British journal of clinical pharmacology最新文献

{"title":"Budget impact analysis of new drugs in oncology and haematology: Principles and practice.","authors":"Javier Soto-Alsar, José L Revuelta-Herrero, Cristina Villanueva-Bueno, Carmen Cobos-Lama, Marc A Cañete-Muñoz, Andrés Muñoz-Martín, Pilar García-Alfonso, Javier Soto-Álvarez","doi":"10.1002/bcp.70303","DOIUrl":"https://doi.org/10.1002/bcp.70303","url":null,"abstract":"<p><p>Cancer is currently among the most prevalent and fatal diseases, so new, costly drugs for its treatment will be available in the coming years. Budget impact analyses (BIAs) are an essential component of the economic evaluation of new oncological and haematological drugs, and are increasingly required by health authorities in many countries as part of the pricing and reimbursement process. This article aims to provide updated guidance on the methodology for performing such analyses. In a BIA, the resource consumption in the reference scenario (before the new drug is introduced) is always compared with the resource consumption in the future scenario (after the new treatment is commercialized). The most important parts of a BIA include calculating the number of the existing patient population, the current mix of treatments and the expected mix after the coming of the new drug, the cost of the treatment mixes and other changes in cancer-related costs. The BIA's data sources should be drawn from the best available published evidence, such as clinical trials, observational studies, local epidemiological information, cost databases and expert opinion. Where possible, the decision maker's population and calculations for other parameter estimations should also be included. A deterministic analysis and a scenario sensitivity analysis should be carried out in every BIA. The BIA report must provide details of resource consumption and associated costs in the reference scenario and the future scenario. The difference between the 2 scenarios will represent the budget impact of introducing a new drug to the market.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191012","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":"Efficacy and safety of empagliflozin for treating neutropenia and neutrophil dysfunction in paediatric patients with glycogen storage disease type Ib: A systematic review and meta-analysis.","authors":"Elizabeth Iwasyk, Ryan Jin, Fabio Tuzzolino, Giusy Ranucci, Donatella Madonia, Alessio Provenzani","doi":"10.1002/bcp.70294","DOIUrl":"https://doi.org/10.1002/bcp.70294","url":null,"abstract":"<p><strong>Aims: </strong>Glycogen storage disease type Ib (GSD-Ib) is a rare genetic disorder causing neutropenia and neutrophil dysfunction in children. G-CSF has been the primary treatment, but emerging data support the potential of empagliflozin, an SGLT2 inhibitor, as a promising investigational option. This systematic review and meta-analysis assess its feasibility, efficacy and safety in paediatric GSD-Ib patients.</p><p><strong>Methods: </strong>Following the 2020 PRISMA guidelines, a systematic search was conducted in PubMed, Embase and Web of Science (2015-2025). The last search was performed on 16 May 2025. The inclusion criteria were patients <18 years with GSD-Ib and neutropenia treated with empagliflozin. Eligible study types included randomized controlled trials (RCTs), observational studies and case series. Non-English, pre-2015 and non-primary research were excluded. Bias was assessed using ROBINS-I V2, and certainty via GRADE. Meta-analyses used fixed or random effects depending on heterogeneity. The primary efficacy outcome was defined as resolution of neutropenia, and safety outcome included overall adverse events.</p><p><strong>Results: </strong>Six non-randomized studies (n = 177; 52% male; mean age 6.7) met the inclusion criteria. Two studies showed low risk of bias; three were critically biased. All reported improved neutrophil counts (ANC > 1.5) after empagliflozin treatment. Four studies had >80% resolution of neutropenia; all showed G-CSF reduction or discontinuation. Adverse events were minimal; lactic acidosis was the most serious.</p><p><strong>Conclusions: </strong>Empagliflozin shows promise in treating neutropenia in paediatric GSD-Ib patients, with encouraging efficacy and safety. However, findings are limited by study design and heterogeneity. The majority of included studies were non-randomized and rated as having a serious or critical risk of bias according to the ROBINS-I tool. This substantially limits the reliability and interpretability of pooled outcomes. These results should therefore be viewed as preliminary and interpreted with caution. Further randomized trials, especially those measuring 1,5-AG, are needed to confirm empagliflozin's role as promising therapy in G-CSF.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191049","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":"An experimental medicine protocol for exploring the haemodynamic effects of dual agonism at the glucagon-like peptide-1 and glucagon receptor in healthy subjects.","authors":"James Goodman, Victoria E Parker, Carmel M McEniery, Giovanni Di Stefano, Annette Hubsch, Evangelia Vamvaka, Jo Helmy, Fotini Kaloyirou, Navazh Jalaludeen, Peter Barker, Lutz Jermutus, Joseph Cheriyan, Philip Ambery, Ian B Wilkinson","doi":"10.1002/bcp.70282","DOIUrl":"https://doi.org/10.1002/bcp.70282","url":null,"abstract":"<p><strong>Aims: </strong>Glucagon-like peptide-1 (GLP-1) and glucagon dual receptor agonists are in clinical development for a range of metabolic conditions, including type 2 diabetes and obesity. The cardiovascular actions at these receptors are well studied, but less is known about their combination. The aim was to explore the acute haemodynamic effects of dual agonism at the GLP-1 and glucagon receptor.</p><p><strong>Methods: </strong>Healthy male participants attended randomized, saline-controlled intravenous infusion studies using glucagon (low, 25 ng/kg/min), glucagon (high, 50 ng/kg/min), exenatide (loading dose 50 ng/min for 30 min then 25 ng/min) and exenatide:glucagon co-infusion for 120 min in Part A (glucagon dose-comparison study) and 60 min in Part B (dual-agonism study).</p><p><strong>Results: </strong>In Part A (n = 7, median age 21 years, interquartile range 21-32 years), glucagon (high) increased heart rate by 11 beats per minute (bpm) (95% confidence interval [CI] 4-17 bpm, P < .01). In Part B (n = 12, median age 24 years, interquartile range 22-26 years), exenatide increased heart rate by 4 bpm (95% CI 2-6 bpm, P < .001). Glucagon (low) increased heart rate by 4 bpm (95% CI 1-7 bpm, P < .001). Co-infusion of glucagon (low) and exenatide increased heart rate by 7 bpm (95% CI 4-9 bpm, P < .001) and the rate pressure product by 793 mmHg*bpm (95% CI 460-1127 mmHg*bpm, P < .001). There were no differences in cardiac output, blood pressure or heart rate variability.</p><p><strong>Conclusions: </strong>In healthy males, exenatide and glucagon co-infusion acutely increases the rate pressure product, an indirect measure of cardiac work. This increase is driven by an increase in heart rate, rather than any change in systolic blood pressure.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191010","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":"Challenges in optimizing tacrolimus therapy in patients treated with rifampin: A case series.","authors":"Jeroen P A Houwen, Aurelia H M de Vries Schultink, Bas J M Peters, Dieuwertje Ruigrok, Rob H J Schönwetter, Esther V Uijtendaal, Maaike A Sikma","doi":"10.1002/bcp.70298","DOIUrl":"https://doi.org/10.1002/bcp.70298","url":null,"abstract":"<p><p>Tacrolimus is a cornerstone immunosuppressant in transplantation medicine with a narrow therapeutic window. Drug-drug interactions with strong CYP3A4 and P-glycoprotein modulators, such as rifampin and azole antifungals, significantly alter tacrolimus exposure and complicate therapy. Two transplant cases illustrates the impact of rifampin on tacrolimus pharmacokinetics. In one case, the tacrolimus dosage had to be increased to 120 mg/day during rifampin coadministration to maintain therapeutic concentrations, with a concentration-to-dose ratio (CDR) as low as 0.11 μg/L/mg. In both cases, cessation of rifampin led to a delayed but significant rise in tacrolimus levels, requiring substantial dose reductions within 7-15 days. These cases highlight the extreme variability in tacrolimus metabolism under the influence of rifampin and emphasize the need for daily therapeutic drug monitoring when starting, continuing and discontinuing rifampin. A multidisciplinary approach is essential and, when possible, the tacrolimus-rifampin combination should be avoided.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198397","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":"Ileal bile acid transporter inhibitors in Alagille syndrome and Progressive Familial Intrahepatic Cholestasis: A systematic review into dose-response.","authors":"Alise D E de Groot, Cristina Chiadò, Jos G W Kosterink, Willem S Lexmond, Paola Mian, Henkjan J Verkade","doi":"10.1002/bcp.70277","DOIUrl":"https://doi.org/10.1002/bcp.70277","url":null,"abstract":"<p><p>Ileal bile acid transporter inhibitors (IBATi), including maralixibat and odevixibat, are a novel approach to the treatment of paediatric cholestatic liver diseases, such as Alagille syndrome (ALGS) and different forms of progressive familial intrahepatic cholestasis (PFIC). Multiple phase 3 trials have demonstrated efficacy of IBATi in alleviating pruritus and decreasing serum bile acid (sBA) in a significant subset of patients. While most clinical IBATi trials included low-dose and high-dose treatment, a consistent dose-response effect has not been uniformly reported. This systematic review aims to assess the dose-response relationship for IBATi in patients with ALGS or PFIC, based on available pruritus, sBA and (non-)responder outcomes, identifying minimally effective dosage and exploring the potential for personalized dosing strategies. A systematic search was conducted across PubMed, EMBASE, Web of Science and Cochrane Library of articles, oral presentations, posters presentations and abstracts up to 29 July 2024. The analysis included 75 records, of which 68 reported sBA and 63 reported pruritus outcomes. An evident dose-response relationship was not observed for either maralixibat or odevixibat in PFIC or ALGS. In the case of odevixibat, outcomes measures for patients with ALGS have only been reported for a dosage of 120 μg/kg/day. In conclusion, the variability in therapeutic outcomes of different doses for all IBATi underscores the necessity for personalization of dosing, which may include decreasing the dosage for responders to IBATi.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198461","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":"Evidence to support integrating feedback best practice for computer-based assessment in pharmacology education.","authors":"Claire Y Hepburn","doi":"10.1002/bcp.70302","DOIUrl":"https://doi.org/10.1002/bcp.70302","url":null,"abstract":"<p><p>Feedback is the most powerful driver of learning, but it can afford variable effects depending on the method used. The design of feedback for computer-based assessment-now increasingly prevalent in higher education-remains relatively underexplored, particularly for pharmacology education. The growing momentum of curricular evolution in pharmacology education presents a timely opportunity to appraise and improve feedback practices in computer-based assessment within the discipline. While there is extensive literature which outlines the principles of effective feedback, there is not a universal model we can apply with consistently positive outcomes. This review explores how empirical evidence can inform the development of effective feedback for use in computer-based assessment. Drawing on findings from multiple meta-analyses and primary research exploring elements of feedback design from across disciplines, this review confirms that elaborate feedback is more effective than corrective feedback alone. However, to support students to develop metacognitive skills for life-long learning, feedback should be tailored to the characteristics of the learner with dialogic support necessary to optimize impact. It is also clear that a key prognostic indicator of successful feedback for performance and satisfaction is clear links to goals and standards. This review argues for feedback for computer-based assessment to go beyond that which is efficient. Instead, it should be constructively aligned with clear goals, and be learner-centred and dialogic to ensure we support the development of reflective and capable graduates of pharmacology education.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191175","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":"Prediction of neutrophil nadir and recovery following paediatric haematopoietic cell transplantation with busulfan conditioning.","authors":"Beth Apsel Winger, Joseph W Polli, Janel Long-Boyle, Andrew Weber, Jordan Brooks, Jaimit Parikh, Valeriu Damian","doi":"10.1002/bcp.70251","DOIUrl":"https://doi.org/10.1002/bcp.70251","url":null,"abstract":"<p><strong>Aims: </strong>In haematopoietic cell transplantation (HCT), neutropenia resulting from myelosuppression is an expected endpoint following busulfan-based conditioning. However, if prolonged, neutropenia can lead to complications like serious infection and death. The routine use of pharmacokinetic (PK)-guided busulfan dosing has decreased toxicities; however, patients still have serious, sometimes fatal, complications of drug-induced neutropenia. We sought to investigate whether the time-course of neutropenia after HCT could be predicted for paediatric patients following busulfan-based conditioning. Such predictions could guide care, such as timing of infectious prophylaxis and/or growth factor administration.</p><p><strong>Methods: </strong>This was a single-centre, retrospective study of 146 patients with malignant or nonmalignant disorders treated with allogeneic or autologous HCT. An advanced PKPD model of neutrophil dynamics post-HCT was built that included two parallel neutrophil maturation pathways for host and donor cells, expanded transit compartments for neutrophil maturation, cell number-based feedback loops to the proliferating compartment, GCSF effects, and direct/indirect busulfan killing effects.</p><p><strong>Results: </strong>The model predicted neutrophil recovery well using patient data beyond Day +21 post-HCT. When using patient data prior to Day +21 post-HCT, neutrophil recovery was less accurate (as measured by the sum of the absolute neutrophil count prediction error) due to unpredictable complications influencing neutrophil counts. Four clinical cases illustrate the strengths and challenges of the model.</p><p><strong>Conclusions: </strong>This study suggests real-time incorporation of patient-specific data through Day +21 post-HCT is required to predict neutrophil dynamics following neutrophil nadir in paediatric HCT.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184563","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":"Pharmacogenomics in clinical practice: Biomarker information in Brazilian drug labels.","authors":"Guilherme Suarez-Kurtz","doi":"10.1002/bcp.70278","DOIUrl":"https://doi.org/10.1002/bcp.70278","url":null,"abstract":"<p><p>This review examines the PGx annotations in package inserts (bulas in Brazilian Portuguese) approved by ANVISA, the Brazilian Health Regulatory Agency, for 19 gene-drug pairs with strong or moderate recommendations for initial dosing alteration in the CPIC (Clinical Pharmacogenetic Implementation Consortion) guidelines and PGx testing required or recommended by health regulatory agencies listed in the PharmGKB Drug Label Annotations table. It is assumed that drug-gene pairs with these two features should be prioritized for adoption by the Brazilian Public Health System (SUS). PGx annotations were distributed across seven of the ten sections of the bulas and classified as PGx testing required (n = 5), PGx testing recommended (n = 5), actionable PGx (n = 4) and no PGx clinical information (n = 4). Pairwise comparison of assigned PGx levels in ANVISA bulas vs. the selected regulatory agencies revealed poor concordance (Cohen's kappa coefficient κ < 0.20 for all pairs); however, discordance among these agencies is also considerable (Fleiss's kappa coefficient κ = 0.08). The frequency of the examined PGx risk biomarkers in representative Brazilian cohorts range from <0.1% to 10.8%. Importantly, Native Americans (0.4% of the current Brazilian population), display wide PGx diversity, both interethnically and in relation to non-Indigenous Brazilians. The author suggests that addition of a PGx section to the ANVISA bulas would avoid dispersion of clinically relevant PGx information across sections, assure integration of this information with SUS determinations and prevent discrepancies across sections, as observed in the bulas for thiopurines.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184565","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":"Prescription use of acetaminophen among pregnant women in Denmark from 2000 to 2023: A drug utilization study.","authors":"Erika B Gram, Mette Bliddal, Sophie Pflugfelder, Peter Bjødstrup Jensen, Per Damkier","doi":"10.1002/bcp.70296","DOIUrl":"https://doi.org/10.1002/bcp.70296","url":null,"abstract":"<p><strong>Aims: </strong>The aim of this study was to describe prescription use of acetaminophen, a widely used analgesic and antipyretic generally considered safe during pregnancy, among pregnant women from 2000 to 2023 in Denmark with special attention towards variations following the change in over-the-counter (OTC) availability in 2013.</p><p><strong>Methods: </strong>In this population-based drug utilization study, individually linked data from nationwide health registries on pregnant women in Denmark between 2000 and 2023 were used to evaluate time trends on prescription use of acetaminophen and describe distributions of maternal characteristics among prescription-based drug users and non-users.</p><p><strong>Results: </strong>Among 1 446 841 eligible pregnancies included, 27 per 1000 pregnant women redeemed at least one prescription for acetaminophen during pregnancy, and among these, 18% redeemed more than one. In 2023, 74 per 1000 pregnancies were exposed to prescription use of acetaminophen. Relative to non-users, prescription-based drug users were generally older and had a higher body mass index. They more frequently presented with pain-related, chronic or psychiatric conditions and used other prescription medications throughout the study period. However, these differences were less pronounced in the cohort restricted to pregnancies ending in 2015-2023 compared to 2000-2012.</p><p><strong>Conclusions: </strong>Prescription use of acetaminophen in the pregnant population in Denmark has increased since 2000, with a notable sharp increase from 2013 onwards, coinciding with the regulatory restriction that reduced over-the-counter pack sizes, alongside a concurrent rise in general-population prescription use. Prescription-based drug users were more likely to have comorbidities and multiple medication use than non-users, although these differences have become less pronounced in recent years.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145173465","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":"Pregabalin dependence, withdrawal, suicidality and psychosis reports: A disproportionality analysis of the Australian adverse events database.","authors":"Amy G McNeilage, Ali Gholamrezaei, Bridin Murnion, Suzanne Nielsen, Claire E Ashton-James","doi":"10.1002/bcp.70279","DOIUrl":"https://doi.org/10.1002/bcp.70279","url":null,"abstract":"<p><strong>Aims: </strong>Globally, Australia has the highest per capita consumption rate of pregabalin, commonly prescribed for neuropathic pain. Emerging evidence suggests pregabalin may be associated with the onset or recurrence of several potentially life-threatening psychiatric events in some individuals.</p><p><strong>Methods: </strong>We conducted disproportionality analyses using case reports involving adverse events related to dependence, withdrawal, suicidality and psychosis, submitted to Australia's Therapeutic Goods Administration between 2005 and 2024. Reporting odds ratios (RORs) were calculated to determine whether these adverse events were disproportionately reported for pregabalin compared to all other drugs in the database and to an active comparator group of other neuropathic pain drugs (gabapentin, duloxetine and amitriptyline).</p><p><strong>Results: </strong>Compared to all other drugs in the database, pregabalin showed strong signals of disproportionate reporting for drug abuse and dependence (ROR = 13.53, 95% confidence interval [CI]: 12.12, 15.10), drug withdrawal (ROR = 6.76, 95% CI: 4.99, 9.15), suicide and self-injury (ROR = 12.40, 95% CI: 10.71, 14.36), and psychosis and psychotic disorders (ROR = 5.81, 95% CI: 4.99, 6.76). When compared to other neuropathic pain drugs, the signal of disproportionate reporting remained for drug abuse and dependence (ROR = 1.38, 95% CI: 1.17, 1.62) and psychosis and psychotic disorders (ROR = 1.26, 95% CI: 1.002, 1.57), albeit with less pronounced effects.</p><p><strong>Conclusions: </strong>Adverse events related to drug dependence and psychosis are reported to the Australian pharmacovigilance database at a higher rate for pregabalin compared to other drugs, including other neuropathic pain drugs, signalling a potential concern that warrants further investigation.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145147803","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}