Risk of depression and anemia in users of hormonal endometriosis treatments: Results from the VIPOS study

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

“…Although there are inherent limitations within the boundaries of observational research, 38 the VIPOS study benefited from a methodology that optimized the validity and generalizability of its findings, as described in detail previously. 16,31 Specific limitations of the here presented results were an unequal distribution of study participants among countries and non-standardized diagnostic procedures among physicians, due to the realworld, non-interventional character of the study.…”

“…All participating countries contributed to the data on long-term DNG use as shown in Table 3, although distribution of study participants among countries was unequal; 16 the majority of DNG long-term users originated from Hungary.…”

“…During the VIPOS study, following participants for up to 7 years, a substantial number of women (when compared to previously published data) originating from all participating countries used DNG 2 mg longer than 15 months, though country distribution was unequal. 16 The study thereby provided an important dataset for a long-term safety assessment. Previously published data on the safety of DNG for treatment periods of at least 15 months were derived from studies with relatively low numbers of patients and limited follow-up time; [32][33][34][35][36][37] the longest follow-up was 60 months 32,34 and the highest number of study participants taking DNG approximately 150.…”

“…6,11 Adequate treatment often requires a dynamic multidisciplinary approach of surgical, hormonal and pain management strategies and may depend on the presented symptoms, endometriosis type and severity, as well as on the women's personal choice. 12 The complexity of the disease with its multiple manifestations and many unexplored aspects is reflected also in an uneven treatment and diagnostic landscape among physicians, medical centers and countries, [13][14][15][16] although best-practice guidelines are increasingly attempting to close this gap and to standardize endometriosis-related procedures. 6,11,[17][18][19][20] Even though endometriosis is a chronic disease, some medications have a limited duration of use due to their side effects; gonadotropin-releasing hormone analogues (GnRH-a) have a negative effect on bone mineral density and are normally prescribed for 3-6 months and users of Danazol, a testosterone analog which can cause androgenization, are advised not to take the medication on a continuous, long-term basis without an intake break.…”

“…[25][26][27][28][29][30] The VIPOS study was a post-marketing authorization measure initiated following European approval of Visanne and aimed to investigate the safety of DNG 2 mg for the treatment of endometriosis. VIPOS followed women with endometriosis for up to 7 years and thus provides valuable real-world data on the long-term use of DNG 2 mg. 16,31 In the here presented analysis we assessed the safety of DNG long-term (⩾15 months) compared to DNG short-term (<15 months) use.…”