Clinical efficacy and safety of combined estradiol valerate and dienogest: a new no-bleed treatment

B von Schoultz
Climacteric: the Journal of the International Menopause Society 2003, 6: 24-32
A combination of 2 mg estradiol valerate with 2 mg dienogest (E2V/DNG) (Climodien, Schering AG, Berlin, Gemany) is the first continuous combined postmenopausal hormone replacement therapy (HRT) preparation to contain a progestogen with substantial antiandrogenic activity. A study of its clinical efficacy and safety in a comparative study versus a combination of 2 mg estradiol with 1 mg norethisterone acetate (E2/NETA) has shown both preparations to be highly effective in achieving a rapid response in women with postmenopausal symptoms, in terms of hot flushes and the Kupperman index. Biopsy and ultrasound studies have demonstrated that E2V/DNG quickly and effectively achieved endometrial atrophy in the vast majority of subjects, suggesting a protective role in endometrial proliferation. Data on PP-14 (glycodelin) levels may indicate that E2V/DNG is even more effective than E2/NETA in maintaining endometrial atrophy. No-bleed rates with E2V/DNG at 1, 6 and 12 months were at least as favorable as those with other standard HRT products, with evidence that the no-bleed state is attained more quickly with E2V/DNG. The proportions of women with the no-bleed state in a large-scale study (n = 1501) at 1, 6 and 12 months were 71.8%, 76.6% and 86.4%, respectively. Women with irregular bleeding before treatment responded to E2V/DNG in a manner similar to those without bleeding; this concordance was especially marked after five cycles of treatment. In the comparative study, the mean number of days of bleeding over 12 cycles was significantly lower for E2V/DNG than for E2/NETA. Overall, the profiles of adverse events recorded in clinical use were similar in the two preparations, whilst the safety profile of E2V/DNG in the large-scale study was similar to that of other HRT preparations and gave no cause for clinical concern. The 2 mg E2V/2 mg DNG preparation was associated with a favorable lipid profile, whilst a similar combination (2 mg E2V/3 mg DNG) showed no impact on carbohydrate metabolism or hemostasis, compared to placebo. In summary, 2 mg E2V/2 mg DNG is a novel continuous combined HRT preparation that is effective in treating postmenopausal symptoms rapidly, and has a highly favorable bleeding profile. Studies of the safety of 2 mg E2V/2 mg DNG in clinical use have uncovered no factors likely to be disadvantagous in comparison with other HRT products in widespread use.

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