Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study
Authors' conclusion
Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. The study was placebo-controlled for 12 weeks followed by a 40-week blinded extension to assess the maintenance of effect. Furthermore, the population studied was diverse and representative of the potential target population for fezolinetant therapy. Further characterisation of the benefit of fezolinetant on quality of life, including on symptoms of mood and sexual wellbeing, merits investigation.
Study context
- Population
- Women aged 40–65 years with an average of ≥7 moderate-to-severe hot flashes per day; 97 facilities in USA, Canada, Czech Republic, Hungary, Poland, Spain and UK2,205 recruited
- Participants
- 175 / 176 / 176
- Comparison
- Fezolinetant 30 mg or 45 mg once daily vs placebo
- Placebon = 175reference
- Fezolinetant 30 mgn = 176
- Fezolinetant 45 mgn = 176
- Primary endpoint
- Coprimary: mean change in frequency and severity of VMS from baseline
- Follow-up
- Weeks 4 and 12
Methodological detailsdouble-blind, placebo-controlled, 12-week, phase 3, 40-week active treatment extension, multicentre (97 facilities), Recruitment July 11, 2019 to Aug 11, 2021
- Double-blind
- Placebo-controlled
- 12-week
- Phase 3
- 40-week active treatment extension
- Multicentre (97 facilities)
- Recruitment July 11, 2019 to Aug 11, 2021
Primary result
As reported in the abstract
- Fezolinetant 30 mg · VMS frequency, week 4; SE 0.42
- difference in change in least squares mean −1.87; P < 0.001
- Fezolinetant 45 mg · VMS frequency, week 4; SE 0.42
- difference in change in least squares mean −2.07; P < 0.001
- Fezolinetant 30 mg · VMS frequency, week 12; SE 0.44
- difference in change in least squares mean −2.39; P < 0.001
- Fezolinetant 45 mg · VMS frequency, week 12; SE 0.43
- difference in change in least squares mean −2.55; P < 0.001
- Fezolinetant 30 mg · VMS severity, week 4; 0.06
- difference −0.15; P = 0.012
- Fezolinetant 45 mg · VMS severity, week 4; 0.06
- difference −0.19; P = 0.002
- Fezolinetant 30 mg · VMS severity, week 12; 0.08
- difference −0.24; P = 0.002
- Fezolinetant 45 mg · VMS severity, week 12; 0.08
- difference −0.20; P = 0.007
Further findings
Events
| Outcome | Placebo | Fezolinetant 30 mg | Fezolinetant 45 mg |
|---|---|---|---|
| Discontinued treatment before week 12Mostly due to adverse events or participant withdrawal | 23 | 31 | 13 |
Time course of VMS frequency and severity · 1 week to 52 weeks
- Improvements observed after 1 week and maintained over 52 weeks
Safety
Treatment-emergent adverse events · first 12 weeks
Events
| Outcome | Placebo | Fezolinetant 30 mg | Fezolinetant 45 mg |
|---|---|---|---|
| Liver enzyme elevations | 1 | 2 | 0 |
- Treatment-emergent adverse events: safety analysis set: 174, 173, 175
- Liver enzyme elevations: generally asymptomatic, transient, and resolved on treatment or after discontinuation
Original publication
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