Oral estradiol/micronized progesterone may be associated with lower risk of venous thromboembolism compared with conjugated equine estrogens/medroxyprogesterone acetate in real-world practice. (June 2023)

• Record Type: Journal Article
• Authors: Panay, Nick; Nappi, Rossella E.; Stute, Petra; Palacios, Santiago; Paszkowski, Tomasz; Kagan, Risa; Archer, David F.; Héroux, Julie; Boolell, Mitra
• Is Part Of: Maturitas. Volume 172(2023)
• Page Start: 23
• Page End: 31
• Publication Date: 2023-06
• Subjects: Venous thromboembolism -- 17β-Estradiol/micronized progesterone -- Conjugated equine estrogens/medroxyprogesterone acetate -- Menopause -- Hormone therapy -- Safety; Climacteric -- Periodicals; Menopause -- Periodicals; Climacteric -- Periodicals; Geriatrics -- Periodicals; Menopause -- Periodicals; Middle Aged -- Periodicals; Climatère -- Périodiques; Ménopause -- Périodiques; Climacterium; Climacteric; Menopause; Electronic journals; Periodicals; 612.66
• DOI: 10.1016/j.maturitas.2023.04.004
• Languages: English
• ISSNs: 0378-5122

Abstract

Highlights: Conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA) is associated with increased risk of venous thromboembolism (VTE). VTE risk was compared for the first time between CEE/MPA and the new combined oral product 17β-estradiol/micronized progesterone (E2/P4). This retrospective longitudinal study used real-world claims data from the USA. Oral E2/P4 was associated with significantly lower VTE risk than oral CEE/MPA. Abstract: Objectives: The Women's Health Initiative study reported an increased risk of venous thromboembolism among menopausal women treated with conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA) versus placebo. Newer hormone therapies may have a lower venous thromboembolism risk. The study compared the risk of venous thromboembolism between women treated with the combined oral product 17β-estradiol/micronized progesterone (E2/P4) and those treated with oral CEE/MPA regimens. Study design: In a retrospective longitudinal study using real-world claims data from April 2019 to June 2021, women aged 40 years or more treated with oral E2/P4 or oral CEE/MPA who did not have a venous thromboembolism diagnosis before first dispensing claim of CEE/MPA or E2/P4 identified on or after May 1st 2019 (index date) were observed for 6 months or more after the index date. Oral E2/P4 and oral CEE/MPA had been prescribed by the treating physician in real-world practice and were observed through pharmacy dispensing records. Main outcome measures: Venous thromboembolism risk was compared between women receiving oral E2/P4 versus oral CEE/MPA. Results: The study included 36, 061 women treated with oral E2/P4 or oral CEE/MPA. In the analyses weighted by the inverse probability of treatment for control of potential confounding factors, the incidence of venous thromboembolism was significantly lower for oral E2/P4 compared with oral CEE/MPA (37/10, 000 women-years for oral E2/P4 vs 53/10, 000 women-years for oral CEE/MPA; incidence rate ratio 0.70, 95 % confidence interval: 0.53–0.92). Conclusions: Real-world evidence suggests that the risk of venous thromboembolism is significantly lower among women treated with oral E2/P4 compared with oral CEE/MPA.