11,850 results match your criteria Br J Clin Pharmacol[Journal]


Potential role of IL-17 blocking agents in the treatment of severe COVID-19?

Br J Clin Pharmacol 2020 Jul 5. Epub 2020 Jul 5.

School of Medicine, University of Zagreb, Zagreb, Croatia.

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http://dx.doi.org/10.1111/bcp.14437DOI Listing

Comparing risk of major bleeding between users of different oral anticoagulants in patients with non-valvular atrial fibrillation.

Br J Clin Pharmacol 2020 Jul 6. Epub 2020 Jul 6.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.

Background: The introduction of direct oral anticoagulants (DOACs) has broadened the treatment arsenal for non-valvular atrial fibrillation (NVAF), but observational studies on the benefit-risk balance of DOACs compared to vitamin K antagonists (VKAs) are needed.

Aim: To characterize the risk of major bleeding in DOAC users using longitudinal data collected from electronic health care databases from four different EU-countries analysed with a common study protocol.

Methods: A cohort study was conducted among new users (≥18 years) of DOACs or VKAs with NVAF using data from the United Kingdom (UK), Spain, Germany and Denmark. Read More

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http://dx.doi.org/10.1111/bcp.14450DOI Listing

Effectiveness and safety of toripalimab, camrelizumab and sintilimab in a real-world cohort of hepatitis B virus associated hepatocellular carcinoma patients.

Br J Clin Pharmacol 2020 Jul 5. Epub 2020 Jul 5.

Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China.

Aims: The investigation regarding the clinical significance of programmed cell death protein-1 (PD-1)-targeted immunotherapy in Chinese patients is rare. This study evaluated safety and efficacy of PD-1 inhibitors with Toripalimab, Camrelizumab or Sintilimab for Chinese Hepatocellular carcinoma (HCC) patients in a real-life cohort.

Methods: We analyzed HBV associated HCC patients treated with Toripalimab, Camrelizumab or Sintilimab in a retrospective single-center cohort from Nov 2018 to Dec 2019. Read More

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http://dx.doi.org/10.1111/bcp.14452DOI Listing

On precision dosing of oral small molecule drugs in oncology.

Br J Clin Pharmacol 2020 Jul 4. Epub 2020 Jul 4.

Departments of Pathology & Cell Biology and Medicine, Columbia University Irving Medical Center, New York, NY, 10032, United States of America.

Personalization of oral small molecule anticancer drug doses based on individual patient blood drug levels, also known as therapeutic drug monitoring or TDM, has the potential to significantly improve the effectiveness of treatment by maximizing drug efficacy and minimize toxicity. However, this option has not yet been widely embraced by the oncology community. Some reasons for this include increased logistical complexity of dose individualization, the lack of clinical laboratories that measure small molecule drug concentrations in support of patient care, and the lack of reimbursement of costs. Read More

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http://dx.doi.org/10.1111/bcp.14454DOI Listing

A Framework for Simplification of Quantitative Systems Pharmacology Models in Clinical Pharmacology.

Br J Clin Pharmacol 2020 Jul 4. Epub 2020 Jul 4.

School of Pharmacy, University of Otago, Dunedin, New Zealand.

Quantitative systems pharmacology (QSP) is a relatively new discipline within modelling and simulation that has gained wide attention over the past few years. The application of QSP models spans drug-target identification and validation, through all drug development phases as well as clinical applications. Due to their detailed mechanistic nature, QSP models are capable of extrapolating knowledge to predict outcomes in scenarios that have not been tested experimentally making them an important resource in experimental and clinical pharmacology. Read More

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http://dx.doi.org/10.1111/bcp.14451DOI Listing

Inhibition of CYP2D6 with low dose (5 mg) paroxetine in patients with high 10-hydroxynortriptyline serum levels - a prospective pharmacokinetic study.

Br J Clin Pharmacol 2020 Jul 4. Epub 2020 Jul 4.

Department of Pharmacy Jeroen Bosch Hospital,'s-Hertogenbosch, The Netherlands.

The antidepressant nortriptyline is metabolized by cytochrome P450 2D6 (CYP2D6) to the less active and more cardiotoxic drug metabolite, 10-hydroxynortriptyline. High serum levels of this metabolite (>200μg/l) may lead to withdrawal of nortriptyline therapy. Adding CYP2D6 inhibitors reduce the metabolic activity of CYP2D6 (phenoconversion) and so decrease the forming of hydroxynortriptyline. Read More

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http://dx.doi.org/10.1111/bcp.14455DOI Listing

Increased Concentrations of bioactive Adrenomedullin subsequently to ARNi Treatment in Chronic Systolic Heart Failure.

Br J Clin Pharmacol 2020 Jun 29. Epub 2020 Jun 29.

Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria.

Aims: The clinically investigated rationale for neprilysin (NEP)-inhibition by ARNi-therapy is to induce elevations in endogenous natriuretic peptides. NEP, however, cleaves a broad spectrum of substrates, which partially hold significant implications in HFrEF. The effect of NEP-inhibition on these peptides has not been investigated thoroughly. Read More

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http://dx.doi.org/10.1111/bcp.14442DOI Listing

Candidates registered for reasonable adjustments underperform compared to other candidates in the national undergraduate Prescribing Safety Assessment: retrospective cohort analysis (2014-2018).

Br J Clin Pharmacol 2020 Jun 29. Epub 2020 Jun 29.

St Bartholomew's and the Royal London Hospitals, Barts Health NHS Trust, London, UK.

Introduction: Candidates with disabilities are eligible for reasonable adjustments while undertaking the national Prescribing Safety Assessment (PSA). The PSA is a novel open-book, time-constrained, multi-format assessment which may pose challenges to candidates with dyslexia and other disabilities.

Methods: Retrospective cohort analysis of 36140 UK candidates undertaking first-sitting of the PSA (2014-2018). Read More

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http://dx.doi.org/10.1111/bcp.14446DOI Listing

Effects of statins and exercise on postprandial lipoproteins in metabolic syndrome vs metabolically healthy individuals.

Br J Clin Pharmacol 2020 Jun 29. Epub 2020 Jun 29.

Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.

Aim: To determine if the combination of exercise and statin could normalize postprandial triglyceridemia (PPTG) in hypercholesteraemic individuals.

Methods: Eight hypercholesteraemic (blood cholesterol 182±38 mg·dL ; LDL-c 102±32 mg·dL ) overweight (BMI 30±4 kg·m ) individuals with metabolic syndrome (i.e. Read More

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http://dx.doi.org/10.1111/bcp.14447DOI Listing

Systemic exposure to 5-Fluorouracil and its metabolite, 5,6-dihydrofluorouracil, and development of a limited sampling strategy for therapeutic drug management of 5-Fluorouracil in patients with gastrointestinal malignancy.

Br J Clin Pharmacol 2020 Jun 27. Epub 2020 Jun 27.

Department of Pharmacology and Clinical Pharmacology, Christian Medical College and Hospital, Vellore, Tamil Nadu, India.

Aim: 5-Fluorouracil (5-FU) is widely used in combination chemotherapy, and literature suggests pharmacokinetic (PK) guided dosing to improve clinical efficacy and reduce toxicity. This study aimed to determine the pharmacokinetic exposure of both 5-FU and its metabolite 5,6-dihydrofluorouracil (DHFU), in patients with gastrointestinal malignancy and to establish a simplified strategy to assist in therapeutic drug management (TDM) for dose optimization.

Methods: This was a prospective, observational study, performed in 27 patients diagnosed with gastrointestinal malignancy who were prescribed 5-FU. Read More

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http://dx.doi.org/10.1111/bcp.14444DOI Listing

Cerebral toxoplasmosis associated with treatment with rituximab, azathioprine and prednisone for dermatomyositis.

Br J Clin Pharmacol 2020 Jun 27. Epub 2020 Jun 27.

Hospital pharmacy, Hospital San Cecilio, Granada, Spain.

We observed a severe case of cerebral toxoplasmosis in a 22-year-old woman diagnosed with dermatomyositis in 2016 in Venezuela, and treated with rituximab and azathioprine. The patient met clinical and microbiological. Treatment with pyrimethamine and sulfadiazine was initiated and the patient was discharged. Read More

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http://dx.doi.org/10.1111/bcp.14445DOI Listing

The effects of vilaprisan on the pharmacodynamics and pharmacokinetics of a combined oral contraceptive - A randomized controlled trial.

Br J Clin Pharmacol 2020 Jun 27. Epub 2020 Jun 27.

Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, 13353, Berlin, Germany.

Aim: The primary objective was to explore whether the suppression of ovarian activity induced by a combined oral contraceptive (COC) is influenced by the simultaneous intake of the selective progesterone receptor modulator (SPRM) vilaprisan (VPR).

Methods: In this exploratory randomized, double-blind, parallel-group study, 71 healthy premenopausal women were randomized (1:1) to receive either 2 mg/d VPR or placebo for 3 months. Concomitantly, a COC (0. Read More

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http://dx.doi.org/10.1111/bcp.14443DOI Listing

Model informed dosing of Hydroxycholoroquine in COVID-19 patients: Learnings from the recent experience, remaining uncertainties and Gaps.

Br J Clin Pharmacol 2020 Jun 19. Epub 2020 Jun 19.

Belgian Federal Agency for Medicines and Health Products, Brussels, Belgium.

Aims: In the absence of a commonly agreed dosing protocol based on pharmacokinetic considerations, the dose and treatment duration for hydroxychloroquine (HCQ) COVID-19 disease currently vary across national guidelines and clinical study protocols. We have used a model-based approach to explore the relative impact of alternative dosing regimens proposed in different dosing protocols for hydroxychloroquine in COVID-19.

Methods: We compared different PK exposures using Monte Carlo simulations based on a previously published population pharmacokinetic model in patients with rheumatoid arthritis, externally validated using both independent data in lupus erythematous patients and recent data in French COVID-19 patients. Read More

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http://dx.doi.org/10.1111/bcp.14436DOI Listing

Pharmacokinetic and pharmacodynamic evidence of adrenaline administered via auto-injector for anaphylactic reactions: a review of literature.

Br J Clin Pharmacol 2020 Jun 19. Epub 2020 Jun 19.

Evelina Pharmacy, Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.

Anaphylaxis is a severe and life-threatening allergic reaction that can lead to death if not treated quickly. Adrenaline (epinephrine) is the first-line treatment for anaphylaxis and its prompt administration is vital to reduce mortality. Following a number of high profile cases, serious concerns have been raised, both about the optimal dose of intramuscular adrenaline via an auto-injector and the correct needle length to ensure maximal penetration every time. Read More

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http://dx.doi.org/10.1111/bcp.14438DOI Listing

Prescription patterns of outpatients and the potential of multiplexed pharmacogenomic testing.

Br J Clin Pharmacol 2020 Jun 19. Epub 2020 Jun 19.

Health Services and Systems Research, Duke-NUS Medical School, Singapore.

Background: Pre-emptive pharmacogenomic (PGx) testing is potentially an efficient approach to improve drug safety and efficacy but the target population to test is unclear.

Objectives: We aim to describe the prescription pattern of PGx drugs among adult medical outpatients.

Methods: We estimated the 5-year cumulative incidence (CI) for receiving three groups of PGx drugs using competing risks analysis: (i) all PGx drugs, (ii) PGx drugs with guidelines and (iii) PGx drugs with serious clinical effects. Read More

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http://dx.doi.org/10.1111/bcp.14439DOI Listing

Patterns of use and safety of ibrutinib in real-life practice.

Br J Clin Pharmacol 2020 Jun 19. Epub 2020 Jun 19.

Pharmacologie Clinique et Vigilances, CHU de Poitiers, Poitiers, France.

Aims: To provide real-life data on patterns of use and safety of ibrutinib.

Methods: A cohort study including all patients initiating ibrutinib between 21 November 2014 and 21 November 2018, and followed for 1 year was conducted. Patient characteristics, ibrutinib use and adverse drug reactions (ADRs) were collected from medical records. Read More

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http://dx.doi.org/10.1111/bcp.14440DOI Listing

Evaluation of ABC gene polymorphisms on the pharmacokinetics and pharmacodynamics of capecitabine in colorectal patients: implications for dosing recommendations.

Br J Clin Pharmacol 2020 Jun 19. Epub 2020 Jun 19.

Department of Pharmacy and Pharmaceutical Technology and Parasitology, University of Valencia. Valencia, Spain.

Aims: The aims are to develop a population pharmacokinetic model of CAP and its main metabolites after the oral administration of CAP in colorectal cancer patients with different polymorphisms of the ABC gene; a population pharmacokinetic/pharmacodynamic model capable of accounting for the neutropenic effects; and to optimize the dosing strategy based on the polymorphisms of the ABC gene and/or the administration regimen as a single agent or in combination.

Methods: 48 patients diagnosed with colorectal cancer were included, with 432 plasma levels of CAP, 5'-DFUR and 5-FU, and 370 neutrophil observations. Capecitabine doses ranged from 1,250 to 2,500 mg/m /24h. Read More

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http://dx.doi.org/10.1111/bcp.14441DOI Listing

TDM is dead. Long live TCI!

Br J Clin Pharmacol 2020 Jun 16. Epub 2020 Jun 16.

Department of Pediatrics, University of Melbourne, Melbourne, Victoria, Australia.

Twenty years ago, target concentration intervention (TCI) was distinguished from therapeutic drug monitoring (TDM). It was proposed that TCI would bring more clinical benefit because of the precision of the approach and the ability to link TCI to principles of pharmacokinetics and pharmacodynamics to predict the dose required by an individual (1). We examine the theory and clinical trial evidence supporting the benefits of TCI over TDM and conclude that in the digital age TDM should be abandoned and replaced by TCI. Read More

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http://dx.doi.org/10.1111/bcp.14434DOI Listing

Evolving Insights into the Mechanisms of Toxicity Associated with Immune Checkpoint Inhibitor Therapy.

Br J Clin Pharmacol 2020 Jun 16. Epub 2020 Jun 16.

Departments of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

Immune checkpoint inhibitors have emerged as a revolutionary treatment option for patients with various types of malignancy. Although these agents afford a significant improvement in outcomes for melanoma and other previously untreatable malignancies, their novel mechanism of action may predispose patients to immune-related adverse effects (irAEs). In the tumor neoantigen environment these irAEs are due to the activation of the immune system by the blockade of suppressive checkpoints, leading to increases in T-cell activation and proliferation. Read More

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http://dx.doi.org/10.1111/bcp.14433DOI Listing

Effect of pharmaceutical regulatory policy on health impact.

Br J Clin Pharmacol 2020 Jun 14. Epub 2020 Jun 14.

Chair of Clinical Pharmacology, University of Newcastle, New South Wales, 2308, Australia.

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http://dx.doi.org/10.1111/bcp.14390DOI Listing

Drug-drug interaction between warfarin and statins: A Danish cohort study.

Br J Clin Pharmacol 2020 Jun 13. Epub 2020 Jun 13.

Clinical Pharmacology and Pharmacy, Department of Public health, University of Southern Denmark, Odense, Denmark.

Initiation of statin treatment is suggested to increase the international normalised ratio (INR) among warfarin users. However, available data is limited and conflicting. We conducted a register-based cohort study to evaluate the drug-drug interaction between warfarin and statins. Read More

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http://dx.doi.org/10.1111/bcp.14428DOI Listing

The timing of cyclic cytotoxic chemotherapy can worsen neutropenia and neutrophilia.

Br J Clin Pharmacol 2020 Jun 13. Epub 2020 Jun 13.

Department of Physiology, McGill University, Montreal, Canada.

Despite recent advances in immunotherapies, cytotoxic chemotherapy continues to be a first-line treatment option for the majority of cancers. Unfortunately, a common side effect in patients undergoing chemotherapy treatment is neutropenia. To mitigate the risk of neutropenia and febrile neutropenia, prophylactic treatment with granulocyte-colony stimulating factor (G-CSF) is administered. Read More

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http://dx.doi.org/10.1111/bcp.14424DOI Listing

Factors associated with serious vehicular accidents: a cross-sectional study in hospital emergency rooms.

Br J Clin Pharmacol 2020 Jun 12. Epub 2020 Jun 12.

Bordeaux INSERM CIC1401, CHU de Bordeaux - Université de Bordeaux, 33076, Bordeaux.

Aim: Pictograms on medicine boxes warn of potential drug-related driving hazard; We studied their association with serious accidents.

Methods: Prospective study in Emergency departments of the Hospitals in Bordeaux and Périgueux (France), of drivers with serious (admitted at least 24 hours) or non-serious vehicular accidents. Minors, passengers, pedestrians or subjects incapable of answering an interview were excluded. Read More

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http://dx.doi.org/10.1111/bcp.14427DOI Listing

The effect of initiation of renin-angiotensin system inhibitors on haemoglobin: A national cohort study.

Br J Clin Pharmacol 2020 Jun 12. Epub 2020 Jun 12.

Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.

Aims: To determine whether initiation of treatment with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers (ACEI/ARBs) is associated with a subsequent reduction in haemoglobin in the general population.

Methods: We undertook a national cohort study over a 13-year period (2004-2016), using routine primary healthcare data from the UK Clinical Practice Research Datalink. We compared ACEI/ARB initiation with calcium channel blocker (CCB) initiation, to minimise confounding by indication. Read More

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http://dx.doi.org/10.1111/bcp.14429DOI Listing

Bone mineral density improves during 2 years of treatment with bisphosphonates in patients with ankylosing spondylitis.

Br J Clin Pharmacol 2020 Jun 12. Epub 2020 Jun 12.

Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, RB, The Netherlands.

Aims: To evaluate whether 2 years of treatment with bisphosphonates in combination with calcium/vitamin D supplements has an effect on lumbar spine and hip bone mineral density (BMD) in ankylosing spondylitis (AS) patients starting tumour necrosis factor-α inhibitors or receiving conventional treatment. Secondly, to explore the development of radiographic vertebral fractures.

Methods: Patients from the Groningen Leeuwarden AS cohort receiving bisphosphonates based on clinical indication and available 2-year follow-up BMD measurements were included. Read More

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http://dx.doi.org/10.1111/bcp.14431DOI Listing

Scotland's 2009-2015 methadone-prescription cohort: quintiles for daily-dose of prescribed methadone and risk of methadone-specific death.

Br J Clin Pharmacol 2020 Jun 12. Epub 2020 Jun 12.

MRC Biostatistics Unit, University of Cambridge School of Clinical Medicine, CAMBRIDGE, CB2 0SR.

Background: As methadone-clients age, their drug-related death (DRD) risks increase, more than doubling at 45+ years for methadone-specific DRDs.

Methods: Using Community Health Index (CHI) numbers, mortality to 31 December 2015 was ascertained for 36,347 methadone-prescription-clients in Scotland during 2009-2015. Cohort-entry, quantity of prescribed methadone and daily-dose (actual or recovered by effective, simple rules) were defined by clients' first CHI-identified methadone-prescription after 30 June 2009 and used in proportional hazards analysis. Read More

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http://dx.doi.org/10.1111/bcp.14432DOI Listing

Clinical outcomes of nonvitamin K oral anticoagulants and acenocoumarol for stroke prevention in contemporary practice: A population-based propensity-weighted cohort study.

Br J Clin Pharmacol 2020 Jun 12. Epub 2020 Jun 12.

Health Services Research Unit. Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain.

Aim: Acenocoumarol is a vitamin-K antagonist (VKA) primarily used in certain countries (e.g India, Netherlands, Spain). The half-life of acenocoumarol is similar to that of non-VKA oral anticoagulants (NOAC), unlike warfarin, and this could affect comparative effectiveness and safety (CES). Read More

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http://dx.doi.org/10.1111/bcp.14430DOI Listing
June 2020
3.878 Impact Factor

Clinical implementation of pharmacogenetics and model-informed precision dosing to improve patient care.

Br J Clin Pharmacol 2020 Jun 11. Epub 2020 Jun 11.

Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.

Providing maximal therapeutic efficacy without toxicity is a universal goal of rational drug therapy. However, substantial between patient variability in drug response often impedes such successful treatments and brings the necessity of tailoring drug dose to individual needs for more precise therapy. In many cases plenty of patient's characteristics such as body size, genetic makeup and environmental factors needs to be taken into consideration to find optimal dose in clinical practice. Read More

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http://dx.doi.org/10.1111/bcp.14426DOI Listing

Advancing structured decision-making in drug regulation at the FDA and EMA.

Br J Clin Pharmacol 2020 Jun 11. Epub 2020 Jun 11.

London School of Economics and Political Science, London, UK.

The recent benefit-risk framework (BRF) developed by the Food and Drug Administration (FDA) is intended to improve the clarity and consistency in communicating the reasoning behind the FDA's decisions, acting as an important advancement in US drug regulation. In the PDUFA VI implementation plan, the FDA states that it will continue to explore more structured or quantitative decision analysis approaches; however, it restricts their use within the current BRF that is purely qualitative. By contrast, European regulators and researchers have been long exploring the use of quantitative decision analysis approaches for evaluating drug benefit-risk balance. Read More

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http://dx.doi.org/10.1111/bcp.14425DOI Listing

Cost-utility and cost-effectiveness analysis of a clinical medication review focused on personal goals in older persons with polypharmacy compared to usual care: Economic evaluation of the DREAMeR study.

Br J Clin Pharmacol 2020 Jun 10. Epub 2020 Jun 10.

Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.

Aims: The ageing society may lead to increasing healthcare expenditure. A clinical medication review (CMR) could potentially reduce costs. The aim of this study is to perform a cost-utility and cost-effectiveness analysis from a societal perspective of a patient-centred CMR. Read More

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http://dx.doi.org/10.1111/bcp.14421DOI Listing

The Pharmacotherapy team: a novel strategy to improve appropriate in-hospital prescribing using a participatory intervention action method.

Br J Clin Pharmacol 2020 Jun 10. Epub 2020 Jun 10.

Department of Internal Medicine, Amsterdam UMC location VUmc, Amsterdam, The Netherlands.

Prescribing medication is a complex process which, when done inappropriately, can lead to adverse drug events (ADEs), resulting in patient harm and hospital admissions. Worldwide cost are estimated at 42 billion USD each year. Despite several efforts in the past years, medication-related harm has not declined. Read More

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http://dx.doi.org/10.1111/bcp.14418DOI Listing

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review.

Br J Clin Pharmacol 2020 Jun 10. Epub 2020 Jun 10.

School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.

Aims: This systematic review aimed to quantify the prevalence of adverse drug events (ADEs) and adverse drug reactions (ADRs) in older inpatients with dementia.

Methods: A systematic search of observational studies was performed in Embase, Medline, PsycINFO, International Pharmaceutical Abstracts, Scopus and Informit. Articles published in English that reported the prevalence of ADEs or ADRs in hospital patients aged 65 years or older with dementia were included. Read More

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http://dx.doi.org/10.1111/bcp.14417DOI Listing

Grapefruit juice enhances the systolic blood pressure-lowering effects of dietary nitrate-containing beetroot juice.

Br J Clin Pharmacol 2020 Jun 10. Epub 2020 Jun 10.

School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.

Introduction: Dietary nitrate from sources such as beetroot juice lowers blood pressure (BP) via the nitrate-nitrite-nitric oxide (NO) pathway. However, NO and nitrite are inactivated via re-oxidation to nitrate, potentially limiting their activity. Cytochrome P450-3A4 inhibition with troleandomycin prevents nitrite re-oxidation to nitrate in rodent liver. Read More

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http://dx.doi.org/10.1111/bcp.14420DOI Listing

First-in-human study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of SAR247799, a selective G-protein-biased Sphingosine-1 phosphate receptor-1 agonist for endothelial protection.

Br J Clin Pharmacol 2020 Jun 10. Epub 2020 Jun 10.

Sanofi US Services, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.

Aim: SAR247799 is a selective G-protein-biased sphingosine-1 phosphate receptor-1 (S1P ) agonist with potential to restore endothelial function in vascular pathologies. SAR247799, a first-in-class molecule differentiated from previous S1P -desensitizing molecules developed for multiple sclerosis, can activate S1P without desensitization and consequent lymphopenia. The aim was to characterize SAR247799 for its safety, tolerability, pharmacokinetics and pharmacodynamics (activation and desensitization). Read More

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http://dx.doi.org/10.1111/bcp.14422DOI Listing

Over a decade of experience with carboplatin therapeutic drug monitoring in a childhood cancer setting in the United Kingdom.

Br J Clin Pharmacol 2020 Jun 10. Epub 2020 Jun 10.

Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK.

The widely used platinum agent carboplatin represents a good example of an anticancer drug where clear relationships between pharmacological exposure and clinical response and toxicity have previously been shown. Within the setting of childhood cancer, there are defined groups of patients who present a particular challenge when dosing with carboplatin, including neonates and infants, those who are anephric, and poor prognosis patients receiving high-dose chemotherapy. For these groups, nonstandard chemotherapy dosing regimens are currently utilised, often with different approaches between clinical study protocols and between treatment centres. Read More

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http://dx.doi.org/10.1111/bcp.14419DOI Listing

Understanding the association between metformin plasma concentrations and lactate.

Br J Clin Pharmacol 2020 Jun 9. Epub 2020 Jun 9.

School of Pharmacy, University of Otago, Dunedin, New Zealand.

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http://dx.doi.org/10.1111/bcp.14394DOI Listing

Acute Toxicity Related to Misuse (Non-Medical Use) of Tramadol: Experience of the European Drug Emergencies Network Plus (Euro-DEN Plus) Project.

Br J Clin Pharmacol 2020 Jun 5. Epub 2020 Jun 5.

Clinical Toxicology, Guy's and St Thomas' NHS Foundation Trust and King's Health Partners, London, UK.

Following the development of the tramadol crisis currently affecting countries in the Middle East, and Africa, there has been increasing international interest in the regulation of tramadol. This study investigates the misuse of tramadol in patients presenting to emergency departments across Europe. Data from 32 emergency departments in 21 countries were extracted from the Euro-DEN Plus database for the 4-year period from 1 January 2014 to 31 December 2017. Read More

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http://dx.doi.org/10.1111/bcp.14408DOI Listing

Assessing the effect of extracorporeal treatments for lithium poisoning.

Br J Clin Pharmacol 2020 Jun 5. Epub 2020 Jun 5.

Departments of Clinical Pharmacology, Toxicology and Renal Medicine, St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia.

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http://dx.doi.org/10.1111/bcp.14367DOI Listing

Are high cost drug funding mechanisms fit for purpose? - A retrospective study of Individual Funding Requests in an NHS tertiary hospital.

Br J Clin Pharmacol 2020 Jun 5. Epub 2020 Jun 5.

Centre for Clinical Pharmacology, Division of Medicine, University College London.

Objectives: To report on a retrospective study of individual funding request (IFR) submissions from a large tertiary hospital and describe gaps in current mechanisms for funding of high-cost medicines in England.

Methods: Data on the number and outcome of IFR submissions submitted to commissioners between 2014/15 and 2018/19 was extracted from the electronic patient health record and a local high-cost drug database.

Results: In total 230 IFRs were submitted; 112 to NHS England and 118 to a CCG. Read More

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http://dx.doi.org/10.1111/bcp.14409DOI Listing

Pharmacogenomics of anticancer drugs: Personalising the choice and dose to manage drug response.

Br J Clin Pharmacol 2020 Jun 5. Epub 2020 Jun 5.

Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.

The field of pharmacogenomics has made great strides in oncology over the last 20 years and indeed a significant number of pre-emptive genetic tests are now routinely undertaken prior to anticancer drug administration. Many of these gene-drug interactions are the fruits of candidate gene and genome-wide association studies, which have largely focused on common genetic variants (allele frequency>1%). Examples where there is clinical utility include genotyping or phenotyping for G6PD to prevent rasburicase-induced RBC haemolysis, and TPMT to prevent thiopurine-induced bone marrow suppression. Read More

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http://dx.doi.org/10.1111/bcp.14407DOI Listing

Population pharmacokinetics of olanzapine in children.

Br J Clin Pharmacol 2020 Jun 4. Epub 2020 Jun 4.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.

Aims: The aim of this study was to evaluate the population pharmacokinetics (PopPK) of olanzapine in children and devise a model-informed paediatric dosing scheme.

Methods: The PopPK of olanzapine was characterized using opportunistically collected plasma samples from children receiving olanzapine per standard of care for any indication. A nonlinear mixed effect modelling approach was employed for model development using the software NONMEM (v7. Read More

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http://dx.doi.org/10.1111/bcp.14414DOI Listing
June 2020
3.878 Impact Factor

Ten-year trend of opioid and nonopioid analgesic use in the French adult population.

Br J Clin Pharmacol 2020 Jun 4. Epub 2020 Jun 4.

Centre d'addictovigilance, Service de pharmacologie médicale, CHU Bordeaux, Bordeaux, France.

Aims: Analgesics are the most widely used medicines worldwide. In parallel, opioid abuse has increased and is of major concern. The accessibility of pharmacologically powerful medicines and the addictovigilance signals in France about the risk of opiates addiction call for an overview of analgesic use. Read More

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http://dx.doi.org/10.1111/bcp.14415DOI Listing

Plasma and cerebrospinal fluid pharmacokinetics of ondansetron in humans.

Br J Clin Pharmacol 2020 Jun 4. Epub 2020 Jun 4.

Division of Clinical and Translational Research and Washington University Pain Center, Department of Anesthesiology, Washington University School of Medicine, St Louis, MO, USA.

Aims: Changes in serotonergic sensory modulation associated with overexpression of 5-HT receptors in the central nervous system (CNS) have been implicated in the pathophysiology of neuropathic pain after peripheral nerve damage. 5-HT receptor antagonists such as ondansetron can potentially alleviate neuropathic pain, but have limited effectiveness, due potentially to limited CNS access. However, there is currently limited information on CNS disposition of systemically-administered 5-HT receptor antagonists. Read More

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http://dx.doi.org/10.1111/bcp.14412DOI Listing

Safety profile of Immune Checkpoint Inhibitors: an analysis of Italian Spontaneous Reporting System Database.

Br J Clin Pharmacol 2020 Jun 4. Epub 2020 Jun 4.

Dept. of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy.

Aim: To provide an overview of Immune Checkpoint Inhibitors (ICIs) safety profile using the Italian Spontaneous Adverse Drug Reaction (ADR) Reporting System.

Methods: We selected all ADR reports attributed to ipilimumab (CTLA-4 inhibitor), nivolumab, pembrolizumab, atezolizumab (PD-1/PD-L1 inhibitors) from the Italian SRS (period 2011-2018). Descriptive analyses of reports for ICIs have been conducted. Read More

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http://dx.doi.org/10.1111/bcp.14413DOI Listing

Managing access to advanced therapy medicinal products: Challenges for NHS Wales.

Br J Clin Pharmacol 2020 Jun 3. Epub 2020 Jun 3.

Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.

Advanced Therapy Medicinal Products (ATMPs), which include gene, somatic cell therapies and tissue-engineered medicines, have the potential to transform current care pathways by offering durable and potentially curative outcomes. However, they are exceptionally expensive, with prices exceeding £1m per patient in some cases. With an expectation that a large number of ATMPs will soon gain marketing authorisation (global market is estimated to reach £9bn to £14bn by 2025), healthcare payers and providers face a number of challenges to facilitate patient access to this new category of medicines. Read More

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http://dx.doi.org/10.1111/bcp.14286DOI Listing

Bayes-based dosing of infliximab in inflammatory bowel diseases: Short-term efficacy.

Br J Clin Pharmacol 2020 Jun 3. Epub 2020 Jun 3.

Department of Pharmacy, Hospital Universitari de Bellvitge-HUB. Pharmacotherapy, Pharmacogenetics and Pharmaceutical Technology Program, Institut d'Investigació Biomèdica de Bellvitge-IDIBELL. L'Hospitalet de Llobregat, Barcelona, Spain.

Aims: Therapeutic drug monitoring of infliximab can guide clinical decisions in patients with loss of response and in those who can benefit from a de-intensification. The aim of this study was to determine the impact of therapeutic drug monitoring combined with Bayesian forecasting methodology on clinical response in a real-world dataset of patients suffering from inflammatory bowel disease.

Methods: We performed a single-centre prospective study with one-group pre-test/post-test design in 108 adult inflammatory bowel disease patients treated with model-based dosing of infliximab maintenance treatment. Read More

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http://dx.doi.org/10.1111/bcp.14410DOI Listing

Personalised dosing of vancomycin: A prospective and retrospective comparative quasi-experimental study.

Br J Clin Pharmacol 2020 Jun 4. Epub 2020 Jun 4.

Department of Pharmacy, University Hospitals of Leicester NHS Trust, UK.

Aims: The 2019 update to the US consensus guideline for vancomycin therapeutic monitoring advocates using Bayesian-guided personalised dosing to maximise efficacy and minimise toxicity of vancomycin. We conducted an observational cohort study of the implementation of bed-side Bayesian-guided vancomycin dosing in vascular surgery patients.

Methods: Over a 9-month prospective study period, vascular surgery patients were dosed vancomycin using Bayesian-guided dosing decision tool (DoseMeRx) and compared retrospectively with a control group admitted to the same ward in the 14 months prior to the study and dosed using a standard algorithmic approach. Read More

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http://dx.doi.org/10.1111/bcp.14411DOI Listing

Effect of low-dose aspirin on health outcomes: An umbrella review of systematic reviews and meta-analyses.

Br J Clin Pharmacol 2020 Jun 2. Epub 2020 Jun 2.

Centre for Global Health Research, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.

Aims: This study aimed to use an umbrella review methodology to capture the range of outcomes that were associated with low-dose aspirin and to systematically assess the credibility of this evidence.

Methods: Aspirin is associated with several health outcomes, but the overall benefit/risk balance related to aspirin use is unclear. We searched three major databases up to 15 August 2019 for meta-analyses of observational studies and randomized controlled trials (RCTs) including low-dose aspirin compared to placebo or other treatments. Read More

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http://dx.doi.org/10.1111/bcp.14310DOI Listing
June 2020
3.878 Impact Factor