From Trial Data to Real-World Practice: Safety, Monitoring, and Patient Selection for VMS Treatment

This episode, titled 'From Trial Data to Real-World Practice: Safety, Monitoring, and Patient Selection for VMS Treatment,' features menopause experts discussing the following critical questions:

1. What were the most common adverse events reported in the trials of each agent? How does this compare to real-world patient experiences?
2. How long were patients followed, and how does that duration inform our understanding of long-term safety?
3. Are there any long-term safety concerns with these therapies, and how can pharmacists monitor and aid in their management?

Led by the moderator, the panelists examined the adverse event profiles of both fezolinetant and elinzanetant as reported in clinical trials, noting that side effects for both agents were generally mild to moderate with small percentages of liver enzyme elevations observed, underscoring the importance of the structured liver function monitoring protocols that differ between the two agents. The discussion also explored which patient populations are most appropriate candidates for these non-hormonal therapies in real-world practice, identifying breast cancer survivors, patients with high-risk VTE or cardiovascular history, those who have discontinued hormone therapy due to intolerable bleeding or progesterone-related side effects, and women past the window of opportunity for estrogen initiation as the core groups, while also highlighting the emerging use of these agents as adjuvants for patients on optimized hormone therapy who continue to experience breakthrough VMS. The panelists further noted that elinzanetant has a particular advantage in the oncology space, having been specifically studied in patients on endocrine therapies such as tamoxifen, and that both agents are increasingly being considered for patients with elevated breast cancer risk, positioning this growing and underserved population as a defining frontier for non-hormonal VMS treatment.

Throughout the conversation, the experts provide a comprehensive reflection on the field and the factors that may shape how clinicians approach care moving forward.

The next episode in this series, 'Listening First: How to Start, Guide, and Personalize Menopause Conversations with Patients,' features the panelists advancing their conversation on vasomotor symptoms and menopause and focusing on what a symptom-first patient conversation looks like in practice, how pharmacists can identify patients who warrant counseling, and how clinicians can gauge patient preferences around hormonal versus non-hormonal therapy while setting realistic expectations around onset of effect.