Long-term safety and efficacy of Dienogest in endometriosis: Observational study

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Created On: 16/03/2024

This observational study aimed to assess the effectiveness and safety of long-term (up to 108 months) treatment with Dienogest in women battling endometriosis-linked chronic pelvic pain.

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Key take away

In women with chronic cyclic pelvic pain related to endometriosis, long-term (up to 108 months) Dienogest 2 mg therapy effectively and safely controls symptoms, reduces endometrioma size, and shows increasing positive effects with prolonged intake.

Background

This observational study aimed to assess the effectiveness and safety of long-term (up to 108 months) treatment with Dienogest in women battling endometriosis-linked chronic pelvic pain.

Method

The study encompassed 157 patients, who took Dienogest 2 mg daily. The enrolled subjects were segregated into two groups based on treatment duration. Group A received short-term therapy (0-15 months) while Group B received long-term therapy (over 15 months). The visual analog scale (VAS) scale was employed to evaluate the impact of the drug on pain levels at baseline (T0) and after 12 (T1), 24 (T2), 36 (T3), 48 (T4), 60 (T5), 72 (T6), and 84 (T7) months.

Ultrasonographic assessment was utilized to measure the dimensions of endometriomas. Additionally, the occurrence of noxious effects and the drug's influence on bone metabolism were examined in Group B through the examination of bone mineral density every 24 months.

Result

Results illustrated a progressive drop in the size of major endometriomas from 33.2 mm to 7 mm after 108 months. Substantial improvements were witnessed in dyschezia, dyspareunia, dysmenorrhea, and non-cyclic pelvic pain (Figure 1).

Menstrual alterations were reported by 22.9% of both groups, while osteopenia was found in 27.6% of long-term therapy patients. Group B also experienced statistically significant higher rates of weight gain, headaches, and libido reduction as opposed to Group A.

Conclusion

In conclusion, long-term therapy with Dienogest adequately controlled endometriosis symptoms, minimized endometrioma size, and demonstrated enhanced positive effects with longer intake, with no serious adverse events reported.