title: Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women.
abstract: OBJECTIVE
  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.
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: S-Q
authors.initials: SQ
authors.lastname: Lin
authors.forename: L-Z
authors.initials: LZ
authors.lastname: Sun
authors.forename: J-F
authors.initials: JF
authors.lastname: Lin
authors.forename: X
authors.initials: X
authors.lastname: Yang
authors.forename: L-J
authors.initials: LJ
authors.lastname: Zhang
authors.forename: J
authors.initials: J
authors.lastname: Qiao
authors.forename: Z-H
authors.initials: ZH
authors.lastname: Wang
authors.forename: Y-X
authors.initials: YX
authors.lastname: Xu
authors.forename: Z-A
authors.initials: ZA
authors.lastname: Xiong
authors.forename: Y-Z
authors.initials: YZ
authors.lastname: Zhou
authors.forename: M-L
authors.initials: ML
authors.lastname: Wang
authors.forename: J
authors.initials: J
authors.lastname: Zhu
authors.forename: S-R
authors.initials: SR
authors.lastname: Chen
authors.forename: H
authors.initials: H
authors.lastname: Su
authors.forename: C-S
authors.initials: CS
authors.lastname: Yang
authors.forename: S-H
authors.initials: SH
authors.lastname: Wang
authors.forename: Y-Z
authors.initials: YZ
authors.lastname: Zhang
authors.forename: X-J
authors.initials: XJ
authors.lastname: Dong
mesh_terms: D000368:Aged; D000736:Androstenes / Q000008:administration & dosage*; D002681:China; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage; D010919:Placebos; D017698:Postmenopause; D014623:Vaginal Diseases / Q000188:drug therapy
chemical_list: D000736:Androstenes; D004338:Drug Combinations; D000451:Mineralocorticoid Receptor Antagonists; D010919:Placebos; C488382:estradiol-drospirenone combination; D004958:Estradiol; C035144:drospirenone