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.
OBJECTIVES
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 <60 months (p < 0.05) and ≥ 60 months (p < 0.005), and with a BMI at baseline of <25 kg/m2 (p < 0.05) and 25 to <30 kg/m2 (p < 0.01). Low-dose estradilol/dydrogesterone was well tolerated across the different subgroups. The incidence of breast-related adverse events was very low. No breast malignancy was reported. Only one adverse endometrial outcome of simple hyperplasia was observed.


CONCLUSION
The results of our analyses confirmed the consistent treatment effect on vasomotor symptoms and the favourable safety profile of 0.5 mg 17β estradiol and 2.5 mg dydrogesterone in different patient subgroups.
['Tsiligiannis|Sophia|S|', 'Wick-Urban|Bettina C|BC|', 'van der Stam|Jan|J|', 'Stevenson|John C|JC|']
D000368:Aged D004311:Double-Blind Method D004338:Drug Combinations D004394:Dydrogesterone D004958:Estradiol D005260:Female D020249:Hormone Replacement Therapy D019584:Hot Flashes D006801:Humans D008875:Middle Aged D017698:Postmenopause
Hormone replacement therapy Dydrogesterone Postmenopausal Vasomotor symptoms Estradiol Low dose