Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial
An erratum to this article was published (BMJ, 27 Nov 2024 ↗)
Primary result · Daily frequency of moderate-severe VMSResult — go to the resultLeast squares mean difference −1.93 95% CI −2.64 to −1.22Authors' conclusion
Fezolinetant was efficacious and well tolerated over a six month period for treating moderate-severe vasomotor symptoms in individuals considered unsuitable for hormone therapy. These results highlight the utility of fezolinetant as an effective treatment option for those who have contraindications to or choose not to use hormone therapy.
Study context
- Population
- Individuals aged 40–65 years with moderate-severe VMS associated with menopause, unsuitable for hormone therapy (contraindicated, caution, stoppers or averse)370 completed
- Participants
- 453 individuals
- Comparison
- Fezolinetant 45 mg vs placebo once daily for 24 weeks
- Fezolinetantn = 227
- Placebon = 226reference
- Primary endpoint
- Mean change in daily frequency of moderate-severe VMS from baseline
- Follow-up
- Week 24
Methodological detailsphase 3b, placebo-controlled, 16 countries
- Phase 3b
- Placebo-controlled
- 16 countries
Primary result
Daily frequency of moderate-severe VMS
Least squares mean difference
−1.93
95% CI −2.64 to −1.22
P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Estimate | P value | |
|---|---|---|---|
| Severity of VMS · week 24 | least squares mean difference −0.39 (95% CI −0.57 to −0.21) | P < 0.001 | |
| Sleep disturbance (PROMIS SD-SF 8b total score) · week 24Greater reduction with Fezolinetant | difference −2.5 (95% CI −3.9 to −1.1) | P < 0.001 | |
| −4−202Difference (linear scale) |
Onset of improvement
- Improvements over placebo observed as early as week 1
Safety
TEAEs
Serious TEAEs
Treatment emergent adverse events (TEAEs)
- Similar incidences in both groups
Most common TEAEs with fezolinetant
- Covid-19
- 30 (13.3%)
- Headache
- 20 (8.8%)
- Fatigue
- 13 (5.8%)
Original publication
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