John C Stevenson, Rodney Baber, Risa Kagan, Rossella E Nappi, Santiago Palacios, Nick Panay, Tomasz Paszkowski, Petra Stute, Julie Heroux, Renata Zablotna-Pociupany, Mitra Boolell
{"title":"口服雌二醇/微粉孕酮与结合雌激素/甲羟孕酮治疗绝经妇女的主要不良心血管事件风险：美国的一项索赔数据分析","authors":"John C Stevenson, Rodney Baber, Risa Kagan, Rossella E Nappi, Santiago Palacios, Nick Panay, Tomasz Paszkowski, Petra Stute, Julie Heroux, Renata Zablotna-Pociupany, Mitra Boolell","doi":"10.1080/13697137.2025.2509850","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Using real-world data, the current study compared the risk of major adverse cardiovascular events (MACE) between two regulated combined oral hormonal products that are currently available to women in the USA: body-identical oral 17β-estradiol/micronized progesterone (E2/P4) and conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA).</p><p><strong>Methods: </strong>Women aged ≥40 years treated with E2/P4 or CEE/MPA were selected from a US claims database (April 2019-June 2021). The E2/P4 or CEE/MPA cohorts were defined based on the first dispensation of E2/P4 or CEE/MPA (index) as prescribed in the real world. Women with pre-index MACE hospitalization were excluded. Confounding was controlled via inverse probability of treatment (IPT) weighting. MACE risk was compared between the IPT-weighted cohorts using Cox and Poisson/negative binomial regression models.</p><p><strong>Results: </strong>The E2/P4 and CEE/MPA cohorts included 6520 and 29,426 women respectively (mean follow-up 1.2 and 1.4 years). In the IPT-weighted analyses, MACE rates were 23.5 versus 85.4 per 10,000 women-years among women treated with E2/P4 and CEE/MPA (IPT-weighted incidence rate ratio [IRR] 0.28, 95% confidence interval [CI] 0.17 - 0.45; IPT-weighted hazard ratio [HR] 0.37, 95% CI 0.27 - 0.50).</p><p><strong>Conclusions: </strong>Real-world evidence suggests that the MACE risk is significantly lower among women treated with E2/P4 compared to CEE/MPA.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"1-11"},"PeriodicalIF":3.2000,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Major adverse cardiovascular events risk in menopausal women treated with oral estradiol/micronized progesterone versus conjugated estrogens/medroxyprogesterone: a claims data analysis in the USA.\",\"authors\":\"John C Stevenson, Rodney Baber, Risa Kagan, Rossella E Nappi, Santiago Palacios, Nick Panay, Tomasz Paszkowski, Petra Stute, Julie Heroux, Renata Zablotna-Pociupany, Mitra Boolell\",\"doi\":\"10.1080/13697137.2025.2509850\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Using real-world data, the current study compared the risk of major adverse cardiovascular events (MACE) between two regulated combined oral hormonal products that are currently available to women in the USA: body-identical oral 17β-estradiol/micronized progesterone (E2/P4) and conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA).</p><p><strong>Methods: </strong>Women aged ≥40 years treated with E2/P4 or CEE/MPA were selected from a US claims database (April 2019-June 2021). The E2/P4 or CEE/MPA cohorts were defined based on the first dispensation of E2/P4 or CEE/MPA (index) as prescribed in the real world. Women with pre-index MACE hospitalization were excluded. Confounding was controlled via inverse probability of treatment (IPT) weighting. MACE risk was compared between the IPT-weighted cohorts using Cox and Poisson/negative binomial regression models.</p><p><strong>Results: </strong>The E2/P4 and CEE/MPA cohorts included 6520 and 29,426 women respectively (mean follow-up 1.2 and 1.4 years). In the IPT-weighted analyses, MACE rates were 23.5 versus 85.4 per 10,000 women-years among women treated with E2/P4 and CEE/MPA (IPT-weighted incidence rate ratio [IRR] 0.28, 95% confidence interval [CI] 0.17 - 0.45; IPT-weighted hazard ratio [HR] 0.37, 95% CI 0.27 - 0.50).</p><p><strong>Conclusions: </strong>Real-world evidence suggests that the MACE risk is significantly lower among women treated with E2/P4 compared to CEE/MPA.</p>\",\"PeriodicalId\":10213,\"journal\":{\"name\":\"Climacteric\",\"volume\":\" \",\"pages\":\"1-11\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-08-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Climacteric\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/13697137.2025.2509850\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Climacteric","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/13697137.2025.2509850","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Major adverse cardiovascular events risk in menopausal women treated with oral estradiol/micronized progesterone versus conjugated estrogens/medroxyprogesterone: a claims data analysis in the USA.
Objective: Using real-world data, the current study compared the risk of major adverse cardiovascular events (MACE) between two regulated combined oral hormonal products that are currently available to women in the USA: body-identical oral 17β-estradiol/micronized progesterone (E2/P4) and conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA).
Methods: Women aged ≥40 years treated with E2/P4 or CEE/MPA were selected from a US claims database (April 2019-June 2021). The E2/P4 or CEE/MPA cohorts were defined based on the first dispensation of E2/P4 or CEE/MPA (index) as prescribed in the real world. Women with pre-index MACE hospitalization were excluded. Confounding was controlled via inverse probability of treatment (IPT) weighting. MACE risk was compared between the IPT-weighted cohorts using Cox and Poisson/negative binomial regression models.
Results: The E2/P4 and CEE/MPA cohorts included 6520 and 29,426 women respectively (mean follow-up 1.2 and 1.4 years). In the IPT-weighted analyses, MACE rates were 23.5 versus 85.4 per 10,000 women-years among women treated with E2/P4 and CEE/MPA (IPT-weighted incidence rate ratio [IRR] 0.28, 95% confidence interval [CI] 0.17 - 0.45; IPT-weighted hazard ratio [HR] 0.37, 95% CI 0.27 - 0.50).
Conclusions: Real-world evidence suggests that the MACE risk is significantly lower among women treated with E2/P4 compared to CEE/MPA.
期刊介绍：
Climacteric is the official journal of the International Menopause Society (IMS). As an international peer-reviewed journal it publishes original research and reviews of all aspects of aging in women.
Climacteric was founded by the IMS in 1998 and today has become a leading journal in the publication of peer-reviewed papers on the menopause, climacteric and mid-life health. Topics covered include endocrine changes, symptoms attributed to the menopause and their treatment, hormone replacement and alternative therapies, lifestyles, and the counselling and education of peri- and postmenopausal women. Climacteric, published bimonthly, also features regular invited reviews, editorials and commentaries on recent developments.
The editorial review board of Climacteric includes leading scientific and clinical experts in the field of midlife medicine and research and is headed by its Editor-in-Chief, Professor Rod Baber of Australia. He and his team of Associate Editors act independently to set a clear editorial policy, co-ordinate peer review, and ensure a rapid response to submitted papers.
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