Saltus C, Djibo DA, Peetluk L, Kaye J, McMahill-Walraven C, Johannes C, Bernick B, Calingaert B, Franklin J, Graham S, Pigoga J, Shuminski P, Margulis AV. Use of very low-dose vaginal estrogens among postmenopausal women in the US. Poster presented at the 39th ICPE Annual Conference; August 26, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):352-3. doi: 10.1002/pds.5687

BACKGROUND: Vulvar and vaginal atrophy (VVA) is a common condition, reported in surveys by approximately half of postmenopausal women. It results from estrogen deficiency; its symptoms include dyspareunia, vaginal dryness, and dysuria. Systemic and vaginal estrogen treatments, including but not limited to very low-dose vaginal estrogen (VLDVE) therapy, defined as 10 µg or less estradiol or 0.30 mg or less conjugated estrogens daily, have proven successful in controlling VVA symptoms.

OBJECTIVE: The objective of this drug-utilization study was to describe the duration and patterns of use of VLDVE products as part of a postmarketing requirement for the VLDVE Imvexxy (estradiol vaginal inserts) from the United States Food and Drug Administration (EUPAS41957). Methods: This cohort study used United States Aetna claims data from July 2018 through June 2022 and the Optum Research Database from July 2018 through December 2021 and included women aged 50 years or older with 12 months of continuous enrollment and no documented hysterectomy. Follow-up ended at the earliest of endometrial cancer diagnosis, hysterectomy, death, disenrollment, or end of the study period. Among these women, we quantified the number of treatment episodes, duration of treatment, prior use of systemic estrogens, and concomitant use of VLDVE and systemic estrogens.

RESULTS: Among 4,893,157 eligible women, the mean age was 66 years, and the mean duration of follow-up was approximately 2 years. Of these women, 379,532 (7.8%) used estrogen products during follow-up. In total, 50,899 women (1.0%) used VLDVEs (including Imvexxy) with a total of 92,643 treatment episodes. Approximately half of the VLDVE episodes were preceded by a visit to a primary care provider for routine gynecologic care. Among VLDVE users, 30,646 (60.2%) had one treatment episode during follow-up, 8,657 (17%) had previously used opposed systemic estrogens, and 4,755 (9.3%) had used unopposed systemic estrogens. The median treatment duration was approximately 4 months, and 84,899 treatment episodes (91.6%) did not have concomitant use of a systemic estrogen.

CONCLUSION: Among nearly 5 million women aged 50 years or older without hysterectomy, VLDVE use was rare (1% over a mean 2-year follow-up). VLDVE treatment episodes were generally short; the vast majority did not have concomitant systemic estrogen use. Although VVA is commonly reported in surveys, current treatment with hormonal therapy is reported in less than 10% of women. Our study also found very little use of VLDVE treatment in women of postmenopausal age likely to experience VVA, suggesting potential barriers to the management of VVA.

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