Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women.
Climacteric
; 14(4): 472-81, 2011 Aug.
Article
in En
| MEDLINE
| ID: mdl-21469973
ABSTRACT
OBJECTIVES:
Drospirenone is a novel progestogen that, combined with 17ß-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.
Full text:
1
Database:
MEDLINE
Main subject:
Estrogen Replacement Therapy
/
Postmenopause
/
Estradiol
/
Androstenes
Type of study:
Clinical_trials
Limits:
Aged
/
Female
/
Humans
/
Middle aged
Country/Region as subject:
Asia
Language:
En
Journal:
Climacteric
Journal subject:
GINECOLOGIA
Year:
2011
Type:
Article
Affiliation country:
China