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

A Correction to this article was published on 22 November 2018

This article has been updated

Abstract

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.

Methods

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.

Results

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.

Conclusions

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.

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Fig. 1

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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Acknowledgements

Editorial assistance was provided by Bill Wolvey of PAREXEL International, which was contracted by Bayer AG.

Funding

No study funding was received.

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TR participated in the project development, data collection and management, data analysis, and manuscript editing.

Corresponding author

Correspondence to Thomas Römer.

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Conflict of interest

Prof. Römer has received honoraria for lectures and advisory boards from: Bayer, MSD, Gedeon Richter, Dr. KADE, and Aristo Pharma.

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Informed consent was obtained from all individual participants included in the study.

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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

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  • DOI: https://doi.org/10.1007/s00404-018-4864-8

Keywords

  • Dienogest
  • Endometriosis
  • Long-term management