Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice

Purpose Endometriosis is a debilitating disease with high recurrence rates requiring long-term management. Progestins such as dienogest are used empirically when first symptoms occur and post-surgery to reduce recurrence. This retrospective, practice-based study assessed the efficacy and safety of dienogest in women with endometriosis treated for at least 60 months.

37 women (age 39 ± 8 years) with laparoscopically diagnosed endometriosis received dienogest 2 mg orally once daily. Endometriosis-associated pelvic pain (EAPP) was measured on a 0–100 mm visual analog scale at baseline and every 12 months. Laboratory measures of lipid and liver metabolism, hemostatic and hormonal parameters were investigated in a subgroup of 15 women. Adverse events including bleeding disturbances and depressive symptoms were recorded.

In 22 women, dienogest was begun after laparoscopy; median EAPP score was 70 mm pre-surgery and 10, 10, 20, 20, and 20 mm, respectively, after 12, 24, 36, 48, and 60 months of dienogest treatment. Another 15 women began dienogest without prior surgery; median EAPP score was 80 mm pretreatment and 20, 20, 30, 30, and 30 mm, respectively, after 12, 24, 36, 48, and 60 months. All laboratory parameters remained within the normal range. Mean serum estradiol was 28 ± 12 pg/ml after 60 months. Seven women experienced spotting episodes and four women presented with phases of depressed mood, which could all be clinically managed.

Long-term (60-month) treatment with dienogest 2 mg once-daily in women with endometriosis effectively reduced EAPP and avoided pain recurrence post-surgery. Dienogest was well tolerated and adverse effects were clinically managed. Similar content being viewed by others Change history 22 November 2018 In the original publication of the article, the word laparotomy has been presented in the proofs instead of laparoscopy in the below places. 22 November 2018 In the original publication of the article, the word laparotomy has been presented in the proofs instead of laparoscopy in the below places. 22 November 2018 In the original publication of the article, the word laparotomy has been presented in the proofs instead of laparoscopy in the below places.

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Editorial assistance was provided by Bill Wolvey of PAREXEL International, which was contracted by Bayer AG. Funding No study funding was received. Author information Authors and Affiliations Contributions TR participated in the project development, data collection and management, data analysis, and manuscript editing. Corresponding author Ethics declarations Conflict of interest Prof. Römer has received honoraria for lectures and advisory boards from: Bayer, MSD, Gedeon Richter, Dr. KADE, and Aristo Pharma. Informed consent Informed consent was obtained from all individual participants included in the study. Rights and permissions About this article Cite this article Römer, T. Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice. Arch Gynecol Obstet 298, 747–753 (2018). https://doi.org/10.1007/s00404-018-4864-8 Received: Accepted: Published: Version of record: Issue date: DOI: https://doi.org/10.1007/s00404-018-4864-8