Long-term treatment of endometriosis with dienogest: Real-world results from the VIPOS study. Issue 2 (June 2021)

• Record Type: Journal Article
• Authors: Moehner, Sabine; Becker, Kerstin; Lange, Jens A; von Stockum, Sophia; Serrani, Marco; Heinemann, Klaas
• Is Part Of: Journal of endometriosis and pelvic pain disorders. Volume 13:Issue 2(2021)
• Page Start: 104
• Page End: 110
• Publication Date: 2021-06
• Subjects: Epidemiology -- endometriosis -- medical treatment -- pain -- women's health; Endometriosis -- Periodicals; Pelvic pain -- Periodicals; 618.1
• DOI: 10.1177/2284026521993688
• Languages: English
• ISSNs: 2284-0265

Abstract

Introduction: The Visanne Post-approval Observational Study (VIPOS) was designed to assess the safety of dienogest 2 mg (DNG, Visanne) compared to other hormonal endometriosis treatments. Methods: Large, prospective, non-interventional, active surveillance study in six European countries (Germany, Poland, Russia, Hungary, Switzerland, and Ukraine). Women with a new hormonal therapy for endometriosis were enrolled by gynecologists and specialized centers between 2010 and 2016 and observed for up to 7 years. Self-administered questionnaires during study entry and follow-up collected information on baseline characteristics, health status and endometriosis treatment. Self-reported clinical outcomes of interest were validated by health care professionals. Results: Among the >27, 000 enrolled participants, 3262 women started DNG use either at study entry or during follow-up. A total of 798 study participants used DNG during follow-up continuously for 15 months or longer (DNG long-term users). When comparing the occurrence of serious adverse events (SAE) in users treated with DNG, no safety signal emerged for long-term users; the SAE incidence rate per 10, 000 women-years was 367.7 (95% CI: 274.1–481.9) in DNG long-term users and 416.4 (349.1–492.5) in short-term users (treated with DNG for less than 15 months). Conclusions: Previous data on DNG long-term safety were derived from studies with relatively low numbers of patients and limited follow-up time. VIPOS provided valuable real-world data on the long-term use of DNG 2 mg in around 800 women treated in Europe and observed no safety signal regarding serious adverse events.