Safety and Effectiveness of Dienogest (Visanne®) for Treatment of Endometriosis: A Large Prospective Cohort Study
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 ® ) for endometriosis was conducted to assess the safety and effectiveness of...
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Published in | Reproductive sciences (Thousand Oaks, Calif.) Vol. 27; no. 3; pp. 905 - 915 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Cham
Springer International Publishing
01.03.2020
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Subjects | |
Online Access | Get full text |
ISSN | 1933-7191 1933-7205 1933-7205 |
DOI | 10.1007/s43032-019-00094-5 |
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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
®
) 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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AbstractList | 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
) 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. 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®) 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.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®) 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. 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 ® ) 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. |
Author | Cho, BaikSeol Cho, Chi-Heum Park, Jonghoon Park, Sung Ho Jeong, Kyungah Kim, Yun Sook Kwon, Yong-Soon Kim, Tae-Hee Roh, Ju-Won Kim, Sung Hoon |
Author_xml | – sequence: 1 givenname: BaikSeol surname: Cho fullname: Cho, BaikSeol organization: Medical Affairs Women’s Healthcare, Bayer Korea Ltd. Pharmaceutical – sequence: 2 givenname: Ju-Won surname: Roh fullname: Roh, Ju-Won organization: Department of Obstetrics and Gynecology, Dongguk University Ilsan Hospital – sequence: 3 givenname: Jonghoon surname: Park fullname: Park, Jonghoon organization: Department of Obstetrics and Gynecology, Ilsin Christian Hospital, Department of Obstetrics and Gynecology, Bonseng Memorial Hospital – sequence: 4 givenname: Kyungah surname: Jeong fullname: Jeong, Kyungah organization: Department of Obstetrics and Gynecology, College of Medicine, Ewha Womans University Mokdong Hospital – sequence: 5 givenname: Tae-Hee surname: Kim fullname: Kim, Tae-Hee organization: Department of Obstetrics and Gynecology, Soonchunhyang University Bucheon Hospital – sequence: 6 givenname: Yun Sook surname: Kim fullname: Kim, Yun Sook organization: Soonchunhyang University College of Medicine, Soonchunhyang University Cheonan Hospital – sequence: 7 givenname: Yong-Soon surname: Kwon fullname: Kwon, Yong-Soon organization: Department of Obstetrics and Gynecology, Ulsan University Hospital, Ulsan University College of Medicine, Department of Obstetrics and Gynecology, Eulji University, Nowon Eulji Medical Center – sequence: 8 givenname: Chi-Heum surname: Cho fullname: Cho, Chi-Heum organization: Obstetrics and Gynecology, School of Medicine, Keimyung University – sequence: 9 givenname: Sung Ho surname: Park fullname: Park, Sung Ho organization: Department of Obstetrics and Gynecology, Kangnam Sacred Heart Hospital, Hallym University – sequence: 10 givenname: Sung Hoon surname: Kim fullname: Kim, Sung Hoon email: kimsung@amc.seoul.kr organization: Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan College of Medicine |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32052358$$D View this record in MEDLINE/PubMed |
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Snippet | Dienogest (DNG) is a progestin with highly selective progesterone activity and known to be effective in the treatment of endometriosis. This prospective cohort... |
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SubjectTerms | Adult Embryology Endometriosis - complications Endometriosis - drug therapy Female Hormone Antagonists - therapeutic use Humans Medicine Medicine & Public Health Middle Aged Nandrolone - analogs & derivatives Nandrolone - therapeutic use Obstetrics/Perinatology/Midwifery Original Article Pain - complications Pain - prevention & control Prospective Studies Reproductive Medicine Treatment Outcome |
Title | Safety and Effectiveness of Dienogest (Visanne®) for Treatment of Endometriosis: A Large Prospective Cohort Study |
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