Dataset Information

Prevalence, severity, and associated factors in women in East Asia with moderate-to-severe vasomotor symptoms associated with menopause.

ABSTRACT:

Objective

To understand prevalence, severity, impact, and treatment of vasomotor symptoms associated with menopause, using cross-sectional survey data.

Methods

This online, two-part survey was conducted in East Asia among women 40-65 years recruited from established online panels (Edelman, Beijing; Hankook Research, Seoul; Rakuten Insight, Taipei) using stratified sampling. Part I collected demographics/disease characteristics, including menopausal status and vasomotor symptom severity. Women with moderate-to-severe vasomotor symptoms completed Part II, including clinical characteristics, health-related quality of life, and healthcare-seeking behavior. Primary endpoints included vasomotor symptom prevalence and severity and proportions of women eligible and willing to take hormone therapy. Results are presented for each of the three online panels separately and as a pooled total. All analyses are descriptive with no formal hypothesis testing across groups.

Results

Numbers of peri- versus postmenopausal women completing Part I were Edelman, 1,588 (55.1% vs 44.9%); Hankook Research, 1,000 (43.6% vs 56.4%); Rakuten Insight, 773 (61.7% vs 38.3%). Vasomotor symptom prevalence was =80% in each region; overall moderate-to-severe vasomotor symptom prevalence was 55%; >50% of women were untreated. Most of those treated used non-prescription treatments. Menopausal hormone therapy use was reported by 11.6% of peri- and 7.2% of postmenopausal women. In peri- and postmenopausal women with moderate-to-severe vasomotor symptoms, 8.6% and 3.4%, respectively, were hormone therapy-willing, 19.3% and 16.8% hormone therapy-contraindicated, 25.4% and 23.0% hormone therapy-cautious, and 10.2% and 8.3% hormone therapy-averse. Women experienced significant burden on health-related quality of life and substantial impairment of work productivity and daily activities.

Conclusions

Vasomotor symptoms associated with menopause affected =80% of women aged 40 to 65 years. A substantial proportion of women are unsuitable for, or choose not to take, menopausal hormone therapy, resulting in an unmet need for nonhormonal treatment options.

SUBMITTER: Yu Q

PROVIDER: S-EPMC9060817 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Prevalence, severity, and associated factors in women in East Asia with moderate-to-severe vasomotor symptoms associated with menopause.

Yu Qi Q Chae Hee-Dong HD Hsiao Sheng-Mou SM Xie Jipan J Blogg Martin M Sumarsono Budiwan B Kim Soyoung S

Menopause (New York, N.Y.) 20220501 5

<h4>Objective</h4>To understand prevalence, severity, impact, and treatment of vasomotor symptoms associated with menopause, using cross-sectional survey data.<h4>Methods</h4>This online, two-part survey was conducted in East Asia among women 40-65 years recruited from established online panels (Edelman, Beijing; Hankook Research, Seoul; Rakuten Insight, Taipei) using stratified sampling. Part I collected demographics/disease characteristics, including menopausal status and vasomotor symptom sev ...[more]

PMID: 35231007

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Project description:ImportanceAlthough premenstrual disorders (PMDs) end at menopause, it is unclear whether they are associated with the timing and symptom severity of menopause.ObjectiveTo prospectively examine whether women with PMDs have increased risks of early menopause and menopause-related vasomotor symptoms (VMS).Design, setting, and participantsThis population-based cohort study was nested in the Nurses' Health Study II (data collected from questionnaire sent between June 1991 and June 2017). Analysis of menopause timing included participants who did not have natural or surgical menopause before study entry, while the analysis of VMS was restricted to women who provided information on VMS. Data were analyzed from August 2022 to March 2023.ExposuresPMDs were identified by self-reported diagnosis and confirmed with symptom questionnaires from 1991 to 2005. Participants were age-matched to women without PMD diagnoses and confirmed absence of or minimal premenstrual symptoms.Main outcomes and measuresDuring follow-up through 2017, timing of natural menopause was assessed biennially, and VMS were assessed in 2009, 2013, and 2017. The association of PMDs with early menopause was assessed by Cox proportional hazards models and with VMS by logistic regression models.ResultsOf 1220 included women with PMDs, the median (IQR) age was 40.7 (37.3-43.8) years; of 2415 included women without PMDs, the median (IQR) age was 41.7 (38.3-44.8) years. The median (IQR) follow-up in this study was 20.3 (17.8-22-2) years. Early natural menopause (menopause before age 45 years) was reported by 17 women with PMDs (7.1 per 1000 person-years) and 12 women without PMDs (2.7 per 1000 person-years; adjusted hazard ratio, 2.67; 95% CI, 1.27-5.59). In addition, 795 women with PMDs (68.3%) and 1313 women without PMDs (55.3%) reported moderate or severe VMS (adjusted odds ratio, 1.68; 95% CI, 1.32-2.14). There was no observed association between PMDs and mild VMS (adjusted odds ratio, 0.99; 95% CI, 0.76-1.28).Conclusions and relevanceIn this cohort study of US women, PMDs were associated with increased risks of early menopause and moderate or severe VMS. PMDs may be indicative of underlying physiology linked to early menopause and VMS, suggesting a phenotype observable during the reproductive years that may allow clinicians to target women at risk of earlier menopause and subsequent health risks later in the life course.

Project description:ObjectivesTo assess the efficacy and safety of the non-hormonal, neurokinin 3 receptor antagonist, fezolinetant, to treat moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy.DesignPhase 3b randomised controlled trial.Setting16 countries.Participants453 individuals aged 40-65 years with moderate-severe vasomotor symptoms associated with menopause who were considered unsuitable candidates for hormone therapy (contraindicated, caution (based on medical history), stoppers (previous discontinuation of hormone therapy), or averse (informed choice not to use hormone therapy)) were randomised to receive fezolinetant (n=227) or placebo (n=226).InterventionFezolinetant 45 mg or placebo once daily for 24 weeks.Main outcome measuresThe primary endpoint was mean change in daily frequency of moderate-severe vasomotor symptoms from baseline to week 24. Secondary endpoints were mean change in symptom severity, sleep disturbance using the Patient-Reported Outcome Measurement Information System Sleep Disturbance Short Form (PROMIS SD-SF) 8b total score, and safety.Results370 (81.7%) participants completed the study (fezolinetant=195, placebo group=175). The safety and full analysis sets comprised 452 participants who received at least one dose of study drug. Mean age was 54.5 (standard deviation 4.7) years and most of the participants (435 (96.7%) were white and categorised as either hormone therapy averse (168 (37.2%)) or caution (165 (36.5%)). At week 24, fezolinetant significantly reduced the frequency (least squares mean difference -1.93, 95% confidence interval (CI) -2.64 to -1.22; P<0.001) and severity of vasomotor symptoms (-0.39, -0.57 to -0.21; P<0.001). At week 24, the fezolinetant group had a greater reduction in sleep disturbance (PROMIS SD-SF 8b total score) compared with placebo (-2.5, -3.9 to -1.1; P<0.001). Improvements over placebo were observed as early as week 1. Both groups showed similar incidences of treatment emergent adverse events (TEAEs, 147 (65.0%) in the fezolinetant group, 138 (61.1%) in the placebo group) and serious TEAEs (10 (4.4%) and 8 (3.5%), respectively). The most common TEAEs in the fezolinetant group were covid-19 (30 (13.3%)), headache (20 (8.8%)), and fatigue (13 (5.8%)).ConclusionsFezolinetant was efficacious and well tolerated over a six month period for treating moderate-severe vasomotor symptoms in individuals considered unsuitable for hormone therapy. These results highlight the utility of fezolinetant as an effective treatment option for those who have contraindications to or choose not to use hormone therapy.Trial registrationClinicalTrials.gov NCT05033886; EudraCT 2021-001685-38.

Project description:IntroductionThis study evaluated the safety and tolerability of fezolinetant in women with vasomotor symptoms (VMS) due to menopause in a pooled analysis of data from three 52-week phase 3 studies (SKYLIGHT 1, 2, and 4).MethodsSKYLIGHT 1 and 2 were double-blind, placebo-controlled studies where women (≥ 40 to ≤ 65 years), with moderate to severe VMS (minimum average ≥ 7 hot flashes/day) were randomized to once-daily placebo, fezolinetant 30 mg or 45 mg. After 12 weeks, those on placebo were re-randomized to fezolinetant 30 mg or 45 mg, while those on fezolinetant continued on their assigned dose for 40 weeks. SKYLIGHT 4 was a placebo-controlled, double-blind, 52-week safety study. Safety was assessed by frequency of treatment-emergent adverse events (TEAEs) and endometrial events. TEAEs of special interest included liver test elevations and endometrial hyperplasia or cancer or disordered proliferative endometrium.ResultsTotals of 952 participants receiving placebo, 1100 receiving fezolinetant 45 mg, and 1103 receiving fezolinetant 30 mg took ≥ 1 dose of study medication. TEAEs occurred in 55.3%, 62.9%, and 65.4%, respectively; exposure-adjusted results were consistent with these results. Most frequent TEAEs in fezolinetant-treated participants included upper respiratory tract infection (7.7-8.3%), headache (6.8-8.2%), coronavirus disease 2019 (5.8-6.1%), back pain (3.1-3.7%), arthralgia (2.9-3.2%), diarrhea (2.3-3.2%), urinary tract infection (2.9-3.4%), and insomnia (2.0-3.0%). The incidence of drug-related serious TEAEs and associated treatment withdrawals was low. Elevations in liver transaminases occurred in 1.5-2.3% of fezolinetant-treated participants, were typically asymptomatic and transient, resolved on treatment or discontinuation, with no evidence of severe drug-induced liver injury (Hy's law). Endometrial safety results were well within US Food and Drug Administration criteria. Analysis of benign and non-benign neoplasm controlled for exposure demonstrated no increased risk versus placebo.ConclusionPooled data confirm the safety and tolerability of fezolinetant over 52 weeks.Trial registrationClinicalTrials.gov identifiers, NCT04003155, NCT04003142, and NCT04003389. Graphical abstract available for this article.

Project description:ObjectiveTo evaluate the safety, tolerability, and effect of fezolinetant on endometrial health over 52 weeks.MethodsWe conducted a phase 3, randomized, double-blind, 52-week safety study (SKYLIGHT 4 [Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause]) of placebo, fezolinetant 30 mg, and fezolinetant 45 mg once daily (1:1:1). Participants were postmenopausal and seeking treatment for vasomotor symptoms associated with menopause. Primary endpoints were treatment-emergent adverse events, percentage of participants with endometrial hyperplasia, and percentage with endometrial malignancy. Endometrial hyperplasia or malignancy was evaluated according to U.S. Food and Drug Administration guidance (point estimate of 1% or less with an upper bound of one-sided 95% CI of 4% or less). Secondary endpoints included change in bone mineral density (BMD) and trabecular bone score. A sample size of 1,740 was calculated to enable observation of one or more events (≈80% probability for events with background rate of less than 1%).ResultsA total of 1,830 participants were randomized and took one or more medication dose (July 2019-January 2022). Treatment-emergent adverse events occurred in 64.1% (391/610) of the placebo group, 67.9% (415/611) of the fezolinetant 30-mg group, and 63.9% (389/609) of the fezolinetant 45-mg group. Treatment-emergent adverse events leading to discontinuation were similar across groups (placebo, 26/610 [4.3%]; fezolinetant 30 mg, 34/611 [5.6%]; fezolinetant 45 mg, 28/609 [4.6%]). Endometrial safety was assessed in 599 participants. In the fezolinetant 45-mg group, 1 of 203 participants had endometrial hyperplasia (0.5%; upper limit of one-sided 95% CI 2.3%); there were no cases in the placebo (0/186) or fezolinetant 30 mg (0/210) group. Endometrial malignancy occurred in 1 of 210 in the fezolinetant 30-mg group (0.5%; 95% CI 2.2%) with no cases in the other groups. Liver enzyme elevations more than three times the upper limit of normal occurred in 6 of 583 placebo, 8 of 590 fezolinetant 30 mg, and 12 of 589 fezolinetant 45 mg participants; no Hy's law cases were reported (ie, no severe drug-induced liver injury with alanine aminotransferase or aspartate aminotransferase more than three times the upper limit of normal and total bilirubin more than two times the upper limit of normal, with no elevation of alkaline phosphatase and no other reason to explain the combination). Changes in BMD and trabecular bone score were similar across groups.ConclusionResults from SKYLIGHT 4 confirm the 52-week safety and tolerability of fezolinetant and support its continued development.Funding sourceAstellas Pharma Inc.Clinical trial registrationClinicalTrials.gov , NCT04003389.

Dataset Information

Prevalence, severity, and associated factors in women in East Asia with moderate-to-severe vasomotor symptoms associated with menopause.

Objective

Methods

Results

Conclusions

Publications

Prevalence, severity, and associated factors in women in East Asia with moderate-to-severe vasomotor symptoms associated with menopause.

Similar Datasets

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