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British Journal of Clinical Pharmacology

Serge Cremers, Matthew T Drake, F Hal Ebetino, John P Bilezikian, R Graham G Russell
The biological effects of the bisphosphonates (BPs) as inhibitors of calcification and bone resorption were first described in the late 1960s. In the 50 years that have elapsed since then, the BPs have become the leading drugs for the treatment of skeletal disorders characterised by increased bone resorption, including Paget's disease of bone, bone metastases, multiple myeloma, osteoporosis and several childhood inherited disorders. The discovery and development of the BPs as a major class of drugs for the treatment of bone diseases is a paradigm for the successful journey from 'bench to bedside and back again'...
January 16, 2019: British Journal of Clinical Pharmacology
D Cavalla
Retrospective evidence drawn from real-world experience of a medicine's use outside its labelled indication is one of a number of techniques used in drug repurposing (DRP). Relying as it does on large numbers of real incidences of human experience, rather than individual case reports with limited statistical support, preclinical experiments with poor translatability or in silico associations which are early-stage hypotheses, it represents the best validated form of DRP. Cancer is the most frequent of such DRP examples (e...
January 16, 2019: British Journal of Clinical Pharmacology
Mita Kuchimanchi, Min Zhu, John D Clements, Sameer Doshi
AIMS: The relationship between blinatumomab exposure and efficacy endpoints (occurrence of complete remission [CR] and duration of overall survival [OS]) or adverse events (occurrence of cytokine release syndrome [CRS] and neurologic events) were investigated in adult patients with relapsed/refractory acute lymphoblastic leukaemia (r/r ALL) receiving blinatumomab or standard of care (SOC) chemotherapy to evaluate appropriateness of the blinatumomab dosing regimen. METHODS: Exposure, efficacy, and safety data from adult patients (n=646) with r/r ALL receiving stepwise (9 then 28 μg day-1 , 4-week cycle) continuous intravenous infusion (n=537) of blinatumomab or SOC (n=109) chemotherapy were pooled from phase 2 and 3 studies...
January 15, 2019: British Journal of Clinical Pharmacology
Keso Skhirtladze-Dworschak, Doris Hutschala, Georg Reining, Peter Dittrich, Anna Bartunek, Martin Dworschak, Edda M Tschernko
AIM: Surgical site infections contribute to morbidity and mortality after surgery. The authors hypothesized that higher antibiotic tissue concentrations can be reached for a prolonged time span by continuous administration of prophylactic cefuroxime compared to bolus administration. METHODS: Twelve patients undergoing elective cardiac surgery were investigated. Group A received 1.5 g cefuroxime as bolus infusions before surgery, and 12 and 24 hours thereafter. In group B, a continuous infusion of 3...
January 12, 2019: British Journal of Clinical Pharmacology
Erwin Dreesen, Ruben Faelens, Gert Van Assche, Marc Ferrante, Séverine Vermeire, Ann Gils, Thomas Bouillon
AIMS: Therapeutic failure of infliximab therapy in patients with ulcerative colitis remains a challenge even two decades after its approval. Therapeutic drug monitoring (TDM) has shown value during maintenance therapy, but induction therapy is still unexplored. The patients may be primary nonresponders or underexposed with the standard dosing regimen. We aimed to (i) develop a population pharmacokinetic-pharmacodynamic (popPK-PD) model, (ii) identify the best exposure metric that predicts mucosal healing and (iii) build an exposure-response (ER) model to demonstrate model-based dose finding during induction therapy with infliximab...
January 11, 2019: British Journal of Clinical Pharmacology
X Delavenne, Y Dargaud, E Ollier, C Négrier
BACKGROUND: The use of prophylaxis in haemophilia A is considered the standard of care, particularly in children. Despite adjustment of doses for body weight and/or age, a large pharmacokinetic (PK) variability between patients has been observed. PK-tailored prophylaxis may help clinicians adjust coagulation factor FVIII activity (FVIII:C) to the desired level, which may differ in individual patients. OBJECTIVES: To develop a population PK model for simoctocog alfa based on pooled clinical trial data and to develop a Bayesian estimator to allow PK parameters in individual patients to be estimated using a reduced number of blood samples...
January 11, 2019: British Journal of Clinical Pharmacology
C Salcedo, P H Joubert, M D Ferrer, A Z Canals, F Maduell, V Torregrosa, J M Campistol, R Ojeda, J Perelló
AIMS: SNF472 is a calcification inhibitor that is being studied as a novel treatment for calciphylaxis and cardiovascular calcification (CVC). A first study showed acceptable safety and tolerability in a single ascending dose administration in healthy volunteers and a single dose administration in haemodialysis (HD) patients. This study aimed to assess the safety, tolerability, and pharmacokinetics (PK)/pharmacodynamics (PD) relationship of intravenous (iv) SNF472 in HD patients in a multiple ascending dose administration trial with 5 doses tested for one week (three administrations) and one dose tested for four weeks (12 administrations)...
January 10, 2019: British Journal of Clinical Pharmacology
Carina Lundby, Trine Graabaek, Jesper Ryg, Jens Søndergaard, Anton Pottegård, Dorthe Nielsen
AIMS: The aim of this systematic review was to explore health care professionals' attitudes towards deprescribing in older people with limited life expectancy. METHODS: A systematic literature search was conducted from inception to December 2017 using MEDLINE, EMBASE, and CINAHL. Studies were included if they specifically concerned older people (≥65 years) with limited life expectancy, including those residing in any kind of aged care facility, or were based on representative patient profiles...
January 10, 2019: British Journal of Clinical Pharmacology
Muhammad Wasif Saif, Lee Rosen, Michelle A Rudek, Weijing Sun, Dale R Shepard, Carlos Becerra, Fumiaki Yamashita, Paul Bebeau, Robert Winkler
AIMS: Trifluridine/tipiracil (FTD/TPI) prolongs survival in refractory metastatic colorectal cancer, but limited data exist on its use in patients with hepatic impairment. This Phase I, open-label, non-randomised study investigated the safety, tolerability and pharmacokinetics of FTD/TPI in patients with advanced solid tumours (except breast cancer) and varying degrees of hepatic impairment, to provide dosing recommendations. METHODS: Patients aged ≥18 years with advanced solid tumours and normal hepatic function, or mild, moderate or severe hepatic impairment according to National Cancer Institute criteria, were planned to be enrolled...
January 9, 2019: British Journal of Clinical Pharmacology
Li-Ming Gan, Maria Lagerström-Fermér, Hans Ericsson, Karin Nelander, Eva-Lotte Lindstedt, Erik Michaëlsson, Magnus Kjaer, Maria Heijer, Carl Whatling, Rainard Fuhr
AIMS: Myeloperoxidase activity can contribute to impaired vascular endothelial function and fibrosis in chronic inflammation-related cardiovascular disease. Here we investigated the safety, tolerability and pharmacokinetics of the myeloperoxidase inhibitor AZD4831. METHODS: In this randomized, single-blind, placebo-controlled, phase 1, first-in-human study, healthy men in five sequential cohorts were randomized 3:1 to receive a single oral dose of AZD4831 (5, 15, 45, 135 or 405 mg) or placebo, after overnight fasting...
January 7, 2019: British Journal of Clinical Pharmacology
Danielle Aparecida Guimaraes, Jose Eduardo Tanus-Santos
No abstract text is available yet for this article.
January 4, 2019: British Journal of Clinical Pharmacology
B Batteux, V Gras, Y Mahboud, S Liabeuf, Y Bennis, K Masmoudi
In patients with age-related macular degeneration (AMD), the intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents reduces disease progression and choroidal neovascularization. We report on a first case of ischaemic colitis associated with intravitreal injection of the anti-VEGF agent aflibercept in an 80-year-old female patient. Conservative treatment resulted in a favourable clinical outcome. The anti-VEGF agent was discontinued, and the symptoms did not recur. Although the intravitreal injection of anti-VEGF agents has not previously been linked to the occurrence of ischaemic colitis, consideration of aflibercept's pharmacological properties and the chronological relationship between the administration of this anti-VEGF agent and the occurrence of this systemic adverse event are strongly suggestive of a causal relationship in the present case...
January 4, 2019: British Journal of Clinical Pharmacology
Maria Rita Dionísio, André Mansinho, Catarina Abreu, Joana Cavaco-Silva, Sandra Casimiro, Luís Costa
Bone disease is a frequent event in cancer patients, both due to cancer spread to bone and to cancer therapies. Bone is the organ most frequently affected by metastatic disease when considering the two most frequent cancers in the western world (breast and prostate cancers). Bone metastases can have a substantial detrimental effect on patients' quality of life, as well as significant morbidity due to complications collectively known as skeletal-related events (SREs), which include hypercalcemia, pathological fractures, spinal cord compression, and need of radiotherapy or surgery to the bone...
January 2, 2019: British Journal of Clinical Pharmacology
Huan-Xi Zhang, Chang-Cheng Sheng, Long-Shan Liu, Bi Luo, Qian Fu, Qun Zhao, Jun Li, Yan-Feng Liu, Rong-Hai Deng, Zheng Jiao, Chang-Xi Wang
AIMS: Various mycophenolate mofetil (MMF) population pharmacokinetic (popPK) models have been developed to describe its PK characteristics and facilitate its optimal dosing in adult kidney transplant recipients co-administered with tacrolimus. However, the external predictive performance has been unclear. Thus, this study aimed to comprehensively evaluate the external predictability of published MMF popPK models in such populations and investigate the potential influencing factors. METHODS: The external predictability of qualified popPK models was evaluated using an independent dataset...
December 29, 2018: British Journal of Clinical Pharmacology
Lotte A Minnema, Thijs J Giezen, Helga Gardarsdottir, Antoine C G Egberts, Hubert G M Leufkens, Aukje K Mantel-Teeuwisse
AIM: To evaluate post-marketing label changes in dosing information of biologicals. METHODS: Biologicals authorised between 2007 and 2014 by the European Medicines Agency (EMA) were included and followed up from marketing authorisation until 31 December 2016 or date of withdrawal of the marketing authorisation. The primary outcome of the study was defined as label change in dosing information for the initially approved indication. Incidence of changes, type of change and mean time to change were assessed...
December 28, 2018: British Journal of Clinical Pharmacology
Yu Eun Sunwoo, Phuong Thi Thu Nguyen, May Chien Chin, Ji Young Ryu, Jihong Shon, Jae-Gook Shin
AIMS: In vitro study showed that benidipine is exclusively metabolised by cytochrome P450 (CYP) 3A. This study evaluated the effect of rifampin on the enantioselective disposition and anti-hypertensive effect of benidipine. METHODS: Benidipine (8 mg) was administered to healthy subjects with or without repeated rifampin dosing, in a crossover design. Plasma concentrations of (S)-(S)-(+)-α and (R)-(R)-(-)-α isomers of benidipine and blood pressure were measured for up to 24 h after dosing...
December 27, 2018: British Journal of Clinical Pharmacology
Blessed Winston Aruldhas, Richard M Hoglund, Jaya Ranjalkar, Joel Tarning, Sumith K Mathew, Valsan Philip Verghese, Anuradha Bose, Binu Susan Mathew
BACKGROUND: Pharmacokinetic studies in the past have shown inadequate antituberculosis drug levels in children with the currently available dosing regimens. This study attempted to investigate the pharmacokinetics of isoniazid and rifampicin, when used in children, and to optimise their dosing regimens. METHODS: Data were collected from 41 children, aged 2 to 16 years, who were being treated with anti-tuberculosis drugs for at least 2 months. Concentration measurements were done for a 6-hour period and analysed using a non-linear, mixed-effects model...
December 26, 2018: British Journal of Clinical Pharmacology
Dave Singh, Frans van den Berg, Brian Leaker, Massimo Corradi, Sunny Jabbal, Sara Collarini, Valentina Mongelli, Luigi Santoro, Annalisa Piccinno, Sonia Biondaro, Brian Lipworth
AIM: To demonstrate the non-inferiority of extrafine beclomethasone/formoterol Fumarate (BDP/FF) dry powder inhaler (DPI) vs extrafine BDP/FF pressurised metered dose inhaler (pMDI) (Foster® 100/6 μg NEXThaler® and pMDI, respectively) in the onset of reliever effect after methacholine induced bronchospasm in asthmatic patients, evaluated in terms of FEV1 at 5 min post-dose. The DPI provides an alternative device option for patients who cannot use a pMDI properly during an acute asthma attack...
December 26, 2018: British Journal of Clinical Pharmacology
Daniele Pastori, Ivano Mezzaroma, Pasquale Pignatelli, Francesco Violi, Gregory Y H Lip
The prevalence and incidence of atrial fibrillation/flutter (AF/AFL) in patients with Human Immunodeficiency Virus type-1 (HIV-1) infection have been poorly investigated. We performed a systematic review using PubMed and Cochrane Database of Systematic Reviews, and screening of references, searching for clinical studies reporting on the association between HIV-1 infection and AF/AFL. We also summarised the main interactions of antiretroviral agents with antithrombotic and antiarrhythmic drugs. We found a prevalence of AF/AFL ranging from 2...
December 21, 2018: British Journal of Clinical Pharmacology
Thitiporn Supasitthumrong, Blanca M Bolea-Alamanac, Selim Asmer, Vincent L Woo, Petal S Abdool, Simon J C Davies
AIMS: The prevalence of dementia is rising as life expectancy increases globally. Behavioural and psychological symptoms of dementia (BPSD) including agitation and aggression are common, presenting a challenge to clinicians and caregivers. METHODS: Following PRISMA guidelines, we systematically reviewed evidence for gabapentin and pregabalin against BPSD symptoms of agitation or aggression in any dementia, using six databases (Pubmed, CINHL, PsychINFO, HealthStar, Embase, and Web of Science)...
December 21, 2018: British Journal of Clinical Pharmacology
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