Efficacy and safety of a low-dose continuous combined hormone replacement therapy with 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone in subgroups of postmenopausal women with vasomotor symptoms

• Published in: Maturitas 2020-09, Vol.139, p.20-26
• Main Authors: Tsiligiannis, Sophia, Wick-Urban, Bettina C., van der Stam, Jan, Stevenson, John C.
• Format: Article
• Language: English
• Subjects: Dydrogesterone; Estradiol; Hormone replacement therapy; Low dose; Postmenopausal; Vasomotor symptoms
• ISSN: 0378-5122; 1873-4111
• DOI: 10.1016/j.maturitas.2020.05.002

•Combined estradiol and dydrogesterone provides an effective treatment for menopausal vasomotor symptoms and may offer safety advantages.•This combination demonstrated a consistent treatment effect and safety profile across subgroups of age, menopause duration and body mass index.•The combination studied offers a lowest dose continuous combined hormone replacement therapy. Various combinations of estrogens and progestogens are available for menopausal hormone therapy that differ in their efficacy and safety profile. We evaluated the efficacy and long-term safety of low-dose estradiol (0.5 mg) / dydrogesterone (2.5 mg) in subgroups of postmenopausal women with vasomotor symptoms. Analysis: Efficacy analysis was performed on data from 2 previously published studies for subgroups defined by age, duration of menopause, and body mass index at baseline. The primary efficacy variable was the number of moderate to severe hot flushes from baseline to week 13. Long-term safety was evaluated in relation to age and duration of menopause. Safety variables included adverse events to week 52 and change from baseline to endpoint in laboratory and vital sign values. Results: The treatment difference seen in the overall population in favour of low-dose estradiol/dydrogesterone was also observed in the subgroups of patients aged 45 to < 55 years (p < 0.01) and ≥55 years (p < 0.05), with menopause duration of >12 months to