CLINICAL QUESTION

Is fezolinetant (Veozah) more effective than placebo for treatment of vasomotor symptoms of menopause in individuals who cannot or will not take hormones?

BOTTOM LINE

In people with moderate to severe vasomotor symptoms of menopause who will not or cannot receive hormone therapy, fezolinetant decreases the frequency and severity of symptoms and improves sleep. More people are likely to receive benefit from fezolinetant than placebo, but placebo is effective in some users. (Level of Evidence = 1b)

SYNOPSIS

The investigators enrolled 453 participants with moderate to severe vasomotor symptoms associated with menopause. Participants had to be considered unsuitable for hormone therapy, because they preferred not to receive hormones (37.2%), had a strong contraindication (history of breast cancer, uterine cancer, active liver disease, or thromboembolic diseases) or a weaker contraindication (cardiovascular disease, diabetes, or raised triglyceride levels) (47.6%), or had discontinued previous hormone treatment (15.3%). The patients were randomized using concealed allocation to receive placebo or fezolinetant once daily. After 6 months of treatment, the primary outcome of patient-rated frequency of vasomotor symptoms decreased from an average of 10.6 events per day to an average of 2.61 events per day compared with 4.67 events per day with placebo (P < .001). The global impression of change in vasomotor symptoms was much better or moderately better in 78.6% of participants who received treatment compared with 52.3% who received placebo (number needed to treat = 3.8). Similarly, patient-rated sleep scores were much better or moderately better in 61% of treated patients compared with 40.5% of control patients (number needed to treat = 4.9). There were similar rates of adverse events in both groups.