Fezolinetant effect on vasomotor symptoms due to menopause in women unsuitable for hormone therapy.

• Tác giả: Martin Blogg, Shayna Mancuso, Antonia Morga, Genevieve Neal-Perry, Faith D Ottery, Nanette Santoro, Emad Siddiqui, Petra Stute
• Ngôn ngữ: eng
• Ký hiệu phân loại: 304.2 Human ecology
• Thông tin xuất bản: England : Current medical research and opinion , 2025
• Bộ sưu tập: NCBI
• ID: 703582

Tóm tắt

 OBJECTIVE: To assess efficacy and safety of fezolinetant in women unsuitable for hormone therapy (HT), using pooled SKYLIGHT 1 and 2 data. METHODS: SKYLIGHT 1 and 2 were double-blind, placebo-controlled studies of once-daily placebo, fezolinetant 30 mg or 45 mg for 12 weeks in women aged ≥40-≤65 years with moderate to severe vasomotor symptoms (VMS
  average ≥7 hot flashes/d), followed by a double-blind, non-controlled extension period for 40 weeks. The HT unsuitable group comprised 4 mutually exclusive subgroups, categorized using the following hierarchy: contraindicated
  caution
  stopper for medical concerns
  averse. RESULTS: A total of 1,022 participants received ≥1 dose of study medication (fezolinetant 30 mg, CONCLUSION: This pooled analysis demonstrated efficacy of fezolinetant vs. placebo in reducing frequency and severity of VMS due to menopause in participants unsuitable for HT. CLINICAL TRIAL REGISTRATION: SKYLIGHT 1 - ClinicalTrials.gov, NCT04003155
  https://clinicaltrials.gov/ct2/show/NCT04003155 (conducted between July 2019 and August 2021)
  SKYLIGHT 2 - ClinicalTrials.gov, NCT04003142
  https://clinicaltrials.gov/ct2/show/NCT04003142 (conducted between July 2019 and April 2021).