Fezolinetant impact on health-related quality of life for vasomotor symptoms due to the menopause: Pooled data from SKYLIGHT 1 and SKYLIGHT 2 randomised controlled trials.

Autor: Cano A; Department of Paediatrics, Obstetrics and Gynaecology, INCLIVA, University of Valencia, Valencia, Spain., Nappi RE; Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy.; Research Centre for Reproductive Medicine and Gynaecological Endocrinology - Menopause Unit, Fondazione Policlinico IRCCS S. Matteo, Pavia, Italy., Santoro N; University of Colorado School of Medicine, Aurora, Colorado, USA., Stute P; Department of Obstetrics and Gynaecology, Inselspital, Bern, Switzerland., Blogg M; Astellas Pharma Europe Ltd, Addlestone, UK., English ML; Astellas Pharma Global Development, Northbrook, Illinois, USA., Morga A; Astellas Pharma Europe Ltd, Addlestone, UK., Scrine L; Astellas Pharma Europe Ltd, Addlestone, UK., Siddiqui E; Astellas Pharma Europe Ltd, Addlestone, UK., Ottery FD; Astellas Pharma Global Development, Northbrook, Illinois, USA.
Jazyk: angličtina
Zdroj: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2024 Aug; Vol. 131 (9), pp. 1296-1305. Date of Electronic Publication: 2024 Feb 06.
DOI: 10.1111/1471-0528.17773
Abstrakt: Objective: To assess the effect of fezolinetant treatment on health-related quality of life using pooled data from SKYLIGHT 1 and 2 studies.
Design: Prespecified pooled analysis.
Setting: USA, Canada, Europe; 2019-2021.
Population: 1022 women aged ≥40 to ≤65 years with moderate-to-severe vasomotor symptoms (VMS; minimum average seven hot flushes/day), seeking treatment for VMS.
Methods: Women were randomised to 12-week double-blind treatment with once-daily placebo or fezolinetant 30 or 45 mg. Completers entered a 40-week, active extension (those receiving fezolinetant continued that dose; those receiving placebo re-randomised to fezolinetant received 30 or 45 mg).
Main Outcome Measures: Mean changes from baseline to weeks 4 and 12 on Menopause-Specific Quality of Life (MENQoL) total and domain scores, Work Productivity and Activity Impairment questionnaire specific to VMS (WPAI-VMS) domain scores, Patient Global Impression of Change in VMS (PGI-C VMS); percentages achieving PGI-C VMS of 'much better' (PGI-C VMS responders). Mean reduction was estimated using mixed model repeated measures analysis of covariance.
Results: Fezolinetant 45 mg mean reduction over placebo in MENQoL total score was -0.57 (95% confidence interval [CI] -0.75 to -0.39) at week 4 and -0.47 (95% CI -0.66 to -0.28) at week 12. Reductions were similar for 30 mg. MENQoL domain scores were also reduced and WPAI-VMS scores improved. Twice as many women receiving fezolinetant reported VMS were 'much better' than placebo based on PGI-C VMS assessment.
Conclusions: Fezolinetant treatment was associated with improvement in overall QoL, measured by MENQoL, and work productivity, measured by WPAI-VMS. A high proportion receiving fezolinetant felt VMS were 'much better' based on PGI-C VMS responder analysis.
(© 2024 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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