Ultra-low dose estradiol and dydrogesterone for the treatment of menopausal symptoms in a pooled, multi-ethnic population.

Evidence suggests ethnicity-specific differences in postmenopausal symptoms, highlighting the need for therapies that are efficacious across different ethnicities. We evaluated the efficacy of an ultra-low dose combination of 0.5 mg estradiol and 0.25 mg dydrogesterone (E 0.5 mg/D 2.5 mg) in alleviating vasomotor symptoms across a multi-ethnic population. Data from two controlled trials were pooled to form a dataset of 583 postmenopausal women from across Europe and China. Participants were randomized to receive treatment with E 0.5 mg/D 2.5 mg or placebo for 12 weeks. The main efficacy variable was absolute change in the number of hot flushes from baseline to end of treatment. Health-related quality of life and safety were also assessed. Change in the number of hot flushes per day was greater with E 0.5 mg/D 2.5 mg versus placebo (mean difference - 1.5, 95 % confidence interval - 2.1, -1.0; p < 0.001). Participants treated with E 0.5 mg/D 2.5 mg reported improvement in health-related quality of life (including psychological symptoms, vaginal dryness), and high amenorrhea rates. Combined E 0.5 mg/D 2.5 mg was well tolerated: there were no differences between groups in the percentage of participants with at least one serious adverse event or treatment-emergent serious adverse events. Analysis of change in body weight indicated no differences between groups. This pooled analysis demonstrates the consistent efficacy of E 0.5 mg/D 2.5 mg in the treatment of menopause-related symptoms across a multi-ethnic population of postmenopausal women.

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Déclaration de conflit d'intérêts

Declaration of competing interest MR, QY, and TT declare no conflicts of interest. JCS reports having received speaker's honoraria in the past three years from Abbott, Theramex and Viatris; he is also chairman of Women's Health Concern, a trustee of the British Menopause Society and an expert advisor to the National Institute for Health and Care Excellence (UK). EK is an employee of Abbott Laboratories GmbH, Hannover, Germany and owns shares in Abbott. MGC is an employee of Abbott Products Operations AG, Allschwil, Switzerland and owns shares in Abbott. REN reports having received a grant from Fidia to her institution, consulting fees from Astellas, Bayer HealthCare AG, Besins Healthcare and Fidia, and speaker's honoraria from Abbott, Bayer HealthCare AG, Gedeon Richter, Merck & Co, Shionogi Limited, Theramex, Viatris and Vichy Laboratories; she is also president elect of the International Menopause Society. VK is an employee of Established Pharmaceuticals Division, Abbott Ukraine LLC, Kyiv, Ukraine. TS reports having received consulting fees in the past three years from Abbott, Actavis, Applied Medical, Astellas, Estetra, Gedeon Richter, Johnson & Johnson, Medtronic, Mitsubishi Tanabe and Sojournix, and speaker's honoraria from Abbott, Applied Medical, Gedeon Richter, Intuitive Surgical, Shionogi and Theramex.