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

Abstract

Objectives Drospirenone is a novel progestogen that, combined with 17β-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.

Key words:

• DROSPIRENONE
• ESTRADIOL
• HORMONE REPLACEMENT THERAPY
• HORMONE THERAPY
• MENOPAUSE
• VASOMOTOR SYMPTOMS
• RANDOMIZED CONTROLLED TRIAL

ACKNOWLEDGEMENTS

Editorial support was provided by Claire Price of PAREXEL International. Funding for this editorial support was provided by Bayer Schering Pharma AG.

Conflict of interest  The authors have no financial, personal, political or academic conflict of interest capable of influencing their judgement.

Source of funding  Bayer Schering Pharma AG.