1. Fezolinetant 30 mg and 45 mg significantly reduced the frequency and severity of vasomotor symptoms compared to placebo.
2. The beneficial effects of fezolinetant on vasomotor symptoms were sustained for up to 52 weeks.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Vasomotor symptoms can substantially negatively impact the quality of life of post-menopausal women. Neurokinin 3 receptor antagonists, such as fezolinetant, may serve as potential non-hormonal alternatives in menopausal women experiencing vasomotor symptoms. This randomized controlled trial aimed to assess the safety and efficacy of fezolinetant for the treatment of vasomotor symptoms in post-menopausal symptoms. The coprimary outcomes were the frequency and severity of vasomotor symptoms in each group from baseline to weeks 4 and 12. According to study results, patients in the fezolinetant groups experienced significantly fewer and less severe vasomotor symptoms compared to placebo. There were no significant differences in adverse events between groups. This study was strengthened by a large sample size with patients from multiple countries, thus increasing its validity and generalizability.
Click to read the study in The Lancet
Relevant Reading: Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol
In-depth [randomized-controlled trial]: Between Jul 11, 2019, and Aug 11, 2021, 2205 women were assessed for eligibility at 97 facilities across 7 nations. Included were women aged 40-65 with ≥ 7 hot flashes per day. Altogether, 522 women (175 in placebo, 173 in fezolinetant 30 mg, and 174 in fezolinetant 45 mg) were included in the full analysis. The frequency of vasomotor symptoms at week 4 (change in the least squares mean -1.87 and -2.07, p<0.001) and week 12 (-2.39 and -2.55, p<0.001) was significantly reduced in the fezolinetant 30 mg and fezolinetant 45 mg groups compared to placebo, respectively. A similar trend was seen in the severity of vasomotor symptoms among fezolinetant 30 mg and 45 mg groups compared to placebo at week 4 (-0.15, p=0.012 and -0.19, p=0.002, respectively) and week 12 (-0.24, p=0.002 and -.020, p=0.007, respectively). The frequency of treatment-related adverse events was comparable between groups (37% in fezolinetant 30 mg, 43% in fezolinetant 45 mg, and 45% in the placebo group). Findings from this study support the use of fezolinetant for the treatment of vasomotor symptoms associated with menopause.
Image: PD
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