Fezolinetant Veoza™ As a Nonhormonal Treatment for Moderate to Severe Vasomotor Symptoms in Postmenopausal Women: A Systematic Literature Review and Meta-Analysis
Author(s)
Geetank Kamboj, MPharm1, Parinita Barman, MPH1, Surabhi Aggarwal, MPharm1, George Papadopoulos, BSc (Hons)2, Michael Aristides, MSc2, Kathryn Williams, MHealthEc2, Hemant Rathi, MSc1.
1Skyward Analytics, Gurugram, India, 2Lucid Health Consulting, Sydney, Australia.
1Skyward Analytics, Gurugram, India, 2Lucid Health Consulting, Sydney, Australia.
OBJECTIVES: To evaluate the dose-specific efficacy and safety of fezolinetant 30mg and 45mg versus placebo in postmenopausal women with moderate-to-severe vasomotor symptoms (VMS).
METHODS: A systematic literature search was conducted across PubMed, the Cochrane Library, and clinical trial registries from inception to May 2025 to identify randomised controlled trials (RCTs) evaluating fezolinetant versus placebo. Separate meta-analyses were conducted for the 30mg and 45mg doses, to assess change from baseline in VMS frequency and severity. Meta-regression explored whether trial population (MHT-unsuitable versus overall) modified treatment effects. Safety data were summarised descriptively.
RESULTS: Of 208 records identified, 36 publications for five RCTs (DAYLIGHT, MOONLIGHT 1, SKYLIGHT 1, SKYLIGHT 2, SKYLIGHT 4) were included. At Week 12, compared to placebo, fezolinetant 30mg showed a least squares (LS) mean difference versus placebo of -1.58 VMS/day (95% CI: -2.70 to -0.47; I²=80%) for frequency and -0.16 units (95% CI: -0.25 to -0.07; I²=0%) for severity. Compared to placebo, the 45mg dose showed greater reductions: -2.25 VMS/day (95% CI: -2.74 to -1.77; I²=0%) in frequency and -0.29 units (95% CI: -0.39 to -0.18; I²=20%) in severity, based on combined Week 12 and Week 24 data. Meta-regression showed no statistically significant effect modification by trial population (MHT-unsuitable versus overall) for either VMS frequency (p=0.215) or VMS severity (p=0.173). Forest and bubble plots demonstrated consistent treatment effects across studies, particularly for 45mg, where heterogeneity was minimal. Adverse event rates were similar between fezolinetant and placebo groups, with no dose-related increase in discontinuations.
CONCLUSIONS: Fezolinetant provides dose-dependent reductions in VMS frequency and severity. The 45mg dose exceeded the commonly accepted clinical benefit threshold of ≥2 VMS/day reduction, indicating a clinically meaningful benefit. These findings support fezolinetant 45mg as an effective and well-tolerated targeted non-hormonal treatment option for postmenopausal women, including those unsuitable for MHT.
METHODS: A systematic literature search was conducted across PubMed, the Cochrane Library, and clinical trial registries from inception to May 2025 to identify randomised controlled trials (RCTs) evaluating fezolinetant versus placebo. Separate meta-analyses were conducted for the 30mg and 45mg doses, to assess change from baseline in VMS frequency and severity. Meta-regression explored whether trial population (MHT-unsuitable versus overall) modified treatment effects. Safety data were summarised descriptively.
RESULTS: Of 208 records identified, 36 publications for five RCTs (DAYLIGHT, MOONLIGHT 1, SKYLIGHT 1, SKYLIGHT 2, SKYLIGHT 4) were included. At Week 12, compared to placebo, fezolinetant 30mg showed a least squares (LS) mean difference versus placebo of -1.58 VMS/day (95% CI: -2.70 to -0.47; I²=80%) for frequency and -0.16 units (95% CI: -0.25 to -0.07; I²=0%) for severity. Compared to placebo, the 45mg dose showed greater reductions: -2.25 VMS/day (95% CI: -2.74 to -1.77; I²=0%) in frequency and -0.29 units (95% CI: -0.39 to -0.18; I²=20%) in severity, based on combined Week 12 and Week 24 data. Meta-regression showed no statistically significant effect modification by trial population (MHT-unsuitable versus overall) for either VMS frequency (p=0.215) or VMS severity (p=0.173). Forest and bubble plots demonstrated consistent treatment effects across studies, particularly for 45mg, where heterogeneity was minimal. Adverse event rates were similar between fezolinetant and placebo groups, with no dose-related increase in discontinuations.
CONCLUSIONS: Fezolinetant provides dose-dependent reductions in VMS frequency and severity. The 45mg dose exceeded the commonly accepted clinical benefit threshold of ≥2 VMS/day reduction, indicating a clinically meaningful benefit. These findings support fezolinetant 45mg as an effective and well-tolerated targeted non-hormonal treatment option for postmenopausal women, including those unsuitable for MHT.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO123
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
Reproductive & Sexual Health