Drovelis

Pharmacotherapeutic group: progestogens and estrogens, combinations.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ ATC code: G03FA17 Estradiol Angeliq contains synthetic 17ß-estradiol, which is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy. Drospirenone Drospirenone is a synthetic progestogen. As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestogen reduces, but does not eliminate the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women. Drospirenone displays aldosterone antagonist activity. Therefore, increases in sodium and water excretion and decreases in potassium excretion may be observed. In animal studies, drospirenone has no oestrogenic, glucocorticoid or antiglucocorticoid activity. Clinical trial information • Relief of oestrogen-deficiency symptoms and bleeding patterns Relief of menopausal symptoms was achieved during the first few weeks of treatment. Amenorrhea was seen in 73% of the women during months 10-12 of treatment. Breakthrough bleeding and /or spotting appeared in 59% of the women during the first three months of treatment and in 27% during months 10-12 of treatment. • Prevention of osteoporosis Oestrogen deficiency at menopause is associated with an increasing bone turnover and decline in bone mass. The effect of oestrogen on the bone mineral density is dose-dependent. Protection appears to be effective as long as treatment is continued. After discontinuation of HRT, bone mass is lost at a rate similar to that in untreated women. Evidence from WHI trial and meta-analysed trials shows that current use of HRT, alone or in combination with a progestogen – given to predominantly healthy women – reduces the risk of hip, vertebral, and other osteoporotic fractures. HRT may also prevent fractures in women with low bone density and/or established osteoporosis, but the evidence for that is limited. After 2 years of treatment with Angeliq, the increase in hip bone mineral density (BMD) was 3.96 +/- 3.15% (mean +/- SD) in osteopenic patients and 2.78 +/- 1.89% (mean +/- SD) in non-osteopenic patients. The percentage of women who maintained or gained BMD in hip zone during treatment was 94.4% in osteopenic patients and 96.4% in non-osteopenic patients. Angeliq also had an effect on lumbar spine BMD. The increase after 2 years was 5.61 +/- 3.34% (mean +/- SD) in osteopenic women and 4.92+/- 3.02% (mean +/- SD) in non-osteopenic women. The percentage of osteopenic women who maintained or gained BMD in lumbar zone during treatment was 100% , whereas this percentage was 96.4% in non-osteopenic women. • Antimineralocorticoid activity DRSP has aldosterone antagonistic properties that can result in a decrease in blood pressure in hypertensive women. In a double-blind placebo-controlled trial hypertensive postmenopausal women treated with Angeliq (n=123) for 8 weeks experienced a significant decrease in systolic/diastolic blood pressure values (office cuff versus baseline -12/-9 mm Hg, corrected for placebo effect -3/-4 mm Hg; 24h ambulatory blood pressure measurement versus baseline -5/‑‑3 mm Hg, corrected for placebo effect -3/-2 mm Hg). Angeliq should not be used to treat hypertension. Women with hypertension should be treated according to hypertension guidelines.