title: Efficacy and safety of drospirenone 2 mg/17β-estradiol 1 mg hormone therapy in Korean postmenopausal women.
abstract: This regulatory post-marketing surveillance study aimed to evaluate the therapeutic efficacy and safety of drospirenone (DRSP) 2 mg/estradiol (E2) 1 mg tablet in Korean postmenopausal women. A total of 4,149 patients were enrolled and the study was conducted at 207 clinical research centers. The patients' source data was collected between November 2006 and November 2012. More than 85% of patients experienced improvement of menopausal symptoms. The most frequently reported adverse events were vaginal bleeding and breast pain; most of the women suffering from these symptoms fully recovered. The incidence of adverse event was higher in patients of younger age (20 to 39 years), in patients with concomitant diseases, previous hormone replacement therapy in medical history, those treated with DRSP 2 mg/E21 mg for shorter duration (3 years or less) and in patients using concomitant medication. In conclusion, the results from this large post-marketing surveillance study confirm the efficacy and safety of DRSP 2 mg/E21 mg tablet in Korean postmenopausal women.
authors.affiliation: Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Asan, Korea.
authors.forename: Bo Ra
authors.initials: BR
authors.lastname: Park
authors.affiliation: Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Asan, Korea.
authors.forename: Hye Na
authors.initials: HN
authors.lastname: Park
authors.affiliation: Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Asan, Korea.
authors.forename: Ji Back
authors.initials: JB
authors.lastname: Jung
authors.affiliation: Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Asan, Korea.
authors.forename: Eun Sil
authors.identifier: 0000-0003-4132-5533
authors.initials: ES
authors.lastname: Lee
authors.affiliation: Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Asan, Korea.
authors.forename: Jeong Sig
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Asan, Korea.
authors.forename: Gyu Yeon
authors.initials: GY
authors.lastname: Choi
authors.affiliation: Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Asan, Korea.
authors.forename: Jeong Jae
authors.initials: JJ
authors.lastname: Lee
authors.affiliation: Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Asan, Korea.
authors.forename: Im Soon
authors.initials: IS
authors.lastname: Lee
keywords: Drospirenone; Effectiveness; Menopause; Safety