Abstract
BackgroundDienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). To date, there is no data on patient-reported outcomes reflecting the real-world practice in Asia where endometriosis is a relevant health, social and economic burden. This non-interventional, multi-center, prospective study aims to investigate the influence of dienogest on HRQoL.MethodsAsian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the “pain” domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented.ResultsDienogest therapy decreased EHP-30 scores in all assessed domains (score 0–100, lower scores indicate better HRQoL). Primarily, the “pain” domain was improved in 78.4% of patients. EAPP was reduced (score 0–10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by − 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (− 6.2 points mean change) compared to patients with low baseline EAPP severity (− 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment.Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.ConclusionThe data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated.Trial registrationName of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.
Highlights
Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL)
The data indicate an amelioration of HRQoL and endometriosis-associated pelvic pain (EAPP) upon dienogest therapy
The analyses described were performed on Treatmentemergent adverse event (TEAE)
Summary
The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Patients The inclusion criteria were: Asian female ≥18 years old; clinical or surgical diagnosis of endometriosis; presence of EAPP; uninfluenced decision taken by the physician to newly prescribe dienogest; written informed consent. Women were excluded in case of participation in an investigational program with interventions outside of routine clinical practice; any contraindication listed in the local summary of product characteristics. Data sources and measurement The treating physician collected historical data (demographic and clinical characteristics) from medical records if available and treatment-related data during visits that took place in routine practice.
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