Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN

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.

Quality of life and clinical factors in women with endometriosis, the role of Dienogest vs EE/ Dienogest over time: a single-center study.

“…Even if dysmenorrhea decreased in both group, patients that took DNG showed a more rapid reduction compared with women that took EE/DNG, DNG treatment works faster than EE/DNG over time in symptom reduction, so, according to the literature, DNG was the best choice in the treatment of dysmenorrhea over time. Techatraisak [32] showed that DNG already improved scores for all EHP-30 scales at month 6 of treatment, until month 24. Caruso [19] considered that DNG was well tolerated with a favorable safety pro le until a period of 65 weeks.…”

Quality of life and clinical factors in women with endometriosis, the role of dienogest vs EE/dienogest over time: a single-center study

“…Even if dysmenorrhea decreased in both group, patients that took DNG showed a more rapid reduction compared with women that took EE/DNG, DNG treatment works faster than EE/DNG over time in symptom reduction, so, according to the literature, DNG was the best choice in the treatment of dysmenorrhea over time. Techatraisak [ 32 ] showed that DNG already improved scores for all EHP-30 scales at month 6 of treatment, until month 24. Caruso [ 19 ] considered that DNG was well tolerated with a favorable safety profile until a period of 65 weeks.…”

Efficacy of Dienogest in Adolescent Endometriosis: A Narrative Review

“…A prospective, non-interventional study was carried out by Techatraisak et al [ 15 ] in six Asian nations to evaluate the health-related quality of life (HRQoL) of patients receiving DNG in a practical context. The inclusion criteria for the trial comprised all women under the age of 18 years who had endometriosis, experienced endometriosis-associated pelvic pain (EAPP), and had started using DNG.…”