British journal of clinical pharmacology最新文献

{"title":"Pharmacist's role in managing drug-drug interactions in people with HIV receiving antiretroviral therapy or HIV pre-exposure prophylaxis: A focus on polypharmacy and transitions of care in the United States.","authors":"Shawnalyn W Sunagawa, Elizabeth M Sherman, Melissa Badowski, David B Cluck, Spencer H Durham, Joshua P Havens, Emily Huesgen, Justin K Ma, Roxane Rohani, Eric G Sahloff, Kristy M Shaeer, Radhika S Polisetty","doi":"10.1002/bcp.70884","DOIUrl":"https://doi.org/10.1002/bcp.70884","url":null,"abstract":"","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164055","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":"Patient preferences for medicines information in cardiovascular disease and the influence of unmet needs on medication adherence: A cross-sectional study.","authors":"Lachlan L Dalli, Susie Cartledge, Caroline Trin, Zuhayr Alji, Justine Causing, Monique F Kilkenny, Antonia Arfaras, Stella Talic","doi":"10.1002/bcp.70867","DOIUrl":"https://doi.org/10.1002/bcp.70867","url":null,"abstract":"<p><p>Limited evidence exists on how patients with cardiovascular disease (CVD) prefer to receive medicines information and whether having unmet needs influences medication adherence. We conducted a cross-sectional study using national survey data (20/05/2025-25/06/2025) from Australian MedAdvisor application users taking ≥4 CVD medicines. The questionnaire covered demographics, medication adherence (MARS-5), and information needs and preferences. Multivariable linear regression examined associations between unmet information needs and adherence. Among 313 participants (mean age 68.5 years, 38.7% female), 52.4% reported unmet information needs, particularly on drug interactions and side effects/precautions. One third (31.9%) were completely adherent (MARS-5 25/25), while 49.2% were partially adherent (MARS-5 23-24). Most preferred receiving information via electronic messages (45%) or mobile applications (22%). After adjustment, unmet medicine information needs was associated with medication non-adherence (coefficient: -0.83 [95% CI: -1.22, -0.44]). These findings highlight a substantial need for improved medicines information, particularly via digital modalities, to enhance adherence in CVD.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164160","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":"Comparison of pooled and Bayesian approaches for the analysis of paediatric pharmacokinetic data leveraging prior adult knowledge: A simulation case study for monoclonal antibodies against soluble targets.","authors":"Misako Takenaka, Scott Marshall, Frances Stringer, Masanori Yamada, Chiara Zecchin","doi":"10.1002/bcp.70869","DOIUrl":"https://doi.org/10.1002/bcp.70869","url":null,"abstract":"<p><strong>Aims: </strong>Population pharmacokinetic (popPK) modelling is widely used to support paediatric dose optimization, yet consensus on appropriate modelling approaches remains limited. This study compared pooled and Bayesian popPK approaches for paediatric pharmacokinetics (PK) analysis using monoclonal antibody (mAb) examples.</p><p><strong>Methods: </strong>Paediatric and adult PK datasets were simulated using popPK models inspired by a published mepolizumab model, incorporating two clinically relevant scenarios reflecting different mechanisms of paediatric-adult mAb PK differences. Six paediatric study designs were evaluated. Paediatric PK was analysed using pooled and Bayesian approaches, and model performance was assessed based on absolute prediction error (PE) and precision of population and individual PK parameters.</p><p><strong>Results: </strong>When paediatric-adult PK differences were explained primarily by body size, pooled approach estimated paediatric population clearance more accurately (median absolute PE: 1.1%-1.2% with pooled approach vs. 4.1%-10.4% with the Bayesian approach) and was robust across study designs. In contrast, when age-related PK differences were present and paediatric sample size was small (≤ 30 subjects), the Bayesian approach provided more accurate population clearance estimates for 11-year-old population (median absolute PE: 3.4%-8.2% with the Bayesian approach vs.7.4%-15.7% with pooled approach). Individual exposure estimates were comparable between modelling approaches.</p><p><strong>Conclusions: </strong>In this case study based on mAbs acting on soluble targets, relative performance of pooled and Bayesian popPK approaches varied with the analysis objective, paediatric age group, ADME characteristics and paediatric study design. These findings provide practical considerations for applying pooled and Bayesian approaches in this context and may help inform the selection of popPK strategies to support model-informed paediatric dosing decisions.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149170035","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":"Triangulation of dispensing and wastewater data for surveillance during lisdexamfetamine shortages: A descriptive time series analysis.","authors":"Jack Janetzki, Emma Keller, Nicole Pratt, Cobus Gerber, Lisa Kalisch Ellett","doi":"10.1002/bcp.70877","DOIUrl":"https://doi.org/10.1002/bcp.70877","url":null,"abstract":"<p><strong>Aims: </strong>Lisdexamfetamine, a long-acting stimulant for attention-deficit hyperactivity disorder (ADHD), has experienced widespread shortages in Australia since late 2023, raising concerns about treatment continuity and shifts in stimulant use patterns. This study assessed the impact of shortages in South Australia (SA) and Western Australia (WA) by triangulating prescription dispensing and wastewater-based epidemiology (WBE).</p><p><strong>Methods: </strong>Monthly Pharmaceutical Benefits Scheme (PBS) dispensing data for lisdexamfetamine and dexamfetamine were converted to defined daily doses (DDD) per 1000 population per day. Concurrently, bimonthly wastewater samples from metropolitan sites were analysed for amphetamine and methamphetamine concentrations, with methamphetamine serving as a control as its use was unlikely to be affected by the shortage. Data were compared from February 2022 to December 2024.</p><p><strong>Results: </strong>In WA, lisdexamfetamine DDDs increased from 5.59 to 13.02 and dexamfetamine from 2.55 to 6.03 per 1000 population per day, doubling combined stimulant DDDs from 8.14 to 19.05. In SA, lisdexamfetamine DDDs rose from 1.05 to 5.00. Wastewater amphetamine levels fluctuated (WA: 5.07-17.10; SA: 0.79-3.46 doses/day/1000 people) but declined sharply during shortages, while methamphetamine levels remained high (peaking at 62.65 in WA and 66.22 in SA).</p><p><strong>Conclusions: </strong>Triangulation revealed variations in lisdexamfetamine use during shortages and highlighted potential behavioural responses. While these behaviours may partly explain differences between prescription dispensing and wastewater amphetamine levels, they do not fully account for the observed temporal patterns. Nonetheless, triangulating these data sources offers valuable insights for monitoring medicine use and informing public health and policy responses during supply disruptions.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164135","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":"Practice-level variation in potentially inappropriate prescribing in middle-aged adults: A repeated cross-sectional study in South London general practice.","authors":"Ryan Jayesinghe, Amandeep Khatter, Stevo Durbaba, Mark Ashworth, Benjamin Jacob, Frank Moriarty, Patrick Redmond","doi":"10.1002/bcp.70866","DOIUrl":"https://doi.org/10.1002/bcp.70866","url":null,"abstract":"<p><strong>Aim: </strong>To quantify between-practice variation in potentially inappropriate prescribing (PIP) among middle-aged adults (45-64 years) in UK general practice, and to identify patient- and practice-level characteristics associated with PIP.</p><p><strong>Methods: </strong>Repeated cross-sectional study using linked data from the Lambeth DataNet and Quality Outcomes Framework across 41 GP practices in South London (2014-2019). The study included patients aged 45-64 years prescribed ≥1 medicines in each year from 2014 to 2019 (n = 46 633-52 582). PIP was identified using the 22 PROMPT (PRescribing Optimally in Middle-aged People's Treatments) criteria. Multilevel negative binomial regression estimated associations with patient- and practice-level characteristics, expressed as rate ratios (RR) with 95% confidence intervals.</p><p><strong>Results: </strong>PIP prevalence was 18%-20%, stable across the study period. Practice-level prevalence ranged from 14% to 24%. The SCV was 1.72 (low) and the ICC was 0.08, with approximately 8% of variance attributable to practice-level differences. Polypharmacy was the strongest predictor (adjusted RR 4.04, 95% CI 3.96-4.11), followed by multimorbidity (RR 2.44, 95% CI 2.40-2.50). Black/African/Caribbean/Black British ethnicity was associated with lower PIP (RR 0.77, 95% CI 0.75-0.78). Practice-based pharmacist presence and teaching practice status were associated with modestly lower PIP, while APMS contract type was associated with higher PIP (RR 1.20, 95% CI 1.10-1.32).</p><p><strong>Conclusion: </strong>Most variation occurred at the patient level, but practice organizational characteristics were also associated with PIP and warrant further investigation in an age group for which direct medicines-optimization evidence remains limited.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149165256","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":"Comment on 'Semaglutide vs. liraglutide and incidence of diabetes and cardiovascular disease: A target trial emulation using real-world data'.","authors":"Muhammad Adil Choudhry","doi":"10.1002/bcp.70882","DOIUrl":"https://doi.org/10.1002/bcp.70882","url":null,"abstract":"","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149147600","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":"Attrition adjustment in sample size calculation for Intention-to-treat (ITT)-based clinical trials: Evidence from a clinical trial simulation study.","authors":"Archana Mishra, Anand Srinivasan, Rituparna Maiti, Debasish Hota","doi":"10.1002/bcp.70876","DOIUrl":"https://doi.org/10.1002/bcp.70876","url":null,"abstract":"<p><strong>Aims: </strong>Attrition in randomized clinical trials (RCTs) threatens internal validity and reduces statistical power, challenging the integrity of analyses. Different methods to handle missing data such as last observation carried forward (LOCF), multiple imputation (MI) and per-protocol (PP) vary in bias and impact. Whether to inflate sample size to offset dropout remains debated, necessitating systematic investigation to evaluate effects of missing data strategies and sample size adjustments on trial outcomes.</p><p><strong>Methods: </strong>A Monte Carlo simulation modelled parallel-arm RCTs with correlated baseline and longitudinal continuous outcomes. Four missingness mechanisms, that is, missing completely at random (MCAR), missing at random (MAR), missing not at random (MNAR) and differential dropout, were studied with dropout rates up to 20%. Analytical approaches included PP, LOCF and MI. Scenarios were replicated 1000 times. Key metrics were power, bias, Type I error and sensitivity assessed by tipping point and scenario analyses.</p><p><strong>Results: </strong>At 20% dropout, MI preserved power at approximately 72%-73% under MCAR, MAR and MNAR mechanisms, surpassing PP (~68%-70%) and LOCF (~59%-61%). Attrition-adjusted sample size restored power to approximately 79%-82% across mechanisms. Differential dropout produced the greatest bias and power reduction for all methods and was the only mechanism showing meaningful Type I error inflation. Tipping-point analyses confirmed that conclusions remain robust to deviations from the MAR assumption.</p><p><strong>Conclusions: </strong>Combining prospective sample size inflation with MI enhances internal validity and power in RCTs facing attrition. These findings have important implications for clinical trial guidelines, especially in sample size estimation and missing data handling, promoting evidence-based standards to maintain trial integrity.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135257","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":"Real-world effectiveness of pain pharmacotherapy for caesarean section in a low- and middle-income setting: A multicentre cross-sectional study in Ghana.","authors":"Sara Agyemang Antwi, Angela Owusu-Ansah, Patrick Nsor Agasiya, Kwesi Boadu Mensah, Charles Ansah","doi":"10.1002/bcp.70862","DOIUrl":"https://doi.org/10.1002/bcp.70862","url":null,"abstract":"<p><strong>Aims: </strong>Effective analgesia is needed after caesarean section to enhance maternal health-related quality. Unfortunately, little is known about the realities on the ground in low-and middle-income countries. This study investigated the prevalent perioperative pharmacotherapeutic practices in Ghanaian healthcare settings for women undergoing elective caesarean section and their association with acute postoperative pain.</p><p><strong>Method: </strong>A multicentre cross-sectional study was conducted among 515 women who underwent elective caesarean section at four teaching hospitals in Ghana. Demographic and clinical data were collected using structured questionnaires and medical record reviews. Acute postoperative pain was assessed using the Numerical Pain Rating Scale (NRS) within the first 72 h after surgery. Data were analysed using R (Version 4.6.1). Statistical significance was defined as p < 0.05.</p><p><strong>Results: </strong>Moderate to severe acute postoperative pain was reported by 60.0% (95% CI: 55.7%-64.1%) of participants despite widespread use of opioid-based analgesia. Multimodal analgesia was associated with significantly lower acute postoperative pain (OR = 0.34; 95% CI: 0.22-0.48; p < 0.001). The use of midazolam was associated with a 62% reduction in the odds of acute post-surgery pain (OR = 0.38; 95% Bootstrap CI: 0.20-0.63; p < 0.001).</p><p><strong>Conclusion: </strong>Multimodal analgesia was associated with superior postoperative pain control compared with opioid-based therapy alone; however, the persistently high prevalence of moderate to severe pain indicates substantial gaps in the implementation of contemporary pain management strategies during and following caesarean deliveries in Ghana.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149147466","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":"Association of extracorporeal therapy with persistent neurologic sequelae after lithium poisoning: A multicentre cohort study.","authors":"Amir Shabaka, Eugenia Landaluce-Triska, Maria José Ortega Fernández-Reyes, Miguel Martínez-Belotto, Mario Botella, Ana Mendoza-Cedeño, Verónica Rubio Menéndez, Javier Vian, Clara Cases-Corona, Fabio Procaccini, Maria Jose Alcaide-Martin, Maria Patricia Sanz-de Pedro, Rubén Gómez Rioja, Juan Manuel Acedo, Begoña Rivas, Cristina Vega, Gema Fernández-Juárez","doi":"10.1002/bcp.70864","DOIUrl":"https://doi.org/10.1002/bcp.70864","url":null,"abstract":"<p><strong>Aims: </strong>Lithium poisoning may result in persistent neurologic sequelae, including irreversible neurotoxicity. Although extracorporeal therapy enhances lithium elimination, its effect on clinically meaningful outcomes remains uncertain. We evaluated the association between extracorporeal therapy and persistent neurologic sequelae in patients with lithium poisoning.</p><p><strong>Methods: </strong>We conducted a multicentre retrospective cohort study including 268 patients with lithium poisoning from four tertiary hospitals in Spain. The primary outcome was persistent neurologic sequelae for ≥2 months. Secondary outcomes included mortality, hospital length of stay and treatment-related complications. Multivariable logistic regression and propensity score weighting were used to adjust for differences in baseline severity and treatment indication.</p><p><strong>Results: </strong>Among 268 patients, 108 (40.3%) received extracorporeal therapy. Patients receiving extracorporeal therapy had more severe poisoning, with higher peak lithium concentrations and more frequent acute kidney injury and neurologic manifestations. Persistent neurologic sequelae occurred in 55 patients (20.5%) and were less frequent among patients treated with extracorporeal therapy (11.1% vs. 26.9%; p = 0.002). In multivariable analysis, extracorporeal therapy was independently associated with lower odds of persistent neurologic sequelae (adjusted odds ratio 0.20, 95% CI 0.09-0.45). Higher peak lithium concentration and pre-existing neurologic disease were independently associated with persistent neurologic sequelae. Findings remained consistent after propensity score weighting. The association was strongest among patients meeting EXtracorporeal TReatments In Poisoning (EXTRIP)-recommended criteria.</p><p><strong>Conclusions: </strong>Extracorporeal therapy was associated with a lower frequency of persistent neurologic sequelae in lithium poisoning, particularly among patients meeting EXTRIP Workgroup 'recommended' criteria. Prospective studies are needed to confirm these findings, particularly in intermediate-risk poisoning.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135313","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":"Interpreting low-dose apixaban during renal replacement therapy: From anti-Xa exposure to clinical effectiveness.","authors":"Fang Rong Jiang, Ting Shen","doi":"10.1002/bcp.70880","DOIUrl":"https://doi.org/10.1002/bcp.70880","url":null,"abstract":"","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135260","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}