17β-Estradiol and Progesterone combination oral therapy may be associated with lower thromboembolism risk than Conjugated Equine Estrogens/Medroxyprogesterone in menopausal women based on Real World Evidence data

Objective To compare venous thromboembolism risk (VTE) in menopausal women treated with bioidentical oral capsule containing 1mg 17β-estradiol/100mg micronized progesterone (E2/P4) versus conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA).

Materials Women treated with E2/P4 or CEE/MPA were selected from a US claims database covering a 3-year period till June 2021. E2/P4 and CEE/MPA were prescribed by physician in the real-world practice and observed through pharmacy records.

Methods VTE risk was assessed starting from the first prescription of E2/P4 or CEE/MPA (index date) until treatment switch or end of clinical activity records. The confounding control was achieved by using inverse probability of treatment (IPT)-weighted Kaplan-Meier plots and IPT-weighted regression models. Menopausal women aged ≥40 y who started therapy on E2/P4 (n= 6,526) or CEE/MPA (n= 29,535) did not have a VTE diagnosis in the 6 months prior to inclusion date (mean follow-up was 1.2 vs 1.4 years respectively).

Results At baseline, women initiated on E2/P4 were younger (mean age: 54 vs 56 for CEE/MPA), had less cardiovascular disease (34 vs 44%), less hypercholesterolemia (24 vs 31 In the IPT-weighted analyses). The VTE incidence per 10,000 women years was 37 for E2/P4 and 53 for CEE/MPA (IRR 0.70, 95% confidence interval [CI]: 0.53-0.92, p < 0.05); the hazard ratio for the time to first VTE was 0.70 (95% CI 0.53-0.92, p < 0.05).

Summary Continuous oral bio-identical therapy of 1mg estradiol/100 mg micronized progesterone might be associated with a lower risk of VTE in menopausal women compared to CEE/MPA.

Disclosures Study funded by Theramex.

Publication History

Article published online:
11 October 2022