Dienogest 2 Mg Daily for 60 Months Significantly Reduces Endometriosis Associated Pelvic Pain

Table of Content

Introduction

The efficacy of dienogest, a selective progestin, was found to be equivalent to the GnRH agonists in the relief of pain associated with endometriosis, but it showed a better safety profile than GnRH agonists due to its mild hypoestrogenic effects. Studies upto 15 months duration have demonstrated the efficacy of dienogest in reducing the endometriotic lesions and associated pain. However, there is limited data on the efficacy and safety of dienogest for a period of more than 15 months.

Aim

To evaluate the efficacy and safety of dienogest 2 mg once daily over a treatment period of at least 60 months in women with endometriosis.

Method

Study Design

  • Retrospective study
  • A total of 37 women with laparoscopically diagnosed endometriosis, with and without prior surgery were selected
  • Dienogest 2 mg once daily was prescribed for 60 months

End Points

  • Endometriosis-associated pelvic pain (EAPP) was assessed on a 100 mm visual analog scale (VAS); (0 mm - no pain, 100 mm - unbearable pain) at baseline and at 12, 24, 36, 48 and 60 months
  • Patient satisfaction was evaluated by questionnaire annually
  • Annual ultrasound assessment of endometrium
  • Occurrence of adverse events including bleeding disturbances and depressive symptoms
  • Hormone, haemostasis, liver and lipid parameters were evaluated at 60 months in subgroup of 15 women who required extensive surgery and/or recurrent laparoscopy

Results

  • Group 1 - 22 women who underwent surgery before receiving dienogest
  • Group 2 – 15 women who received dienogest without prior surgery
  • The median VAS scores for EAPP at baseline and at all time-points in both the groups were significantly reduced as seen in figure 1.
Figure 1. Median VAS scores (mm) at baseline and at 12, 24, 36, 48 and 60 months of treatment

  • The patient satisfaction during the dienogest treatment was very high with 21 women very satisfied and another 16 women satisfied
  • The mean serum estradiol concentrations were 36+13 pg/ml after 36 months and 28+12 after 60 months
  • All the hormone, haemostasis, liver and lipid parameters were within the normal reference ranges.
  • Spotting episodes were reported by 7 women and phases of depressed mood by 4 women.

Conclusion

  • Treatment with dienogest 2 mg daily over a period of 60 months was significantly effective in reducing endometriosis-associated pelvic pain and recurrence of pain after surgery
  • Dienogest was well tolerated and the adverse effects could be clinically managed

Arch Gynecol Obstet. 2018 Oct;298(4):747-753. Doi: 10.1007/s00404-018-4864-8.