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.
Highlights
Endometriosis affects approximately 10% of women in the reproductive age, with a prevalence of up to 50% in infertile women [1, 2]
We report the final analysis of health-related quality of life (HRQoL), endometriosis-associated pelvic pain (EAPP) and safety in patients receiving dienogest for up to 24 months within the ENVISIOeN study
From April 2015 to August 2016, 895 patients at 36 sites were enrolled in the study (Fig. 1). 887 patients were included in full analysis set (FAS); 551 patients were included in efficacy analysis set (EFF) set
Summary
Endometriosis affects approximately 10% of women in the reproductive age, with a prevalence of up to 50% in infertile women [1, 2]. The prevalence of endometriosis varies by race and ethnicity with Asian women ( in East Asian countries) more likely to be affected by this disease than Caucasians [1, 3,4,5]. The most common clinical signs of endometriosis are menstrual irregularities, chronic pelvic pain, dysmenorrhea, dyspareunia and infertility [6]. Symptoms of endometriosis often affect psychological and social functioning of patients. For this reason, endometriosis is considered as a disabling condition that may significantly reduce health-related quality of life (HRQoL). Hormonal therapy and surgical treatment may improve HRQoL and reduce pelvic pain in patients with endometriosis [13]
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