干旱区生态环境知识资源中心(Arid): Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause

Arid

DOI	10.1001/jama.2024.14618
	Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause
	Pinkerton, JoAnn V.; Simon, James A.; Joffe, Hadine; Maki, Pauline M.; Nappi, Rossella E.; Panay, Nick; Soares, Claudio N.; Thurston, Rebecca C.; Caetano, Cecilia; Haberland, Claudia; Mashhadi, Nazanin Haseli; Krahn, Ulrike; Mellinger, Uwe; Parke, Susanne; Seitz, Christian; Zuurman, Lineke
通讯作者	Pinkerton, JV
来源期刊	JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
ISSN	0098-7484
EISSN	1538-3598
出版年	2024
英文摘要	Importance Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed. Objective To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms. Design, Setting, and Participants Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023). Intervention Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 weeks followed by elinzanetant, 120 mg, for 14 weeks. Main Outcomes and MeasuresPrimary end points included mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, measured by the electronic hot flash daily diary. Secondary end points included Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and Menopause-Specific Quality of Life questionnaire total score from baseline to week 12. Results Eligible participants (mean [SD] age, OASIS 1: 54.6 [4.9] years; OASIS 2: 54.6 [4.8] years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). A total of 309 (78.0%) and 324 (81.0%) completed OASIS 1 and 2, respectively. For the elinzanetant and placebo groups, the baseline mean (SD) VMS per 24 hours were 13.4 (6.6) vs 14.3 (13.9) (OASIS 1) and 14.7 (11.1) v 16.2 (11.2) (OASIS 2). Baseline VMS severity was 2.6 (0.2) vs 2.5 (0.2) (OASIS 1) and 2.5 (0.2) vs 2.5 (0.2) (OASIS 2). Elinzanetant significantly reduced VMS frequency at week 4 (OASIS 1: -3.3 [95% CI, -4.5 to -2.1], P < .001; OASIS 2: -3.0 [95% CI, -4.4 to -1.7], P < .001) and at week 12 (OASIS 1: -3.2 [95% CI, -4.8 to -1.6], P < .001; OASIS 2: -3.2 [95% CI, -4.6 to -1.9], P < .001). Elinzanetant also improved VMS severity at week 4 (OASIS 1: -0.3 [95% CI, -0.4 to -0.2], P < .001; OASIS 2: -0.2 [95 CI, -0.3 to -0.1], P < .001) and week 12 (OASIS 1: -0.4 [95% CI, -0.5 to -0.3], P < .001; OASIS 2: -0.3 [95% CI, -0.4 to -0.1], P < .001). Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable. Conclusions and RelevanceElinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS. Trial RegistrationClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159
类型	Article ; Early Access
语种	英语
收录类别	SCI-E
WOS记录号	WOS:001304097800006
WOS关键词	SLEEP DISTURBANCE ; HOT FLASHES ; B NEURONS ; KISSPEPTIN ; TRANSITION ; SECRETION ; EFFICACY ; HEALTH
WOS类目	Medicine, General & Internal
WOS研究方向	General & Internal Medicine
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/404309
推荐引用方式 GB/T 7714	Pinkerton, JoAnn V.,Simon, James A.,Joffe, Hadine,et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause[J],2024.
APA	Pinkerton, JoAnn V..,Simon, James A..,Joffe, Hadine.,Maki, Pauline M..,Nappi, Rossella E..,...&Zuurman, Lineke.(2024).Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause.JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
MLA	Pinkerton, JoAnn V.,et al."Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause".JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2024).