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British Journal of Clinical Pharmacology

Magnus Åstrand, Carl Amilon, Daniel Röshammar, Anders Himmelmann, Dominick J Angiolillo, Robert F Storey, Paul A Gurbel, Marc P Bonaca, Bengt Hamrén
AIM: To characterize ticagrelor exposure-response relationship for platelet inhibition in patients with stable coronary artery disease (CAD) and a history of myocardial infarction (MI), using non-linear mixed effects modelling and simulation. METHODS: Platelet function data were integrated with plasma concentration data of ticagrelor and its active metabolite AR-C1249010XX in a population pharmacokinetic and pharmacodynamic (PK/PD) model, based on two clinical studies...
November 10, 2018: British Journal of Clinical Pharmacology
Olivia Campagne, Donald E Mager, Daniel Brazeau, Rocco C Venuto, Kathleen M Tornatore
AIMS: Tacrolimus has been associated with notable extrarenal adverse effects (AEs), which are unpredictable and impact patient morbidity. The association between model-predicted tacrolimus exposure metrics and standardized extrarenal AEs in stable renal transplant recipients was investigated and a limited sampling strategy (LSS) was developed to predict steady-state tacrolimus area under the curve over 12-hour dosing period (AUCss,0-12hr ). METHODS: All recipients receiving tacrolimus and mycophenolic acid ≥6 months completed a 12-hour cross-sectional observational pharmacokinetic-pharmacodynamic study...
November 10, 2018: British Journal of Clinical Pharmacology
Pier Giorgio Cojutti, Maria Merelli, Lorenzo Allegri, Giuseppe Damante, Matteo Bassetti, Federico Pea
We report the case of a patient who had cerebral aspergillosis after otorhinolaryngologic surgery and who was successfully and safely treated with high-dose voriconazole (200 mg q6h) for more than 1 year thanks to a TDM-guided approach coupled with pharmacological review and with genotyping of CYP2C19 polymorphisms. The findings support the idea that personalized medicine based on TDM coupled with the need of avoiding drug-drug interactions may be helpful for maximizing the net benefit (probability of efficacy vs...
November 9, 2018: British Journal of Clinical Pharmacology
Cécile Ollivier, Yeruk Lily Mulugeta, Lucia Ruggieri, Agnes Saint-Raymond, Lynne Yao
Legislative initiatives have been successful in increasing the availability of approved therapies for paediatric patients. However, additional measures to ensure the timely completion of paediatric studies are necessary to further increase the number of medicines available to children. Over the last three years, international experts convened to revise the ICH E11 guideline on clinical investigations of medicinal products in paediatric populations to harmonise approaches to paediatric extrapolation, striving to reduce substantial differences between regions in the acceptance of data for global paediatric medicine development programmes...
November 7, 2018: British Journal of Clinical Pharmacology
Richard Ofori-Asenso, Jenni Ilomäki, Mark Tacey, Si Si, Andrea J Curtis, Ella Zomer, J Simon Bell, Sophia Zoungas, Danny Liew
AIMS: The aim of this study was to examine the level of and predictors of statin nonadherence and discontinuation among older adults. METHODS: Among 22 340 Australians aged ≥65 years who initiated statin therapy from January 2014 to December 2015, we estimated the first-year nonadherence (proportion of days covered [PDC] <0.80) and discontinuation (≥90 days without statin coverage) rates. Predictors of nonadherence and discontinuation were examined via multivariable logistic regression...
November 6, 2018: British Journal of Clinical Pharmacology
Florence Daviet, Franck Rouby, Pascale Poullin, Julie Moussi-Francès, Marion Sallèe, Stéphane Burtey, Julien Mancini, Florence Duffaud, Renaud Sabatier, Bertrand Pourroy, Aurélie Grandvuillemin, Steven Grange, Véronique Frèmeaux-Bacchi, Paul Coppo, Joëlle Micallef, Noémie Jourde-Chiche
AIMS: Gemcitabine has been associated with thrombotic microangiopathy (TMA). We conducted a national retrospective study of Gemcitabine-associated TMA (G-TMA). METHODS: From 1998 to 2015, all cases of G-TMA reported to the French Pharmacovigilance Network and the French TMA Reference Center, and cases explored for complement alternative pathway (CAP) abnormalities, were analyzed. RESULTS: G-TMA was diagnosed in 120 patients (median age 61...
November 5, 2018: British Journal of Clinical Pharmacology
Hiroyuki Inoue, Yoko Tamaki, Yushi Kashihara, Shota Muraki, Makoto Kakara, Takeshi Hirota, Ichiro Ieiri
AIMS: The aim of the present study was to quantitate the hypoglycaemic effects of dipeptidyl peptidase-4 inhibitors (DPP-4i), glucagon-like peptide-1 receptor agonists (GLP-1r), and sodium glucose cotransporter 2 inhibitors (SGLT2i) as add-on treatments to metformin monotherapy in patients with type 2 diabetes mellitus (T2DM) using a model-based meta-analysis (MBMA). METHODS: A systematic literature search of public databases was conducted to develop models that describe the time courses of the fasting plasma glucose (FPG)- and haemoglobin A1c (HbA1c)-lowering effects of 3 antidiabetic classes using NONMEM 7...
November 5, 2018: British Journal of Clinical Pharmacology
M B Mulder, H L van den Hoek, E Birnie, A J P van Tilburg, E M Westerman
AIM: Intravenous iron supplementation is widely used to treat iron deficiency and iron deficiency anemia when oral iron administration is ineffective or poorly tolerated. Hypersensitivity reactions (HSRs) during infusions are rare, but can be life-threatening. This study aimed to compare the risk on HSRs with the intravenous administration of iron isomaltoside-1000 and ferric carboxymaltose for the treatment of iron deficiency and iron deficiency anemia. METHODS: Single centre cohort study...
November 4, 2018: British Journal of Clinical Pharmacology
Kangbin Zhou, John D Parker
AIM: Nitroglycerin (or glyceryl trinitrate, GTN) has been long considered as an endothelium-independent vasodilator since GTN vasodilation is intact in the absence of the endothelium and in the presence of endothelial dysfunction. However, in animal and in vitro models, GTN has been shown to stimulate the release of certain endothelium-derived vasodilators such as nitric oxide (NO) and prostacyclin (PGI2 ). In addition, chronic GTN therapy leads to endothelial dysfunction. In this series of experiments, we explored how GTN might interact with the vascular endothelium in normal humans, without cardiovascular disease or risk factors associated with abnormalities in vascular function...
October 30, 2018: British Journal of Clinical Pharmacology
Sihang Liu, Can Hu, Jane Peters, Amanda Tsang, Serge Cremers, Robert Bies, Gabrielle Page-Wilson
OBJECTIVE: Treatment of prolactinomas with ergoline dopamine agonists (DA) can be complicated by intolerance and resistance. This study investigated the pharmacokinetics and pharmacodynamics of the non-ergot DA ropinirole, to assess its therapeutic potential as a novel therapy for prolactinomas. METHODS: Five female subjects with prolactinomas participated in this dose-response study. Subjects received up to 3 doses of ropinirole (0.5, 1.0, and 2.0 mg), each on separate occasions...
October 25, 2018: British Journal of Clinical Pharmacology
Kerry Layne, Louise Hope, Edmund Rab, J R H Archer, David M Wood, Paul I Dargan
Intravenous acetylcysteine is commonly prescribed as a course of three infusions for the management of paracetamol poisoning. Previous studies have demonstrated large variation in administered doses of intravenous acetylcysteine, which has been attributed to numerous factors, including inadequate mixing of infusion bags. The aim of this study was to determine whether the amount of mixing of infusion bags contributes significantly to this variation. Using acetylcysteine doses for a 60-69 kg patient we added the appropriate volume of acetylcysteine to 5% glucose and subsequently inverted the infusion bags to mix the solutions 0-5 times...
October 25, 2018: British Journal of Clinical Pharmacology
Fadil M Hannan, Paul J Newey, Michael P Whyte, Rajesh V Thakker
Metabolic bone diseases comprise a diverse group of disorders characterized by alterations in skeletal homeostasis, and are often associated with abnormal circulating concentrations of calcium, phosphate or vitamin D metabolites. These diseases commonly have a genetic basis and represent either a monogenic disorder due a germline or somatic single gene mutation, or an oligogenic or polygenic disorder that involves variants in more than one gene. Germline single gene mutations causing Mendelian diseases typically have a high penetrance, whereas the genetic variations causing oligogenic or polygenic disorders are each associated with smaller effects with additional contributions from environmental factors...
October 24, 2018: British Journal of Clinical Pharmacology
Patrick W Mantyh
Disorders of the skeleton are frequently accompanied by bone pain and a decline in the functional status of the patient. Bone pain occurs following a variety of injuries and diseases including; bone fracture, osteoarthritis, low back pain, orthopedic surgery, fibrous dysplasia, rare bone diseases, sickle cell disease, and bone cancer. In the past two decades, significant progress has been made in understanding the unique population of sensory and sympathetic nerves that innervate bone and the mechanisms that drive bone pain...
October 24, 2018: British Journal of Clinical Pharmacology
Alana Cavadino, David Prieto-Merino, Joan K Morris
AIMS: Surveillance of medication use in pregnancy is essential in order to identify associations between first trimester medications and congenital anomalies (CAs). Medications in the same Anatomical Chemical Therapeutic classes may have similar effects. We aimed to use this information to improve the detection of potential teratogens in CA surveillance data. METHODS: Data on 15,058 malformed foetuses with first trimester medication exposures from 1995-2011 were available from EUROmediCAT, a network of European CA registries...
October 23, 2018: British Journal of Clinical Pharmacology
Marcel J H Kenter
No abstract text is available yet for this article.
October 20, 2018: British Journal of Clinical Pharmacology
Antonia M Joussen, Sebastian Wolf, Peter K Kaiser, David Boyer, Thomas Schmelter, Rupert Sandbrink, Oliver Zeitz, Gesa Deeg, Annett Richter, Torsten Zimmermann, Joachim Hoechel, Ulf Buetehorn, Walter Schmitt, Brigitte Stemper, Michael K Boettger
AIMS: This program investigated topical regorafenib, a multikinase inhibitor, in patients with neovascular age-related macular degeneration (nAMD). METHODS: Topical regorafenib was investigated in an open-label, phase IIa/b study in which patients with choroidal neovascularization (CNV) secondary to nAMD received regorafenib (25 μL, 30 mg/mL TID) for 12 weeks. The primary endpoint of the phase II/a/b study was mean change in best-corrected visual acuity (BCVA) from baseline to weeks 4 and 12...
October 20, 2018: British Journal of Clinical Pharmacology
Andrew Rowland, Warit Ruanglertboon, Madelé van Dyk, Dhilushi Wijayakumara, Linda S Wood, Robyn Meech, Peter I Mackenzie, A David Rodrigues, Jean-Claude Marshall, Michael J Sorich
AIMS: Demonstrate the presence of cytochrome P450 (CYP) and UDP-glucuronosyltransferase (UGT) proteins and mRNAs in isolated human plasma exosomes and evaluate the capacity for exosome- derived biomarkers to characterise variability in CYP3A4 activity. METHODS: The presence of CYP and UGT protein and mRNA in exosomes isolated from human plasma and HepaRG cell culture medium was determined by mass spectrometry and RT-PCR, respectively. The concordance between exosome-derived CYP3A4 biomarkers and midazolam apparent oral clearance (CL/F) was evaluated in a small proof-of-concept study involving six genotyped (CYP3A4 *1/*1 and CYP3A5 *3/*3) Caucasian males...
October 19, 2018: British Journal of Clinical Pharmacology
Samanta Lalic, Jenni Ilomäki, J Simon Bell, Maarit Jaana Korhonen, Natasa Gisev
AIMS: To determine the prevalence and incidence of prescription opioid analgesic use in Australia and compare the characteristics of people with and without cancer initiating prescription opioid analgesics. METHODS: A retrospective population-based study was conducted using the random 10% sample of adults who were dispensed prescription opioid analgesics in Australia between July 2013 and June 2017 through the Pharmaceutical Benefits Scheme. Poisson regression was used to calculate rate ratios (RR) for opioid prevalence and incidence...
October 19, 2018: British Journal of Clinical Pharmacology
Theresa Kehoe, Eberhard Blind, Heidi Janssen
Regulation of medicines involves complex scientific and public health policies which are reflected in the regulatory approaches used by the European Medicines Agency and the United States Food and Drug Administration for the approval of products developed for metabolic bone diseases. For osteoporosis therapies, utilized by many patients, approaches and existing guidance for product development of both Agencies are similar; confirmatory studies for the approval of osteoporosis products can rely on well-defined efficacy outcome parameters...
October 18, 2018: British Journal of Clinical Pharmacology
Hardeep Kaur, Phulen Sarma, Ajay Prakash, Bikash Medhi
Lots of factors can influence CYP2E1 activities, e.g. thyroid status, different types of anaemia (fanconi anaemia and sideroblastic anaemia), etc. Alcohol is a known inducer of CYP2E1, therefore a justifiable duration of abstinence is required before the subjects are enrolled into a study for normalization of CYP2E1 activity. In this letter we address these confounding factors and their role in CYP2E1 activity.
October 17, 2018: British Journal of Clinical Pharmacology
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