British journal of clinical pharmacology最新文献

{"title":"Correction to “Incidence and trend of cardiac events among children and young adults exposed to psychopharmacological treatment (2006–2018): A nationwide register-based study”","authors":"","doi":"10.1002/bcp.70058","DOIUrl":"10.1002/bcp.70058","url":null,"abstract":"<p>\u0000 <span>Elmowafi, H</span>, <span>Kindblom, JM</span>, <span>Halldner, L</span>, <span>Gyllenberg, D</span>, <span>Naumburg, E</span>. <span>Incidence and trend of cardiac events among children and young adults exposed to psychopharmacological treatment (2006–2018): A nationwide register-based study</span>. <i>Br J Clin Pharmacol</i>. <span>2025</span>; <span>91</span>(<span>3</span>): <span>817</span>–<span>828</span>. doi:10.1111/bcp.16321</p><p>In Figure 2B, the word male and females <b>are</b> missed in the legend as illustrated below.</p><p>In Figure 2C, the word male and females are missed in the legend the word male and female should be added in the legend as illustrated below.</p><p>In figure 3A, the word male and female should be added in the legend as illustrated below.</p><p>In figure 3B, the word male and female should be added in the legend as illustrated below.</p><p>In figure 3C, the word male and female should be added in the legend as illustrated below.</p><p>We apologize for the errors.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 5","pages":"1520-1523"},"PeriodicalIF":3.1,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/bcp.70058","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First-time cefuroxime target tissue concentrations in long-lasting spine surgery: Continuous evaluation after repeated weight-dosed administrations.","authors":"Magnus Andreas Hvistendahl, Mats Bue, Pelle Hanberg, Sara Kousgaard Tøstesen, Sofus Vittrup, Maiken Stilling, Kristian Høy","doi":"10.1002/bcp.70052","DOIUrl":"https://doi.org/10.1002/bcp.70052","url":null,"abstract":"<p><strong>Aims: </strong>Antimicrobial prophylaxis is central in preventing postoperative spine infections, yet knowledge on clinical target spine tissue concentrations remain limited. Current dosing regimens often involve fixed doses based on empirical knowledge, surrogate measures, non-clinical evidence and methodology of variying quality. The objective was to continuously evaluate peri- and postoperative cefuroxime target tissue concentrations in long-lasting spine surgery.</p><p><strong>Methods: </strong>Twenty patients scheduled for spine deformity surgery with hypotensive anaesthesia completed the study. Weight-dosed cefuroxime was administered intravenously (20 mg/kg) to all patients preoperativey and after 4 h. Microdialysis probes were placed in vertebral bone (intraoperative sampling), paravertebral muscle, subcutaneous tissue and profoundly/superficially in the wound. Microdialysates and plasma samples were obtained for up to 12 h. The primary endpoint was the time with cefuroxime concentrations above the minimal inhibitory concentration for Staphylococcus aureus of 4 μg/mL as a percentage (%fT>MIC4).</p><p><strong>Results: </strong>The median cefuroxime %fT>MIC4 (range) of patients' individual surgery time was 100% (100-100) in all investigated tissues and plasma. Median cefuroxime %fT>MIC4 (range) in the first dosing interval was 93% (93-93) in vertebral bone, paravertebral muscle and subcutaneous tissue, and 100% (99-100) in plasma. Median cefuroxime %fT>MIC4 (range) in the second dosing interval was 85% (52-100) in paravertebral muscle, 94% (52-100) in subcutaneous tissue, 99% (71-100) in the profound wound, 100% (72-100) in the superficial wound, and 70% (42-100) in plasma.</p><p><strong>Conclusions: </strong>Repeated weight-dosed intravenous cefuroxime administrations (20 mg/kg) provided homogenous and sufficient intraoperative target tissue exposure of cefuroxime (100% fT>MIC4) in long-lasting spine surgery with hypotensive anaesthesia and postoperative exposure (>4 μg/mL) for 5.5-7.5 h.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751181","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":"Epigenetic modifications in drug-induced liver injury: A systematic review.","authors":"Romina Lorena de Los Santos-Fernández, Antonio Segovia-Zafra, Guillermo Paz-López, Gonzalo Matilla-Cabello, Hao Niu, Ismael Álvarez-Álvarez, Camilla Stephens, Andrés González-Jiménez, M Isabel Lucena, Raúl J Andrade, Inmaculada Medina-Cáliz","doi":"10.1002/bcp.70053","DOIUrl":"https://doi.org/10.1002/bcp.70053","url":null,"abstract":"<p><p>Genetic susceptibility has been identified in idiosyncratic drug-induced liver injury, a potentially severe adverse reaction towards drugs, herbal products and dietary supplements. However, its occurrence cannot be fully explained by the presence of genetic variants in specific genes, suggesting that other factors are involved. Drug-induced liver injury epigenetic signatures could help explain genetic regulatory mechanisms behind this disease and might provide disease biomarkers. This systematic review aims to analyse all available information on epigenetic risk association studies in drug-induced liver injury. The main inclusion criterion was population studies on idiosyncratic drug-induced liver injury with significant risk association analysis between drug-induced liver injury and an epigenetic regulation mechanism. Out of the 7 included articles, 6 focused on DNA methylation and 1 on long noncoding RNA. All of the studies were on antituberculosis drug-induced liver injury and came from Asia. CpG site methylation in the CYP2D6 (odds ratio: 9.19, 95% confidence interval: 3.26-25.89, P < .001) and NAT2 (odds ratio: 8.37, 95% confidence interval: 2.39-29.32, P = .001) promoters conferred the highest risk. Hypomethylation of LINE-1 and Alu transposable elements has potential as antituberculosis drug-induced liver injury biomarkers, showing an area under the curve value of 0.94. To conclude, the studies mainly focused on DNA methylation modifications associated with antituberculosis drug-induced liver injury, with all of them coming from Asia, where tuberculosis is a public health burden. Despite the lack of knowledge in this area, the evidence has shown that DNA methylation alterations in antituberculosis drug-induced liver injury could have potential as a new diagnostic and therapeutic target.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708636","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":"Safety of sulfamethoxazole-trimethoprim for the treatment of bacterial infection in outpatient settings: A systematic review and meta-analysis with active comparator disproportionality analysis.","authors":"Rebecca Preyra, Lujain Ez Eddin, Fatemeh Ahmadi, Atefeh Jafari, Flory T Muanda","doi":"10.1002/bcp.70051","DOIUrl":"https://doi.org/10.1002/bcp.70051","url":null,"abstract":"<p><strong>Aims: </strong>Sulfamethoxazole-trimethoprim (SMX-TMP) is a widely used antibiotic for treating bacterial infections, but its safety in adult outpatients remains understudied. This systematic review and meta-analysis evaluated the safety profile of SMX-TMP and identified critical research gaps. The pharmacovigilance study aimed to validate and extend findings from meta-analyses to better understand the real-world safety of SMX-TMP.</p><p><strong>Methods: </strong>We searched MEDLINE and Embase up to 12 August 2024, to identify studies comparing adverse drug events (ADEs) following SMX-TMP vs. other antibiotics in adult outpatients. Meta-analyses were performed where data allowed. A pharmacovigilance study using the Food and Drug Administration Adverse Event Reporting System was conducted to supplement our findings.</p><p><strong>Results: </strong>Our review, which included 43 studies, found SMX-TMP had a nearly 3-fold higher risk of rash compared to other antibiotics (pooled risk ratio 2.56, 95% confidence interval [1.69, 3.89], I² = 0%, n = 4458 participants, 24 randomized control trials). Pharmacovigilance data confirmed a higher frequencies of skin disorders and other ADEs compared to various comparator drugs. Compared to azithromycin, SMX-TMP was associated with a 5-fold increase in Stevens-Johnson syndrome, a 3-fold increase in toxic epidermal necrolysis, and a 10-fold increase in drug reaction with eosinophilia and systemic symptoms. Additionally, SMX-TMP showed a 10-fold increase in reports of pancytopenia, a 6-fold increase in neutropenia, a 4-fold increase in both thrombocytopenia and aplastic anaemia, a 56-fold increase in hyperkalaemia, and a 10-fold increase in hyponatraemia.</p><p><strong>Conclusion: </strong>Our meta-analyses and pharmacovigilance study suggested SMX-TMP was associated with increased risk of ADEs compared to other antibiotics including amoxicillin/clavulanate, azithromycin and nitrofurantoin. Further robust research is essential to confirm these safety signals and guide clinical practice.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699743","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":"Education about deprescribing for pre-licensed and licensed healthcare professionals: A scoping review.","authors":"Brian J Chow, Alexi M Yuzwenko, Liz Dennett, Cheryl A Sadowski","doi":"10.1002/bcp.70040","DOIUrl":"https://doi.org/10.1002/bcp.70040","url":null,"abstract":"<p><p>Deprescribing is complex because it involves patients' health, values, and preferences. The World Health Organization and Canadian Medication Appropriateness and Deprescribing Network have recommended that deprescribing be integrated into health curricula, prompting the need for further understanding about deprescribing education. The purpose of this research is to describe the literature regarding deprescribing education provided to healthcare professionals. We conducted a scoping review using the five-step model by Arksey and O'Malley with revisions from Levac et al. The databases searched included Medline, Scopus, Embase and ERIC. Papers were included if they were written in English and contained an educational intervention about deprescribing tailored toward physicians, pharmacists or nurses. White papers and conference abstracts were included. A total of 4853 abstracts were eligible for screening and 46 papers were included (25 full texts, 15 conference abstracts and 6 white papers). Thirty-three papers utilized group education for their intervention and of these, 20 involved interactive portions. Medicine was the most targeted profession, included in 29 papers. The most common outcomes were the number of medications deprescribed and an increase in learner knowledge and self-efficacy regarding deprescribing using self-assessment surveys or post-educational examinations. We found that there is evidence that educational interventions can increase participant knowledge regarding deprescribing and improve self-efficacy. To expand the education of deprescribing, future interventions should engage and utilize a variety of health professions and interventions could include real patients. Further research is required to determine the retention and application of deprescribing knowledge gained from single educational interventions.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699741","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":"European Medicines Agency (EMA) commentary on EMA/CHMP Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations","authors":"Andreas Bonertz,&nbsp;Catherine Drai,&nbsp;Thomas Castelnovo,&nbsp;Diana Hartenstein,&nbsp;Susanne Kaul,&nbsp;Milica Mitrevski,&nbsp;Jose M. Zubeldia","doi":"10.1002/bcp.70048","DOIUrl":"10.1002/bcp.70048","url":null,"abstract":"&lt;p&gt;The European Medicines Agency (EMA) promotes regulatory science and innovation by providing state-of-the-art recommendations to medicines developers. Guidelines developed by EMA's committees and working parties support evidence generation and encourage appropriate methodology, enabling the evaluation of medicinal products. The newly developed &lt;i&gt;Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate-to-low-sized study populations&lt;/i&gt; provides regulatory and scientific guidance on the development of medicinal products for the diagnosis and immunotherapy of allergies.&lt;/p&gt;&lt;p&gt;The guideline is addressed to all stakeholders involved in developing medicinal products for in vivo diagnosis of allergies and allergen immunotherapy (AIT).&lt;/p&gt;&lt;p&gt;In this commentary, we outline the historical and regulatory background, as well as the anticipated benefits of the new guideline for the development of allergen products for immunotherapy and the diagnosis of allergies when only moderate- to low-sized study populations are available. The guideline is anticipated to be published in the coming months.&lt;/p&gt;&lt;p&gt;The guideline considers a moderate- to low-sized study population as a population for which a standard development programme with the usual statistical rigor on a clinically relevant endpoint is not feasible, necessitating alternative strategies to collect data required for regulatory decision-making. Guidance is provided on quality, nonclinical and clinical aspects of allergen product development for in vivo diagnosis of type I allergy (prick test, provocation test) and type IV allergy (epicutaneous patch test) as well as for allergen immunotherapy.&lt;/p&gt;&lt;p&gt;The guideline is not applicable to any common clinically relevant allergen of type I allergy (diagnostic or allergen immunotherapy), defined in Annex 1 of the recommendations on common regulatory approaches for allergen products (CMDh/399/2019).&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;Further, the guideline does not cover medicinal allergen products manufactured using recombinant DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations, as these differ substantially from the allergen products.&lt;/p&gt;&lt;p&gt;According to the European Union Directive for medicinal products currently in force (Directive 2001/83/EC), allergen products (for therapy and diagnosis) are defined as medicinal products throughout the EU, and a marketing authorization is therefore required for their distribution. There are several guidelines for the development and evaluation of allergen products in the EU, all of which aim to define how to develop allergen products according to current scientific knowledge. However, none of these guidelines provide specific advice on the clinical development of allergen products intended for use in small populations.&lt;/p&gt;&lt;p&gt;For example, requirements according to the &lt;i&gt;Guideline on clinical evaluation of diagnostic agents&lt;/i&gt; (CPMP/EWP/1119/98/Rev. 1)&lt;span&gt;&lt;","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 5","pages":"1293-1296"},"PeriodicalIF":3.1,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/bcp.70048","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The tacrolimus concentration-to-dose ratio is associated with kidney function in heart transplant recipients.","authors":"Maaike R Schagen, Teun B Petersen, Boris C A Seijkens, Jasper J Brugts, Kadir Caliskan, Alina A Constantinescu, Brenda C M de Winter, Isabella Kardys, Dennis A Hesselink, Olivier Manintveld","doi":"10.1002/bcp.70041","DOIUrl":"https://doi.org/10.1002/bcp.70041","url":null,"abstract":"<p><strong>Aim: </strong>Heart transplantation (HT) is frequently complicated by chronic kidney disease, of which tacrolimus-related nephrotoxicity is an important cause. In kidney and liver transplant recipients, fast tacrolimus metabolism (defined as a low concentration-to-dose [C₀/D] ratio), negatively affects kidney function. Here, the association between the C₀/D ratio and kidney function in HT recipients was investigated.</p><p><strong>Methods: </strong>This was a retrospective study including 209 HT recipients who received an immediate-release tacrolimus formulation. The C₀/D ratio and kidney function (estimated glomerular filtration rate [eGFR]) were assessed at 3, 6, 12, 36 and 60 months post-HT. Patients were categorized as fast, intermediate and slow metabolisers, depending on their individual median C₀/D ratio as calculated over the follow-up period. A linear mixed-effects model analysis was performed, in which the time-varying eGFR was the dependent variable.</p><p><strong>Results: </strong>The distribution of the individual median C₀/D ratios ranged from 0.41 to 8.9 ng/mL/mg. At baseline, patients' kidney function was comparable. In the multivariable linear mixed-effects model, fast metabolisers (C₀/D ratio ≤1.53) had a significantly lower eGFR compared to slow metabolisers (C₀/D ratio >2.27) (-6.8 mL/min/1.73 m², 95% CI -11.2, -2.4, p = 0.002). This association was confirmed when utilizing the individual median C₀/D ratio as a continuous variable: for each 1 unit increase in the C₀/D ratio there was a 2.8 mL/min/1.73 m² (95% CI 1.0, 4.5) increase in eGFR (P = 0.002).</p><p><strong>Conclusion: </strong>Fast tacrolimus metabolism is significantly associated with worse kidney function in HT recipients in the first 5 years post-HT when compared to recipients with intermediate and slow tacrolimus metabolism.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656075","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":"Severe myelosuppression and alopecia after thiopurine initiation in a patient with NUDT15 deficiency","authors":"Annie Siyu Wu,&nbsp;Lee Mozessohn,&nbsp;Richard B. Kim,&nbsp;Jonathan S. Zipursky","doi":"10.1002/bcp.70047","DOIUrl":"10.1002/bcp.70047","url":null,"abstract":"<p>Thiopurines are a class of immunosuppressant and antineoplastic agents. They are widely used in the treatment of inflammatory bowel disease, haematological malignancies and autoimmune diseases, but can cause significant toxicity. Inherited gene mutations are now recognized as independent risk factors for severe adverse drug reactions to thiopurines even at 10-fold dose reductions. We present a case of thiopurine toxicity resulting in severe myelosuppression, hepatotoxicity and alopecia in an individual with homozygous *3/*3 loss-of-function alleles in the <i>NUDT15</i> gene. Our case highlights important differences in gene mutation frequencies between races that can help guide pharmacogenomic testing.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 5","pages":"1511-1515"},"PeriodicalIF":3.1,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/bcp.70047","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the environmental impact of medicines in Italy using data from the Italian Medicines Agency","authors":"Valentina Giunchi,&nbsp;Michele Fusaroli,&nbsp;Agnese Cangini,&nbsp;Filomena Fortinguerra,&nbsp;Simona Zito,&nbsp;Andrea Pierantozzi,&nbsp;Carlotta Lunghi,&nbsp;Elisabetta Poluzzi,&nbsp;Francesco Trotta","doi":"10.1002/bcp.70046","DOIUrl":"10.1002/bcp.70046","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>This study builds on the environmental risk analysis presented in the 2022 National Report on Medicines Use in Italy by the Italian Medicines Agency and aims to assess the environmental risk posed by medicines in Italy and its regions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The analysis selected 90 medicines based on three criteria: high utilization, low predicted no effect concentration (PNEC), and inclusion or candidacy for the European Watch List. For each medicine, the environmental risk was computed as the ratio between the predicted environmental concentration (PEC) and the PNEC. The PEC was derived following the approach of the Swedish Association of Pharmaceutical Industries and Italian drug utilization data. The risk was classified high if the ratio was greater than 10 and moderate if greater than 1.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Overall, 13 medicines were identified as posing a high risk, including cardiovascular agents, antibiotics, analgesics, antidepressants and antiparasitic agents. The high risk was driven by either a very low PNEC (eg, estradiol and lacidipine) or high utilization (eg, amoxicillin, ibuprofen and diclofenac). Regional analysis showed higher risk due to high consumption for azithromycin and ofloxacin in central and southern Italy, and for levonorgestrel in northern Italy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This study points to the need for prioritizing targeted sampling in surface waters for medicines estimated at high risk. To prevent and mitigate the risk, a more conscious clinical practice coupled with appropriate waste management are required.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 5","pages":"1297-1305"},"PeriodicalIF":3.1,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/bcp.70046","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"General practitioner consultation for postmenopausal bleeding after COVID-19 vaccination-a self-controlled cohort study.","authors":"Rana Jajou, Eugène P van Puijenbroek, Renee Veldkamp, Jetty A Overbeek, Florence P A M van Hunsel, Agnes C Kant","doi":"10.1002/bcp.70045","DOIUrl":"https://doi.org/10.1002/bcp.70045","url":null,"abstract":"<p><strong>Aims: </strong>The incidence of postmenopausal bleeding (PMB) has been increasing over the past years. Little is known about the risk of PMB after COVID-19 vaccination. Our study aimed to investigate this based on routine general practitioner (GP) healthcare data from the Netherlands.</p><p><strong>Methods: </strong>A retrospective self-controlled cohort study was performed, which included women aged ≥50 years who received at least 1 COVID-19 vaccination in 2021 and were registered in the GP databases of Nivel (the Nivel Primary Care Database, Nivel-PCD) or PHARMO by 1 January 2021. GP consultations for PMB in the exposed period (28 days after each COVID-19 vaccination) were compared with the nonexposed period (all-time outside the exposed period). Incidence rate ratios (IRRs) were calculated using Poisson regression, adjusting for SARS-CoV-2 infection during the study follow-up period.</p><p><strong>Results: </strong>A total of 692 760 COVID-19 vaccinated women aged ≥50 years were included. No increased GP consultations for PMB was observed for all COVID-19 vaccines together, as well as when stratifying the results by vaccine type (mRNA vs. vector) and vaccine brand (Pfizer/BioNTech, Moderna, AstraZeneca, Johnson & Johnson). After the second Moderna dose an adjusted IRR of 1.47 (95% confidence interval: 0.93-2.32) was observed and after the third Pfizer/BioNTech dose an adjusted IRR of 1.33 (95% confidence interval: 0.92-1.93); however, these results were not statistically significant.</p><p><strong>Conclusion: </strong>No increased number of GP consultations for PMB in primary care was observed after COVID-19 vaccination in general, nor for any of the COVID-19 vaccine brands, vaccine doses or potential risk groups.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656125","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}