Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women.

Objectives Drospirenone is a novel progestogen that, combined with 17ββ-estradiol, reduces the frequency and severity of menopausal vasomotor symptoms (VMS) in different populations. This double-blind, multicenter study compared the efficacy, safety and tolerability of 2 mg drospirenone/1 mg estradiol (DRSP/E2) vs. placebo in Chinese postmenopausal women with moderate to severe VMS. Methods Women, aged 45--65 years, were randomized to DRSP/E2 ( n  ==  183) or placebo ( n  ==  61) once daily for four 28-day cycles. Changes in the frequency and severity of hot flushes were analyzed as primary variables, together with other climacteric and urogenital symptoms, clinical global improvement, adverse events and physical/gynecological parameters. Results Relative changes in numbers of hot flushes/week were −−80.4%% for DRSP/E2 vs. −−51.9%% for placebo (treatment difference −−28.5%%, p  <  0.0001). There were trends toward a greater reduction in severity of hot flushes with DRSP/E2 treatment. Patients treated with DRSP/E2 were more often free from sweating episodes ( p  <  0.0001) and vaginal dryness ( p  ==  0.0008). Other climacteric symptoms, including nervousness and pollakisuria, followed a trend of greater response with DRSP/E2. Similar to other combination HRT regimens, DRSP/E2 increased occurrences of bleeding, but these decreased over time. Adverse events in patients treated with DRSP/E2 were mostly mild to moderate and withdrawal rates were low. Conclusions Daily treatment of postmenopausal Chinese women with DRSP/E2 for 16 weeks significantly reduced the incidence of hot flushes and demonstrated advantages vs. placebo for other climacteric symptoms. These results indicate that DRSP/E2 is effective, safe and well tolerated in postmenopausal Chinese women. [ABSTRACT FROM AUTHOR]