Early onset, maintenance of effect, and day-/night-time findings following fezolinetant treatment for moderate to severe vasomotor symptoms associated with menopause: A pooled phase 3 analysis
EndocrinologiaResumo original em inglês
O que aconteceu
To evaluate onset of action, maintenance of effect, day-/night-time efficacy, and treatment response with fezolinetant for the treatment of vasomotor symptoms (VMS) using phase 3 data.
SKYLIGHT 1 and 2 enrolled individuals (≥40-≤65 years) assigned female at birth who were seeking treatment/relief from moderate to severe VMS. Participants were randomised to placebo, or fezolinetant 30 or 45 mg for 12 weeks. Subsequently, fezolinetant-treated participants continued their dose and placebo participants were re-randomised to fezolinetant 30 or 45 mg for 40 weeks.
SKYLIGHT 1 ClinicalTrials.gov: NCT04003155 (https://clinicaltrials.gov/ct2/show/NCT04003155). SKYLIGHT 2 ClinicalTrials.gov: NCT04003142 (https://clinicaltrials.gov/ct2/show/NCT04003142).
O que encontraram
Daily frequency and severity of VMS during week 1, up to week 12, over 52 weeks, during the day and night; and proportion of responders.
Improvements in VMS frequency and severity with fezolinetant versus placebo were observed from day 1 (1022 participants). At weeks 1 and 12, least squares mean (95 % confidence interval [CI]) reductions in VMS frequency for fezolinetant 45 mg versus placebo were - 1.46 (-2.01, -0.92) and - 2.51 (-3.20, -1.82). VMS frequency and severity improvements were maintained throughout 52 weeks and for both the day- and night-time assessments. A greater proportion of fezolinetant-treated participants had a reduction of ≥50 % in VMS frequency from baseline to week 12 versus placebo (58.7 % versus 36.0 %, odds ratio [95 % CI]: 2.542 [1.868-3.472]). Similar trends were noted with 30 mg.
Por que isso importa
The onset of action for fezolinetant was observed from day 1 for VMS frequency and severity and was maintained for 52 weeks. Fezolinetant can provide rapid and prolonged relief from VMS.
Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.
O estudo original
Early onset, maintenance of effect, and day-/night-time findings following fezolinetant treatment for moderate to severe vasomotor symptoms associated with menopause: A pooled phase 3 analysis
Marla Shapiro C M, Genevieve Neal-Perry, Petra Stute, Rebecca C Thurston, Wendy Wolfman, Marci English, Xi Wu, Faith D Ottery
Descritores MeSH
- Hot Flashes
- Menopause
- Vasomotor System
- Female
- Humans
- Treatment Outcome
- Middle Aged
- Severity of Illness Index
- Adult
- Aged
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