Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice.

Abstract

Endometriosis is a debilitating disease with high recurrence rates requiring long-term management. Progestins such as dienogest are used empirically when first symptoms occur and post-surgery to reduce recurrence. This retrospective, practice-based study assessed the efficacy and safety of dienogest in women with endometriosis treated for at least 60months. 37 women (age 39 ± 8years) with laparoscopically diagnosed endometriosis received dienogest 2mg orally once daily. Endometriosis-associated pelvic pain (EAPP) was measured on a 0-100mm visual analog scale at baseline and every 12months. Laboratory measures of lipid and liver metabolism, hemostatic and hormonal parameters were investigated in a subgroup of 15 women. Adverse events including bleeding disturbances and depressive symptoms were recorded. In 22 women, dienogest was begun after laparoscopy; median EAPP score was 70mm pre-surgery and 10, 10, 20, 20, and 20mm, respectively, after 12, 24, 36, 48, and 60months of dienogest treatment. Another 15 women began dienogest without prior surgery; median EAPP score was 80mm pretreatment and 20, 20, 30, 30, and 30mm, respectively, after 12, 24, 36, 48, and 60months. All laboratory parameters remained within the normal range. Mean serum estradiol was 28 ± 12pg/ml after 60months. Seven women experienced spotting episodes and four women presented with phases of depressed mood, which could all be clinically managed. Long-term (60-month) treatment with dienogest 2mg once-daily in women with endometriosis effectively reduced EAPP and avoided pain recurrence post-surgery. Dienogest was well tolerated and adverse effects were clinically managed.