Expert opinion on the treatment of vulvovaginal atrophy with ospemifene based on new evidence

Vulvovaginal atrophy (VVA) is an underdiagnosed and undertreated chronic condition resulting in physiological and histological changes in the genitourinary tract of postmenopausal women. Treatment of moderate to severe VVA includes local estrogens, dehydroepiandrosterone (DHEA) and oral ospemifene, a third-generation selective estrogen receptor modulator (SERM). Due to venous thromboembolism (VTE) safety concerns classically associated with the SERM class, and as part of its original marketing authorization approval (MAA), the European Medicines Agency (EMA) requested the performance of a 5-year post-authorization safety study (PASS) to study the incidence rate of VTE among women receiving ospemifene. The results have led to important regulatory changes to ospemifene's labeling, extending its indication and eliminating concerted risk management measures. A panel of experts discussed and reached consensus on the impact of these regulatory changes on clinical practice, reflecting on the reassurance of ospemifene's benefit-risk balance and recommending its positioning as a first-line pharmacological treatment option for moderate to severe VVA together with local therapies. In a scenario where different treatments present similar efficacy and safety profiles, a shared decision between clinician and patient, according to her needs and preferences over time, is fundamental to improve adherence and persistence with sequential treatment, contributing to the achievement of health outcomes.

Automated summary

Vulvovaginal atrophy (VVA) is a chronic condition in postmenopausal women, with underdiagnosis and undertreatment. Treatment options for moderate to severe VVA include local estrogens, dehydroepiandrosterone (DHEA), and oral ospemifene. A 5-year post-authorization safety study (PASS) was conducted to study the incidence of venous thromboembolism (VTE) in women receiving ospemifene. The results of the study led to regulatory changes in the labeling of ospemifene, expanding its indication and removing risk management measures.