Efficacy and Safety of Long-Term Use of Dienogest in Women With Ovarian Endometrioma

Abstract

Dienogest (DNG) is a progestin with highly selective progesterone activity and minimal androgenic activity and is helpful in reducing endometriosis-related pain. This study assessed the long-term efficacy and safety and recurrence rate of endometrioma with DNG use beyond 12 months of treatment. A retrospective cohort study was conducted with data collected from 7 university-affiliated hospitals and included a total of 514 women with ovarian endometrioma. All patients received 2 mg of oral DNG daily for at least 48 weeks postoperatively. During continuation of DNG, the recurrence rate of ovarian endometrioma on ultrasound, adverse events, changes in menstrual pattern, and pain score (visual analogue scale) were analyzed. The average period of DNG administration in this study was 72.2 ± 5.2 weeks (range: 48-164). The recurrence rate of endometrioma was 1.8% (9 of 514), and the median duration to recurrence was 58 weeks (range: 24-76). Pain was described as overall improved by 82.2% of patients; 61.6% stated the pain was "improved" and 20.6% reported "much improved." The mean VAS score was 4.9 at baseline and significantly decreased to 2.68, 2.2, 1.6, and 2.6 at 12, 24, 48, and 96 weeks. Amenorrhea rate was 58.3% in the first 12 weeks and increased to 86.4% at 72 weeks. Prolonged daily administration of 2 mg DNG followed by surgery was associated with a lower recurrence rate of ovarian endometrioma and a reduced pain score and symptoms.

Recurrence Patterns after Surgery in Patients with Different Endometriosis Subtypes: A Long-Term Hospital-Based Cohort Study

“…However, recurrent surgery on the ovary is related to ovarian reserve damage [28] and recurrent surgery for endometriosis in general is related to stress, complications, as well as personal and social costs. Therefore, caution is required firstly to adhere to the guidelines on the indications for endometriosis surgery and surgical technique and secondly to decrease the risk of recurrence via hormonal suppressive therapy [29][30][31][32].…”

Use of dienogest in endometriosis: a narrative literature review and expert commentary

“…Even after successful surgery, recurrence of endometriosis-associated symptoms is frequently observed 79,80 , and prescription of medical treatment for the long-term prevention of recurrence is recommended 2 . Several studies support the use of long-term dienogest for the prevention of recurrence 29,30,33,[81][82][83][84][85][86][87] , and a reduction in recurrent endometrioma size 30 has been observed for up to 5 years following surgery (Table 3) 29,30,33,[81][82][83][84][85] . In a retrospective cohort study of 568 women with endometrioma, cumulative disease recurrence rates 5 years postsurgery were 69% in women receiving no medical treatment, compared with 4% in women taking dienogest 2 mg 81 .…”

“…Although there have been few interventional studies since to investigate treatment durations beyond 15 months, supportive evidence for long-term dienogest treatment is available from a number of studies (Table 1) [1][2][3][4][5][6][7][8][9][10][11][12][13] . These studies show that administration of dienogest for up to 5 years is effective in preventing recurrence of disease and/or symptoms following surgery, and reducing endometriosis-associated pain 19,[29][30][31][32][33][34][35][36][37] .…”

“…The most commonly reported adverse events were headache, breast discomfort, depressed mood, and acne, each occurring in <10% of patients, which were generally mild to moderate in intensity and associated with low discontinuation rates 41 . Administration of dienogest for up to 5 years has also demonstrated a favorable safety and tolerability profile [29][30][31][32][33][34] .…”

“…Asymptomatic ovarian endometriomas should be monitored but do not require medical or surgical treatment; if the endometrioma is large and there is a risk of rupture, then surgery should be considered Surgery should be considered in cases of atypical findings via ultrasound examination Painful ovarian cysts >3-4 cm in diameter should be treated surgically, in line with treatment guidelines 2 Medical treatments can be prescribed for symptomatic relief when awaiting surgery Medical treatments, including dienogest 2 mg, should be prescribed postsurgery to prevent the recurrence of endometriosis, unless there is an immediate desire for pregnancy. Postoperative dienogest 2 mg treatment has been effective in the prevention of endometriosis symptom recurrence and endometrioma 29,30,33,[81][82][83][84][85][86] Long-term treatment with dienogest 2 mg has been shown to decrease recurrent endometrioma size, which may indicate an additional benefit of its use in medical treatment 30…”