A non-hormonal therapy to treat hot flashes and other symptoms associated with menopause was found to be effective in a recent clinical trial, according to a published study by a team of researchers including faculty from the University of Colorado School of Medicine.
Fezolinetant, an oral, non-hormone therapy in clinical development, offers relief for hot flashes and night sweats, which are the most common menopause-associated symptoms for which women seek treatment. About 80 percent of American women experience these symptoms.
“An effective alternative to estrogen for the treatment of hotflashes is needed to provide better care." - Nanette Santoro
“An effective alternative to estrogen for the treatment of hot flashes is needed to provide better care,” said Nanette Santoro, chair of the Department of Obstetrics and Gynecology at the University of Colorado School of Medicine, and an author of the study published online this week by the journal Menopause. “There are some medications that can be used, but all have significant side effects and are of lesser efficacy than estrogen.”
The study, published online by the journal Menopause, reviewed the experience of 352 women with moderate to severe menopausal vasomotor symptoms, such as hot flashes, who were enrolled in a 12-week study that compared treatment with fezolinetant versus a placebo. The treatment was tested in a range of dosages.
“The occurrence of VMS [vasomotor symptoms] interfere with sleep, concentration, memory, work productivity, and personal relationships and has been linked to feelings of depression, irritability, anxiety, fatigue, and social embarrassment/isolation,” Santoro and her co-authors write. “All of these factors contribute to the observed negative influence of VMS on psychological well-being and health-related quality of life.”
VMS symptoms are triggered by neuron activity that affects the thermoregulatory functioning of the brain. Estrogen helps regulate that activity, but during menopause estrogen levels decline and no longer modulate as effectively. Fezolinetant works by blocking neurokinin B (NKB) signaling and normalizing KNDy (kisspeptin/NKB/dynorphin) neuron activity.
In this study, more than 80 percent of the women taking fezolinetant reported a reduction in symptoms and more than half of the women taking the treatment indicated a reduction of symptoms of 90 percent or greater. Participants recorded their symptoms daily in an e-dairy and filled out quality-of-life questionnaires. They had a mean age of 54.6 years old. A majority of women (73 percent) self-identified as white, 25 percent Black, 1 percent Asian and 1 percent other.
“This is an extraordinarily successful result and offers promise of relief to millions of women,” said Santoro. “This study paves the way for further studies of a longer treatment duration and in a larger group of people.”
Nine authors, including Santoro, are listed on the study. Santoro, who is the E. Stewart Taylor Chair of Obstetrics and Gynecology at the CU School of Medicine, is the corresponding author. The study was sponsored by Astellas Pharma Inc.