11,133 results match your criteria British journal of clinical pharmacology[Journal]


Comment on 'Measuring the impact of medicines regulatory interventions - systematic review and methodological considerations' by Goedecke et al.

Br J Clin Pharmacol 2018 Jun 22. Epub 2018 Jun 22.

Department of Population Medicine, Harvard School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.

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Effect of tildrakizumab (MK-3222), a high affinity, selective anti-IL23p19 monoclonal antibody, on cytochrome P450 metabolism in subjects with moderate to severe psoriasis.

Br J Clin Pharmacol 2018 Jun 21. Epub 2018 Jun 21.

Merck & Co., Inc., Kenilworth, NJ, USA.

Aims: Tildrakizumab, an interleukin (IL)-23 inhibitor, is indicated for the treatment of moderate to severe chronic plaque psoriasis. Although tildrakizumab is not metabolized by, and does not alter, cytochrome P450 (CYP) expression in vitro, clinically-significant pharmacokinetic effects through changes in systemic inflammation, which alters CYP metabolism, have been well documented. At the time of study conduct, the effect of modulation of inflammation/cytokines, including IL-23 inhibition with tildrakizumab, on CYP metabolism, and therefore the potential for disease-drug interactions, in psoriasis patients was unknown. Read More

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June 2018
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A Pharmacokinetics Phase 1 Bioequivalence Study of the Trastuzumab Biosimilar MYL-1401O vs EU-Trastuzumab and US-Trastuzumab.

Br J Clin Pharmacol 2018 Jun 21. Epub 2018 Jun 21.

Mylan Inc, Canonsburg, PA, USA.

Aims: Trastuzumab is a humanized monoclonal antibody that binds the human epidermal growth factor receptor 2 (HER2) oncoprotein and is an effective therapy for HER2-overexpressing breast cancer. MYL-1401O is a trastuzumab biosimilar. Here, we report results from a phase 1 study that investigated bioequivalence among MYL-1401O, reference EU-trastuzumab, and US-trastuzumab. Read More

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MEDI0382, a GLP-1-glucagon receptor dual agonist, meets safety and tolerability endpoints in a single-dose, healthy-subject, randomised, phase 1 study.

Br J Clin Pharmacol 2018 Jun 21. Epub 2018 Jun 21.

Cardiovascular, Renal, and Metabolism iMED, MedImmune Inc, Gaithersburg, MD, USA.

Aims: MEDI0382 is a balanced glucagon-like peptide-1/glucagon receptor dual agonist under development for the treatment of type 2 diabetes mellitus and non-alcoholic steatohepatitis. The primary objective was to assess the safety of MEDI0382 in healthy subjects.

Methods: In this placebo-controlled, double-blind, phase 1 study, healthy subjects (aged 18-45 years) were randomised (3:1) to receive a single subcutaneous dose of MEDI0382 or placebo after ≥8 hours of fasting. Read More

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June 2018
2 Reads

The challenges of 'medical cannabis' and mental health: a clinical perspective.

Br J Clin Pharmacol 2018 Jun 20. Epub 2018 Jun 20.

Department of Psychological Medicine, University of Otago, Wellington, New Zealand.

The use of cannabis as a medicine has a long tradition in western medicine. It has been seen as a viable option for the treatment of various neurological and psychiatric conditions, and recently there is again interest in the place of cannabinoids in the pharmacopoeia. What has become increasingly clear, however, is these benefits need to be weighed carefully against the potential difficulty associated with herbal cannabis and cannabinoid compounds for an individual's mental health. Read More

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Medicinal Cannabinoids in Palliative Care.

Authors:
M Agar

Br J Clin Pharmacol 2018 Jun 20. Epub 2018 Jun 20.

IMPACCT centre (Improving Palliative, Chronic and Aged Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, NSW, Australia.

The treatment of symptoms in people with palliative diagnoses begins with meticulous clinical assessment with treatment choice (s) selected based on an understanding of the symptom aetiology and the evidence which underpins its treatment. Increasingly the merits of palliative care have been established earlier in the disease trajectory where treatment outcomes may include increased survival and maintenance of function. There is strong public support for the availability of medicinal cannabis, particularly for people with palliative diagnoses. Read More

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The UK's Life Sciences Strategy: opportunities for clinical pharmacology.

Br J Clin Pharmacol 2018 Jun 19. Epub 2018 Jun 19.

Medicines and Healthcare Products Regulatory Agency, London, UK.

The UK's Life Sciences Strategy provides UK clinical pharmacologists with a unique opportunity to enhance the impact of their discipline on patients and the NHS as well as the pharmaceutical industry. The full benefits of electronic prescribing systems, supported by artificial intelligence, will require clinical pharmacological expertise. Similarly, the Strategy's support for 'healthy ageing' will only be realized if clinical pharmacologists are able to use their expertise in promoting the safe and effective use of medicines in older people. Read More

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Coadministration of Probenecid and Cimetidine with Mirogabalin in Healthy Subjects: A Phase 1, Randomized, Open-Label, Drug-Drug Interaction Study.

Br J Clin Pharmacol 2018 Jun 19. Epub 2018 Jun 19.

Daiichi Sankyo Inc.,, Basking Ridge, NJ, USA.

Aims: The primary aim of this study was to assess the individual effects of probenecid and cimetidine on mirogabalin exposure.

Methods: This phase 1, open-label, crossover study randomized healthy adults to receive three treatment regimens, each separated by ≥5-day washout: a single oral dose of mirogabalin 15 mg on day 2, mirogabalin 15 mg on day 2 plus probenecid 500 mg every 6 hours from days 1-4, and mirogabalin 15 mg on day 2 plus cimetidine 400 mg every 6 hours from days 1-4.

Results: Coadministration of mirogabalin with probenecid or cimetidine increased the maximum and total mirogabalin exposure. Read More

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New drug controls and reduced hospital presentations due to novel psychoactive substances in Edinburgh.

Br J Clin Pharmacol 2018 Jun 17. Epub 2018 Jun 17.

Edinburgh Clinical Toxicology, Royal Infirmary of Edinburgh, Edinburgh, UK.

Aims: Recreational use of novel psychoactive substance (NPS) has become increasingly common. We aimed to assess the association of national legislation and local trading standards activity with hospital presentations.

Methods: We established observational cohorts of patients with recreational drug toxicity presenting to Edinburgh Royal Infirmary and dying with detectable recreational drugs in Edinburgh. Read More

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Total flucloxacillin plasma concentrations poorly reflect unbound concentrations in hospitalised patients with Staphylococcus aureus bacteraemia.

Br J Clin Pharmacol 2018 Jun 16. Epub 2018 Jun 16.

Emeritus Professor of Medicine, Department of Medicine, University of Otago, Christchurch, New Zealand.

Background: Flucloxacillin dosing may be guided by measurement of its total plasma concentrations. Flucloxacillin is highly protein bound with fraction unbound in plasma (f ) of around 0.04 in healthy individuals. Read More

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In vivo affinity and target engagement in skin and blood in a first-time-in-human study of an anti-oncostatin M monoclonal antibody.

Br J Clin Pharmacol 2018 Jun 13. Epub 2018 Jun 13.

ImmunoInflammation, GlaxoSmithKline, Stevenage, UK.

Background: The oncostatin M (OSM) pathway drives fibrosis, inflammation and vasculopathy and is a potential therapeutic target for inflammatory and fibrotic diseases.

Methods: This was a Phase I, randomised, double-blind, placebo-controlled, single-dose escalation, first-time-in-human study of subcutaneously administered GSK2330811, an anti-OSM monoclonal antibody, in healthy adults (NCT02386436). Safety and tolerability, GSK2330811 pharmacokinetic profile, OSM levels in blood and skin and potential for anti-drug antibody formation were assessed. Read More

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A first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition.

Br J Clin Pharmacol 2018 Jun 8. Epub 2018 Jun 8.

Inotrem, Paris, France.

Background: The peptide nangibotide is the first clinical-stage agent targeting the immunoreceptor TREM-1 (Triggering Receptor Expressed on Myeloid cells-1) and is being investigated as a novel therapy for acute inflammatory disorders such as septic shock.

Aims: This first-in-man, randomised, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability, and pharmacokinetics of nangibotide.

Methods: 27 healthy subjects (aged 18-45 years) were randomised into eight groups. Read More

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A systematic literature review of the human skin microbiome as biomarker for dermatological drug development.

Br J Clin Pharmacol 2018 Jun 7. Epub 2018 Jun 7.

Centre for Human Drug Research, Leiden, the Netherlands.

Aims: To explore the potential of the skin microbiome as biomarker in six dermatological conditions i.e. atopic dermatitis (AD), acne vulgaris (AV), psoriasis vulgaris (PV), hidradenitis suppurativa (HS), seborrheic dermatitis/pityriasis capitis (SD/PC) and ulcus cruris (UC). Read More

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Incidence and risk factors of major bleeding following major orthopaedic surgery with fondaparinux thromboprophylaxis. A time-to-event analysis.

Br J Clin Pharmacol 2018 Jun 7. Epub 2018 Jun 7.

University of Otago, School of Pharmacy, PO Box 56, Dunedin, New Zealand.

Aims: Increased exposure to fondaparinux, as observed in patients with renal impairment, may increase bleeding risk. This study aims to determine the time course of major bleeding after major orthopaedic surgery, identify predictors of bleeding and simulate the effect of a reduced dose of fondaparinux on bleeding for patients with moderate renal impairment (creatinine clearance = 20-50 ml. min ). Read More

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Evaluation of a Pharmacokinetic-Pharmacodynamic Model for Hypouricemic Effects of Febuxostat Using Datasets Obtained from Real-world Patients.

Br J Clin Pharmacol 2018 Jun 6. Epub 2018 Jun 6.

Department of Pharmacotherapy, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo, 204-8588, Japan.

Aim: Febuxostat is an active xanthine oxidase (XO) inhibitor that is widely used in the hyperuricemia treatment. We aimed to evaluate the predictive performance of a pharmacokinetic-pharmacodynamic (PK-PD) model for hypouricemic effects of febuxostat.

Methods: Previously, we have formulated a PK--PD model for predicting hypouricemic effects of febuxostat as a function of baseline serum urate levels, body weight, renal function, and drug dose using datasets reported in preapproval studies (Hirai T et al. Read More

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Comment on 'Genotype-guided warfarin dosing versus conventional dosing strategies: a systematic review and meta-analysis of randomized clinical trials' by Tse et al.

Br J Clin Pharmacol 2018 Jun 7. Epub 2018 Jun 7.

Department of Pharmacology and Therapeutics, College of Medicine and Medical Sciences, Arabian Gulf University, Manama, Bahrain.

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Evaluation of accuracy of IHI Trigger Tool in identifying adverse drug events: a prospective observational study.

Br J Clin Pharmacol 2018 Jun 6. Epub 2018 Jun 6.

Hospital das Clínicas, Universidade Federal de Minas Gerais, Av. Prof. Alfredo Balena, 110, Santa Efigênia, Belo Horizonte, Minas Gerais, 30130-100, Brazil.

Aims: Adverse drug events (ADEs) can seriously compromise the safety and quality of care provided to hospitalized patients, requiring the adoption of accurate methods to monitor them. We sought to prospectively evaluate the accuracy of the triggers proposed by the Institute for Healthcare Improvement (IHI) for identifying ADEs.

Methods: A prospective study was conducted in a public university hospital, in 2015, with patients ≥18 years. Read More

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Stakeholders' views and experiences of pharmacist prescribing: a systematic review.

Br J Clin Pharmacol 2018 Jun 5. Epub 2018 Jun 5.

School of Pharmacy and Life Sciences, Robert Gordon University, UK.

Aims: The aims of this systematic review were to: (1) critically appraise, synthesize and present the available evidence on the views and experiences of stakeholders on pharmacist prescribing and; (2) present the perceived facilitators and barriers for its global implementation.

Methods: Medline, CINAHL, International Pharmaceutical Abstracts, PsychArticles and Google Scholar databases were searched. Study selection, quality assessment and data extraction were conducted independently by two reviewers. Read More

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Reply to Iuga and Genaidy 'Comment on Falconer et al. (2018) - the need for specific adverse drug reaction outcomes'.

Br J Clin Pharmacol 2018 Jun 5. Epub 2018 Jun 5.

School of Pharmacy, Pharmacy Australia Centre of Excellence, The University of Queensland, Brisbane, QLD, 4102, Australia.

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Gestational changes in buprenorphine exposure: A physiologically-based pharmacokinetic analysis.

Br J Clin Pharmacol 2018 Jun 5. Epub 2018 Jun 5.

University of Pittsburgh, Department of Pharmaceutical Sciences, School of Pharmacy, Pittsburgh, PA.

Aims: Buprenorphine (BUP) is approved by the US Food and Drug Administration for the treatment of opioid addiction. The current dosing regimen of BUP in pregnant women is based on recommendations designed for nonpregnant adults. However, physiological changes during pregnancy may alter BUP exposure and efficacy. Read More

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June 2018
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Gastrointestinal bleeding risk of selective serotonin reuptake inhibitors by level of kidney function: a population-based cohort study.

Br J Clin Pharmacol 2018 Jun 4. Epub 2018 Jun 4.

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

Aim: To estimate the risk of gastrointestinal (GI) bleeding associated with serotonin reuptake inhibitors (SSRIs) by level of kidney function.

Methods: We conducted a cohort study using the Clinical Practice Research Datalink linked to Hospital Episode Statistics. We identified patients with chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] <60 mL/min/1. Read More

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June 2018
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Long-term Adverse Effects of Paracetamol - a Review.

Br J Clin Pharmacol 2018 Jun 4. Epub 2018 Jun 4.

Pharmacology, Toxicology & Therapeutics, BHF Centre of Research Excellence (CoRE), Queen's Medical Research Institute, Scotland, Edinburgh, UK.

Paracetamol (Acetaminophen) is the most commonly used drug in the world, with a long record of use in acute and chronic pain. In recent years the benefits of paracetamol use in chronic conditions has been questioned, notably in the areas of osteoarthritis and lower back pain. Over the same period, concerns over the long-term adverse effects of paracetamol use have increased, initially in the field of hypertension, but more recently in other areas also. Read More

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Identifying signals of interest when screening for drug-outcome associations in health care data.

Br J Clin Pharmacol 2018 Jun 3. Epub 2018 Jun 3.

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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Evolving treatment strategies in CML - moving from early and deep molecular responses to TKI discontinuation and treatment-free remission: is there a need for longer-term trial outcomes?

Br J Clin Pharmacol 2018 Jun 3. Epub 2018 Jun 3.

Division of Hematology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine, Istanbul University, Istanbul, Turkey.

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Medical cannabis: aligning use to evidence-based medicine approach.

Br J Clin Pharmacol 2018 Jun 2. Epub 2018 Jun 2.

Cannabis Clinical Research Institute, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev.

During the last decade we are witnessing a rise in medical cannabis use, yet the evidence for the safety and effectiveness of the different cannabinoid compounds is scarce. We believe that the role of the clinical research community is to identify the potential benefit of the new compounds under the Evidence Based Medicine paradigm. In this editorial review we shall present a summary of selected evidence of safety and efficacy of cannabis derived products with an emphasis on prospective studies in Israel. Read More

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Use of antipsychotics and risk of breast cancer: A Danish nationwide case-control study.

Br J Clin Pharmacol 2018 Jun 1. Epub 2018 Jun 1.

Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.

Aims: Some antipsychotics increases prolactin levels, which might increase the risk of breast cancer. Existing evidence is conflicting and based on sparse data, especially for the increasingly used second-generation antipsychotics. We conducted a nationwide case-control study of the association between antipsychotic use and incident breast cancer. Read More

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Safety, tolerability and pharmacokinetics/-dynamics of the adrenomedullin antibody Adrecizumab in a first-in-human study and during experimental human endotoxemia in healthy subjects.

Br J Clin Pharmacol 2018 Jun 1. Epub 2018 Jun 1.

Department of Intensive Care Medicine, Radboud Center for Infectious Diseases (RCI), Radboud university medical center, HP: 710, PO Box 9101, 6500, HB, Nijmegen, The Netherlands.

Background And Purpose: Adrenomedullin (ADM) is an important regulator of endothelial barrier function and vascular tone, and may represent a novel treatment target in sepsis. The non-neutralizing ADM antibody Adrecizumab showed promising results in preclinical sepsis models. We investigated the safety, tolerability and pharmacokinetics/-dynamics of Adrecizumab in a first-in-man study and in a second study during experimental human endotoxemia. Read More

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New-onset epilepsy in the elderly.

Br J Clin Pharmacol 2018 Jun 1. Epub 2018 Jun 1.

Melbourne Brain Centre at the Royal Melbourne Hospital; Departments of Medicine and Neurology, Royal Melbourne Hospital, The University of Melbourne, Victoria, 3050, Australia.

People who are 60 years old and older have the highest incidence of developing new-onset epilepsy. The increase of the ageing population has resulted in a greater number of patients with new-onset epilepsy or at risk of developing the condition. Previously published review articles regarding epilepsy in older patients have had a broad focus, including people who were diagnosed with epilepsy in childhood or in middle age. Read More

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Vitamin D Assays and the Definition of Hypovitaminosis D: Results from the 1 International Conference on Controversies in Vitamin D.

Br J Clin Pharmacol 2018 May 31. Epub 2018 May 31.

Osteoporosis Clinical Research Program and Institute on Aging, University of Wisconsin-Madison, Madison, WI, USA.

The 1st International Conference on Controversies in Vitamin D was held in Pisa, Italy June 14-16, 2017. The meeting's purpose was to address controversies in vitamin D research, review data available to help resolve them and suggest a research agenda to clarify areas of uncertainty. Serum 25-hydroxyvitamin D (25 (OH)D) concentration, i. Read More

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Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP.

Br J Clin Pharmacol 2018 Jul 30;84(7):1399-1400. Epub 2018 May 30.

Institute of Translational Pharmacology, Italian National Research Council, Rome, Italy.

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A multiple treatment comparison meta-analysis of monoamine oxidase type-B inhibitors for Parkinson's disease.

Br J Clin Pharmacol 2018 May 30. Epub 2018 May 30.

Department of Pharmacology, University of Oslo, Oslo, Norway.

Aims: We could not find any systematic reviews or meta-analyses that compared rasagiline, selegiline and safinamide. Therefore, we aimed to perform a drug class review comparing all available MAO-B inhibitors in a multiple treatment comparison.

Methods: We performed a systematic literature search to identify randomized controlled trials assessing the efficacy of MAO-B inhibitors in patients with Parkinson's disease. Read More

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Biopharmaceutical Optimization in neglected diseases for paediatric patients by applying the provisional paediatric Biopharmaceutical Classification System.

Br J Clin Pharmacol 2018 May 30. Epub 2018 May 30.

Department of Pharmacokinetics and Pharmaceutical Technology, Miguel Hernandez University, San Juan de Alicante, 03550, Alicante, Spain.

Aims: Unavailability and lack of appropriate, effective and safe formulations are common problems in paediatric therapeutics. Key factors such as swallowing abilities, organoleptic preferences and dosage requirements determine the need of for optimization of formulations. The provisional Biopharmaceutics Classification System can be used in paediatric formulation design as a risk analysis and optimization tool. Read More

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Desogestrel and panic attacks - a new suspected adverse drug reaction reported by patients and health care professionals on spontaneous reports.

Br J Clin Pharmacol 2018 May 24. Epub 2018 May 24.

The Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.

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Comparison of the Cockcroft-Gault, MDRD and CKD-EPI equations for estimating ganciclovir clearance.

Br J Clin Pharmacol 2018 May 23. Epub 2018 May 23.

Department of Pharmacy, Vall d'Hebron University Hospital, Barcelona, Spain.

Background: Accurately estimating kidney function is essential for the safe administration of renally cleared drugs like ganciclovir. Current practice recommends adjusting renally eliminated drugs according to the Cockcroft-Gault equation. There is no data on the utility of the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations in ganciclovir dosing. Read More

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The pharmacokinetics, pharmacodynamics and tolerability of PUR0200, a novel tiotropium formulation, in chronic obstructive pulmonary disease.

Br J Clin Pharmacol 2018 May 23. Epub 2018 May 23.

Pulmatrix Inc, 99 Hayden Ave, Suite 390, Lexington, MA, 02421.

Aims: PUR0200 is a tiotropium bromide formulation engineered with the iSPERSE dry powder delivery technology. PUR0200 is being developed as a bioequivalent alternative to tiotropium bromide delivered using Spiriva® HandiHaler® (HH). We investigated the bronchodilator effects, pharmacokinetics and safety of PUR0200 in COPD patients. Read More

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Incidence and cost of medication harm in older adults following hospital discharge: a multicentre prospective study in the UK.

Br J Clin Pharmacol 2018 May 22. Epub 2018 May 22.

Academic Department of Geriatric Medicine, Brighton and Sussex Medical School, Brighton, Sussex, UK.

Aims: Polypharmacy is increasingly common in older adults, placing them at risk of medication-related harm (MRH). Patients are particularly vulnerable to problems with their medications in the period following hospital discharge due to medication changes and poor information transfer between hospital and primary care. The aim of the present study was to investigate the incidence, severity, preventability and cost of MRH in older adults in England postdischarge. Read More

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The analgesic efficacy and pharmacokinetics of epidural oxycodone after gynaecological laparotomy: a randomized, double-blind, double-dummy comparison with intravenous administration.

Br J Clin Pharmacol 2018 May 21. Epub 2018 May 21.

Kuopio University Hospital, Department of Anaesthesia and Operative Services, Kuopio, Finland.

Aim: The aim of the present study was to compare the analgesic efficacy of epidural and intravenous (i.v.) oxycodone at the same dose. Read More

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Pharmacokinetics and C-Reactive Protein Modelling of Anti-IL-6 Antibody (PF-04236921) in Healthy Volunteers and Patients with Autoimmune Disease.

Br J Clin Pharmacol 2018 May 18. Epub 2018 May 18.

Clinical Research, Pfizer Inc., 610 Main Street, Cambridge, MA, USA, 02140.

Aims: The purpose of this study was to characterize pharmacokinetics (PK) of PF-04236921, a novel anti-IL-6 monoclonal antibody, and its pharmacokinetics/pharmacodynamics (PK/PD) relationship on serum C-Reactive Protein (CRP) in healthy volunteers and patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Crohn's disease (CD) METHODS: Population modelling analyses were conducted using nonlinear mixed effects modelling. Data from 2 phase 1 healthy volunteer studies, a phase 1 RA study, a Phase 2 CD study, and a Phase 2 SLE study were included.

Results: A 2-compartment model with first order absorption and linear elimination and a mechanism-based indirect response model adequately described the PK and PK/PD relationships, respectively. Read More

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May 2018
2 Reads

Patient involvement is essential in identifying drug-related problems.

Br J Clin Pharmacol 2018 May 18. Epub 2018 May 18.

Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.

Aims: The aim of this study is to evaluate how critical patient involvement is in pharmacist-led clinical medication reviews and in identifying the most significant clinical drug-related problems (DRPs).

Methods: Pharmacist-led clinical medication reviews were conducted with 161 consenting patients aged ≥75 years with at least seven prescribed medicines, living independently at home in Finland. A pharmacist, a nurse and a physician evaluated the clinical significance of the DRPs identified during the patient interview at an interprofessional case conference. Read More

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The use of complementary and alternative medicines during breastfeeding: results from the Herbal supplements in Breastfeeding InvesTigation (HaBIT).

Br J Clin Pharmacol 2018 May 16. Epub 2018 May 16.

Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence; Tuscan Regional Centre of Pharmacovigilance and Phytovigilance, Florence, Italy.

Aims: Use of complementary and alternative medicines (CAMs) during breastfeeding is commonly increasing, mainly due to their presumed higher safety compared to conventional medications. Indeed, CAMs can cause serious adverse effects, and high-quality evidence supporting their use during lactation is limited. In Italy, specific investigations on the attitude of lactating women towards CAMs are lacking. Read More

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May 2018
1 Read

Dipeptidyl Peptidase-4 Inhibitor Use is Associated with Decreased Risk of Fracture in Patients with Type 2 Diabetes: A Population-Based Cohort Study.

Br J Clin Pharmacol 2018 May 16. Epub 2018 May 16.

Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan City, Taiwan.

Aims: To investigate the putative link between dipeptidyl peptidase-4 inhibitor (DPP-4i) use and the risk of fracture in patients with type 2 diabetes.

Methods: This propensity-score-matched population-based cohort study was performed between 2009 and 2013 on patients with type 2 diabetes who were stable metformin users. A total of 3,996 patients with type 2 diabetes used DPP-4i as a second-line antidiabetic drug. Read More

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Gaps in predicting clinical doses for cannabinoids therapy: Overview of issues for pharmacokinetics and pharmacodynamics modelling.

Br J Clin Pharmacol 2018 May 16. Epub 2018 May 16.

School of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Kookaburra Circuit, NSW, 2305, Australia.

Model-based prediction on clinical doses for cannabinoids therapy is beneficial in the clinical setting, especially for seriously ill patients with both altered pharmacokinetics and pharmacodynamic responses. The objective of this article is to review the currently available PK and/or PD models of Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to highlight the major issues for modelling this complex therapeutic area. A systematic search was conducted in the electronic databases PubMed and EMBASE using the key words 'cannabis', 'cannabinoid', 'tetrahydrocannabinol', 'THC', 'cannabidiol', 'CBD', 'pharmacokinetic model', 'pharmacodynamics model' and their combinations. Read More

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May 2018
4 Reads

Pharmacokinetics of cefuroxime in infants and neonates undergoing cardiac surgery.

Br J Clin Pharmacol 2018 May 14. Epub 2018 May 14.

Institute of Anaesthesiology, German Heart Centre Munich, Technical University Munich, Germany.

Aims: Very little data exist regarding the effect of cardiopulmonary bypass (CPB) on cefuroxime (CXM) pharmacokinetics in children less than one year of age.

Methods: 50 mg kg CXM i.v. Read More

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Gjestad et al. reply to 'Was 4β-hydroxycholesterol ever going to be a useful marker of CYP3A4 activity?' by Neuhoff and Tucker.

Br J Clin Pharmacol 2018 Jul 10;84(7):1624-1625. Epub 2018 May 10.

Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway.

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July 2018
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Appropriateness of oral anticoagulant therapy prescription and its associated factors in hospitalized older people with atrial fibrillation.

Br J Clin Pharmacol 2018 May 10. Epub 2018 May 10.

Scientific Direction, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Aims: Although oral anticoagulants (OACs) are effective in preventing stroke in older people with atrial fibrillation (AF), they are often underused in this particularly high-risk population. The aim of the present study was to assess the appropriateness of OAC prescription and its associated factors in hospitalized patients aged 65 years or older.

Methods: Data were obtained from the retrospective phase of Simulation-based Technologies to Improve the Appropriate Use of Oral Anticoagulants in Hospitalized Elderly Patients With Atrial Fibrillation (SIM-AF) study, held in 32 Italian internal medicine and geriatric wards. Read More

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High exposure compared with standard exposure to metoclopramide associated with a higher risk of parkinsonism: a nationwide population-based cohort study.

Br J Clin Pharmacol 2018 May 10. Epub 2018 May 10.

Department of Neurology, Taipei Medical University Hospital, Taipei, Taiwan.

Aims: We conducted a cohort study utilizing a nationwide health insurance database to assess the European Medicines Agency's restrictions on using metoclopramide and its association with the risk of parkinsonism.

Methods: New oral metoclopramide users aged ≥20 years, and age- and gender-matched non-users were recruited between 2001 and 2011. Users were divided into high-exposure (dose >30 mg day and/or duration >5 days) and standard-exposure (dose ≤30 mg day and duration ≤5 days) groups. Read More

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Hospital readmissions, mortality and potentially inappropriate prescribing: a retrospective study of older adults discharged from hospital.

Br J Clin Pharmacol 2018 May 9. Epub 2018 May 9.

The Division of Applied Health Sciences, The University of Aberdeen, Aberdeen, UK.

Aims: Applying version 2 of the STOPP/START criteria to discharge prescriptions of older adults discharged from a general medical unit, the aim of this study is to assess potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) and their association with hospital readmission and mortality.

Methods: Discharge medications, co-morbidities and patient demographics were recorded over an 8-month period for consecutive emergency admissions of patients aged ≥65 years. PIMs and PPOs were identified using version 2 of the STOPP/START criteria. Read More

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Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.

Br J Clin Pharmacol 2018 May 10. Epub 2018 May 10.

Neonatal Intensive Care Unit, S. Anna Hospital, Torino, Italy.

Aims: The pharmacokinetics (PK) of fluconazole and micafungin differ in neonates compared with children and adults. Dosing instructions in product labels appear to be inconsistent with the emerging scientific evidence. Limited information is available on the safety profile of these agents in neonates. Read More

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Moderate correlation between systemic IL-6 responses and CRP with trough concentrations of voriconazole.

Br J Clin Pharmacol 2018 May 9. Epub 2018 May 9.

Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.

Aims: Voriconazole (VCZ) exhibits wide intrapatient pharmacokinetic variability, which is disadvantageous because of its narrow therapeutic range. A considerable part of this variation remains unexplainable, despite extensive knowledge of this drug. It is hypothesized that inflammation has an impact on VCZ pharmacokinetics. Read More

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May 2018
1 Read