Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women.
Author(s): Lin SQ, Sun LZ, Lin JF, Yang X, Zhang LJ, Qiao J, Wang ZH, Xu YX, Xiong ZA, Zhou YZ, Wang ML, Zhu J, Chen SR, Su H, Yang CS, Wang SH, Zhang YZ, Dong XJ
Affiliation(s): Peking Union Medical College Hospital, Beijing, China.
Publication date & source: 2011-08, Climacteric., 14(4):472-81. Epub 2011 Apr 6.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
OBJECTIVES: Drospirenone is a novel progestogen that, combined with 17beta-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.