Evaluating the safety of dienogest in women with adenomyosis: A retrospective analysis

Abstract

Aim Dienogest (DNG) is highly effective for relieving pain caused by endometriosis and adenomyosis. However, women with severe uterine swelling due to adenomyosis who take DNG usually experience metrorrhagia. This study aimed to examine the safety of DNG usage in women with adenomyosis. Methods This study included 20 women who were prescribed DNG for adenomyosis in our hospital from January 2016 to December 2016. We retrospectively analyzed women's clinical background characteristics (age, the use of the gonadotropin‐releasing hormone agonist as pre‐treatment of DNG, the uterus size [major axis, minor axis, maximum thickness in the myometrium, and length of the uterine body] by transvaginal ultrasonography [TVUS], hemoglobin level, and the presence of metrorrhagia during treatment). These variables were compared between the DNG continuation and discontinuation groups using the Mann–Whitney U test. Results Thirteen women continued DNG, and seven discontinued DNG within 12 months because of metrorrhagia. The uterine size was significantly larger in the discontinuation group than in the continuation group. All uterine measurements had high Spearman rank correlation coefficients (ρ > 0.8, P < 0.05). In six of seven cases in the discontinuation group, adenomyosis was in the anterior wall. Measuring the uterus size and locating adenomyosis by TVUS are simple methods of predicting DNG discontinuation. Conclusion We consider that DNG can be safely administered in women with adenomyosis if the uterine size is <6 cm in the minor axis and the main lesion of adenomyosis is located in the posterior uterine wall.

Proposal for developing treatment algorithms of women with symptomatic adenomyosis: A single‐center experience

“…There are many reports that DNG treatment has a high risk of uterine bleeding. 9,[14][15][16][17][18][19] Treatment is often discontinued due to uterine bleeding, especially in women under the age of 38 years, 14 but in our study, age was not a criterion for discontinuing DNG treatment. There are several reports that the incidence and severity of abnormal bleeding from DNG treatment may depend on the phenotype of the disease.…”

“…22,32 Thus, menorrhagia is less common in women with extrinsic adenomyosis. 17 This may be the reason why patients with early-stage intrinsic adenomyosis are advised to undergo surgery. This information may assist physicians in deciding whether to recommend surgery or hormone therapy.…”

“…There are several reports that the incidence and severity of abnormal bleeding from DNG treatment may depend on the phenotype of the disease. [15][16][17] Patients with extrinsic adenomyosis exposed to DNG had a lower incidence of abnormal bleeding than those with intrinsic adenomyosis. 15 On the other hand, unpredictable bleeding from DNG treatment has been reported to be more common in patients with intrinsic adenomyosis.…”

“…3,[9][10][11][12][13] Occasionally, we encounter cases of discontinuing DNG treatment due to abnormal bleeding. 9,[14][15][16][17][18][19] Therefore, women with hemoglobin levels below 8.0 g/dL, a maximum diameter of the uterine body greater than 10 cm in diameter, and a maximum thickness of the myometrium greater than 4 cm in diameter were excluded from previous clinical study in Japan. 11,17 Although DNG has become an important option for hormone therapy, there are currently no specific guidelines for the use of DNG in the field of adenomyosis management.…”

“…9,[14][15][16][17][18][19] Therefore, women with hemoglobin levels below 8.0 g/dL, a maximum diameter of the uterine body greater than 10 cm in diameter, and a maximum thickness of the myometrium greater than 4 cm in diameter were excluded from previous clinical study in Japan. 11,17 Although DNG has become an important option for hormone therapy, there are currently no specific guidelines for the use of DNG in the field of adenomyosis management. Hormone therapy plays a role in alleviating the symptoms, but it is difficult to preserve the uterus in women with symptomatic adenomyosis who do not respond to pharmacological treatment.…”