Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN
Issued Date
2022-04-01
Resource Type
ISSN
19337191
eISSN
19337205
Scopus ID
2-s2.0-85124090806
Pubmed ID
35112299
Journal Title
Reproductive Sciences
Volume
29
Issue
4
Start Page
1157
End Page
1169
Rights Holder(s)
SCOPUS
Bibliographic Citation
Reproductive Sciences Vol.29 No.4 (2022) , 1157-1169
Suggested Citation
Techatraisak K. Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN. Reproductive Sciences Vol.29 No.4 (2022) , 1157-1169. 1169. doi:10.1007/s43032-021-00787-w Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/86007
Title
Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN
Author(s)
Author's Affiliation
The Catholic University of Korea Seoul St. Mary's Hospital
Siriraj Hospital
Bayer Pharma AG
Severance Hospital
University of the Philippines College of Medicine
Universitas Indonesia, RSUPN Dr. Cipto Mangunkusumo
Bayer AG
College of Medicine, Pochon CHA University
Hermina Pandanaran Hospital
Sabah Women and Children's Hospital
Siriraj Hospital
Bayer Pharma AG
Severance Hospital
University of the Philippines College of Medicine
Universitas Indonesia, RSUPN Dr. Cipto Mangunkusumo
Bayer AG
College of Medicine, Pochon CHA University
Hermina Pandanaran Hospital
Sabah Women and Children's Hospital
Other Contributor(s)
Abstract
Several clinical trials in women with endometriosis demonstrated that dienogest reduces endometrial lesions and improves health-related quality of life (HRQoL). To assess HRQoL in dienogest-treated patients in real-world setting, we conducted a prospective, non-interventional study in 6 Asian countries. Women aged ≥18 years with clinical or surgical diagnosis of endometriosis, presence of endometriosis-associated pelvic pain (EAPP) and initiating dienogest therapy were enrolled. The primary objective was to evaluate HRQoL using the Endometriosis Health Profile-30 (EHP-30) questionnaire. The secondary objectives included analysis of EAPP, satisfaction with dienogest, endometriosis symptoms and bleeding patterns. 887 patients started dienogest therapy. Scores for all EHP-30 scales improved with the largest mean changes at month 6 and 24 in scale pain (−28.9 ± 27.5 and − 34 ± 28.4) and control and powerlessness (−23.7 ± 28.2 and − 28.5 ± 26.2). Mean EAPP score change was −4.6 ± 3.0 for both month 6 and 24 assessments. EAPP decrease was similar in surgically and only clinically diagnosed patients. From baseline to month 24, rates of normal bleeding decreased (from 85.8% to 17.5%) while rates of amenorrhea increased (from 3.5% to 70.8%). Majority of patients and physicians were satisfied with dienogest. Over 80% of patients reported symptoms improvement. 39.9% of patients had drug-related treatment-emergent adverse events, including vaginal hemorrhage (10.4%), metrorrhagia (7.3%) and amenorrhea (6.4%). In conclusion, dienogest improves HRQoL and EAPP in the real-world setting in women with either clinical or surgical diagnosis of endometriosis. Dienogest might be a promising first-line treatment option for the long-term management of debilitating endometriosis-associated symptoms. NCT02425462, 24 April 2015.