Pharmacoepidemiology and Drug Safety最新文献

{"title":"A Real-World Pharmacovigilance Study of FDA Adverse Event Reporting System Events for Obeticholic Acid.","authors":"Le Hai, Jiaojiao Wu, Xiaohong Pan, Weicheng Yin, Zhishan Wu","doi":"10.1002/pds.70084","DOIUrl":"https://doi.org/10.1002/pds.70084","url":null,"abstract":"<p><strong>Background and objectives: </strong>Based on the Adverse Event Reporting System (FAERS) data from the US FDA, this study mined the adverse drug reactions of obeticholic acid (OCA) in the real world and provided reference for clinical safe drug use.</p><p><strong>Methods: </strong>Adverse event reports for OCA from the second quarter of 2016 to the third quarter of 2023 were extracted. The analysis for adverse reaction signal detection was conducted using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods.</p><p><strong>Results: </strong>A total of 5661 OCA-related adverse event reports were collected, and 105 OCA-related adverse reaction signals were obtained, involving 14 systems, among which 46 new signals were not previously mentioned in the product labeling. Severe adverse event of OCA accounted for a relatively high proportion (1445 cases, 25.53%), among which the number of hospitalization reports was the largest (1042 cases, 18.41%). The top five adverse events were pruritus, fatigue, constipation, elevated blood alkaline phosphatase, and abdominal distention. The top five adverse reaction signals intensity were abnormal blood alkaline phosphatase, abnormal ratio of albumin globulin, spider nevus, combined with abnormal bilirubin, and γ-abnormal glutamyl transferase.</p><p><strong>Discussion: </strong>Based on the pharmacovigilance study of the FAERS database, it is necessary to strengthen the clinical medication monitoring of OCA, so as to provide reference for effective pharmaceutical monitoring and rational clinical medication.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70084"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In Memoriam-Helle Kieler (1956-2024).","authors":"Carolyn E Cesta, Gabriella Bröms, Kari Furu, Sonia Hernandez-Diaz, Krista F Huybrechts, Olof Stephansson, Helga Zoega","doi":"10.1002/pds.70073","DOIUrl":"https://doi.org/10.1002/pds.70073","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70073"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142951488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictors of Potentially Inappropriate Stimulant Prescribing Among Adults.","authors":"Pavan V Thakkar, Angelique E Boutzoukas, Scott N Compton, Ohviya Sivashankar, Kanecia O Zimmerman, Daniel K Benjamin, M Alan Brookhart","doi":"10.1002/pds.70079","DOIUrl":"10.1002/pds.70079","url":null,"abstract":"<p><strong>Purpose: </strong>Increases in adult stimulant prescribing pose a potential risk due to the higher prevalence of contraindicated conditions among this population. We sought to identify patient, provider, and visit characteristics predictive of potentially inappropriate adult stimulant prescriptions.</p><p><strong>Methods: </strong>We conducted a repeated cross-sectional study using the National Ambulatory Medical Care Survey, a nationally representative weighted sample of 5 453 702 723 ambulatory care visits from 2012 to 2019. Potentially inappropriate prescriptions were defined as prescriptions to patients with potentially contraindicated conditions, as determined by US Food and Drug Administration stimulant labels.</p><p><strong>Results: </strong>Of the 5 453 702 723 visits, stimulant use was prevalent at 121384694 (2.23%) visits and newly prescribed at 18880152 (0.34%) visits. Of these, 4 620 138 (24.47%) new stimulant prescriptions and 28 055 947 (23.11%) prevalent prescriptions were potentially inappropriate. Potentially inappropriate prescribing increased over time and with age. Visits to primary care providers (relative risk [RR] 1.65, 95% CI 1.05-2.59) were predictive of inappropriate prescribing. Non-Hispanic Black (RR 0.48, 95% CI 0.33-0.70) and Hispanic race/ethnicity (RR 0.46, 95% CI 0.35-0.60), coronary artery disease (RR 0.54, 95% CI 0.33-0.86), pregnancy (RR 0.05, 95% CI 0.03-0.11), hypertension (RR 0.69, 95% CI 0.56-0.84), and glaucoma (RR 0.07, 95% CI 0.02-0.24) were predictive of decreased prevalent stimulant prescriptions; substance abuse was predictive of new stimulant prescribing (RR 2.14, 95% CI 1.07-4.27).</p><p><strong>Conclusions: </strong>The proportion of potentially inappropriate adult stimulant prescriptions increased over time and with patient age. Visits to primary care providers were predictive of potentially inappropriate prescribing, and a history of substance abuse was predictive of new stimulant prescriptions; therefore, quality improvement interventions regarding safe stimulant prescribing practices may be warranted.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70079"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11731891/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"More Drugs and Fewer Strokes? Time Trends in CVD Medication and Incidence of Stroke With German Health Insurance Data.","authors":"Lieselotte Mond, Siegfried Geyer, Juliane Tetzlaff, Karin Weißenborn, Johanna Schneider, Jelena Epping","doi":"10.1002/pds.70077","DOIUrl":"10.1002/pds.70077","url":null,"abstract":"<p><strong>Background: </strong>Successful prevention of cardiovascular diseases (CVD) may reduce the burden of diseases. Preventive medication is an important measure to decrease the risks of cardiovascular events, in particular myocardial infarction and stroke. The aim of this study is to analyze the prevalence of CVD preventive medication in Germany over time with respect to sex and age and to compare it with the temporal development of strokes.</p><p><strong>Methods: </strong>The study is based on statutory health insurance claims data from the AOK Niedersachsen (AOKN) covering the years 2005-2018. The study population comprises all AOKN insured persons aged 18 years and older (N = 2 088 495). Age-standardized time trends of the prevalence of CVD preventive medication and incidence of stroke were calculated for men and women in different age groups. After that, the relationship of both measures was examined in an ecological correlation.</p><p><strong>Results: </strong>We found a clear increase in medication prevalence over time. In 2018, about 35% of the total population and about 85% of those over 85 years of age received CVD preventive medication. At the same time, age-standardized incidence rates of ischemic stroke were decreasing slightly. The ecological correlation showed a negative association between medication prevalence and stroke incidence especially in the higher age groups.</p><p><strong>Conclusion: </strong>High correlation coefficients indicate that higher medication prevalence could be linked to better population health. Further research is needed to draw conclusions about the effects of increasing medicalization, including adverse risks and side effects at the population level.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70077"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706669/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142951568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Post-Market Evidence for Cancer Medicines in Regulatory and Clinical Decision-Making: A Scoping Review.","authors":"Eliza J McEwin, Ashleigh Hooimeyer, Barbara J Mintzes","doi":"10.1002/pds.70093","DOIUrl":"10.1002/pds.70093","url":null,"abstract":"<p><strong>Background: </strong>Cancer medicines usually have uncertain efficacy and safety profiles when they are first approved by medicines regulators because this evidence usually emerges post-market. Little is known about the extent to which post-market evidence is evaluated and integrated into evidence review processes in regulatory and clinical contexts.</p><p><strong>Objectives: </strong>The objective of this scoping review is to examine the literature on how post-market evidence on benefits and harms is evaluated and integrated in regulatory decisions and guidance for clinical decision-making.</p><p><strong>Methods: </strong>This scoping review focussed on the organisations that review cancer medicines and post-market evidence for their benefits and harms. It examined all regulatory or clinical contexts in which this post-market evidence might be included in evidence review processes for evaluation then integration into regulatory or clinical contexts. Four electronic databases were searched. Titles and abstracts were screened for all retrieved references followed by full-text screening by two independent reviewers according to pre-specified inclusion criteria.</p><p><strong>Results: </strong>In total, 28 studies met inclusion criteria. These included 31 assessments by medicines regulators, four by clinical practice guideline developers and two by health technology assessment agencies. Half of the studies evaluated clinical outcomes for benefit or harms (e.g., overall survival, serious adverse events). We found that more published literature evaluated and integrated post-market evidence for benefits and harms of cancer medicines in regulatory than in clinical situations, such as treatment guidelines and health technology assessments. In these studies, post-market evidence for harms seemed to be integrated more often than for benefits. And the studies showed a gap: only some of the evaluated post-market evidence was subsequently integrated in both regulatory and clinical situations.</p><p><strong>Conclusion: </strong>Overall, these findings raise important questions around the availability, accessibility, and assessment of post-market evidence for benefits and harms of cancer medicines so that it can be used by health professionals working in cancer services and by people with cancer.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70093"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety Assessment of Influenza Vaccination for Neurological Outcomes Among Older Adults in Japan: A Self-Controlled Case Series Study.","authors":"Mitsunori Ogawa, Yoshinori Takeuchi, Yukino Iida, Masao Iwagami, Kohei Uemura, Sachiko Ono, Nobuaki Michihata, Daisuke Koide, Yutaka Matsuyama, Hideo Yasunaga","doi":"10.1002/pds.70082","DOIUrl":"10.1002/pds.70082","url":null,"abstract":"<p><strong>Purpose: </strong>To assess adverse neurological risks following influenza vaccination in older adults.</p><p><strong>Methods: </strong>Using a linked database of healthcare administrative claims data and vaccination records from an urban city in Japan (April 1, 2014, to March 31, 2020), we conducted an observational study utilizing a self-controlled case series design. We identified individuals aged ≥ 65 years who experienced adverse neurological outcomes, defined as hospitalizations related to epilepsy, paralysis, facial paralysis, neuralgia, neuritis, optic neuritis, migraine, extrapyramidal disorders, Guillain-Barre syndrome, or narcolepsy. We used conditional Poisson regression to analyze within-subject incidence rate ratios, comparing the risk of these outcomes during risk periods following influenza vaccination (0-6 days and 7-29 days after each vaccination) with nonvaccination periods. Our analysis was adjusted for age and season groups as time-varying covariates.</p><p><strong>Results: </strong>We enrolled 3283 eligible individuals (men: 1643; mean [standard deviation] age: 76 [7.3] years). The incidence rate ratio for the outcome during the risk periods was 0.93 (95% confidence interval, 0.66-1.30) in risk period 1 (0-6 days after vaccination) and 1.14 (0.96-1.35) in risk period 2 (7-29 days after vaccination), respectively.</p><p><strong>Conclusions: </strong>We found no evidence that the risk of adverse neurological events was increased after influenza vaccination in older adults. These results may help reassure older adults who are hesitant to receive influenza vaccination because of concerns regarding adverse neurological outcomes.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70082"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706699/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142951880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Success of the German Cystic Fibrosis Registry.","authors":"Lutz Naehrlich, Manuel Burkhart","doi":"10.1002/pds.70076","DOIUrl":"https://doi.org/10.1002/pds.70076","url":null,"abstract":"<p><p>The German Cystic Fibrosis (CF) Registry (GCFR) is a national General Data Protection Regulation-compliant centralised database sponsored by the German Cystic Fibrosis Association (Mukoviszidose e.V.) and based on informed consent for each participating patient, ethical approval, and data protection votes. The aims of the GCFR are to optimise quality of care for CF at the centres, generate epidemiologic overviews, address research questions related to improved CF care, and inform caregivers, patients (aimed at patient empowerment), and health authorities and industry (aimed at care planning and pharmacovigilance). Established in 1995, the Registry has captured data on > 9600 individuals with a combined total of more than 140 000 annual assessments with an estimated coverage rate of > 90%. Patient data are collected after informed consent and confirmed diagnosis of CF, or a CFTR-related disorder, or a screening-positive inconclusive diagnosis of CF (i.e., CFSPID). The registry collects core, encounter, and annual health data. Data include demographics, anthropometrics, lung function, microbiology, CF-specific complications and chronic medications, hospitalisations, demand-oriented antibiotic therapies, and outcomes (death and transplants). Real world and pharmacovigilance studies have been published and additional research underway; there is a formal process for requesting access to the GCFR.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70076"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Have People Treated With Antihypertensives Been Diagnosed With Hypertension? A Cross-Sectional Study in Stockholm, Sweden.","authors":"Indre Treciokiene, Tomas Forslund, Thomas Kahan, Katja Taxis, Björn Wettermark","doi":"10.1002/pds.70075","DOIUrl":"10.1002/pds.70075","url":null,"abstract":"<p><strong>Purpose: </strong>Studies on antihypertensive treatment are important, as hypertension remains the major risk factor for cardiovascular morbidity and premature death. However, antihypertensive medicines are also used for other conditions, and the use of these medicines as a proxy for a diagnosis of hypertension might lead to misclassification in pharmacoepidemiological studies. This study aimed to investigate to what extent people dispensed antihypertensive medicines have been diagnosed with hypertension.</p><p><strong>Methods: </strong>Cross-sectional study with data covering all healthcare and all dispensed prescriptions of antihypertensive medicines 2019 and diagnoses recorded 2015-2019 from the Stockholm Region, Sweden. Multinomial logistic regressions were used to assess the probability of having hypertension concerning age, sex, and antihypertensive drug class.</p><p><strong>Results: </strong>A total of 386 860 individuals were included, 49% men, 12% incident users, and 80% of all had a recorded diagnosis of hypertension. In 73% of incident users, only one antihypertensive drug class was dispensed, as compared to 36% of prevalent users. A total of 38% of incident users and 9% of prevalent users had none of the diagnoses selected for the study recorded in any health record during 5 years. Prevalent and older users over the age of 65 from high (50%-79%) to very high (80% and more) probability of a recorded diagnosis of hypertension. Patients on antiadrenergic agents, high-ceiling diuretics, aldosterone antagonists, or beta receptor blockers had a lower probability of having a recorded diagnosis of hypertension than patients dispensed angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers.</p><p><strong>Conclusion: </strong>Most patients dispensed antihypertensive medicines have a diagnosis of hypertension. However, caution is needed using data on dispensed medicines to classify incident antihypertensive users and younger patients as having a diagnosis of hypertension.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70075"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706671/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Glucagon-Like Peptide 1 Receptor Agonists and Chronic Lower Respiratory Disease Among Type 2 Diabetes Patients: Replication and Reliability Assessment Across a Research Network.","authors":"Mitchell M Conover, Yasser Albogami, Jill Hardin, Christian G Reich, Anna Ostropolets, Patrick B Ryan","doi":"10.1002/pds.70087","DOIUrl":"10.1002/pds.70087","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study is to use observational methods to evaluate reliability of evidence generated by a study of the effect of glucagon-like peptide 1 receptor agonists (GLP-1RA) on chronic lower respiratory disease (CLRD) outcomes among Type-2 diabetes mellitus (T2DM) patients.</p><p><strong>Research design and methods: </strong>We independently reproduced a study comparing effects of GLP-1RA versus dipeptidyl peptidase-4 inhibitors (DPP4-i) on CLRD outcomes among patients with T2DM and prior CLRD. We reproduced inputs and outputs using the original study data (national administrative claims) and evaluated the robustness of results in comparison to alternate design/analysis decisions. To evaluate generalizability, we applied an analysis protocol and conducted a meta-analysis across a research network that includes a diverse array of populations and data sources. We also produced additional analyses evaluating individual drugs within the GLP-1RA class and CLRD outcomes.</p><p><strong>Results: </strong>We confirmed alignment of study inputs and outputs and closely reproduced effect estimates and sensitivity analyses. Adjusted effect estimates were robust to empirical calibration. Network meta-analysis confirmed original findings but indicated weaker effects than originally published. Meta-analysis of drugs within the GLP-1RA class against DPP4-i provided evidence that effects vary within the GLP-1RA class, indicating stronger effects for exenatide and weaker effects of dulaglutide.</p><p><strong>Conclusions: </strong>This study supports and establishes the reliability of the original study by (1) producing consistent findings in a range of alternate databases and populations, (2) demonstrating effects for multiple drugs within the GLP-1RA class, and (3) independently confirming the reproducibility of the original study and its findings. This reliability evaluation provides the beginnings of a broader framework for using standardized tools and distributed data networks to systematically interrogate the reliability of findings generated using observational data.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70087"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143056091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-Dose Cyproterone Acetate and Intracranial Meningioma: Impact of the Risk Minimisation Measures Implemented in France in 2018-2019.","authors":"Noémie Roland, Anke Neumann, Bérangère Baricault, Pauline Dayani, Lise Duranteau, Sylvie Fontanel, Isabelle Yoldjian, Sébastien Froelich, Mahmoud Zureik, Alain Weill","doi":"10.1002/pds.70078","DOIUrl":"10.1002/pds.70078","url":null,"abstract":"<p><strong>Purpose: </strong>To measure the impact of national regulatory actions implemented in France in August 2018 and June 2019 to reduce the risk of meningioma associated with the use of cyproterone acetate (CPA).</p><p><strong>Methods: </strong>Using the French National Healthcare database, we calculated the monthly number of CPA users among cisgender women, men and transgender women in 2010-2021, the monthly proportion of users with cerebral imaging screening, and the annual rate of meningioma surgery associated with CPA use. CPA discontinuations and switches were analysed.</p><p><strong>Results: </strong>Between 2018 and 2021, the number of individuals exposed to CPA fell by 85% (55 000 in August 2018 versus 7900 users of high-dose CPA in December 2021), corresponding to two waves of decrease in both use and initiation. This drop was greater among cisgender women (88%) than men (69%) or transgender women (50%). Cerebral imaging screening increased from 11% in June 2018 to 70% in June 2021 for ciswomen (13%-51% for men, 9%-60% for transwomen). After CPA discontinuation, no massive shift to a single product was observed, but, instead, dispersion towards other hormonal therapies. The overall annual rate of meningioma surgery associated with CPA exposure spectacularly decreased between 2017 and 2021 (-93% for ciswomen and -86% for men).</p><p><strong>Conclusion: </strong>In France, high-dose CPA use sharply decreased after the implementation of national regulatory measures without a massive switch to other hormonal therapies. The increase in cerebral imaging screening did not result in an increase in meningioma surgery associated with CPA, but rather a massive drop of over 90%.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70078"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}