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British Journal of Clinical Pharmacology

Gaia Tabacco, John P Bilezikian
Teriparatide (TPTD) and Abaloparatide (ABL) are the only osteoanabolic drugs available, at this time, for treatment of osteoporosis. TPTD is a 34-amino acid fragment that is identical in its primary sequence to the 34 amino acids of full-length human parathyroid hormone [hPTH(1-84)]. ABL is identical to parathyroid hormone related peptide (PTHrP) through the first 22 residues with significantly different amino acids inserted thereafter, between residues 22 and 34. The osteoanabolic actions of PTH are due directly to its effects on cells of the osteoblast lineage and indirectly by stimulating IGF-I synthesis and suppressing sclerostin and associated enhancement of Wnt signaling...
September 15, 2018: British Journal of Clinical Pharmacology
Kentaro Ushijima, Koichi Mizuta, Shinya Otomo, Keiko Ogaki, Yukihiro Sanada, Yuta Hirata, Yoshiyuki Ihara, Taizen Urahashi, Yasushi Imai, Akio Fujimura
ADVERSE EVENT: A drug interaction leading to greater exposure to tacrolimus. DRUG IMPLICATED: Tacrolimus and Beni-Madonna (a new cultivar citrus categorized as 'Tangor'). THE PATIENT: A 9-month-old girl with biliary atresia (body weight, 7.5 kg) taking tacrolimus after liver transplantation. EVIDENCE THAT LINKS THE DRUG TO THE EVENT: The time course was consistent with the appearance of the interaction, which was confirmed by an increase in the blood concentration of tacrolimus...
September 14, 2018: British Journal of Clinical Pharmacology
Saeed Ganjizadeh-Zavareh, Mohit Sodhi, Tori Spangehl, Bruce Carleton, Mahyar Etminan
The Food and Drug Administration (FDA) has recently included a black box warning on fibromyalgia like symptoms with fluoroquinolones (FQs) but no large epidemiologic study is to date available. We undertook a case-control study using a random sample of 9,053,240 subjects obtained from the PharMetrics Plus health claims database in the United States. Cases received at least two fibromyalgia diagnoses coded by a rheumatologist matched to a ten randomly selected controls. After identifying 5,148 cases of fibromyalgia and 51,480 controls, the adjusted rate ratio of fibromyalgia for use of any fluoroquinolones, amoxicillin, and azithromycin were 1...
September 14, 2018: British Journal of Clinical Pharmacology
Garry G Graham
No abstract text is available yet for this article.
September 12, 2018: British Journal of Clinical Pharmacology
Erik A Imel, Kenneth E White
The most common heritable disorder of renal phosphate wasting, X-linked hypophosphatemia (XLH), was discovered to be caused by inactivating mutations in the Phosphate regulating gene with homology to endopeptidases on the X-chromosome (PHEX) gene in 1995. Although the exact molecular mechanisms by which PHEX mutations cause disturbed phosphate handling in XLH remain unknown, focus for novel therapies has more recently been based upon the finding that the bone-produced phosphaturic hormone Fibroblast growth factor-23 (FGF23) is elevated in XLH patient serum...
September 12, 2018: British Journal of Clinical Pharmacology
Trevor N Johnson, Yumi Cleary, Neil Parrott, Bruno Reigner, James R Smith, Stephen Toovey
AIMS: To predict the optimal chemoprophylactic dose of mefloquine in infants of 5 to 10 kg using physiologically based pharmacokinetic (PBPK) and clinical effectiveness models. METHODS: The PBPK model was developed in Simcyp version 14.1 and verified against clinical pharmacokinetic data in adults; the final model, accounting for developmental physiology and enzyme ontogeny was then applied in the paediatric population. The clinical effectiveness model utilized real-world chemoprophylaxis data with stratification of output by age and including infant data from the UK population...
September 10, 2018: British Journal of Clinical Pharmacology
Charlotte K Billington, Jason P Appleton, Eivind Berge, Nikola Sprigg, Mark Glover, Philip M W Bath
BACKGROUND: High blood pressure (BP) is common in acute stroke and associated with poor outcome, but the Efficacy of Nitric Oxide in Stroke (ENOS) trial showed no beneficial effect of antihypertensive treatment in this situation. Antihypertensive agents have accentuated effects in dehydrated patients. We assessed the impact of dehydration on haemodynamics, effects of antihypertensive treatment and prognosis in the ENOS trial. METHODS: ENOS randomised 4011 patients with acute stroke and raised systolic BP to glyceryl trinitrate (GTN) patch or no GTN, and to continue or to stop existing antihypertensive treatment within 48 hours of onset...
September 8, 2018: British Journal of Clinical Pharmacology
Maurizio Stefani, Darren M Roberts
No abstract text is available yet for this article.
September 8, 2018: British Journal of Clinical Pharmacology
Arduino A Mangoni, Elzbieta A Jarmuzewska
Prescribing in heart failure (HF), a common disease state that predominantly affects the older population, is often a challenging task because of the dynamic nature of the condition, requiring frequent monitoring and medication review, the presence of various comorbidities, and the frailty phenotype of many patients. The significant alterations in various organs and tissues occurring in HF, particularly the reduced cardiac output with peripheral hypoperfusion and the structural and functional changes of the gastrointestinal tract, liver, and kidney, might affect the pharmacokinetics of several drugs...
September 7, 2018: British Journal of Clinical Pharmacology
Michael Kriegbaum Skjødt, Morten Frost, Bo Abrahamsen
Osteoporosis is a common condition that leads to substantial morbidity and mortality and affects an increasing number of persons worldwide. Several pharmacological therapies that inhibit bone resorption, promote bone formation, or both, are available for the treatment of osteoporosis. The osteoanabolic treatment spectrum was recently expanded by the introduction of a novel bone-forming agent in the United States, and clinical trials indicate that a new class of bone anabolic therapy may become available. Both antiresorptive and bone anabolic therapies are associated with common and rare adverse effects, which are particularly important to address as these drugs are used for long-term treatment in numerous patients with a large proportion being elderly and/or having multimorbidity...
September 7, 2018: British Journal of Clinical Pharmacology
Andrea Huppertz, Lars Werntz, Andreas D Meid, Kathrin I Foerster, Jürgen Burhenne, David Czock, Gerd Mikus, Walter E Haefeli
AIMS: We assessed the potential mutual interaction of oral macitentan (cytochrome P450 (CYP) 3A4 substrate) at steady-state with single-dose oral rivaroxaban (CYP3A4 and P-glycoprotein (P-gp) substrate) and evaluated the effect of the CYP3A and P-gp inducer St. John's Wort (SJW) on the pharmacokinetics of these drugs in healthy volunteers. METHODS: Twelve healthy volunteers completed this open-label, monocentre, two-period, one sequence phase I clinical trial. The pharmacokinetics of macitentan (10 mg) was assessed on study days 3 (single dose), 15 (steady-state), 16 (impact of rivaroxaban), and 29 (after induction by oral SJW) and of rivaroxaban on days 2 (single dose), 16 (impact of macitentan at steady-state), and 29 (after induction by SJW)...
September 7, 2018: British Journal of Clinical Pharmacology
Oliver J Ziff, David J Werring
No abstract text is available yet for this article.
September 7, 2018: British Journal of Clinical Pharmacology
Adam Todd, Jaafar Al-Khafaji, Nasima Akhter, Adetayo Kasim, Rachel Quibell, Kelly Merriman, Holly Holmes
AIMS: To (1) examine the prescribing of preventative medication in a cohort of people with advanced lung cancer on hospital admission and discharge across different healthcare systems; (2) explore the factors that influence preventative medication prescribing at hospital discharge. METHODS: A retrospective cohort study across two centers in the United Kingdom and the United States. The prescribing of preventative medication was examined at hospital admission and discharge for patients who died of lung cancer; a zero-inflated negative binomial regression model was used to exam the association between preventative medications at discharge and patient- and hospital-based factors...
September 5, 2018: British Journal of Clinical Pharmacology
Dagan O Lonsdale, Emma H Baker, Karin Kipper, Charlotte Barker, Barbara Philips, Andrew Rhodes, Mike Sharland, Joseph F Standing
AIMS: Beta-lactam dose optimisation in critical care is a current priority. We aimed to review the PK of three commonly used beta-lactams (amoxicillin+/-clavulanate, piperacillin-tazobactam and meropenem) to compare PK parameters reported in critically and non-critically ill neonates, children and adults, and to investigate whether allometric and maturation scaling principles could be applied to describe changes in PK parameters through life. METHODS: A systematic review of PK studies of the three drugs was undertaken using MEDLINE and EMBASE...
September 3, 2018: British Journal of Clinical Pharmacology
Tom C Zwart, Sumit R M Gokoel, Paul J M van der Boog, Johan W de Fijter, Dina M Kweekel, Jesse J Swen, Henk-Jan Guchelaar, Dirk Jan A R Moes
AIMS: Tacrolimus and mycophenolic acid dosing after renal transplantation is individualized through therapeutic drug monitoring (TDM). Home-based dried blood spot (DBS) sampling has potential to replace conventional TDM sampling at the clinic. A liquid chromatography tandem mass spectrometry (LC-MS/MS) assay was developed to quantify tacrolimus and mycophenolic acid in DBS and clinically validated for abbreviated area under the concentration-time curve (AUC) monitoring using an innovative volumetric DBS sampling device...
September 3, 2018: British Journal of Clinical Pharmacology
R Donald Harvey, Noemi Reguart Aransay, Nicolas Isambert, Jong-Seok Lee, Tobias Arkenau, Johan Vansteenkiste, Paul A Dickinson, Khanh Bui, Doris Weilert, Karen So, Karen Thomas, Karthick Vishwanathan
AIM: We report on two phase I, open-label, single-arm studies assessing the effect of osimertinib on simvastatin (CYP3A substrate) and rosuvastatin (breast cancer resistance protein substrate [BCRP] substrate) exposure in patients with advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who have progressed after treatment with an EGFR tyrosine kinase inhibitor, to determine, upon coadministration, whether osimertinib could affect the exposure of these agents...
September 1, 2018: British Journal of Clinical Pharmacology
Niladri Chattopadhyay, Tobias Kanacher, Manuela Casjens, Sebastian Frechen, Sandra Ligges, Torsten Zimmermann, Antje Rottmann, Bart Ploeger, Joachim Höchel, Marcus-Hillert Schultze-Mosgau
No abstract text is available yet for this article.
September 1, 2018: British Journal of Clinical Pharmacology
Derbew Fikadu Berhe, Katja Taxis, Flora M Haaijer-Ruskamp, Peter G M Mol
OBJECTIVE: Understanding how much healthcare professionals (HCPs) know about medication can help to devise strategies to improve rational medication use. This study aimed to synthesis information on the level of medication knowledge of HCPs in Africa. METHOD: We performed a systematic literature study in Embase and PubMed. We included original studies quantifying HCPs' medication knowledge, published between 2012 and 2016. We extracted disease focus, country, number and type of HCPs included and all medication-related knowledge questions and scored the quality of papers...
August 31, 2018: British Journal of Clinical Pharmacology
Joanne Ellis, Andre van Maurik, Lea Fortunato, Sophie Gisbert, Keguan Chen, Ann Schwartz, Simon McHugh, Andrew Want, Sara Santos Franco, Joao-Joaquim Oliveira, Jeffrey Price, Alasdair Coles, Kim Brown, Donggang Su, Jenny L Craigen, Jiansong Yang, Sara Brett, Bill Davis, Joseph Cheriyan, Onajite Kousin-Ezewu, Frank Gray, Paul W Thompson, Disala Fernando
AIM: Interleukin-7 (IL-7) signalling modulates T cell activity and is implicated in numerous autoimmune diseases. This study investigated the safety, pharmacokinetics, target engagement, pharmacodynamics and immunogenicity of GSK2618960, an IL-7 receptor-α subunit (CD127) monoclonal antibody. METHODS: Double-blind (sponsor unblind) study of a single intravenous infusion of either GSK2618960 0.6 or 2.0 mg/kg or placebo in 18 healthy subjects over 24 weeks. RESULTS: GSK2618960 was well tolerated; there were no serious or significant adverse events...
August 30, 2018: British Journal of Clinical Pharmacology
Rami A Ballout, Umayya Musharrafieh, Joe Khattar
An 87-year-old woman with a long-standing history of hypertension, hypothyroidism and diabetes presented to us with scaly and pruritic vesicles of an erythematous base and crusted surface of 2-month duration. They first appeared on her abdomen and gradually spread to her lower back, thighs, before spreading to her upper and lower limbs. Her lesions were non-painful, aggravated by sun exposure only, and sparing mucous membranes. Nikolsky sign was positive with no discernible fluid-filled bullae. History was remarkable only for a doubling of her Lisinopril dosage 2 months prior to the appearance of her lesions, with no other potential environmental and/or drug triggers recognizable on history taking...
August 29, 2018: British Journal of Clinical Pharmacology
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