02 - THE EFFICACY OF DIENOGEST FOR THE TREATMENT OF ENDOMETRIOSIS AND ITS PHARMACO-ECONOMIC ASSESSMENT IN THE CAUCASIAN REGION

Purpose: Endometriosis is common in the Caucasian region. According to the official data, based on the birth rate in the region and its low social-economic status, we decided to study the therapeutic efficacy and safety of Dienogest for the treatment of endometriosis in women of reproductive age and to assess its pharmaco-economic effect in our region. Methods: Open, randomised, multi-center trial in which patients are administered DNG orally at a daily dose 2mg or 4mg for a maximum period of 6 months.72 patients(30±6years of age) with histologically confirmed endometriosis at stages I,II or III according to the rAFS score.Patients were randomised to one of two treatment groups via random selection. Endometriosis symptoms were recorded at baseline and after 4,16 and 24weeks of treatment. The effect of DNG on endometriotic lesions was assessed by transvaginal ultrasound. The final assessment of the effect was done via endoscopy after the end of the treatment. Adverse events were documented throughout the study.Results: 34 patients were included in the 2mg group and 38-in the 4mg.group. After 24weeks of treatment, the rates for dysmenorrhea were reduced from 73% to 14% in the 2mg group and 12% in the 4mg group. Pre-menstrual pain was reported by 4% of patients out of 51% in both treatment groups, whereas the degree of dyspareunia was reduced from 63% to 9% in the 2mg group and 7% in the 4mg group according to VAS. The most common adverse events were mood swings-12% in the 2mg group and 14,2% in the 4mg group; headache-7,1% in the 2mg group and 9,7% in the 4mg group; acne-7% in the 2mg group and 9,4% in the 4mg group, nausea-5% in the 2mg. group and 7,2% in the 4mg group.Conclusions: In Caucasian women the 2mg/day dose of DNG has almost the same effect as the 4mg dose. Moreover, its more safe and comfortable for patients with less severe adverse sffects and thus has a clear economic advantage.