Clinical experience of long-term use of dienogest after surgery for ovarian endometrioma

Abstract

ObjectiveEndometriosis is a common and recurring gynecologic disease which have afflicting females of reproductive age. We investigated the efficacy of long-term, post-operative use of dienogest for ovarian endometrioma.MethodsWe studied 203 patients who had undergone laparoscopic or robotic surgery for ovarian endometrioma, and were administrated dienogest 2 mg/day beginning in July of 2013, and continuing. We evaluated side effects of dienogest and ultrasonography was performed every 6 months to detect potential recurrence of endometrioma (2 cm) in these post-surgical patients.ResultsThe follow-up observation periods were 30.2±20.9 months from surgery. The mean age was 34.1±7.2 years old. The mean diameter of pre-operative endometrioma was 5.6±3.0 cm2. One hundred eighty-two (89.7%) women received dienogest continuously for 12.0±7.1 months. Of the subjects, 21 (10.3%) patients discontinued dienogest at 2.4±1.0 months. The most common side effect when dienogest was discontinued was abnormal uterine bleeding. The occurrence rate of vaginal bleeding was 15.8%, a number which did not differ significantly in patients with/without post-operative gonadotropin releasing hormone agonist administration. The other side effects were gastrointestinal trouble including constipation, acne, headache, depression, hot flush, weight gain, and edema. However, no serious adverse events or side effects were documented and recurrent endometriomas were diagnosed in 3 patients (1.5%).ConclusionThe data indicates that dienogest was both tolerable and safe for long-term use as prophylaxis in an effort to obviate the recurrence of ovarian endometrioma post-operatively, as well as potential need for surgical re-intervention.

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…”

“…Guidelines recommend that a levonorgestrel-releasing intrauterine device (LNG-IUD) should be considered initially in women with fibroids <3 cm in diameter 96 . Where an alternative treatment is preferred by the woman or is necessary, evidence suggests that dienogest is effective and 85 6 months 24 months 4/54 N/A Park et al 30 17 (12À32) months 18 months 1/114 Pain improvement in 72.6% of patients Ouchi et al 82 13.28 ± 4.85 months 13.3 ± 4.9 months 0/7 N/A Lee et al 29 72.2 ± 5.2 weeks (range, 48À164) 41 months 9/514 Pain improvement in 82.2% of patients (61.6% "improved"; 20.6% "much improved") Chandra et al 33 12.0 ± 7. well tolerated in the treatment of painful symptoms in patients with this condition 89 . In a phase III randomized trial of women with adenomyosis (n ¼ 67), treatment with dienogest was associated with a significant decrease in visual analog scale scores versus placebo (À58.4 ± 23.6 mm vs. À20.6 ± 23.6 mm, p < .001) 89 .…”