Marla Shapiro C.M. , Antonio Cano , Rossella E. Nappi , Nanette Santoro , Marci L. English , Shayna Mancuso , Antonia Morga , Emad Siddiqui , Udaya Valluri , Faith D. Ottery
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Participants were randomised to receive placebo, fezolinetant 30 mg, or fezolinetant 45 mg during a 12-week treatment period.</p></div><div><h3>Main outcome measures</h3><p>Sleep assessments: Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (PROMIS SD SF 8b), PROMIS Sleep-Related Impairment – Short Form 8a (PROMIS SRI SF 8a), and Patient Global Impression of Change/Severity in SD (PGI-C SD and PGI-S SD). Assessments were completed at baseline (except PGI-C SD), weeks 4 and 12.</p></div><div><h3>Results</h3><p>Overall, 1022 individuals were randomised and took ≥1 dose of study drug. PROMIS SD SF 8b results showed that improvements in sleep disturbance were observed for fezolinetant 30 and 45 mg versus placebo (week 12, least squares [LS] mean differences: −0.6 [95 % confidence interval [CI]: −1.7, 0.4] for 30 mg and –1.5 [−2.5, −0.5] for 45 mg). Similar improvements in sleep impairment were reported using the PROMIS SRI SF 8a (week 12, LS mean differences: –1.1 [95 % CI: −2.1, −0.1] for 30 mg and −1.3 [−2.3, −0.3] for 45 mg). For PGI-C SD at week 12, 33.6 % (98/292 participants) of the placebo group felt much/moderately better versus 40.1 % (110/274) and 51.0 % (154/302) of the fezolinetant 30 mg and 45 mg groups, respectively. For PGI-S SD at week 12, 44.0 % (129/293) of the placebo group had severe/moderate problems versus 41.1 % (113/275) and 36.6 % (111/303) of the fezolinetant 30 mg and 45 mg groups, respectively. The 12-week timeframe for this analysis was limited by the length of the placebo-controlled period.</p></div><div><h3>Conclusions</h3><p>Fezolinetant had a beneficial effect on four measures of sleep disturbance and impairment following treatment for VMS.</p></div>","PeriodicalId":51120,"journal":{"name":"Maturitas","volume":null,"pages":null},"PeriodicalIF":3.9000,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S037851222400094X/pdfft?md5=4ec4a273a3ad9ac290c5e8fe7c019451&pid=1-s2.0-S037851222400094X-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause\",\"authors\":\"Marla Shapiro C.M. , Antonio Cano , Rossella E. Nappi , Nanette Santoro , Marci L. English , Shayna Mancuso , Antonia Morga , Emad Siddiqui , Udaya Valluri , Faith D. 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Participants were randomised to receive placebo, fezolinetant 30 mg, or fezolinetant 45 mg during a 12-week treatment period.</p></div><div><h3>Main outcome measures</h3><p>Sleep assessments: Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (PROMIS SD SF 8b), PROMIS Sleep-Related Impairment – Short Form 8a (PROMIS SRI SF 8a), and Patient Global Impression of Change/Severity in SD (PGI-C SD and PGI-S SD). Assessments were completed at baseline (except PGI-C SD), weeks 4 and 12.</p></div><div><h3>Results</h3><p>Overall, 1022 individuals were randomised and took ≥1 dose of study drug. PROMIS SD SF 8b results showed that improvements in sleep disturbance were observed for fezolinetant 30 and 45 mg versus placebo (week 12, least squares [LS] mean differences: −0.6 [95 % confidence interval [CI]: −1.7, 0.4] for 30 mg and –1.5 [−2.5, −0.5] for 45 mg). 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Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause
Objectives
To analyse the effect of fezolinetant on patient-reported sleep disturbance and impairment in individuals with vasomotor symptoms (VMS) using pooled data from the SKYLIGHT 1 and 2 studies.
Study design
The SKYLIGHT studies were phase-3, double-blind investigations. Individuals (≥40–≤65 years) who were assigned female at birth and seeking treatment of/relief from moderate-to-severe VMS were enrolled. Participants were randomised to receive placebo, fezolinetant 30 mg, or fezolinetant 45 mg during a 12-week treatment period.
Main outcome measures
Sleep assessments: Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (PROMIS SD SF 8b), PROMIS Sleep-Related Impairment – Short Form 8a (PROMIS SRI SF 8a), and Patient Global Impression of Change/Severity in SD (PGI-C SD and PGI-S SD). Assessments were completed at baseline (except PGI-C SD), weeks 4 and 12.
Results
Overall, 1022 individuals were randomised and took ≥1 dose of study drug. PROMIS SD SF 8b results showed that improvements in sleep disturbance were observed for fezolinetant 30 and 45 mg versus placebo (week 12, least squares [LS] mean differences: −0.6 [95 % confidence interval [CI]: −1.7, 0.4] for 30 mg and –1.5 [−2.5, −0.5] for 45 mg). Similar improvements in sleep impairment were reported using the PROMIS SRI SF 8a (week 12, LS mean differences: –1.1 [95 % CI: −2.1, −0.1] for 30 mg and −1.3 [−2.3, −0.3] for 45 mg). For PGI-C SD at week 12, 33.6 % (98/292 participants) of the placebo group felt much/moderately better versus 40.1 % (110/274) and 51.0 % (154/302) of the fezolinetant 30 mg and 45 mg groups, respectively. For PGI-S SD at week 12, 44.0 % (129/293) of the placebo group had severe/moderate problems versus 41.1 % (113/275) and 36.6 % (111/303) of the fezolinetant 30 mg and 45 mg groups, respectively. The 12-week timeframe for this analysis was limited by the length of the placebo-controlled period.
Conclusions
Fezolinetant had a beneficial effect on four measures of sleep disturbance and impairment following treatment for VMS.
期刊介绍：
Maturitas is an international multidisciplinary peer reviewed scientific journal of midlife health and beyond publishing original research, reviews, consensus statements and guidelines, and mini-reviews. The journal provides a forum for all aspects of postreproductive health in both genders ranging from basic science to health and social care.
Topic areas include:• Aging• Alternative and Complementary medicines• Arthritis and Bone Health• Cancer• Cardiovascular Health• Cognitive and Physical Functioning• Epidemiology, health and social care• Gynecology/ Reproductive Endocrinology• Nutrition/ Obesity Diabetes/ Metabolic Syndrome• Menopause, Ovarian Aging• Mental Health• Pharmacology• Sexuality• Quality of Life
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