Long-term treatment of endometriosis with dienogest: Real-world results from the VIPOS study

Abstract

Introduction: The Visanne Post-approval Observational Study (VIPOS) was designed to assess the safety of dienogest 2 mg (DNG, Visanne) compared to other hormonal endometriosis treatments. Methods: Large, prospective, non-interventional, active surveillance study in six European countries (Germany, Poland, Russia, Hungary, Switzerland, and Ukraine). Women with a new hormonal therapy for endometriosis were enrolled by gynecologists and specialized centers between 2010 and 2016 and observed for up to 7 years. Self-administered questionnaires during study entry and follow-up collected information on baseline characteristics, health status and endometriosis treatment. Self-reported clinical outcomes of interest were validated by health care professionals. Results: Among the >27,000 enrolled participants, 3262 women started DNG use either at study entry or during follow-up. A total of 798 study participants used DNG during follow-up continuously for 15 months or longer (DNG long-term users). When comparing the occurrence of serious adverse events (SAE) in users treated with DNG, no safety signal emerged for long-term users; the SAE incidence rate per 10,000 women-years was 367.7 (95% CI: 274.1–481.9) in DNG long-term users and 416.4 (349.1–492.5) in short-term users (treated with DNG for less than 15 months). Conclusions: Previous data on DNG long-term safety were derived from studies with relatively low numbers of patients and limited follow-up time. VIPOS provided valuable real-world data on the long-term use of DNG 2 mg in around 800 women treated in Europe and observed no safety signal regarding serious adverse events.

Effects of Dienogest on breasts of women of reproductive age and women in menopausal transition: A cohort study

“…1 In the Visanne Post-approval Observational Study, seven out of 3262 women developed malignancy of an unspecified organ or origin, and the incidence was 156.18 per 100 000 person-years. 6 In this study, the crude incidence of breast cancer was 104.95 per 100 000 person-years. In comparison, the crude incidence of breast cancer in the general population in the United States and Taiwan in 2018 was 128.8 and 119.71 per 100 000 person-years, respectively.…”

“…Another study reported the development of breast cancer in one patient, which was considered possibly related to DNG, with an incidence of 259.74 per 100 000 person‐years 1 . In the Visanne Post‐approval Observational Study, seven out of 3262 women developed malignancy of an unspecified organ or origin, and the incidence was 156.18 per 100 000 person‐years 6 . In this study, the crude incidence of breast cancer was 104.95 per 100 000 person‐years.…”

Manajemen Jangka Panjang Endometriosis: Dapatkah Progestin Menjadi Andalan?

“…Disimpulkan bahwa tidak didapatkan isu keamanan terhadap penggunaan dienogest jangka panjang. 17 Lebih lanjut, studi ini juga ditujukan untuk mengetahui risiko anemia dan depresi pada penggunaan dienogest dibandingkan obat-obat lain. Hazard ratio (HR) anemia pada dienogest dibandingkan dengan obat endometriosis lain seperti agonis GnRH dan danazol adalah 1,06 (IK 0,42-2,64).…”