Effects of fezolinetant: A Synthesis of Findings from 10 Studies

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Original Abstract of the Article

Main Research Findings

Multiple studies have shown that fezolinetant, a neurokinin 3 receptor antagonist, is a promising non-hormonal treatment for vasomotor symptoms (VMS) associated with menopause. 9 , 6 , 1 Fezolinetant works by targeting the disrupted thermoregulation underlying VMS, modulating neural activity within the thermoregulatory center in the hypothalamus. 9 This mechanism helps relieve hot flashes and night sweats. Clinical trials have established fezolinetant's efficacy and safety profile, demonstrating its superiority over placebo in reducing the frequency and severity of VMS. 5 Fezolinetant has received FDA approval for the treatment of VMS in postmenopausal women. 6 Preclinical studies using ovariectomized rats have also shown that fezolinetant effectively attenuates hot flash-like symptoms. 8 Fezolinetant presents a new non-hormonal option for managing VMS in women experiencing menopause.

Benefits and Risks

Benefits Summary

Fezolinetant effectively reduces the frequency and severity of vasomotor symptoms associated with menopause. 5 It also shows promising results in mitigating hot flash-like symptoms in ovariectomized rat models. 8 Compared to hormone therapy, fezolinetant offers a lower risk profile, expanding treatment options for women. 5 Furthermore, fezolinetant's oral availability makes it a convenient and accessible medication for patients. 9

Risks Summary

Potential side effects associated with fezolinetant include headache and gastrointestinal disturbances. 5 Elevated liver transaminase levels have also been reported. 5 Patients should be aware of these potential risks when considering fezolinetant.

Study Comparisons

Study Similarities

Numerous studies consistently demonstrate the effectiveness of fezolinetant in treating VMS related to menopause. 5 The research further suggests that fezolinetant offers a lower risk profile and improved patient convenience compared to hormone therapy. 5

Study Differences

Dosing regimens for fezolinetant can vary across studies. 1 Furthermore, variations in study design and participant characteristics can lead to differences in observed efficacy and side effect profiles. 1

Consistency and Contradictions in Results

While a majority of studies demonstrate the effectiveness of fezolinetant for managing VMS, some research presents findings that raise questions about its efficacy. 1 These inconsistencies may be attributed to variations in study design and participant characteristics. 1 Further research is crucial to clarify the efficacy of fezolinetant and address these contradictory results.

Implications for Everyday Life

Fezolinetant holds potential as an effective treatment for VMS related to menopause. 5 However, patients should be aware of potential side effects. 5 It's important to remember that fezolinetant may not be effective for everyone. 1 Consulting a physician is essential before considering fezolinetant for treatment.

Limitations of Current Research

Research on fezolinetant is still in its early stages. 1 Therefore, long-term safety and efficacy data remain limited. 1 Further research is needed to address these gaps in knowledge.

Future Research Directions

Additional research is necessary to investigate the long-term safety and efficacy of fezolinetant. 1 Furthermore, studies should explore the potential impact of factors such as age and ethnicity on the effectiveness of fezolinetant. 1

Conclusion

Fezolinetant shows promise as a non-hormonal treatment option for VMS associated with menopause. 5 However, patients should be aware of potential side effects and consult a doctor before considering fezolinetant. 5 Further research is crucial to address unanswered questions regarding long-term safety and efficacy and to explore potential variations in response based on individual characteristics.

Literature analysis of 10 papers
Positive Content
10
Neutral Content
0
Negative Content
0
Article Type
5
0
0
2
10
1.

A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause.

Author: FraserGraeme L, LedermanSamuel, WaldbaumArthur, KrollRobin, SantoroNanette, LeeMisun, SkillernLaurence, RamaelSteven

VMS treatment

This phase 2b study evaluated seven dosing regimens of fezolinetant, a selective neurokinin 3 receptor antagonist, as a nonhormone approach for the treatment of menopausal vasomotor symptoms (VMS), which may result from altered thermoregulatory control in brain regions innervated by neurokinin 3 receptor-expressing neurons.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Effect of the neurokinin 3 receptor antagonist fezolinetant on patient-reported outcomes in postmenopausal women with vasomotor symptoms: results of a randomized, placebo-controlled, double-blind, dose-ranging study (VESTA).

Author: SantoroNanette, WaldbaumArthur, LedermanSamuel, KrollRobin, FraserGraeme L, LademacherChristopher, SkillernLaurence, YoungJames, RamaelSteven

Improved menopausal symptoms
Improved quality of life

This study found that oral fezolinetant was associated with higher responder rates than placebo and larger improvements in quality of life (QoL) and other patient-reported outcomes (PROs) in postmenopausal women with moderate/severe vasomotor symptoms (VMS), including a reduction in VMS-related interference with daily life.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial.

Author: DepypereHerman, TimmermanDirk, DondersGilbert, SieprathPeter, RamaelSteven, CombalbertJean, HoveydaHamid R, FraserGraeme L

Improved quality of life
Reduced VMSs
Gastrointestinal side effects

Fezolinetant, a neurokinin 3 receptor (NK3R) antagonist, significantly reduced moderate/severe vasomotor symptoms (VMSs) in menopausal women. The drug demonstrated a rapid and significant reduction in VMSs from the first day of treatment and was well tolerated.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial.

Author: Neal-PerryGenevieve, CanoAntonio, LedermanSamuel, NappiRossella E, SantoroNanette, WolfmanWendy, EnglishMarci, FranklinCatherine, ValluriUdaya, OtteryFaith D

Endometrial safety
Safety
Tolerability
Liver enzyme elevation

A 52-week safety study of fezolinetant in postmenopausal women seeking treatment for vasomotor symptoms found that fezolinetant was well-tolerated and had a low incidence of endometrial hyperplasia and malignancy.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Fezolinetant: A New Nonhormonal Treatment for Vasomotor Symptoms.

Author: OngeErin St, PhillipsBradley, MillerLisa

Menopause symptom treatment
Gastrointestinal disturbances
Headache
Liver enzyme elevation

Fezolinetant, a neurokinin B inhibitor, is a non-hormonal treatment option for vasomotor symptoms associated with menopause. Fezolinetant is superior to placebo in decreasing the frequency and severity of vasomotor symptoms. Common adverse effects include headache and gastrointestinal disturbances.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

Neurokinin 3 receptor antagonism for menopausal hot flashes.

Author: ComninosAlexander N, DhilloWaljit S

Effective hot flash treatment
Nonhormonal treatment

Menopausal hot flashes are a common and debilitating symptom. This article discusses the development of fezolinetant, a novel non-hormonal treatment for menopausal hot flashes. Fezolinetant is a NK3 receptor antagonist, which has recently been approved by the FDA.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Randomized Controlled Trial of Neurokinin 3 Receptor Antagonist Fezolinetant for Treatment of Polycystic Ovary Syndrome.

Author: FraserGraeme L, Obermayer-PietschBarbara, LavenJoop, GriesingerGeorg, PintiauxAxelle, TimmermanDirk, FauserBart C J M, LademacherChristopher, CombalbertJean, HoveydaHamid R, RamaelSteven

Hyperandrogenism suppression
LH-to-FSH ratio reduction
PCOS treatment

Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, suppressed hyperandrogenism and reduced the LH-to-FSH ratio in women with PCOS.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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