11,392 results match your criteria Br J Clin Pharmacol[Journal]


Opportunities for collaboration between pharmacists and clinical pharmacologists to support medicines optimisation in the UK.

Authors:
Nina L Barnett

Br J Clin Pharmacol 2019 Apr 15. Epub 2019 Apr 15.

Consultant Pharmacist, Care of Older People, London Northwest Healthcare NHS trust and NHS Specialist Pharmacy Service, Visiting professor, Kings College London, London, UK.

Medicines optimisation is a clinician-driven, person-centred ongoing process. Pharmacists and clinical pharmacologists have medicines-related expertise to deliver medication review to optimise clinical and cost effective use of medication, aligned with patient preferences, to contribute to improved health outcomes. There is a large pharmacy workforce, directly accessible to patients, who can provide expert medicines-related care on the high street, and increasingly in General Practice and care homes settings. Read More

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http://dx.doi.org/10.1111/bcp.13966DOI Listing

Methadone and buprenorphine pharmacokinetics and pharmacodynamics when coadministered with fostemsavir to opioid-dependent, HIV-seronegative participants.

Br J Clin Pharmacol 2019 Apr 13. Epub 2019 Apr 13.

ViiV Healthcare, Branford, CT, USA.

Aims: Regional HIV prevalence rates are high in people with history of injection drug use, including those managed with maintenance opioids. Fostemsavir (FTR) is an oral prodrug of temsavir, a first-in-class attachment inhibitor that binds HIV-1 gp120 preventing initial HIV attachment and entry into host immune cells. Here we determine the impact of FTR on the pharmacokinetics of opioids methadone (MET) (R-, S- and total) or buprenorphine and norbuprenorphine (BUP and norBUP) when coadministered. Read More

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https://onlinelibrary.wiley.com/doi/abs/10.1111/bcp.13964
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http://dx.doi.org/10.1111/bcp.13964DOI Listing
April 2019
5 Reads

Dynamics of circulating VEGF-A predict benefit from anti-angiogenic cediranib in metastatic or recurrent cervical cancer patients.

Br J Clin Pharmacol 2019 Apr 13. Epub 2019 Apr 13.

Division of Cancer Sciences, University of Manchester, Christie Hospital NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.

Background And Purpose: There is a need for predictive and surrogate response biomarkers to support treatment with anti-angiogenic VEGF inhibitors. We aimed to identify a minimally-invasive biomarker predicting benefit from cediranib pre-treatment or early during treatment in patients with recurrent or metastatic cervical cancer.

Experimental Approach: Blood samples were collected before treatment, during treatment and upon disease progression where appropriate from patients enrolled in CIRCCa, a randomised phase II trial of carboplatin and paclitaxel with or without cediranib. Read More

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http://dx.doi.org/10.1111/bcp.13965DOI Listing

Cannabinoid use in practice in Australasia - better guidance and new drug information systems will be essential for prescribers.

Br J Clin Pharmacol 2019 Apr 13. Epub 2019 Apr 13.

University of Newcastle, New South Wales, Australia.

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http://dx.doi.org/10.1111/bcp.13963DOI Listing

Reply to "Restricting maintenance allopurinol dose according to kidney function in patients with gout is inappropriate!" by Stamp et al.

Br J Clin Pharmacol 2019 Apr 13. Epub 2019 Apr 13.

Pharmacology department, Amiens University Hospital, Amiens, France.

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http://dx.doi.org/10.1111/bcp.13924DOI Listing
April 2019
1 Read

An unwanted complement: Rare case of potential liver injury induced by an interaction between ginseng and atorvastatin.

Authors:
Robyn Laube Ken Liu

Br J Clin Pharmacol 2019 Apr 13. Epub 2019 Apr 13.

AM Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, Australia.

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http://dx.doi.org/10.1111/bcp.13927DOI Listing
April 2019
3 Reads

Population pharmacokinetic model and Bayesian estimator for two tacrolimus formulations in adult liver transplant patients.

Br J Clin Pharmacol 2019 Apr 11. Epub 2019 Apr 11.

CHU Limoges, Department of Pharmacology and Toxicology, Limoges, France.

Aims: Tacrolimus is a narrow therapeutic range drug that requires fine dose adjustment, for which pharmacokinetic models have been amply proposed in renal, but not in liver, transplant recipients. This study aimed to build population pharmacokinetic (POPPK) models and Bayesian estimators (BE) in adult de novo liver transplant patients receiving either the immediate-release (Prograf®, TD) or prolonged-release (Advagraf®, OD) forms to help pharmacokinetics-guided dose individualization.

Methods: One hundred sixty tacrolimus concentration-time profiles (1654 samples) were collected from 80 patients, at day 7 (D7) and week 6 (W6) post-transplant. Read More

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http://dx.doi.org/10.1111/bcp.13960DOI Listing

Investigation of the Absolute Bioavailability and Human Mass Balance of Navoximod, a Novel IDO1 Inhibitor.

Br J Clin Pharmacol 2019 Apr 11. Epub 2019 Apr 11.

Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080.

Aims: Navoximod (GDC-0919, NLG-919) is a small molecule inhibitor of indoleamine-2,3-dioxygenase 1 (IDO1), developed to treat the acquired immune tolerance associated with cancer. The primary objectives of this study were to assess navoximod's absolute bioavailability (aBA), determine the mass balance and routes of elimination of [ C]-navoximod, and characterize navoximod's metabolite profile.

Methods: A phase 1, open-label, 2-part study was conducted in healthy volunteers. Read More

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http://dx.doi.org/10.1111/bcp.13961DOI Listing
April 2019
1 Read

Hepatic exposure of metformin in patients with non-alcoholic fatty liver disease.

Br J Clin Pharmacol 2019 Apr 11. Epub 2019 Apr 11.

Research Laboratory for Biochemical Pathology, Department of Clinical Medicine, Aarhus University Hospital, Denmark.

Aim: Metformin is first line treatment of type 2 diabetes mellitus and reduce cardiovascular events in patients with insulin resistance and type 2 diabetes. Target tissue for metformin action is suggested to be the liver, where metformin distribution depends on facilitated transport by polyspecific transmembrane organic cation transporters (OCTs). Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in the western world with strong associations to insulin resistance and the metabolic syndrome but if NAFLD affects metformin biodistribution to the liver is not known. Read More

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http://dx.doi.org/10.1111/bcp.13962DOI Listing
April 2019
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Regulatory science: Regulation is too important to leave it to the regulators.

Br J Clin Pharmacol 2019 Apr 10. Epub 2019 Apr 10.

Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.

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http://dx.doi.org/10.1111/bcp.13917DOI Listing

Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios of nifedipine and lorazepam.

Br J Clin Pharmacol 2019 Apr 9. Epub 2019 Apr 9.

Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.

Aims: This study explores the impact of paediatric patient related factors and choice of formulation on the dissolution characteristics of nifedipine and lorazepam, two drug substances regularly applied in very young patients and in compounded formulations.

Methods: Dissolution experiments were designed to reflect clinical practice in a paediatric hospital, with respect to dosage forms, feeding regimens, and methods of administration. Solubility studies addressed the influence of age and prandial state. Read More

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http://dx.doi.org/10.1111/bcp.13956DOI Listing

DPP-4 inhibitors lower the risk of autoimmune disease in patients with type 2 diabetes mellitus: A nationwide population-based cohort study.

Br J Clin Pharmacol 2019 Apr 9. Epub 2019 Apr 9.

College of Pharmacy and Division of Life & Pharmaceutical Sciences, Ewha Womans University, Seoul, Korea.

Aims: To evaluate the real-world effect of DPP-4 inhibitor (DPP4i) on the incidence of autoimmune diseases (AD), including rheumatoid arthritis (RA), inflammatory bowel diseases (IBD), multiple sclerosis (MS), and systemic lupus erythematosus (SLE).

Methods: We identified new users of DPP4i (N=497 619) or non-DPP4i (N=643 165) oral combination therapy between 1 January 2011 and 30 June 2015 among patients with type 2 diabetes mellitus in the Korean national health insurance claims database. Patients were followed from the date of initiation of combination therapy until AD outcome, censoring for treatment discontinuation or switching, death or end of study (31 August 2016). Read More

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http://dx.doi.org/10.1111/bcp.13955DOI Listing
April 2019
1 Read

Exposure-response modeling of tocilizumab in rheumatoid arthritis using continuous composite measures and their individual components.

Br J Clin Pharmacol 2019 Apr 8. Epub 2019 Apr 8.

Department of Pharmacy & Pharmacology, Netherlands Cancer Institute, Amsterdam, The Netherlands.

Aims: Tocilizumab has a direct effect on inflammatory markers. Therefore, composite measures for disease activity assessment in rheumatoid arthritis (RA) using these inflammatory markers may not be suitable for tocilizumab treatment. We used a modeling approach to describe tocilizumab exposure-response relationship and to investigate the different dynamics of the individual components of the routinely used continuous composite measures. Read More

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http://dx.doi.org/10.1111/bcp.13954DOI Listing
April 2019
3 Reads

Population pharmacokinetics of immediate- and prolonged-release tacrolimus formulations in liver, kidney and heart transplant recipients.

Br J Clin Pharmacol 2019 Apr 4. Epub 2019 Apr 4.

Formerly Astellas Pharma Global Development, Inc., Northbrook, Illinois, United States.

Aims: Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice-daily, immediate-release (IR-T; Prograf™) and/or once-daily, prolonged-release (PR-T; Advagraf™ or Astagraf XL™) tacrolimus.

Methods: Tacrolimus concentration-time profiles were analyzed from eight Phase II studies in adult and pediatric liver, kidney, and heart transplant patients receiving IR-T and/or PR-T. A tacrolimus population pharmacokinetic model, including identification of significant covariates, was developed using NONMEM. Read More

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https://onlinelibrary.wiley.com/doi/abs/10.1111/bcp.13952
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http://dx.doi.org/10.1111/bcp.13952DOI Listing
April 2019
5 Reads

Drugs for the treatment of metabolic bone diseases.

Br J Clin Pharmacol 2019 Apr 4. Epub 2019 Apr 4.

Division of Endocrinology, Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York City, New York.

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http://dx.doi.org/10.1111/bcp.13857DOI Listing

Translating the Dose Response into Risk and Benefit.

Authors:
John B Warren

Br J Clin Pharmacol 2019 Apr 3. Epub 2019 Apr 3.

MD FRCP, Flat 15, Porters Edge, 29 Surrey Quays Road, London, SE16 7FZ.

When choosing a medicine two aspects determine the balance between benefit and harm (risk-benefit), matching the medicine to the individual and the choice of dose. Knowing the relationship between dose and response allows a calculation of the dose that causes 50% of the maximal effect, the ED . Rational drug dosing depends on defining the ratio of the dose to the ED . Read More

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http://dx.doi.org/10.1111/bcp.13949DOI Listing
April 2019
1 Read

Erlotinib Treatment Induces Cytochrome P450 3A Activity in Non-Small Cell Lung Cancer Patients.

Br J Clin Pharmacol 2019 Apr 3. Epub 2019 Apr 3.

Clinical Pharmacology, Division of Drug Research, Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.

Aim: Erlotinib is a tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer highly metabolized by the cytochrome P450 (CYP) 3A. Hence, the CYP3A4 activity might be a useful predictor for erlotinib pharmacokinetics in personalized medicine. The effect of erlotinib on CYP3A activity was therefore studied in non-small cell lung cancer patients. Read More

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http://dx.doi.org/10.1111/bcp.13953DOI Listing
April 2019
7 Reads

Gender differences in adverse drug reactions reported to the national pharmacovigilance centre in the Netherlands An explorative observational study.

Br J Clin Pharmacol 2019 Apr 2. Epub 2019 Apr 2.

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

Aims: We aimed to assess and characterize gender differences in adverse drug reactions (ADRs) reported to the national pharmacovigilance centre in the Netherlands while taking into account differences in drug use.

Methods: ADRs spontaneously reported by healthcare professionals and patients to the Netherlands pharmacovigilance centre Lareb were used. Drug-ADR combinations reported at least 10 times between 2003-2016 for drugs used by ≥10,000 persons in that period were included. Read More

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http://dx.doi.org/10.1111/bcp.13923DOI Listing
April 2019
5 Reads

Patient behavior in medication management- Findings from a patient usability study that may impact clinical outcomes.

Br J Clin Pharmacol 2019 Apr 1. Epub 2019 Apr 1.

Graz University of Technology, Graz, Austria.

Aims: Adequate medication management is a key condition to ensuring effective pharmacotherapy. However, it is well acknowledged that older people may encounter difficulties self-administering medicines in a correct manner.

Methods: A mixed method pilot study was performed to investigate medication self-management in older and multimorbid patients with polypharmacy. Read More

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http://dx.doi.org/10.1111/bcp.13946DOI Listing
April 2019
1 Read

Warfarin dose requirement in patients having severe thrombosis or thrombophilia.

Br J Clin Pharmacol 2019 Apr 1. Epub 2019 Apr 1.

Coagulation Disorders Unit, Clinical Chemistry, University of Helsinki and HUSLAB, Helsinki University Hospital, POB 720, 00029, Helsinki, Finland.

Aims: Warfarin dose requirement varies significantly. We compared the clinically established international normalized ratio (INR) -based doses among patients with severe thrombosis and/or thrombophilia with estimates from genetic dosing algorithms.

Methods: Fifty patients with severe thrombosis and/or thrombophilia requiring permanent anticoagulation, referred to the Helsinki University Hospital Coagulation Center, were screened for thrombophilias and genotyped for CYP2C9*2 (c. Read More

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http://dx.doi.org/10.1111/bcp.13948DOI Listing
April 2019
5 Reads

Assessing the impact of the addition of dendritic cell vaccination to neoadjuvant chemotherapy in breast cancer patients: A model-based characterization approach.

Br J Clin Pharmacol 2019 Apr 1. Epub 2019 Apr 1.

Navarra Institute for Health Research (IdisNA), University of Navarra, Pamplona, Spain.

Aim: Immunotherapy is a rising alternative to traditional treatment in breast cancer (BC) patients in order to transform cold into hot immune enriched tumours and improve responses and outcome. A computational modelling approach was applied to quantify modulation effects of immunotherapy and chemotherapy response on tumour shrinkage and progression-free survival (PFS) in naïve BC patients.

Methods: Eighty-three Her2-negative BC patients were recruited for neoadjuvant chemotherapy with or without immunotherapy based on dendritic cell vaccination. Read More

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http://dx.doi.org/10.1111/bcp.13947DOI Listing
April 2019
2 Reads

Dried blood samples can support monitoring of infliximab concentrations in patients with inflammatory bowel disease: a clinical validation.

Br J Clin Pharmacol 2019 Mar 30. Epub 2019 Mar 30.

Department Hospital Pharmacy, Amsterdam University Medical Centres, Amsterdam, the Netherlands.

Background And Aims: Therapeutic drug monitoring (TDM) can optimize the efficacy of infliximab (IFX) in patients with inflammatory bowel disease (IBD). Because of the delay between blood samples taken at trough and availability of results, dose adjustments can only be carried out at the next infusion, typically eight weeks later. Dried blood samples (DBS) performed at home to measure IFX concentrations can reduce the time to adapt dose/dosing interval. Read More

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https://onlinelibrary.wiley.com/doi/abs/10.1111/bcp.13939
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http://dx.doi.org/10.1111/bcp.13939DOI Listing
March 2019
4 Reads

Trends in utilization and dosing of antipsychotic drugs in Scandinavia: comparison of 2006 and 2016.

Br J Clin Pharmacol 2019 Mar 29. Epub 2019 Mar 29.

The Zucker Hillside Hospital, Department of Psychiatry, Glen Oaks, New York, USA.

Aims: To investigate time trends in dosing and prevalence of antipsychotic prescriptions in Scandinavia.

Methods: We retrieved data on antipsychotic use between 2006 and 2016 from Danish, Norwegian and Swedish national prescription registers. For each antipsychotic, we calculated prevalence of use and mean doses, overall and for specific age groups (young, adults and elderly). Read More

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http://dx.doi.org/10.1111/bcp.13945DOI Listing

Pathway Genes and Metabolites in Thiopurine Therapy in Korean Children with Acute Lymphoblastic Leukemia.

Br J Clin Pharmacol 2019 Mar 30. Epub 2019 Mar 30.

Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Aims: We aimed to investigate the impact of various genetic polymorphisms affecting thiopurine metabolism pathways and toxicity in pediatric acute lymphoblastic leukemia patients for the first time in Korea.

Methods: From May 2006 to September 2016, 139 pediatric acute lymphoblastic leukemia patients treated with combination chemotherapy including 6-mercaptopurine were included. One hundred and twenty-three variants in 43 genes including TMPT and NUDT15 genes were screened using targeted genotyping, such as a MassARRAY system, direct sequencing, and polymerase chain reaction-restriction fragment length polymorphism methods. Read More

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http://dx.doi.org/10.1111/bcp.13943DOI Listing
March 2019
1 Read

Pharmacokinetics, safety and tolerability of the novel β-hCG derived immunomodulatory compound, EA-230.

Br J Clin Pharmacol 2019 Mar 29. Epub 2019 Mar 29.

Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.

Aims: EA-230 is a newly developed synthetic linear tetrapeptide (AQGV) derived from the chorionic gonadotropin hormone (β-hCG). Herein, we investigated the pharmacokinetics, safety and tolerability of EA-230 in healthy subjects using different administration strategies.

Methods: Double-blind, randomized, placebo-controlled, dose-escalating phase I studies in healthy subjects using intravenous administration were conducted. Read More

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http://dx.doi.org/10.1111/bcp.13942DOI Listing
March 2019
2 Reads

Adverse immunostimulation caused by impurities: the dark side of biopharmaceuticals.

Br J Clin Pharmacol 2019 Mar 28. Epub 2019 Mar 28.

Centre for Human Drug Research, Leiden, The Netherlands.

Drug safety is an important issue, especially in the experimental phases of development. Adverse immunostimulation (AI) is sometimes encountered following treatment with biopharmaceuticals, which can be life-threatening if it results in a severe systemic inflammatory reaction. Biopharmaceuticals that unexpectedly induce an inflammatory response still enter the clinic, even while meeting all regulatory requirements. Read More

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http://dx.doi.org/10.1111/bcp.13938DOI Listing

Intravenous antazoline, a first generation antihistaminic drug with antiarrhythmic properties, is a suitable agent for pharmacological cardioversion of atrial fibrillation induced during pulmonary vein isolation due to the lack of influence on atrio-venous conduction and high clinical effectiveness (AntaEP Study).

Br J Clin Pharmacol 2019 Mar 28. Epub 2019 Mar 28.

II Department of Coronary Artery Disease, Institute of Cardiology, Alpejska 42, 04-628, Warsaw, Poland.

Aims: Antazoline is a first generation antihistaminic drug used primarily in eye drop formulations. When administered intravenously, antazoline displays antiarrhythmic properties resulting in a rapid conversion of recent-onset atrial fibrillation (AF) to sinus rhythm (SR). The aim of the study was to assess the influence of antazoline on atrio-venous conduction and other electrophysiological parameters in patients undergoing AF ablation. Read More

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http://dx.doi.org/10.1111/bcp.13940DOI Listing
March 2019
1 Read

A randomized double-blind, placebo-controlled clinical phase IIa trial on safety, immunomodulatory effects and pharmacokinetics of EA-230 during experimental human endotoxaemia.

Br J Clin Pharmacol 2019 Mar 28. Epub 2019 Mar 28.

Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.

Aims: EA-230 is a human chorionic gonadotropin hormone-derived linear tetrapeptide, developed for the treatment of systemic inflammation-related disorders. EA-230 has shown promising immunomodulatory and tissue-protective effects in animals and an excellent safety profile in human phase I studies that we performed. The present phase IIa study follows-up on these results by investigating the safety, efficacy and pharmacokinetics of EA-230 under systemic inflammatory conditions induced by experimental human endotoxaemia. Read More

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http://dx.doi.org/10.1111/bcp.13941DOI Listing

Perpetrator effects of ciclosporin (P-glycoprotein inhibitor) and its combination with fluconazole (CYP3A inhibitor) on the pharmacokinetics of rivaroxaban in healthy volunteers.

Br J Clin Pharmacol 2019 Mar 25. Epub 2019 Mar 25.

Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.

Aims: Rivaroxaban exposure is considerably increased by drugs that are combined P-glycoprotein (P-gp) and strong cytochrome P450 (CYP) 3A inhibitors (e.g. ketoconazole). Read More

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http://dx.doi.org/10.1111/bcp.13934DOI Listing

Diabetes mellitus comorbidity in patients enrolled in tuberculosis drug efficacy trials around the world: a systematic review.

Br J Clin Pharmacol 2019 Mar 25. Epub 2019 Mar 25.

University Medical Center Groningen, Department of Clinical Pharmacy & Pharmacology, University of Groningen, Groningen, The Netherlands.

Aims: With a prevalence of 16%, diabetes mellitus (DM) is one of the most frequent non-communicable comorbidities of tuberculosis (TB). DM is a major risk factor for adverse TB outcomes and may require personalized TB drug dosing regimens. However, information on the inclusion of DM in TB drug trials is lacking. Read More

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http://dx.doi.org/10.1111/bcp.13935DOI Listing

Haematological adverse events associated with tyrosine kinase inhibitors in chronic myeloid leukemia: a network meta-analysis.

Br J Clin Pharmacol 2019 Mar 25. Epub 2019 Mar 25.

Department of Pharmacy, Universidade Federal do Paraná, Curitiba, Brazil.

Aims: Despite their overall favourable safety profile, tyrosine kinase inhibitors (TKIs) are related to severe adverse events (AEs) including haematological toxicities such as anaemia, leukopenia, neutropenia, and thrombocytopenia. We designed a systematic review and network meta-analysis of randomised controlled trials (RCT) to compare safety among TKIs (bosutinib, dasatinib, imatinib, nilotinib, ponatinib, and radotinib) used by patients diagnosed with chronic myeloid leukemia (CML).

Methods: We obtained data from the PubMed, Scopus, Web of Science, and SciELO databases. Read More

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http://dx.doi.org/10.1111/bcp.13933DOI Listing
March 2019
5 Reads

Relevance of CYP2B6 and CYP2D6 genotypes to methadone pharmacokinetics and response in the OPAL study.

Br J Clin Pharmacol 2019 Mar 25. Epub 2019 Mar 25.

UMR 1246, SPHERE, Methods in Patients-centered outcomes and Health Research, Nantes and Tours University, France.

Our study aimed to evaluate the impacts of the CYP2B6 G516T and CYP2D6 genetic polymorphisms on pharmacokinetic and clinical parameters in patients receiving methadone maintenance treatment. OPAL was a clinical survey of sociodemographic characteristics, history and consequences of pathology, response to treatment, current addictive comorbidities. A subgroup of 72 methadone patients was genotyped. Read More

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http://dx.doi.org/10.1111/bcp.13936DOI Listing
March 2019
1 Read

Consensi: Is it a conscientious combination?

Br J Clin Pharmacol 2019 Mar 21. Epub 2019 Mar 21.

Department of Pharmacology, All India Institute of Medical Sciences, Bhopal, India.

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http://dx.doi.org/10.1111/bcp.13909DOI Listing

Co-administration of the prostaglandin F2α receptor antagonist pre-term labour drug candidate OBE022 with magnesium sulfate, atosiban, nifedipine and betamethasone.

Br J Clin Pharmacol 2019 Mar 19. Epub 2019 Mar 19.

Richmond Pharmacology, St. George's University London, UK.

Aim: To investigate presence or absence of clinically relevant drug interactions (pharmacokinetic and safety/tolerability) of OBE022 with standard-of-care medicines for pre-term labour, enabling co-administration and further clinical development.

Method: Part A: open-label, randomized, three-period crossover assessing co-administration of single doses of OBE022 (1100 mg) and MgSO . Part B: open-label, single-sequence crossover assessing the interactions following administration of OBE022 (1000 mg/day) at steady state co-administered with single doses of atosiban, nifedipine and betamethasone. Read More

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https://onlinelibrary.wiley.com/doi/abs/10.1111/bcp.13925
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http://dx.doi.org/10.1111/bcp.13925DOI Listing
March 2019
3 Reads

Pharmacokinetics and subjective effects of a novel oral LSD formulation in healthy subjects.

Br J Clin Pharmacol 2019 Mar 18. Epub 2019 Mar 18.

Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.

Background And Purpose: The aim of the present study was to characterize the pharmacokinetics and exposure-subjective response relationship of a novel oral solution of lysergic acid diethylamide (LSD) that was developed for clinical use in research and patients.

Experimental Approach: LSD (100 μg) was administered in 27 healthy subjects using a placebo-controlled, double-blind, cross-over design. Plasma levels of LSD, nor-LSD, and 2-oxo-3-hydroxy-LSD (O-H-LSD) and subjective drug effects were assessed up to 11. Read More

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http://dx.doi.org/10.1111/bcp.13918DOI Listing

Effects of cladribine tablets on heart rate, atrio-ventricular conduction and cardiac repolarization in patients with relapsing multiple sclerosis.

Br J Clin Pharmacol 2019 Mar 18. Epub 2019 Mar 18.

Quantitative Pharmacology, Merck Institute for Pharmacometrics, Lausanne, Switzerland.

Aims: Cladribine tablets have shown significant efficacy for the treatment of relapsing multiple sclerosis, a chronic and debilitating immune-mediated disorder. This study was conducted to examine acute and/or cumulative effects of cladribine tablets 10 mg (3.5 or 5. Read More

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http://dx.doi.org/10.1111/bcp.13919DOI Listing
March 2019
1 Read

Effects of Nigella sativa seeds (black cumin) on insulin secretion and lipid profile: a pilot study in healthy volunteers.

Br J Clin Pharmacol 2019 Mar 15. Epub 2019 Mar 15.

CHU de Montpellier, Centre d'Investigation Clinique, Montpellier, France.

Nigella sativa seeds (NSS), also known as black cumin, have been claimed to have antidiabetic and lipid-lowering properties. Our pilot study investigated the effects of powdered NSS on insulin secretion and lipid profile in healthy male volunteers. We conducted a double blind randomized placebo-controlled 4-week trial in 30 subjects, receiving NSS powder (1 g/day) or placebo orally (15 subjects/group). Read More

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http://dx.doi.org/10.1111/bcp.13922DOI Listing

Can Cytidine deaminase be used as predictive biomarker for gemcitabine toxicity and response?

Br J Clin Pharmacol 2019 Mar 13. Epub 2019 Mar 13.

SMARTc Unit, CRCM Inserm U1068 Aix Marseille Université, and La Timone University Hospital of Marseille, Marseille, France.

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http://dx.doi.org/10.1111/bcp.13921DOI Listing
March 2019
3.878 Impact Factor

Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first line immunochemotherapy.

Br J Clin Pharmacol 2019 Mar 13. Epub 2019 Mar 13.

Pharma Development Oncology, F. Hoffmann-La Roche, Basel, Switzerland.

Aims: Obinutuzumab (G) is a humanized type II, Fc-glycoengineered anti-CD20 monoclonal antibody used in various indications, including patients with previously untreated follicular lymphoma (1L FL). We investigated sources of variability in G exposure and association of progression-free survival (PFS) with average concentration over induction (C ) in 1L FL patients treated with G plus chemotherapy (bendamustine, CHOP, or CVP) in the GALLIUM trial.

Methods: Individual exposures (C ) were obtained from a previously established population pharmacokinetic model updated with GALLIUM data. Read More

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http://dx.doi.org/10.1111/bcp.13920DOI Listing
March 2019
1 Read

Key enablers and barriers to implementing adaptive pathways in the European setting.

Br J Clin Pharmacol 2019 Mar 8. Epub 2019 Mar 8.

National Institute for Health and Care Excellence, Manchester, M1 4BT, UK.

In 2016, the European Medicines Agency (EMA) published the conclusions of its pilot on adaptive pathways, with products in early stages of development still building up to their marketing authorisation. Adaptive pathways rests on three principles: iterative development; gathering evidence through real-life use to supplement clinical trial data; and early engagement of patients, payers and health technology assessment bodies in discussions on a medicine's development. While the pilot has now finished, the practical system-wide implications of employing the adaptive pathways approach are not known and further consideration of these three principles is required. Read More

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http://dx.doi.org/10.1111/bcp.13916DOI Listing

Availability and readability of patient education materials for deprescribing: An environmental scan.

Br J Clin Pharmacol 2019 Mar 8. Epub 2019 Mar 8.

The University of Sydney, Sydney School of Public Health, ASK-GP Centre of Research Excellence, NSW, Australia.

Aims: To identify and evaluate content and readability of freely available online deprescribing patient education materials (PEMs).

Methods: Systematic review of PEMs using MEDLINE, Embase, CINAHL, PsycINFO and The Cochrane Library of Systematic Reviews from inception to September 25, 2017 to identify PEMs. Additionally, deprescribing researchers and health professionals were surveyed to identify additional materials. Read More

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http://dx.doi.org/10.1111/bcp.13912DOI Listing

Effects of proton pump inhibitors, esomeprazole and vonoprazan, on the disposition of proguanil, a CYP2C19 substrate, in healthy volunteers.

Br J Clin Pharmacol 2019 Mar 7. Epub 2019 Mar 7.

Research Institute of Pharmaceutical Sciences, Musashino University, Nishitokyo-shi, Tokyo, Japan.

Aims: Vonoprazan, a new class of potassium-competitive proton pump inhibitors has been found to attenuate the antiplatelet function of clopidogrel in a recent clinical study, despite weak in vitro activity against CYP2C19. To elucidate the mechanism of this interaction, the present study investigated the effects of esomeprazole and vonoprazan on the pharmacokinetics of proguanil, a CYP2C19 substrate.

Methods: Seven healthy male volunteers (CYP2C19 extensive metabolizers) received a single oral administration of 100 mg proguanil/250 mg atovaquone (control phase), oral esomeprazole (20 mg) for 5 days followed by proguanil/atovaquone (esomeprazole phase) and oral vonoprazan (20 mg) for 5 days followed by proguanil/atovaquone (vonoprazan phase). Read More

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http://dx.doi.org/10.1111/bcp.13914DOI Listing
March 2019
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A multiple methods approach to determine adherence with prescribed mycophenolate in children with kidney transplant.

Br J Clin Pharmacol 2019 Mar 7. Epub 2019 Mar 7.

Clinical and Practice Research Group, School of Pharmacy, Queen's University Belfast, Belfast, UK.

Aims: The aim of the present study was, to use a multiple methods approach, including, for the first time, dried blood spot (DBS) sampling with PopPK interpretation, to assess adherence to mycophenolate in children with kidney transplant. A second aim was to identify patient/parental factors that influenced adherence and to link adherence behaviour to clinical outcomes.

Methods: A convenience sample of 33 children with kidney transplant (≤18 years old) who had been prescribed mycophenolate for at least 3 months were recruited from participating outpatient clinics in the UK and Jordan. Read More

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http://dx.doi.org/10.1111/bcp.13911DOI Listing
March 2019
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Effect of CYP3A inhibitors on the pharmacokinetics of pevonedistat in patients with advanced solid tumours.

Br J Clin Pharmacol 2019 Mar 7. Epub 2019 Mar 7.

Winship Cancer Institute, Emory University, Atlanta, GA, USA.

Aims: This phase I study evaluated the effects of the moderate cytochrome P450 (CYP) 3A inhibitor fluconazole and the strong CYP3A/P-glycoprotein (P-gp) inhibitor itraconazole on the pharmacokinetics of the investigational neural precursor cell expressed, developmentally downregulated 8 (NEDD8)-activating enzyme inhibitor pevonedistat in patients with advanced solid tumours.

Methods: Patients received single doses of intravenous pevonedistat 8 mg m , alone and with fluconazole (loading: 400 mg; maintenance: 200 mg once daily), or pevonedistat 8, 15, or 20 mg m , alone and with itraconazole 200 mg once daily. Serial blood samples for pevonedistat pharmacokinetics were obtained pre- and post-infusion on days 1 (alone) and 8 (with fluconazole/itraconazole). Read More

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http://doi.wiley.com/10.1111/bcp.13915
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http://dx.doi.org/10.1111/bcp.13915DOI Listing
March 2019
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Acute interaction between oral glucose (75 g as Lucozade) and inorganic nitrate: decreased insulin clearance, but lack of blood pressure-lowering.

Br J Clin Pharmacol 2019 Mar 7. Epub 2019 Mar 7.

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

Introduction: Dietary inorganic nitrate (NO ) lowers peripheral blood pressure (BP) in healthy volunteers, but lacks such effect in individuals with, or at risk of, type two diabetes mellitus. Whilst this is commonly assumed to be a consequence of chronic hyperglycaemia/hyperinsulinaemia, we hypothesised that acute physiological elevations in plasma [glucose]/[insulin] blunt the haemodynamic responses to NO ; a pertinent question for carbohydrate-rich Western diets.

Methods: We conducted an acute, randomised, placebo-controlled, double-blind, crossover study on the haemodynamic and metabolic effects of potassium nitrate (8 or 24 mmol KNO ) versus potassium chloride (KCl; placebo) administered 1 h prior to an oral glucose tolerance test in 33 healthy volunteers. Read More

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http://dx.doi.org/10.1111/bcp.13913DOI Listing
March 2019
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Associations of statin use with glycaemic traits and incident type 2 diabetes.

Br J Clin Pharmacol 2019 Mar 5. Epub 2019 Mar 5.

Department of Epidemiology, Erasmus University Medical Centre, Rotterdam, The Netherlands.

Aims: There are several epidemiological studies on the association between statins and incident diabetes, but most of them lack details. In this study, we aimed to investigate the association of statin use with glycaemic traits and incident type 2 diabetes.

Methods: Using the prospective population-based Rotterdam Study, we included 9535 individuals free from diabetes at baseline (>45 years) during the study period between 1997 and 2012. Read More

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http://dx.doi.org/10.1111/bcp.13898DOI Listing
March 2019
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A Six Sigma framework to successfully manage medication adherence.

Authors:
Bernard Vrijens

Br J Clin Pharmacol 2019 Mar 4. Epub 2019 Mar 4.

Research and Development, AARDEX Group, Liège, Belgium.

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http://dx.doi.org/10.1111/bcp.13905DOI Listing

Maturational changes in vancomycin protein binding affect vancomycin dosing in neonates.

Br J Clin Pharmacol 2019 Mar 4. Epub 2019 Mar 4.

Department of Development and Regeneration, KU Leuven, Leuven, Belgium.

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http://dx.doi.org/10.1111/bcp.13899DOI Listing
March 2019
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3.878 Impact Factor

Reply to 'Comment on 'Cardiac effects of 6 months' dietary nitrate and spironolactone in patients with hypertension and with/at risk of type 2 diabetes, in the factorial design, double-blind, randomised controlled VaSera trial' by Faconti et al.'

Br J Clin Pharmacol 2019 Mar 4. Epub 2019 Mar 4.

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

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http://dx.doi.org/10.1111/bcp.13890DOI Listing
March 2019
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