British journal of clinical pharmacology最新文献

{"title":"Letter to the editor of the Brit J Clin Pharmacol on Hartjes et al. 2025 https://doi.org/10.1002/bcp.70176.","authors":"Rafael Henry-Venson","doi":"10.1002/bcp.70297","DOIUrl":"https://doi.org/10.1002/bcp.70297","url":null,"abstract":"","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145147742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of clinical pharmacology and competence during medicine clerkships.","authors":"Nicole C Cheung, Kelly M Quesnelle, Hsinling Sonya Hung, Uzoma Ikonne, Yeshwanth R Karkal, Deborah D Divis, Pius S Fasinu, Munder Zagaar, Mostafa Hosseinzadeh, Toby Tally, Khalil Eldeeb","doi":"10.1002/bcp.70290","DOIUrl":"https://doi.org/10.1002/bcp.70290","url":null,"abstract":"<p><p>Safe and effective prescribing is a competency recognized in frameworks created by various countries for medical students entering clinical practice. Clinical pharmacology education, when aligned with competency-based medical education (CBME), offers an opportunity to improve pharmacotherapeutic decision-making and medication safety. This narrative review summarizes the current assessment methods used to evaluate clinical pharmacology competencies of undergraduate medical students during clerkships, including objective structured clinical exams (OSCEs), mini-clinical evaluation exercises (mini-CEX), case-based discussions, and written and oral exams. While these assessments are commonly used, their application to evaluate competencies related to clinical pharmacology is limited. The review illustrates the need for a structured, multimodal approach to assessment that emphasizes frequent formative feedback in a longitudinal manner, observable behaviours or tasks, and the implementation of online educational resources developed to target these competencies. Developing and aligning clinical pharmacology assessments with clear, specified competencies during clinical clerkships can potentially promote learner confidence, knowledge and skills necessary to optimize patient-centred care.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Availability, use, efficacy and safety of bevacizumab in European hereditary haemorrhagic telangiectasia centres.","authors":"Pernille D Haahr, Anette D Kjeldsen, Annette D Fialla, Anne-Emmanuelle Fargeton, Alexandre Guilhem, Elisabetta Buscarini, Freya Droege, Guido Manfredi, Hans-Jurgen Mager, Jean-Christophe Saurin, Jens Kjeldsen, Josefien Hessels, Marco C Post, Robert Mandic, Sanne Boerman, Stefan Kasper-Virchow, Sören Möller, Urban Geisthoff, Sophie Dupuis-Girod","doi":"10.1002/bcp.70273","DOIUrl":"https://doi.org/10.1002/bcp.70273","url":null,"abstract":"<p><strong>Introduction: </strong>Bevacizumab, a vascular endothelial growth factor inhibitor, is used off-label for treatment of severe anaemia related to epistaxis, gastrointestinal bleeding and/or severe hepatic arteriovenous malformations (HAVM) and right-sided cardiac failure in patients with hereditary haemorrhagic telangiectasia (HHT).</p><p><strong>Aim: </strong>To report the experience of treatment with bevacizumab within European Reference Network for Rare Multisystemic Vascular Diseases (VASCERN) centres.</p><p><strong>Method: </strong>A retrospective analysis of the usage, availability, efficacy and safety in HHT patients treated with bevacizumab in European VASCERN centres.</p><p><strong>Results: </strong>A total of 151 patients received treatment with bevacizumab in European VASCERN centres. Most patients were treated in Denmark, France and the Netherlands. There was an improvement in haemoglobin with a mean increase of 2.9 g/dL (95% confidence interval 2.4, 3.6) and significant reduction in the number of red blood cell transfusions. Cardiac output was measured and improved in 85% of patients treated for high output cardiac failure in relation to severe HAVM. No severe adverse events were recorded, but 70 patients experienced at least one adverse event.</p><p><strong>Conclusion: </strong>Although this is a retrospective study, we demonstrated convincing efficacy of bevacizumab in the treatment of patients with HHT, with a good risk-benefit balance.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodological considerations on paracetamol pharmacokinetics in spinal muscular atrophy: A response to Zhao et al.","authors":"Elvira Meni Maria Gkrinia, Iva Kristić, Andrej Belančić, Dinko Vitezić, Hesham S Al-Sallami","doi":"10.1002/bcp.70304","DOIUrl":"https://doi.org/10.1002/bcp.70304","url":null,"abstract":"","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A scoping review of disease-modifying antirheumatic drug nonadherence in rheumatoid arthritis: Measurement, prevalence and implications for clinical practice.","authors":"Lauren Fraser, Nagham Ailabouni, Lisa Kalisch Ellett, Jiun Ming Tan, Anthea Freeman, Susanna M Proudman, Emily Reeve, Michael D Wiese","doi":"10.1002/bcp.70280","DOIUrl":"https://doi.org/10.1002/bcp.70280","url":null,"abstract":"<p><strong>Aims: </strong>Adherence to disease-modifying antirheumatic drugs (DMARDs) has been associated with improved treatment outcomes, but how adherence is reported ranges between studies. We therefore aimed to determine how nonadherence to DMARDs used to treat rheumatoid arthritis (RA) has been measured and to report the nonadherence rate with each measure identified. Additionally, we aimed to explore what factors are associated with nonadherence.</p><p><strong>Methods: </strong>A scoping review was conducted in the following databases: Embase, Medline, Scopus and Cochrane, searching from 2000 up to 31 August 2022 using search terms related to 'adherence'; 'measures'; rheumatoid arthritis'; and 'medication'. Descriptive analyses were used to analyse and interpret the data according to the stated aims. We included 172 manuscripts that met the inclusion criteria and the median number of participants for each study was 249 (interquartile range 120-767). Measures of adherence included dispensing data, tablet counts, self-report and physician estimates, electronic monitors, questionnaires and blood assays.</p><p><strong>Results: </strong>Nonadherence was most commonly reported as a proportion and ranged from 1.5 to 100% for any DMARDs as a class, 0 to 95% for conventional synthetic DMARDs and 3 to 95% for biologic DMARDs. Increased disease activity, younger age and comorbidities were found in several studies to be associated with nonadherence, while there were inconsistent findings for sex, education, disease duration and other patient characteristics.</p><p><strong>Conclusion: </strong>Much variability exists in the reported prevalence of nonadherence in RA, in what measures are used to assess nonadherence, how nonadherence is reported and which patient characteristics are associated with nonadherence.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative analysis of the characteristics and trends of adverse drug reaction reports from patients in Japan and the Japanese Adverse Drug Event Report database.","authors":"Masami Tsuchiya, Ryohkan Funakoshi, Koichi Masuyama, Nariyasu Mano, Satoko Hori, Taku Obara","doi":"10.1002/bcp.70291","DOIUrl":"https://doi.org/10.1002/bcp.70291","url":null,"abstract":"<p><strong>Aims: </strong>Spontaneous reporting of adverse drug reactions (ADR) after a product has reached the market is essential for drug safety. This study analysed patient ADR reports and compared them with reports from the Japanese Adverse Drug Event Report (JADER) database to identify differences and trends.</p><p><strong>Methods: </strong>ADR reports from the Pharmaceuticals and Medical Devices Agency website, including patient reports from March 2019 to March 2024, and JADER reports from January 2019 to March 2024, were utilized. Information on demographics, drugs, ADR types and outcomes was analysed. Frequencies and comparisons between the two reporting groups were performed.</p><p><strong>Results: </strong>A total of 2913 patient reports and 343 894 JADER reports were analysed. Patients were often younger (30-50 years) and mostly female, whereas JADER reports included older patients (60-80 years) and mostly male. Patients reported subjective symptoms, such as fatigue and headache, often associated with drugs targeting the central nervous system. In contrast, JADER reports focused on serious conditions, such as interstitial lung disease and pneumonia, which are commonly associated with anticancer drugs. Patient and professional ADR reports differed in focus. Patients highlighted quality-of-life-related symptoms, whereas professionals reported more serious medical conditions. Differences in demographics and reporting methods indicate that these systems are complementary. Offering more reporting options, such as telephone-based submissions, can make the system more inclusive.</p><p><strong>Conclusions: </strong>The study highlights how patient ADR reports provide valuable insights into drug safety. Although differences exist, patient and professional reports improve monitoring after drug approval.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145090945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring Definity-related adverse reaction: A real-world pharmacovigilance study via FAERS database analysis.","authors":"Wenrong Lin, Yuhao Lin, Siqi Xu, Naxiang Liu, Wanping Chen, Danfeng Huang, Lina Tang","doi":"10.1002/bcp.70295","DOIUrl":"https://doi.org/10.1002/bcp.70295","url":null,"abstract":"<p><strong>Aims: </strong>Definity, an ultrasound contrast agent (UCA), is widely utilized in echocardiography. Real-world studies on the safety of Definity in large populations are still lacking. This study aims to explore Definity-related adverse events via real-world data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>We adopted disproportionality analysis to identify significant adverse drug reactions (ADRs) related to Definity by utilizing algorithms like reporting odds ratio (ROR), roportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and the empirical Bayes geometric mean (EBGM).</p><p><strong>Results: </strong>In our analysis, there were 1522 cases specifically attributed to Definity. Thirty-five Definity-related preferred terms (PTs) across 10 system organ classes (SOCs) were identified through disproportionality analysis. The top five SOCs with the highest reported cases included \"Musculoskeletal and connective tissue disorders\", \"Cardiac disorders\", \"Immune system disorders\", \"Respiratory, thoracic and mediastinal disorders\" and \"General disorders and administration site conditions.\"</p><p><strong>Conclusions: </strong>This real-world pharmacovigilance study has identified vital ADRs linked to Definity, particularly hypersensitivity-mediated and cardiopulmonary reactions, underscoring the need for vigilant monitoring and further studies to clarify their clinical relevance.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Population pharmacokinetic/pharmacodynamic model of LY06006 in Chinese healthy subjects and postmenopausal osteoporotic women.","authors":"Yun Kuang, Ya-Xin Liu, Yan-Ni Teng, Lin-Feng Zhang, Jie Huang, Qi Pei, Cheng-Xian Guo, Jin-Fu Peng, Guo-Ping Yang","doi":"10.1002/bcp.70275","DOIUrl":"https://doi.org/10.1002/bcp.70275","url":null,"abstract":"<p><strong>Aims: </strong>LY06006, a biosimilar of denosumab, is a recombinant fully human monoclonal antibody targeting the receptor activator of nuclear factor κB ligand. LY06006 has completed Phase I and Phase III clinical studies. The objective of this study is to develop a pharmacokinetic (PK)/pharmacodynamic (PD) model of LY06006 in healthy male and osteoporotic female populations in China.</p><p><strong>Methods: </strong>In total, 420 subjects were enrolled in this study, including 84 healthy male subjects from the Phase I study and 336 osteoporotic postmenopausal women from the Phase III study. A nonlinear mixed-effects model was used for model development. The free serum concentration of LY06006 was used for PK analysis, and Type 1 collagen C-terminal telopeptide was used for PD analysis.</p><p><strong>Results: </strong>A two-compartment Michaelis-Menten approximate model was used to describe the PK profiles of LY06006. Body weight was a significant covariate for the volume of distribution of the central compartment (V₁) and clearance. The estimated values of V₁ in postmenopausal women with osteoporosis were 0.87×, those observed in healthy male subjects. The indirect effect model was used to describe PK/PD relationship. Subjects' height significantly influenced the baseline values of C-terminal telopeptide.</p><p><strong>Conclusion: </strong>A population PK/PD model was developed in Chinese healthy male subjects and postmenopausal osteoporotic women. A 60-mg dose of LY06006 achieves similar PD efficacy to denosumab.</p><p><strong>Clinical trial registration: </strong>Chinese Clinical Trial Registry (https://www.chictr.org.cn/): ChiCTR2000039637, ChiCTR2000032882.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience.","authors":"Juliette A van den Noort, Marella C E van Ruissen, Lisanne C A Smidt, Naomi B Klarenbeek, Philip H K Kremer, Manon A A Jansen, Jacobus Burggraaf, Joop M A van Gerven, Matthijs Moerland","doi":"10.1002/bcp.70276","DOIUrl":"https://doi.org/10.1002/bcp.70276","url":null,"abstract":"<p><strong>Problem setting: </strong>The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further. AIS may have significant impact on trial participants and clinical staff exposed to the adversity and can severely hamper progression of investigational medicinal products (IMPs) in drug development processes. We aim to increase understanding of the mechanistic basis and clinical presentation of AIS by presenting 3 recent cases of drug-induced AIS in early phase clinical trials, conducted at the Centre for Human Drug Research (Leiden, The Netherlands), in the light of ICH S6, S8 and Food and Drug Administration guidelines for AIS evaluation.</p><p><strong>Solution: </strong>We strongly encourage increased vigilance for AIS at early stages in the drug development process. Although AIS can probably never be fully mitigated by preclinical studies alone, preclinical evaluations for IMP-induced AIS allows anticipation on its potential occurrence in subsequent clinical studies. The limited information available on the exact mechanisms behind AIS and uncertainties on the relevance of animal species warrant further research into the translatability of the mechanisms underlying AIS between species and models. Implementation of evidence-based, IMP-specific AIS management, mitigation and monitoring protocols will facilitate AIS recognition and mechanistic understanding, translating into more rational clinical management of AIS. This will improve the overall efficiency of the drug development process while fostering a strong collaborative relationship between pharmaceutical companies and investigators, ultimately helping design and conduct high-quality clinical trials that are equally safe and informative.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145084950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug safety signals in breastfeeding: Bridging evidence from European and US pharmacovigilance systems.","authors":"Hülya Tezel Yalçın, Nadir Yalçın, Michael Ceulemans, Karel Allegaert","doi":"10.1002/bcp.70288","DOIUrl":"https://doi.org/10.1002/bcp.70288","url":null,"abstract":"","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145084931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}