Low-dose and ultra-low-dose estradiol and dydrogesterone in postmenopause: an analysis by body mass index.

IF 2.9 4区医学 Q1 OBSTETRICS & GYNECOLOGY Climacteric Pub Date : 2024-10-30 DOI:10.1080/13697137.2024.2418497

Mulan Ren, Qi Yu, Marcelo Graziano Custodio, Tommaso Simoncini, Rossella E Nappi, Tetiana Tatarchuk, Elke Kahler, Tony Piha, John C Stevenson

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Abstract

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.

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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。

目的：口服、低剂量和超低剂量连续联合使用 17β-estradiol (E) 加地屈孕酮 (D) 可减轻绝经后妇女的血管运动症状 (VMS)：方法：纳入了两项 3 期双盲研究。在欧洲的研究中，绝经后妇女按 2:1:2 的比例随机接受 E0.5 毫克/D2.5 毫克（超低剂量）、E1 毫克/D5 毫克（低剂量）或安慰剂，为期 13 周。在中国的研究中，妇女按 1:1 的比例随机接受 E0.5 毫克/D2.5 毫克或安慰剂，为期 12 周。在体重指数（BMI）亚组（2；≥25 kg/m2）中评估的事后终点包括每天潮热和中度至重度潮热的次数，以及闭经妇女的比例：结果：共纳入了 640 名妇女。治疗结束时，与安慰剂相比，所有治疗组每天潮热的平均次数（95% 置信区间）均显著降低（p ≤ 0.05），其中 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]）和 E1 mg/D5 mg 与安慰剂（BMI < 25 kg/m2：2.7 [1.2，4.2]；BMI ≥ 25 kg/m2：2.3 [1.1，3.5]）相比（BMI < 25 kg/m2：4.4 [3.8，50]；BMI ≥ 25 kg/m2：4.2 [3.6，4.9]）。中度至重度潮热的情况也类似。两项研究和 BMI 亚组的闭经率都很高（79%-98%）：结论：与安慰剂相比，口服超低剂量连续联合 E0.5 mg/D2.5 mg 和低剂量连续联合 E1 mg/D5 mg 可减轻绝经后 VMS，与 BMI 无关。

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来源期刊

Climacteric 医学-妇产科学

CiteScore

1.70

自引率

7.10%

发文量

审稿时长

1 months

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.