Low incidence of endometrial hyperplasia with acceptable bleeding patternsin women taking sequential hormone replacement therapy with dydrogesterone

A meta-analysis was undertaken to assess the incidence of endometrial hyper plasia during sequentially combined oral 17 beta-estradiol and dydrogestero ne (Femoston(R)) treatment in postmenopausal women. Bleeding pattern was as sessed separately in each study. Two studies were double-blind, 6-month stu dies and two were open, long-term (1- or 2-year) studies. 17 beta-estradiol 2 mg daily was combined with dydrogesterone 10 mg for 14 days per 28-day c ycle. Endometrial safety was assessed by endometrial biopsy in 369 women tr eated. In 236 women treated for one year or more, one simple hyperplasia wa s diagnosed (success rate: 99.61%; lower limit of one-sided 95% confidence interval: 98.16). The last observation carried forward analysis in 369 wome n also revealed one simple hyperplasia (success rate: 99.73%; lower limit o f one-sided 95% confidence interval: 98.72). Cyclic bleeding occurred in ap proximately 90% of women; the duration and day of onset was highly predicta ble between cycles and the severity of bleeding was generally rated as slig ht. In conclusion, sequentially combined 17 beta-estradiol 2 mg and dydroge sterone 10 mg has very good endometrial safety and is associated with light and predictable bleeding of short duration.