Safety and Effectiveness of Dienogest (Visanne (R)) for Treatment of Endometriosis: A Large Prospective Cohort Study
- Authors
- Cho, BaikSeol; Roh, Ju-Won; Park, Jonghoon; Jeong, Kyungah; Kim, Tae-Hee; Kim, Yun Sook; Kwon, Yong-Soon; Cho, Chi-Heum; Park, Sung Ho; Kim, Sung Hoon
- Issue Date
- Mar-2020
- Publisher
- SAGE Publications
- Keywords
- Dienogest; Endometriosis; Cohort study; Safety; Effectiveness
- Citation
- Reproductive Sciences, v.27, no.3, pp 905 - 915
- Pages
- 11
- Journal Title
- Reproductive Sciences
- Volume
- 27
- Number
- 3
- Start Page
- 905
- End Page
- 915
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/19565
- DOI
- 10.1007/s43032-019-00094-5
- ISSN
- 1933-7191
1933-7205
- Abstract
- Dienogest (DNG) is a progestin with highly selective progesterone activity and known to be effective in the treatment of endometriosis. This prospective cohort study in patients who had been treated with DNG 2 mg (Visanne(R)) for endometriosis was conducted to assess the safety and effectiveness of DNG in a large Korean cohort. This study included 3356 patients with endometriosis from 73 centers in Korea. All patients were treated with DNG 2 mg daily and were followed up for at least 6 months after initial visit. Any adverse events were recorded including severity, onset/closing date, outcomes, treatments, and the causality with DNG. Effectiveness of DNG was measured by changes in visual analogue scale (VAS) from baseline at the end of follow-up. The mean age of the subjects was 34.96 years, and the mean duration of treatment was 285.44 days. Incidence of adverse drug reaction (ADR) was 13.27% (413/3113). The most frequently reported ADR were "abnormal uterine bleeding" 4.14% (129/3113), "increased weight" 2.57% (80/3113), and "headache" 1.22% (38/3113). The number of patients (%) with favorable bleeding patterns was observed to increase as the duration of treatment increases. Amenorrhea was observed in 29.63%, 41.25%, 46.26%, and 53.20% of patients at 3 months, 6 months, 12 months, and more than 12 months follow-up period, respectively. The mean (+/- SD) VAS change from baseline at the last follow-up visit was -28.19 +/- 28.39 mm (P value < 0.0001). This large cohort study confirms, in routine clinical practice, that DNG is safe and effective for treatment of endometriosis.
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - College of Medicine > Department of Obstetrics and Gynecology > 1. Journal Articles
- College of Medicine > Department of Obstetrics and Gynecology > 1. Journal Articles
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.