Abstract
Summary
The DAYLIGHT study took place in Europe and Canada between 2021 and 2023. Researchers looked at the effect of fezolinetant treatment on hot flashes/flushes and night sweats (known as vasomotor symptoms) associated with menopause. Hot flashes are the main reason that people seek medical attention for menopause.
To take part in the DAYLIGHT study, participants had to be assigned female at birth, between 40 and 65 years old, experiencing moderate to severe hot flashes associated with menopause, and unsuitable for hormone therapy either for a medical reason or because they did not want to take it. All participants took either a fezolinetant pill or a placebo. The placebo looked like fezolinetant but did not have medicine in it.
During the study, researchers and participants did not know who was taking fezolinetant and who was taking the placebo.
The DAYLIGHT study was the first to look at how well fezolinetant worked compared with placebo for 6 months. Researchers wanted to find out how many hot flashes participants had each day. They also looked at how severe the hot flashes were, sleep quality, quality of life, mental health, work productivity, and side effects.
Compared with the placebo, fezolinetant reduced the number of hot flashes that participants had each day. Participants taking fezolinetant also had greater improvements in sleep, quality of life, depression, and work productivity. Side effects were similar for participants who took fezolinetant or the placebo in this study.
The DAYLIGHT study shows that fezolinetant may be a non-hormonal treatment option to reduce hot flashes and improve quality of life for people in menopause. This adds to the evidence that fezolinetant can help people having hot flashes associated with menopause.
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Acknowledgements
The authors and sponsors would like to thank everyone involved in the DAYLIGHT study. Medical writing support for this summary was provided by Kirstie Anderson of Envision Pharma Ltd. (Wilmslow, UK) and funded by Astellas Pharma Inc.
Ethics approval and consent to participate
This study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and International Council for Harmonisation guidelines. An independent ethics committee or institutional review board reviewed ethical, scientific, and medical appropriateness of the study before data collection at each site. Written informed consent was obtained from all participants before any study related procedures.
Author contributions
Marla Shapiro, Rossella E. Nappi and Katrin Schaudig: interpretation of study data, writing – original draft, reviewing and editing, approval for publication. Xuegong Wang and Antonia Morga: study design, acquisition of study data, interpretation of study data, writing – original draft, reviewing and editing, approval for publication.
Funding
This manuscript was funded by Astellas Pharma Inc., who funded the DAYLIGHT study and were involved in the study design, data collection and analysis, decision to publish, and preparation of the manuscript.
Conflict of interest statement
Marla Shapiro sits on advisory boards for and has received consulting fees and honorariums from Amgen, Aspen, Astellas, BioSyent, Bayer, CCRN, Duchesnay, Eisai, GSK, Idorsia, Merck, Mithra, Novo Nordisk, Organon, Pfizer, Sandoz, and Searchlight; receives support for attending meetings and/or travel from Astellas and The Menopause Society; has a leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid, for the International Menopause Society and Terry Fox Research Institute. Rossella E. Nappi receives grants/contracts from Fidia; consulting fees from Astellas, Bayer Pharma, Besins Healthcare, Fidia, and Theramex; payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Abbott, Astellas, Exeltis, Fidia, Gedeon Richter, Merck, Novo Nordisk, Shionogi, Theramex, and Viatris; payment for expert testimony from Vichy Laboratories; and is president of the International Menopause Society. Xuegong Wang is an employee of Astellas Pharma. Antonia Morga is an employee of Astellas Pharma. Katrin Schaudig has received payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events from aidhere, Astellas Pharma, Bayer/Jenapharm, Besins Healthcare, Exeltis, Fidia, Gedeon Richter Pharma, Novo Nordisk, Organon, Theramex, Viatris, and Laborarztpraxis Rhein-Main; participates on a data safety monitoring board or advisory board for Astellas, Bayer, Exeltis, Besins Healthcare, and Viatris; is President of the German Menopause Society organises and lectures at conferences for the society; lectures and participates in conferences for the professional association of gynaecologists in Germany; is honorary member for the German Society of Obstetrics and Gynecology and lectures, is president at conferences, and participates on committees for the society.
Availability of data and materials
Researchers may request access to the data used to support this article by contacting the corresponding author.