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

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). 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. 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). Real-world evidence suggests that the MACE risk is significantly lower among women treated with E2/P4 compared to CEE/MPA. This study examined myocardial infarction, stroke or heart failure events that were serious enough to require hospitalization (collectively referred to as major adverse cardiovascular events [MACE]) among women aged 40 years and older who started hormone therapy for menopause. The study compared the occurrence of MACE between women taking two different types of oral hormone therapy. The specific combined oral menopause hormone therapies compared in the current study were body-identical oral 17β-estradiol/micronized progesterone (E2/P4) and conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA). The study used real-world data from women who began menopause hormone therapy treatment between April 2019 and June 2021 who were not hospitalized for MACE before the start of treatment. The study included 6520 women treated with E2/P4 and 29,426 women treated with CEE/MPA. To make a fair comparison, statistical analysis techniques were used to account for differences between the two groups such as age and health history. The results showed that for every 10,000 women taking E2/P4 over a period of 1 year, 24 women had MACE hospitalization. In contrast, for every 10,000 comparable women taking CEE/MPA over a period of 1 year, 85 women had MACE hospitalization. The study results suggest that the risk of MACE hospitalization is lower among women treated with E2/P4 than those treated with CEE/MPA.