Mulan Ren, Qi Yu, Marcelo Graziano Custodio, Tommaso Simoncini, Rossella E Nappi, Tetiana Tatarchuk, Elke Kahler, Tony Piha, John C Stevenson
{"title":"绝经后低剂量和超低剂量雌二醇和地屈孕酮：按体重指数分析。","authors":"Mulan Ren, Qi Yu, Marcelo Graziano Custodio, Tommaso Simoncini, Rossella E Nappi, Tetiana Tatarchuk, Elke Kahler, Tony Piha, John C Stevenson","doi":"10.1080/13697137.2024.2418497","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Oral, low-dose and ultra-low-dose continuous combined 17β-estradiol (E) plus dydrogesterone (D) reduce vasomotor symptoms (VMS) in postmenopausal women.</p><p><strong>Methods: </strong>Two phase 3, double-blind studies were included. In the European study, postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg (ultra-low dose), E1 mg/D5 mg (low dose) or placebo for 13 weeks. In the Chinese study, women were randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks. Post-hoc endpoints assessed in body mass index (BMI) subgroups (<25 kg/m<sup>2</sup>; ≥25 kg/m<sup>2</sup>) included number of hot flushes and moderate-to-severe hot flushes per day, and the proportion of women with amenorrhea.</p><p><strong>Results: </strong>A total of 640 women were included. At the end of treatment, the mean (95% confidence interval) numbers of daily hot flushes were significantly lower (<i>p</i> ≤ 0.05) for all treatment groups versus placebo, with E0.5 mg/D2.5 mg (BMI < 25 kg/m<sup>2</sup>: 2.5 [1.9, 3.1]; BMI ≥ 25 kg/m<sup>2</sup>: 3.2 [2.5, 3.8]) and E1 mg/D5 mg versus placebo (BMI < 25 kg/m<sup>2</sup>: 2.7 [1.2, 4.2]; BMI ≥ 25 kg/m<sup>2</sup>: 2.3 [1.1, 3.5]) than with placebo (BMI < 25 kg/m<sup>2</sup>: 4.4 [3.8, 50]; BMI ≥ 25 kg/m<sup>2</sup>: 4.2 [3.6, 4.9]). A similar pattern was seen for moderate-to-severe hot flushes. The amenorrhea rate was high (79-98%) across both studies and BMI subgroups.</p><p><strong>Conclusion: </strong>Oral, ultra-low-dose continuous combined E0.5 mg/D2.5 mg and low-dose continuous combined E1 mg/D5 mg alleviated postmenopausal VMS compared with placebo, irrespective of BMI.</p>","PeriodicalId":10213,"journal":{"name":"Climacteric","volume":" ","pages":"1-7"},"PeriodicalIF":2.9000,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Low-dose and ultra-low-dose estradiol and dydrogesterone in postmenopause: an analysis by body mass index.\",\"authors\":\"Mulan Ren, Qi Yu, Marcelo Graziano Custodio, Tommaso Simoncini, Rossella E Nappi, Tetiana Tatarchuk, Elke Kahler, Tony Piha, John C Stevenson\",\"doi\":\"10.1080/13697137.2024.2418497\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Oral, low-dose and ultra-low-dose continuous combined 17β-estradiol (E) plus dydrogesterone (D) reduce vasomotor symptoms (VMS) in postmenopausal women.</p><p><strong>Methods: </strong>Two phase 3, double-blind studies were included. In the European study, postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg (ultra-low dose), E1 mg/D5 mg (low dose) or placebo for 13 weeks. In the Chinese study, women were randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks. Post-hoc endpoints assessed in body mass index (BMI) subgroups (<25 kg/m<sup>2</sup>; ≥25 kg/m<sup>2</sup>) included number of hot flushes and moderate-to-severe hot flushes per day, and the proportion of women with amenorrhea.</p><p><strong>Results: </strong>A total of 640 women were included. At the end of treatment, the mean (95% confidence interval) numbers of daily hot flushes were significantly lower (<i>p</i> ≤ 0.05) for all treatment groups versus placebo, with E0.5 mg/D2.5 mg (BMI < 25 kg/m<sup>2</sup>: 2.5 [1.9, 3.1]; BMI ≥ 25 kg/m<sup>2</sup>: 3.2 [2.5, 3.8]) and E1 mg/D5 mg versus placebo (BMI < 25 kg/m<sup>2</sup>: 2.7 [1.2, 4.2]; BMI ≥ 25 kg/m<sup>2</sup>: 2.3 [1.1, 3.5]) than with placebo (BMI < 25 kg/m<sup>2</sup>: 4.4 [3.8, 50]; BMI ≥ 25 kg/m<sup>2</sup>: 4.2 [3.6, 4.9]). A similar pattern was seen for moderate-to-severe hot flushes. 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Low-dose and ultra-low-dose estradiol and dydrogesterone in postmenopause: an analysis by body mass index.
Objective: Oral, low-dose and ultra-low-dose continuous combined 17β-estradiol (E) plus dydrogesterone (D) reduce vasomotor symptoms (VMS) in postmenopausal women.
Methods: Two phase 3, double-blind studies were included. In the European study, postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg (ultra-low dose), E1 mg/D5 mg (low dose) or placebo for 13 weeks. In the Chinese study, women were randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks. Post-hoc endpoints assessed in body mass index (BMI) subgroups (<25 kg/m2; ≥25 kg/m2) included number of hot flushes and moderate-to-severe hot flushes per day, and the proportion of women with amenorrhea.
Results: A total of 640 women were included. At the end of treatment, the mean (95% confidence interval) numbers of daily hot flushes were significantly lower (p ≤ 0.05) for all treatment groups versus placebo, with E0.5 mg/D2.5 mg (BMI < 25 kg/m2: 2.5 [1.9, 3.1]; BMI ≥ 25 kg/m2: 3.2 [2.5, 3.8]) and E1 mg/D5 mg versus placebo (BMI < 25 kg/m2: 2.7 [1.2, 4.2]; BMI ≥ 25 kg/m2: 2.3 [1.1, 3.5]) than with placebo (BMI < 25 kg/m2: 4.4 [3.8, 50]; BMI ≥ 25 kg/m2: 4.2 [3.6, 4.9]). A similar pattern was seen for moderate-to-severe hot flushes. The amenorrhea rate was high (79-98%) across both studies and BMI subgroups.
Conclusion: Oral, ultra-low-dose continuous combined E0.5 mg/D2.5 mg and low-dose continuous combined E1 mg/D5 mg alleviated postmenopausal VMS compared with placebo, irrespective of BMI.
期刊介绍：
Climacteric is the official journal of the International Menopause Society (IMS). As an international peer-reviewed journal it publishes original research and reviews of all aspects of aging in women.
Climacteric was founded by the IMS in 1998 and today has become a leading journal in the publication of peer-reviewed papers on the menopause, climacteric and mid-life health. Topics covered include endocrine changes, symptoms attributed to the menopause and their treatment, hormone replacement and alternative therapies, lifestyles, and the counselling and education of peri- and postmenopausal women. Climacteric, published bimonthly, also features regular invited reviews, editorials and commentaries on recent developments.
The editorial review board of Climacteric includes leading scientific and clinical experts in the field of midlife medicine and research and is headed by its Editor-in-Chief, Professor Rod Baber of Australia. He and his team of Associate Editors act independently to set a clear editorial policy, co-ordinate peer review, and ensure a rapid response to submitted papers.
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