Dienogest improves health-related quality of life and pelvic pain in women with endometriosis
Endometriosis affects approximately 10% of women in the reproductive age, with a prevalence of up to 50% in infertile women. The prevalence of endometriosis varies by race and ethnicity with Asian women more likely to be affected by this disease than Caucasians. The most common clinical signs of endometriosis are menstrual irregularities, chronic pelvic pain, dysmenorrhea, dyspareunia and infertility. Symptoms of endometriosis often affect psychological and social functioning of patients. For this reason, endometriosis is considered as a disabling condition that may signifcantly reduce health-related quality of life (HRQoL).
Dienogest is an oral progestin approved for endometriosis treatment. Dienogest is an attractive option for prolonged treatment due to a moderate suppression of estrogen levels and a low androgenic, mineralocorticoid, or glucocorticoid activity.
The interim analysis of non-interventional study ENVISIOeN by Kitirat Techatraisak et al demonstrated an improved HRQoL and reduced endometriosis-associated pelvic pain (EAPP) after 6 months of dienogest therapy in clinically or surgically diagnosed Asian women with endometriosis. In this study, authors reported the final analysis of HRQoL, EAPP and safety in patients receiving dienogest for up to 24 months within the ENVISIOeN study.
The ENVISIOeN study was a prospective, multicenter, international, noninterventional cohort study performed in 6 Asian countries at 36 sites. The primary objective of the study was to determine the change in pain dimension of Endometriosis Health Profle-30 (EHP-30) after 6-month therapy with dienogest. The secondary objectives included change in EHP-30 scores at month 6 and 24, efficacy of dienogest in reducing EAPP at month 6, 12 and 24, patients' and clinicians' satisfaction with dienogest, assessment of endometriosis symptoms and bleeding pattern, and rates of dienogest discontinuation and repeated surgery. Data were collected during study visits at baseline, and at months 1, 3, 6, 12, and 24 after start of dienogest therapy; all study visits occurred on site and within the routine clinical practice.
Asian women aged ≥18 years with clinical diagnosis (by suggestive symptoms and positive finding of chocolate cyst on imaging) or surgical diagnosis of endometriosis and presence of EAPP were eligible to participate in the study. In this study, EAPP was defined as pain at menstruation, chronic pelvic pain irrelevant to menstruation, and/or dyspareunia.
536 patients (60.4%) received endometriosis treatment prior to study start. Scores for all EHP-30 core and modular instrument scales improved during the first 6 months of dienogest therapy and continued to improve until month 24. Percentage of patients with improvement in EHP-30 scores was highest for scales Pain, and Control and powerlessness.
More than 90% of patients had an improvement in EAPP at both post baseline study visits. Amelioration of EAPP was more often experienced at month 6 by women with a higher baseline EAPP severity (>4), and at month 24 by those with a lower baseline EAPP (≤4).
Pain recurrence rate in EFF set was approximately three times higher in patients discontinuing than among women continuing dienogest treatment for up to 24 months.
Share of patients with normal bleeding decreased while the rate of amenorrhea increased during the 24-month therapy period. The percentage of patients with irregular bleeding and intermenstrual spotting/bleeding increased during the first 6 months of therapy and then returned to baseline levels at month 24.
66.6% of patients and 67.7% of physicians at month 6 and 52.3% (n =191/365) of both patients and physicians at month 24 were very satisfied or somewhat satisfied with dienogest. At month 6 and month 24, only 4.5% and 2.5% of patients, and 2.1% and 1.9% of physicians were dissatisfied with treatment. 83.7% and 87.0% of patients reported improved of symptoms at month 6 and month 24, respectively.
Almost half of women with endometriosis are dissatisfied with their medical treatment. This indicates that there is an unmet need for therapeutic approaches effective in alleviating disease symptoms and maintaining good HRQoL. In this study, authors found that dienogest improved scores for all EHP-30 scales already at month 6 of treatment, with continuous improvement until month 24. Similarly, continuous improvements in EHP-30 scores were noted in adolescents over the 12-month dienogest therapy. In long-term, dienogest improved all EHP-30 core scores in patients with rectosigmoid endometriosis treated for 36 months. Furthermore, 6-month treatment with dienogest increased HRQoL in patients who had a pain persistence and were unsatisfed with norethisterone acetate therapy.
The results of the ENVISIOeN study indicate that dienogest improves patient-reported HRQoL and EAPP in the real-life setting in Asian women with endometriosis diagnosed either clinically or surgically. Given that observed safety profle was consistent with the previous results and that satisfaction with the treatment was high, dienogest might be a promising frst-line treatment option for the long-term management of only clinically diagnosed patients with debilitating endometriosis-associated symptoms.
Source: Kitirat Techatraisak, Andon Hestiantoro, Ruey Soon et al; Reproductive Sciences (2022) 29:1157–1169
