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Article ; Online: Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause.

Pinkerton, JoAnn V / Simon, James / Panay, Nick / Seitz, Christian / Parke, Susanne / Caetano, Cecilia / Mellinger, Uwe / Haseli Mashhadi, Nazanin / Haberland, Claudia / Atanackovic, Gordana / Holz, Cornelia / Mao, Guangping / Morrison, Marina / Nisius, Sven / Schaefers, Matthias / Zuurman, Lineke

Menopause (New York, N.Y.)

2024

Abstract: Objective: Elinzanetant is a selective neurokinin-1,3 receptor antagonist in development for the treatment of vasomotor symptoms (VMS) associated with menopause. The pivotal, double-blind, randomized, placebo-controlled phase 3 studies Overall ... ...

Abstract	Objective: Elinzanetant is a selective neurokinin-1,3 receptor antagonist in development for the treatment of vasomotor symptoms (VMS) associated with menopause. The pivotal, double-blind, randomized, placebo-controlled phase 3 studies Overall Assessment of efficacy and Safety of elinzanetant In patients with vasomotor Symptoms (OASIS) 1 and 2 will assess the efficacy and safety of elinzanetant in women with VMS. Methods: The OASIS 1 and 2 pivotal studies are designed in accordance with regulatory guidance. Postmenopausal women with moderate/severe VMS are randomized to receive 120 mg elinzanetant or placebo once daily for 12 weeks, followed by a 14-week active treatment extension. Primary endpoints are the mean change in frequency and severity of moderate/severe VMS from baseline to weeks 4 and 12. Key secondary endpoints will assess the onset of action and effects on sleep disturbance and menopause-related quality of life. Primary and key secondary endpoints will be analyzed using a mixed model with repeated measures. Feedback from postmenopausal women with VMS was used during protocol development. Results: Women confirmed the relevance of endpoints that assess the impact of VMS, sleep disturbance, and mood changes, and the need for new nonhormone treatments. Educational materials around study design, conduct and expected assessments and procedures were developed based on questions and concerns raised by women. Conclusions: The OASIS 1 and 2 pivotal phase 3 studies will enable assessment of the efficacy and safety of elinzanetant as a treatment for VMS, together with its effect on sleep disturbances, depressive symptoms, and menopause-related quality of life. Feedback from postmenopausal women with VMS was used to maximize patient centricity in the trials.
Language	English
Publishing date	2024-04-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	1205262-0
ISSN	1530-0374 ; 1072-3714
ISSN (online)	1530-0374
ISSN	1072-3714
DOI	10.1097/GME.0000000000002350
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Sleep quality in middle-aged and elderly Chinese

Lin Xu / Yu Zhijie / Pan An / Dadd Tony / Haseli-Mashhadi Nazanin / Franco Oscar H

BMC Public Health, Vol 9, Iss 1, p

distribution, associated factors and associations with cardio-metabolic risk factors

2009 Volume 130

Abstract: Abstract Background Poor sleep quality has been associated with increased risk of heart disease, diabetes and mortality. However, limited information exists on the distribution and determinants of sleep quality and its associations with cardio-metabolic ... ...

Abstract	Abstract Background Poor sleep quality has been associated with increased risk of heart disease, diabetes and mortality. However, limited information exists on the distribution and determinants of sleep quality and its associations with cardio-metabolic risk factors in Chinese populations. We aimed to evaluate this in the current study. Methods A cross-sectional survey conducted in 2005 of 1,458 men and 1,831 women aged 50–70 years from urban and rural areas of Beijing and Shanghai. Using a questionnaire, sleep quality was measured in levels of well, common and poor. Comprehensive measures of socio-demographical and health factors and biomarkers of cardio-metabolic disease were recorded. These were evaluated in association with sleep quality using logistic regression models. Results Half of the population reported good sleep quality. After adjusting for potential confounders, women and Beijing residents had almost half the probability to report good sleep quality. Good physical and mental health (good levels of self-rated health (OR 2.48; 95%CI 2.08 to 2.96) and no depression (OR 4.05; 95%CI 3.12 to 5.26)) related to an increased chance of reporting good sleep quality, whereas short sleep duration (<7 hrs OR 0.10; 95%CI 0.07 to 0.14)) decreased it substantially. There were significant associations between levels of sleep quality and concentrations of plasma insulin, total and LDL cholesterol, and index of insulin resistance. Conclusion Levels of good sleep quality in middle-age and elderly Chinese were low. Gender, geographical location, self-rated health, depression and sleep quantity were major factors associated with sleep quality. Prospective studies are required to distil the factors that determine sleep quality and the effects that sleep patterns exert on cardio-metabolic health.
Keywords	Public aspects of medicine ; RA1-1270
Subject code	610
Language	English
Publishing date	2009-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Sleep quality in middle-aged and elderly Chinese: distribution, associated factors and associations with cardio-metabolic risk factors.

Haseli-Mashhadi, Nazanin / Dadd, Tony / Pan, An / Yu, Zhijie / Lin, Xu / Franco, Oscar H

BMC public health

2009 Volume 9, Page(s) 130

Abstract: Background: Poor sleep quality has been associated with increased risk of heart disease, diabetes and mortality. However, limited information exists on the distribution and determinants of sleep quality and its associations with cardio-metabolic risk ... ...

Abstract	Background: Poor sleep quality has been associated with increased risk of heart disease, diabetes and mortality. However, limited information exists on the distribution and determinants of sleep quality and its associations with cardio-metabolic risk factors in Chinese populations. We aimed to evaluate this in the current study. Methods: A cross-sectional survey conducted in 2005 of 1,458 men and 1,831 women aged 50-70 years from urban and rural areas of Beijing and Shanghai. Using a questionnaire, sleep quality was measured in levels of well, common and poor. Comprehensive measures of socio-demographical and health factors and biomarkers of cardio-metabolic disease were recorded. These were evaluated in association with sleep quality using logistic regression models. Results: Half of the population reported good sleep quality. After adjusting for potential confounders, women and Beijing residents had almost half the probability to report good sleep quality. Good physical and mental health (good levels of self-rated health (OR 2.48; 95%CI 2.08 to 2.96) and no depression (OR 4.05; 95%CI 3.12 to 5.26)) related to an increased chance of reporting good sleep quality, whereas short sleep duration (<7 hrs OR 0.10; 95%CI 0.07 to 0.14)) decreased it substantially. There were significant associations between levels of sleep quality and concentrations of plasma insulin, total and LDL cholesterol, and index of insulin resistance. Conclusion: Levels of good sleep quality in middle-age and elderly Chinese were low. Gender, geographical location, self-rated health, depression and sleep quantity were major factors associated with sleep quality. Prospective studies are required to distil the factors that determine sleep quality and the effects that sleep patterns exert on cardio-metabolic health.
MeSH term(s)	Aged ; Biomarkers/blood ; Cardiovascular Diseases/blood ; Cardiovascular Diseases/epidemiology ; China/epidemiology ; Cholesterol, LDL/blood ; Cross-Sectional Studies ; Female ; Humans ; Insulin/blood ; Logistic Models ; Male ; Metabolic Diseases/blood ; Metabolic Diseases/epidemiology ; Middle Aged ; Risk Factors ; Sleep/physiology ; Sleep Wake Disorders/blood ; Sleep Wake Disorders/epidemiology ; Surveys and Questionnaires
Chemical Substances	Biomarkers ; Cholesterol, LDL ; Insulin
Language	English
Publishing date	2009-05-09
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1471-2458
ISSN (online)	1471-2458
DOI	10.1186/1471-2458-9-130
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Self-Rated Health in middle-aged and elderly Chinese

Yu Zhijie / Li Huaixing / Liu Yong / Qi Qibin / Wang Jing / Ye Xingwang / Pan An / Haseli-Mashhadi Nazanin / Lin Xu / Franco Oscar H

BMC Public Health, Vol 9, Iss 1, p

distribution, determinants and associations with cardio-metabolic risk factors

2009 Volume 368

Abstract: Abstract Background Self-rated health (SRH) has been demonstrated to be an accurate reflection of a person's health and a valid predictor of incident mortality and chronic morbidity. We aimed to evaluate the distribution and factors associated with SRH ... ...

Abstract	Abstract Background Self-rated health (SRH) has been demonstrated to be an accurate reflection of a person's health and a valid predictor of incident mortality and chronic morbidity. We aimed to evaluate the distribution and factors associated with SRH and its association with biomarkers of cardio-metabolic diseases among middle-aged and elderly Chinese. Methods Survey of 1,458 men and 1,831 women aged 50 to 70 years, conducted in one urban and two rural areas of Beijing and Shanghai in 2005. SRH status was measured and categorized as good (very good and good) vs. not good (fair, poor and very poor). Determinants of SRH and associations with biomarkers of cardio-metabolic diseases were evaluated using logistic regression. Results Thirty two percent of participants reported good SRH. Males and rural residents tended to report good SRH. After adjusting for potential confounders, residence, physical activity, employment status, sleep quality and presence of diabetes, cardiovascular disease, and depression were the main determinants of SRH. Those free from cardiovascular disease (OR 3.68; 95%CI 2.39; 5.66), rural residents (OR 1.89; 95% CI 1.47; 2.43), non-depressed participants (OR 2.50; 95% CI 1.67; 3.73) and those with good sleep quality (OR 2.95; 95% CI 2.22; 3.91) had almost twice or over the chance of reporting good SRH compared to their counterparts. There were significant associations -and trend- between SRH and levels of inflammatory markers, insulin levels and insulin resistance. Conclusion Only one third of middle-aged and elderly Chinese assessed their health status as good or very good. Although further longitudinal studies are required to confirm our findings, interventions targeting social inequalities, lifestyle patterns might not only contribute to prevent chronic morbidity but as well to improve populations' perceived health.
Keywords	Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2009-09-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Self-Rated Health in middle-aged and elderly Chinese: distribution, determinants and associations with cardio-metabolic risk factors.

Haseli-Mashhadi, Nazanin / Pan, An / Ye, Xingwang / Wang, Jing / Qi, Qibin / Liu, Yong / Li, Huaixing / Yu, Zhijie / Lin, Xu / Franco, Oscar H

BMC public health

2009 Volume 9, Page(s) 368

Abstract: Background: Self-rated health (SRH) has been demonstrated to be an accurate reflection of a person's health and a valid predictor of incident mortality and chronic morbidity. We aimed to evaluate the distribution and factors associated with SRH and its ... ...

Abstract	Background: Self-rated health (SRH) has been demonstrated to be an accurate reflection of a person's health and a valid predictor of incident mortality and chronic morbidity. We aimed to evaluate the distribution and factors associated with SRH and its association with biomarkers of cardio-metabolic diseases among middle-aged and elderly Chinese. Methods: Survey of 1,458 men and 1,831 women aged 50 to 70 years, conducted in one urban and two rural areas of Beijing and Shanghai in 2005. SRH status was measured and categorized as good (very good and good) vs. not good (fair, poor and very poor). Determinants of SRH and associations with biomarkers of cardio-metabolic diseases were evaluated using logistic regression. Results: Thirty two percent of participants reported good SRH. Males and rural residents tended to report good SRH. After adjusting for potential confounders, residence, physical activity, employment status, sleep quality and presence of diabetes, cardiovascular disease, and depression were the main determinants of SRH. Those free from cardiovascular disease (OR 3.68; 95%CI 2.39; 5.66), rural residents (OR 1.89; 95% CI 1.47; 2.43), non-depressed participants (OR 2.50; 95% CI 1.67; 3.73) and those with good sleep quality (OR 2.95; 95% CI 2.22; 3.91) had almost twice or over the chance of reporting good SRH compared to their counterparts. There were significant associations -and trend- between SRH and levels of inflammatory markers, insulin levels and insulin resistance. Conclusion: Only one third of middle-aged and elderly Chinese assessed their health status as good or very good. Although further longitudinal studies are required to confirm our findings, interventions targeting social inequalities, lifestyle patterns might not only contribute to prevent chronic morbidity but as well to improve populations' perceived health.
MeSH term(s)	Aged ; Cardiovascular Diseases/blood ; Cardiovascular Diseases/diagnosis ; Cardiovascular Diseases/epidemiology ; China/epidemiology ; Data Collection ; Depression/epidemiology ; Female ; Health Status ; Humans ; Life Style ; Male ; Metabolic Diseases/blood ; Metabolic Diseases/diagnosis ; Metabolic Diseases/epidemiology ; Middle Aged ; Risk Factors ; Rural Population ; Self Disclosure ; Sleep Wake Disorders/epidemiology ; Urban Population
Language	English
Publishing date	2009-09-29
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1471-2458
ISSN (online)	1471-2458
DOI	10.1186/1471-2458-9-368
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Inter-library loan at ZB MED

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Article ; Online: Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause.

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Article ; Online: Sleep quality in middle-aged and elderly Chinese

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Inter-library loan at ZB MED

Article ; Online: Sleep quality in middle-aged and elderly Chinese: distribution, associated factors and associations with cardio-metabolic risk factors.

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Inter-library loan at ZB MED

Article ; Online: Self-Rated Health in middle-aged and elderly Chinese

Full text online

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Inter-library loan at ZB MED

Article ; Online: Self-Rated Health in middle-aged and elderly Chinese: distribution, determinants and associations with cardio-metabolic risk factors.

More links

Kategorien

Order via subito

Inter-library loan at ZB MED