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

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.

• Authors: Nick Panay, Rossella E Nappi, Petra Stute, Santiago Palacios, Tomasz Paszkowski, Risa Kagan, David F Archer, Julie Héroux, Mitra Boolell
• Journal: Maturitas (Maturitas) Vol. 172 Pg. 23-31 (Jun 2023) ISSN: 1873-4111 [Electronic] Ireland
• PMID: 37084589 (Publication Type: Journal Article)
• Copyright: Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.

Chemical References

• Estrogens, Conjugated (USP)
• Progesterone
• Medroxyprogesterone Acetate
• Estradiol

Topics

• Female
• Humans
• Estrogens, Conjugated (USP) (adverse effects)
• Progesterone (adverse effects)
• Medroxyprogesterone Acetate (adverse effects)
• Estradiol
• Venous Thromboembolism (chemically induced, epidemiology)
• Longitudinal Studies
• Retrospective Studies
• Estrogen Replacement Therapy (adverse effects)