Women suffering from bothersome menopausal symptoms found comfort and a better night’s sleep with a new medication for hot flashes.
Elinzanetant was tested in two phase 3 clinical trials at two different timepoints against a placebo. Hot flashes were rapidly reduced by the medication: most users reported at least a 50% decrease in frequency by the fourth week.
According to research published August 22 in the Journal of the American Medical Association, by week 12, more than 70% of patients on elinzanetant had experienced that reduction in hot flash frequency, compared with more than 40% on placebo. At the 12-week period, participants using elinzanetant also reported far better sleep than those taking a placebo.
Talia Sobel, a women’s health doctor at the Mayo Clinic in Scottsdale, Arizona who specializes in menopause and was not involved in the trials, feels that ellinzanetant is a promising new nonhormonal medication.
The trials changed the participants from placebo to medication after the first 12 weeks. According to JoAnn Pinkerton, a gynecologist at the University of Virginia Health System in Charlottesville who specializes in menopause, studies on hot flashes therapies frequently have a placebo effect. Researchers have hypothesized that this may be partially caused by the trials’ therapeutic routines.
According to Pinkerton, “We wanted to see if there was an additional effect beyond the placebo.” “And it was, in fact.” At the 26-week mark, 82 percent of those who took elinzanetant continuously and over 84 percent of those who switched from the placebo reported at least a 50% decrease in the frequency of hot flashes. Regardless of whether they started taking the medication at the beginning of the studies or switched to it midway through, the discovery that more than 80% of all participants had benefits “is pretty dramatic,” according to Pinkerton.
The ovaries produce varying amounts of progesterone and estrogen before stopping completely during the menopausal transition, which marks the end of ovulation and menstruation. People can have a variety of bothersome symptoms leading up to and throughout menopause, such as vaginal dryness, urgency when urinating, mood swings, hot flashes, night sweats, poor sleep, and changes in mood.
Hot flashes can persist for more than seven years in many women, and up to 80% of women have them at some point during the menopausal transition. It is believed that the cause of hot flashes is a narrowing of the body’s temperature sensitivity range, which makes even a slight rise in body temperature feel like a heat wave. Dilated blood vessels can cause flushing and profuse perspiration as a result of the body’s overzealous cooling response.
The best treatment for hot flashes and menopausal symptoms that affect the vagina and urinary system is hormone therapy, either estrogen with progesterone or estrogen alone (SN: 1/9/18). In 2022, the North American Menopause Society reiterated that hormone therapy is a safe option for women under 60 who start therapy within ten years of the onset of menopause, excluding specific health concerns. Additionally, hormone therapy guards against bone loss brought on by the decline in estrogen that comes with menopause.
Additionally, nonhormonal treatments are required. Hormone therapy is associated with an increased risk of blood clots, stroke, and coronary heart disease in women over 60 or who have not gone through menopause for more than ten years. Individuals with a history of severe endometriosis, migraines with aura, blood clots in the past, estrogen-sensitive breast cancer, and stroke would not be excellent candidates for hormone therapy, according to Pinkerton.
Hot flashes can now be treated without the use of hormones thanks to research on KNDy neurons, a type of neurons in the hypothalamus that are important in controlling body temperature. These neurons enlarge and become hyperactive when estrogen levels drop, which increases the synthesis of several chemical messengers. Hot flashes appear to be triggered by one of the messengers binding to a receptor on KNDy neurons and neighboring thermoregulatory neurons.
The U.S. Food and Drug Administration approved fezolinetant, a medication that inhibits that receptor, in 2023. The novel medication, elinzanetant, acts on the same receptor but also blocks a different receptor that KNDy neurons express and which could be connected to sleeplessness.
The two phase 3 clinical trials involving elinzanetant involved post-menopausal women aged 40 to 65 who experienced 50 or more episodes of moderate to severe hot flashes over the course of a week. When comparing individuals taking the medication to those receiving a placebo, the most frequently reported side effects were weariness and headache. Elinzanetant is undergoing a 52-week trial to evaluate its longer-term safety, while another trial (SN: 5/3/23) is examining the drug’s effectiveness in treating women with hormone-positive breast cancer.
According to Sobel, many women who have hot flashes and other troublesome menopausal symptoms aren’t receiving enough or the right kind of care. “Their symptoms and quality of life can be enhanced by safe and efficient hormonal and nonhormonal treatments.I advise women to locate a reputable healthcare professional with menopause management training.(SN: 23/5/).
