Noémie Roland, Anke Neumann, Bérangère Baricault, Pauline Dayani, Lise Duranteau, Sylvie Fontanel, Isabelle Yoldjian, Sébastien Froelich, Mahmoud Zureik, Alain Weill
{"title":"大剂量醋酸环丙孕酮与颅内脑膜瘤：2018-2019年法国实施的风险最小化措施的影响","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":null,"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":2.4000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706701/pdf/","citationCount":"0","resultStr":"{\"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\":null,\"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\":2.4000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706701/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacoepidemiology and Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/pds.70078\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70078","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
High-Dose Cyproterone Acetate and Intracranial Meningioma: Impact of the Risk Minimisation Measures Implemented in France in 2018-2019.
Purpose: 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).
Methods: 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.
Results: 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).
Conclusion: 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%.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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