Safety and Effectiveness of Dienogest (Visanne (R)) for Treatment of Endometriosis: A Large Prospective Cohort Study
- 주제(키워드) Dienogest , Endometriosis , Cohort study , Safety , Effectiveness
- 주제(기타) Obstetrics & Gynecology
- 주제(기타) Reproductive Biology
- 설명문(일반) [Cho, BaikSeol] Bayer Korea Ltd Pharmaceut, Med Affairs Womens Healthcare, Seoul, South Korea; [Roh, Ju-Won] Dongguk Univ, Dept Obstet & Gynecol, Ilsan Hosp, Gyeonggi Do, South Korea; [Park, Jonghoon] Ilsin Christian Hosp, Dept Obstet & Gynecol, Busan, South Korea; [Park, Jonghoon] Bonseng Mem Hosp, Dept Obstet & Gynecol, Busan, South Korea; [Jeong, Kyungah] Ewha Womans Univ, Coll Med, Dept Obstet & Gynecol, Mokdong Hosp, Seoul, South Korea; [Kim, Tae-Hee] Soonchunhyang Univ, Dept Obstet & Gynecol, Bucheon Hosp, Gyeonggi Do, South Korea; [Kim, Yun Sook] Soonchunhyang Univ, Coll Med, Cheonan Hosp, Cheonan, South Korea; [Kwon, Yong-Soon] Ulsan Univ, Ulsan Univ Hosp, Dept Obstet & Gynecol, Coll Med, Ulsan, South Korea; [Kwon, Yong-Soon] Eulji Univ, Nowon Eulji Med Ctr, Dept Obstet & Gynecol, Seoul, South Korea; [Cho, Chi-Heum] Keimyung Univ, Sch Med, Obstet & Gynecol, Daegu, South Korea; [Park, Sung Ho] Hallym Univ, Kangnam Sacred Heart Hosp, Dept Obstet & Gynecol, Seoul, South Korea; [Kim, Sung Hoon] Univ Ulsan, Asan Med Ctr, Dept Obstet & Gynecol, Coll Med, Seoul, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 SPRINGER HEIDELBERG
- 발행년도 2020
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000169238
- 본문언어 영어
- Published As https://dx.doi.org/10.1007/s43032-019-00094-5
- PubMed https://pubmed.ncbi.nlm.nih.gov/32052358
초록/요약
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.
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