemofiltration-cvvh
#7
Niina Kleiber, Ron A A Mathôt, Maurice J Ahsman, Enno D Wildschut, Dick Tibboel, Saskia N de Wildt
AIMS: Clonidine is used for sedation in the pediatric intensive care unit. Extracorporeal membrane oxygenation (ECMO) provides temporary support if respiratory and cardiac function is threatened. ECMO influences the pharmacokinetics of drugs. Clonidine during pediatric ECMO cannot be effectively titrated as PK data are lacking. The aim of this study is to describe clonidine PK in a particular ECMO system and propose dosing guidelines for children on this particular ECMO circuit. METHODS: All children below the age of 18 who received clonidine during ECMO were eligible...
January 12, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28074482/remote-ischaemic-preconditioning-suppresses-endogenous-plasma-nitrite-during-ischaemia-reperfusion-a-randomised-controlled-crossover-pilot-study
#8
Ashok Nair, Sitara Khan, Sami Omar, Xiao-Qing Pei, Karen McNeill, Phil Chowienczyk, Andrew James Webb
AIM: To test the hypothesis that remote ischaemic preconditioning (RIPC) increases circulating endogenous local and systemic plasma [nitrite] during RIPC and ischaemia-reperfusion (IR) as a potential protective mechanism against ischaemia-reperfusion injury (IRI). METHODS: Six healthy male volunteers (mean age 29.5 ± 7.6 years) were randomised in a cross-over study to initially receive either RIPC (4 x 5 min cycles) to the left arm, or no RIPC (Control), both followed by an ischaemia-reperfusion (IR) sequence (20 min cuff inflation to 200 mmHg, 20 min reperfusion) to the right arm...
January 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28072473/pharmacokinetics-of-obinutuzumab-in-chinese-patients-with-b-cell-lymphomas
#9
John Zhai, Yan Qin, Jun Zhu, Yuqin Song, Zhixiang Shen, Xin Du, Candice Jamois, Michael Brewster, Yuankai Shi, Jun Shi
AIM: The Phase Ib GERSHWIN study (NCT01680991) assessed the pharmacokinetic (PK) profile of obinutuzumab following multiple intravenous (i.v.) doses to Chinese patients with B-cell lymphomas, and compared findings with previous obinutuzumab PK studies in mainly Caucasian (non-Chinese) patients. METHODS: GERSHWIN was an open-label, single-arm intervention study. Patients aged >18 years with CD20+ relapsed/refractory chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) were enrolled from four centres in China...
January 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28071818/safety-profile-of-the-direct-oral-anticoagulants-an-analysis-of-the-who-database-of-adverse-drug-reactions
#10
Luca Monaco, Chiara Biagi, Valentino Conti, Mauro Melis, Monia Donati, Mauro Venegoni, Alberto Vaccheri, Domenico Motola
AIM: Direct oral anticoagulants (DOACs) have shown non-inferiority to warfarin for stroke prevention in non-valvular atrial fibrillation (AF) and a more promising safety profile. Unanswered safety aspects remain to addressed and available evidence on the risk associated with these drugs are conflicting. In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase...
January 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28071806/gps-perspectives-on-prescribing-for-older-people-in-primary-care-a-qualitative-study
#11
David O Riordan, Stephen Byrne, Aoife Fleming, Patricia M Kearney, Rose Galvin, Carol Sinnott
AIMS: The aim of this study was firstly to reveal the determinants of GP prescribing behaviour for older adults in primary care and secondly to elicit GPs' views on the potential role for broad intervention strategies involving pharmacists and/or information technology systems in general practice. METHODS: Semi-structured qualitative interviews were carried out with a purposive sample of GPs. Three multidisciplinary researchers independently coded the interview data using a framework approach...
January 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28061018/bronchopulmonary-pharmacokinetics-of-r-salbutamol-and-s-salbutamol-enantiomers-in-pulmonary-epithelial-lining-fluid-and-lung-tissue-of-horses
#12
Glenn A Jacobson, Sharanne Raidal, Kate Robson, Christian K Narkowicz, David S Nichols, E Haydn Walters
AIMS: Salbutamol is usually administered as a racemic mixture but little is known about the enantioselectivity of salbutamol pharmacokinetics in the lung. This study was designed to investigate enantiomer concentrations in lung tissue after inhaled dosing. METHODS: Horses (n = 12) received racemic (rac-) salbutamol 1000 microgram via inhalation. Enantioselective UPLC-MS/MS was used to determine salbutamol concentrations in pulmonary epithelial lining fluid (PELF) sampled 2, 5, 10 and 15 min after administration, in central lung (endoscopic bronchial biopsy) and peripheral lung (percutaneous pulmonary biopsy) tissues (at 20 and 25 minutes respectively), and in plasma samples...
January 6, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28054368/acid-suppression-medications-and-bacterial-gastroenteritis-a-population-based-cohort-study
#13
Li Wei, Lasantha Ratnayake, Gabby Phillips, Chris C McGuigan, Steve V Morant, Robert W Flynn, Isla S Mackenzie, Thomas M MacDonald
AIMS: To investigate whether acid suppression medicines (ASMs) increase the risk of bacterial gastroenteritis. METHODS: A population-based, propensity-score matched cohort study using a record-linkage database in Tayside, Scotland. The study consisted of 188,323 exposed to ASMs [proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RA)] and 376,646 controls (a propensity-score matched cohort from the rest of population who were not exposed to ASMs) between 1999 and 2013...
January 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28044353/donor-cyp3a5-genotype-influences-tacrolimus-disposition-on-the-first-day-after-paediatric-liver-transplantation
#14
Pier Luigi Calvo, Loredana Serpe, Andrea Brunati, Antonello Nonnato, Daniela Bongioanni, Dominic Dell Olio, Michele Pinon, Carlo Ferretti, Francesco Tandoi, Giulia Carbonaro, Mauro Salizzoni, Antonio Amoroso, Renato Romagnoli, Roberto Canaparo
AIM: The aim of our study was to investigate the influence of the CYP3A4/5 genotype in paediatric liver transplant recipients and donors and what contribution age and gender make to tacrolimus disposition on the first day after transplantation. METHODS: The contribution of the CYP3A4/5 genotype in paediatric liver transplant recipients and donors to the tacrolimus blood trough concentrations (C0 ) and tacrolimus concentration/weight-adjusted dose ratio on day one was evaluated in 67 liver transplanted children: 33 boys and 34 girls, mean age 4...
January 3, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28042936/effect-of-type-2-diabetes-mellitus-on-the-pharmacokinetics-and-transplacental-transfer-of-nifedipine-in-hypertensive-pregnant-women
#15
Gabriela Campos de Oliveira Filgueira, Osmany Alberto Silva Filgueira, Daniela Miarelli Carvalho, Maria Paula Marques, Elaine Christine Dantas Moisés, Geraldo Duarte, Vera Lucia Lanchote, Ricardo Carvalho Cavalli
AIMS: Diabetes mellitus can inhibit CYP3A4, an enzyme responsible for the metabolism of nifedipine, used for the treatment of hypertension in pregnant women. We aimed to assess the effect of type 2 diabetes mellitus (T2DM) on the pharmacokinetics, placental transfer and distribution of nifedipine in amniotic fluid in hypertensive pregnant women. METHODS: The study was conducted on 12 hypertensive pregnant women (control group - CG) and 10 hypertensive pregnant women with T2DM taking slow-release nifedipine (20 mg, 12/12 hours)...
January 2, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28035699/lack-of-respiratory-depression-in-paracetamol-codeine-combination-overdoses
#16
Simon P E Heppell, Geoffrey K Isbister
BACKGROUND: Codeine containing analgesics are commonly taken in overdose, but the frequency of respiratory depression is unknown. We investigated whether paracetamol-codeine combination overdoses caused respiratory depression more than paracetamol alone. METHODS: We reviewed deliberate self-poisoning admissions with paracetamol (>2 g) and paracetamol-codeine combinations presenting to a tertiary toxicology unit (1987-2013). Demographic information, clinical effects, treatment (naloxone, length of stay[LOS], mechanical ventilation) were extracted from a prospective database...
December 30, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28035697/modeling-the-dose-response-relationship-the-fair-share-of-pharmacokinetic-and-pharmacodynamic-information
#17
M Gonzalez Sales, F Nekka, M Tanguay, P O Tremblay, J Li
AIM: To investigate the role of drug concentration samplings in the modelling of dose-response relationship. METHODS: Using an initial PK/PD model, a reference dataset was simulated. PK and PD samples were extracted to create reduced datasets. PK/PD and K-PD models were fitted to theses reduced datasets. Post hoc estimates from both types of models were compared to the initial PK/PD model and performance was assessed. RESULTS: K-PD models were largely biased when the drug has a non-linear elimination...
December 30, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28009450/multi-compartment-compliance-aids-in-the-community-the-prevalence-of-potentially-inappropriate-medications
#18
David Counter, Derek Stewart, Joan MacLeod, James S Mclay
AIMS: To assess the prevalence of potentially inappropriate medications (PIM) use in a population of community-based multi-compartment compliance aid (MCA) users in North- Scotland. METHODS: Data for MCAs dispensed by 48 of the 50 community pharmacies in Aberdeen City between 1(st) June to 31(st) October 2014, together with concurrently prescribed medications, patient demographics and Carstairs Index of social deprivation were recorded. Drug-specific quality indicators for PIMs from the Swedish National Board of Health and Welfare were applied and bivariate logistic regression analysis used to assess for associations with demographic variables...
December 23, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28009444/medicine-information-exchange-networks-among-health-care-professionals-and-prescribing-in-geriatric-medicine-wards
#19
Bosco Chan, Emily Reeve, Slade Matthews, Peter Carroll, Janet C Long, Fabian Held, Mark Latt, Vasi Naganathan, Gideon Caplan, Sarah N Hilmer
AIMS: Effective transfer of information is vital for rational drug therapy. This is particularly important for older patients, who have a high prevalence of polypharmacy and are managed by multidisciplinary teams. We aimed to assess medicine information exchange networks in geriatric medicine wards and whether they are associated with prescribing patterns. METHODS: We conducted network analysis in acute geriatric medicine wards from four hospitals to characterise medicine information exchange networks among multidisciplinary team members...
December 23, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28009438/population-pharmacokinetics-and-exposure-response-of-osimertinib-in-patients-with-non-small-cell-lung-cancer
#20
Kathryn Brown, Craig Comisar, Han Witjes, John Maringwa, Rik de Greef, Karthick Vishwanathan, Mireille Cantarini, Eugène Cox
AIMS: To develop a population (pop) pharmacokinetic (PK) model for osimertinib (AZD9291) and its metabolite (AZ5104) and investigate the exposure-response (ER) relationships for selected efficacy and safety parameters. METHODS: PK, safety and efficacy data were collected from two non-small cell lung cancer (NSCLC) patient studies (N = 748) and one healthy volunteer study (N = 32), after single or multiple once-daily dosing of 20 to 240 mg osimertinib. Non-linear mixed effects modelling was used to characterise the popPK...
December 23, 2016: British Journal of Clinical Pharmacology
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