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.

IF 3.2 4区 医学 Q1 OBSTETRICS & GYNECOLOGY
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
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Abstract

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.

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
目的:利用真实世界的数据,本研究比较了目前美国女性可获得的两种受调节的口服联合激素产品的主要不良心血管事件(MACE)风险:与身体相同的口服17β-雌二醇/微化孕酮(E2/P4)和共轭马雌激素/醋酸甲孕酮(CEE/MPA)。方法:从美国索赔数据库(2019年4月- 2021年6月)中选择年龄≥40岁的E2/P4或CEE/MPA治疗的女性。E2/P4或CEE/MPA队列是根据现实世界中规定的E2/P4或CEE/MPA(指数)的首次分配来定义的。排除指数前MACE住院的妇女。通过治疗逆概率(IPT)加权控制混杂。使用Cox和泊松/负二项回归模型比较ipt加权队列之间的MACE风险。E2/P4组和CEE/MPA组分别包括6520名和29426名女性(平均随访1.2年和1.4年)。在ipt加权分析中,E2/P4和CEE/MPA治疗的女性MACE发生率分别为23.5和85.4 / 10000女性年(ipt加权发病率比[IRR] 0.28, 95%可信区间[CI] 0.17 - 0.45;ipt加权风险比[HR] 0.37, 95% CI 0.27 - 0.50)。结论:现实证据表明,E2/P4治疗的女性与CEE/MPA相比,MACE风险显著降低。
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来源期刊
Climacteric
Climacteric 医学-妇产科学
CiteScore
1.70
自引率
7.10%
发文量
53
审稿时长
1 months
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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