Long-term treatment of endometriosis with dienogest: Real-world results from the VIPOS study

Sabine Moehner, Kerstin Becker, Jens A. Lange, Sophia von Stockum, Marco Serrani, Klaas Heinemann
In: Journal of Endometriosis and Pelvic Pain Disorders · 2021 · vol. 13(2) , pp. 104–110 · doi:10.1177/2284026521993688 · W3131876851
article OA: closed CC0 ⤵ 4 in-corpus citations
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The VIPOS study observed that dienogest 2 mg for over 15 months in European women showed no safety concerns regarding serious adverse events compared to shorter treatment durations.

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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.

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endometriosis

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