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British Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28921624/pharmacodynamics-and-pharmacokinetics-of-ticagrelor-versus-clopidogrel-in-patients-with-acute-coronary-syndromes-and-chronic-kidney-disease
#1
Heyang Wang, Jing Qi, Yi Li, Yunbiao Tang, Chao Li, Jing Li, Yaling Han
BACKGROUND: Pivotal clinical trials found ticagrelor reduced ischemic complications to a greater extent than clopidogrel and what is more, the benefit gradually increased with the reduction on creatinine clearance. However, the underlying mechanisms remains poorly explored. METHODS: This is a single-center, prospective, randomized clinical trial involving 60 hospitalized P2Y12 inhibitor naïve patients with CKD (eGFR<60ml/min/1.73m(2) ) and NSTE-ACS. Eligible patients were randomly assigned in a 1:1 ratio to receive ticagrelor(180 mg loading dose, then 90 mg twice daily followed) or clopidogrel(600 mg loading dose, then 75 mg qd followed)...
September 15, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28901643/renal-function-monitoring-in-heart-failure-what-is-the-optimal-frequency-a-narrative-review
#2
REVIEW
A Al-Naher, D J Wright, M A J Devonald, M Pirmohamed
The second most common cause of hospitalisation due to adverse drug reactions in the UK is renal dysfunction due to diuretics, particularly in patients with heart failure, where diuretic therapy is a mainstay of treatment regimens. Therefore the optimal frequency for monitoring renal function in these patients is an important consideration for preventing renal failure and hospitalisation. This review looks at the current evidence for optimal monitoring practices of renal function in patients with heart failure according to national and international guidelines on the management of heart failure (AHA/NICE/ESC/SIGN)...
September 13, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28891596/external-evaluation-of-population-pharmacokinetic-models-for-cyclosporine-in-adult-renal-transplant-recipients
#3
Jun-Jun Mao, Zheng Jiao, Hwi-Yeol Yun, Chen-Yan Zhao, Han-Chao Chen, Xiao-Yan Qiu, Ming-Kang Zhong
AIM: Several population pharmacokinetic (popPK) models for cyclosporine (CsA) in adult renal transplant recipients have been constructed to optimise the therapeutic regimen of CsA. However, little is known about their predictabilities when extrapolated to different clinical centres. Therefore, this study aimed to externally evaluate the predictive ability of CsA popPK models and determine the potential influencing factors. METHODS: A literature search was conducted and the predictive performance was determined for each selected model using an independent data set of 62 patients (471 pre-dose and 500 2-hour post-dose concentrations) from our hospital...
September 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28891590/co-administration-of-cyclosporine-and-ticagrelor-may-lead-to-a-higher-exposure-to-cyclosporine-a-case-report-of-a-49-year-old-man
#4
T T van Sloten, P A G de Klaver, A W L van den Wall Bake
A drug interaction leading to higher exposure to cyclosporine DRUGS IMPLICATED: Cyclosporine and ticagrelor THE PATIENT: A 49-year old man with a stable renal graft, managed with cyclosporine with stable trough blood concentrations for several years, was treated with ticagrelor for unstable angina pectoris EVIDENCE THAT LINKS THE DRUG TO THE EVENT: The timeline was consistent with the appearance of an interaction, the interaction was confirmed by an increase in trough concentration of cyclosporine, and there were no alternative causes that by themselves could have caused the increase in cyclosporine exposure MANAGEMENT: Cessation of ticagrelor MECHANISM: Inhibition of CYP3A4 and P-glycoprotein by ticagrelor IMPLICATIONS FOR THERAPY: Clinicians should be aware of this potential interaction as ticagrelor is frequently prescribed in individuals using cyclosporine...
September 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28891222/global-population-pharmacokinetics-of-the-investigational-aurora-a-kinase-inhibitor-alisertib-in-cancer-patients-rationale-for-lower-dosage-in-asia
#5
X Zhou, D R Mould, T Takubo, E Sheldon-Waniga, D Huebner, A Milton, K Venkatakrishnan
AIMS: This population pharmacokinetic analysis was conducted to quantitatively describe the regional differences and sources of inter-patient variability on the apparent oral clearance of alisertib. METHODS: A population pharmacokinetic analysis was performed on data from 671 cancer patients in Western countries and in Japan/ East Asia administered alisertib 5-150 mg once or twice daily in multiple dosing schedules. The final model was used to simulate alisertib pharmacokinetics in patients in the West and East Asian regions in the single agent schedule of 7 days of dosing in a 21 day cycle...
September 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28888220/pharmacokinetics-of-multiple-doses-of-co-crystal-of-tramadol-celecoxib-findings-from-a-4-way-randomized-open-label-phase-i-clinical-trial
#6
Sebastián Videla, Mounia Lahjou, Anna Vaqué, Mariano Sust, Marisol Escriche, Lluis Soler, Artur Sans, Eric Sicard, Neus Gascón, Gregorio Encina, Carlos Plata-Salamán
AIM: We compared the pharmacokinetic (PK) profiles of Co-Crystal of Tramadol-Celecoxib (CTC) versus each reference product (alone and in open combination) after single (first dose) and multiple dosing. METHODS: Healthy adults aged 18-50 years received, under fasted conditions, 15 twice-daily doses of the following treatments (separated by ≥14-day wash-out): 200 mg immediate-release (IR) CTC (equivalent to 88 mg tramadol and 112 mg celecoxib; Treatment-1); 100 mg IR tramadol (Treatment-2), 100 mg celecoxib (Treatment-3); and 100 mg IR tramadol and 100 mg celecoxib (Treatment-4)...
September 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28888219/factor-xa-inhibition-by-rivaroxaban-in-the-trough-steady-state-can-significantly-reduce-thrombin-generation
#7
Shigeo Horinaka, Rie Sugawara, Yutaka Yonezawa, Toshihiko Ishimitsu
AIMS: The aim of the present study was to demonstrate evidence of reduced thrombin generation at the trough plasma rivaroxaban concentration. METHODS: A single-centre, prospective, non-randomised, drug intervention, self-controlled study was conducted in 51 anticoagulation therapy-naïve patients with non-valvular atrial fibrillation. Plasma rivaroxaban concentration was measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) and anti-factor Xa chromogenic assay...
September 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28888218/impact-of-non-adherence-on-the-safety-and-efficacy-of-uric-acid-lowering-therapies-in-the-treatment-of-gout
#8
Daniel Hill-McManus, Elena Soto, Scott Marshall, Steven Lane, Dyfrig Hughes
AIMS: Dual-urate lowering therapy (ULT) with xanthine oxidase inhibitor and uricosuric medications is a treatment option for severe gout. Uricosurics can cause hyperuricosuria, a risk factor for nephrolithiasis and acute uric acid nephropathy. The aims of this study were to simulate the relation between suboptimal drug adherence and efficacy, and to quantify the risk of hyperuricosuria in gout patients receiving mono and dual-ULTs. METHODS: The impact of poor medication adherence was studied using 2-compartment PK models based on published evidence and a semi-mechanistic, 4-compartment pharmacodynamic (PD) model...
September 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28884840/hydroxycarbamide-in-children-with-sickle-cell-anemia-after-first-dose-vs-chronic-therapy-pharmacokinetics-and-predictive-models-for-drug-exposure
#9
Jeremie H Estepp, Paweł Wiczling, Joseph Moen, Guolian Kang, Joana Marie Mack, Robert Liem, Julie A Panepinto, Uttam Garg, Gregory Kearns, Kathleen A Neville
AIMS: The purpose of this work was to (1) compare pharmacokinetic (PK) parameters for hydroxycarbamide in children receiving their first dose (HCnew ) versus those receiving chronic therapy (HCchronic ), (2) assess the external validity of a published PK dosing strategy, and (3) explore the accuracy of dosing strategies based on a limited number of HC measurements. METHODS: Utilizing data from two prospective, multicenter trials of hydroxycarbamide (Pharmacokinetics of Liquid Hydroxyurea in Pediatric Patients with Sickle Cell Anemia; NCT01506544 and Single-Dose (SD) and Steady-State (SS) Pharmacokinetics of Hydroxyurea in Children and Adolescents with Sickle Cell Disease), plasma drug concentration versus time profiles were evaluated with a model independent approach in the HCnew and HCchronic groups...
September 8, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28881501/drug-drug-interaction-potential-in-men-treated-with-enzalutamide-mind-the-gap
#10
G E Benoist, I M van Oort, S Smeenk, A Javad, D M Somford, D M Burger, N Mehra, N P van Erp
AIM: Metastatic castration resistant prostate cancer (mCRPC) patients are generally older patients with several co-morbidities and are therefore more at risk for complications due to drug-drug interactions(DDIs). We assessed the prevalence of potential DDIs in a cohort of mCRPC patients treated with enzalutamide. METHODS: We conducted a retrospective review of pharmacy records to retrieve individual drug histories of mCRPC patients who started enzalutamide therapy in a tertiary care setting...
September 7, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28880456/urinary-mir-155-5p-and-cxcl10-as-prognostic-and-predictive-biomarkers-of-rejection-graft-outcome-and-treatment-response-in-kidney-transplantation
#11
Olga Millán, Klemens Budde, Claudia Sommerer, Irene Aliart, Olesja Rissling, Beatriz Bardaji, Maaren Matz, Martin Zeier, Irene Silva, Lluis Guirado, Mercè Brunet
BACKGROUND AND PURPOSE: MicroRNAs (miRNAs) may be useful biomarkers of rejection and allograft outcome in kidney transplantation. Elevated urinary CXCL10 levels have been associated with acute rejection (AR) and may predict allograft failure. We examined the correlation of miRNA, CXCL10 levels and immunosuppressive drug exposure with AR and graft function in kidney transplant recipients. EXPERIMENTAL APPROACH: Eighty de novo kidney transplant recipients were recruited from four European centres...
September 7, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28880407/biomarkers-in-solid-organ-transplantation
#12
Teun Van Gelder
Recipients of solid organs such as kidney and heart are treated with standard immunosuppressive regimens, and personalized medicine has not yet reached the clinic for this patient population. Biomarkers potentially will allow treatment regimens to be adjusted, according to the needs of the individual patient. Biomarkers may reflect the degree of immunosuppression of the immune system, or they may reflect early damage to the transplanted organ.
September 7, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28865237/dose-dependent-acute-liver-injury-with-hypersensitivity-features-in-humans-due-to-a-novel-microsomal-prostaglandin-e-synthase-1-inhibitor
#13
Yan Jin, Arie Regev, Jeanelle Kam, Krista Phipps, Claire Smith, Judith Henck, Kristina Campanale, Leijun Hu, D Greg Hall, Xiao Yan Yang, Masako Nakano, Terry Ann McNearney, Jack Uetrecht, William Landschulz
AIM: LY3031207, a novel microsomal prostaglandin E synthase 1 inhibitor, was evaluated in a multiple ascending dose study after nonclinical toxicology studies and a single ascending dose study demonstrated an acceptable toxicity, safety, and tolerability profile. METHODS: Healthy subjects were randomised to receive LY3031207 (25, 75, and 275 mg), placebo, or celecoxib (400 mg) once daily for 28 days. The safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of LY3031207 were evaluated...
September 2, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28865153/evaluation-of-the-pharmacokinetic-drug-interaction-potential-of-tivantinib-arq-197-using-cocktail-probes-in-patients-with-advanced-solid-tumours
#14
Masaya Tachibana, Kyriakos P Papadopoulos, John H Strickler, Igor Puzanov, Roohi Gajee, Yibin Wang, Hamim Zahir
AIM: This phase 1, open-label, crossover study sought to evaluate drug-drug interactions between tivantinib and cytochrome P450 (CYP) substrates and tivantinib and P-glycoprotein. METHODS: The effect of tivantinib doses on the pharmacokinetics of the probe drugs for CYP1A2 (caffeine), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (midazolam), and for P-glycoprotein (digoxin) was investigated in 28 patients with advanced cancer using a cocktail probe approach...
September 2, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28850715/clinical-significance-of-cyp2c19-polymorphisms-on-the-metabolism-and-pharmacokinetics-of-11%C3%AE-hydroxysteroid-dehydrogenase-type-1-inhibitor-bms-823778
#15
Y Cheng, L Wang, L Iacono, D Zhang, W Chen, J Gong, W G Humphreys, J Gan
AIMS: BMS-823778 is an inhibitor of 11β-hydroxysteroid dehydrogenase type-1, thus a potential candidate for Type 2 diabetes treatment. Here, we investigated the metabolism and pharmacokinetics of BMS-823778 to understand its pharmacokinetic variations in early clinical trials. METHODS: The metabolism of BMS-823778 was characterized in multiple in vitro assays. Pharmacokinetics were evaluated in healthy volunteers, prescreened as CYP2C19 extensive metabolizers (EM) or poor metabolizers (PM), with a single oral dose of [(14) C]BMS-823778 (10 mg, 80 μCi)...
August 29, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28841231/non-cholestatic-acute-hepatitis-following-candesartan-administration
#16
J A Lammel-Lindemann, E Flores-Villalba, A J Martagón, E DeObeso-Gonzalez, F Puente-Gallegos
Arterial hypertension is nowadays a highly manageable disorder due to a variety of drugs available for its treatment. Since the late 1990's, angiotensin II receptor blockers have been widely prescribed, achieving appropriate control in patients' blood pressure. Few cases of serious adverse effects have been reported to date. Here we present a case of acute hepatocellular injury secondary to candesartan administration. Further studies should be performed in patients who present this effect in order to prevent more serious outcomes...
August 25, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28833380/population-pharmacokinetics-of-the-mek-inhibitor-selumetinib-and-its-active-n-desmethyl-metabolite-data-from-ten-phase-i-trials
#17
Parul Patel, Eleanor Howgate, Paul Martin, David J Carlile, Leon Aarons, Diansong Zhou
AIMS: To characterise the pharmacokinetics (PK) of selumetinib (AZD6244; ARRY-142886), a MEK1/2 inhibitor in clinical development for numerous indications, and its N-desmethyl metabolite in healthy volunteers, and evaluate clinically important covariates. METHODS: A pooledpopulation PK analysis was performed using a non-linear mixed effects approach with plasma concentration data from 346 subjects who received single oral doses of selumetinib 20-75 mg across ten Phase I studies...
August 23, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28833373/a-comment-on-an-assessment-of-the-variation-in-the-concentrations-of-acetylcysteine-in-infusions-for-the-treatment-of-paracetamol-overdose
#18
LETTER
Lauren O'Grady, Michael E Mullins, Evan S Schwarz
No abstract text is available yet for this article.
August 22, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28833321/population-pharmacokinetic-meta-analysis-of-ramucirumab-in-cancer-patients
#19
Lisa O'Brien, Paul Westwood, Ling Gao, Michael Heathman
AIM: Ramucirumab is a human IgG1 monoclonal antibody that specifically binds vascular endothelial growth factor receptor-2 (VEGFR-2) and blocks binding of VEGF-A, VEGF-C, and VEGF-D. The objective of the analysis was to characterize the clinical pharmacology profile of ramucirumab using a population pharmacokinetic approach. METHODS: A total of 1639 patients with 6427 serum concentrations from 11 Phase 1b, 2, and 3 clinical trials in patients with various cancer indications were included in the analysis...
August 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28815689/medication-adherence-in-patients-with-apparent-resistant-hypertension-findings-from-the-sympathy-trial
#20
R L de Jager, E M van Maarseveen, M L Bots, P J Blankestijn
INTRODUCTION: Hypertension is only controlled in approximately 35% of the patients, which could be partially due to non-adherence. Recently, bioanalytical assessment of adherence to blood pressure (BP) lowering drugs has gaining interest. Our aim was to explore possible determinants of non-adherence in treatment resistant hypertension, assessed by objective screening for antihypertensive agents in serum. Secondary aim was to study the effect of adherence on the change in BP. METHODS: This project was a sub-study of SYMPATHY; an open-label randomized-controlled trial to assess the effect of renal denervation on BP six months after treatment compared to usual care in patients with resistant hypertension...
August 17, 2017: British Journal of Clinical Pharmacology
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