American pharmaceutical company Merck Sharp & Dohme (MSD) has made Duavive (conjugated oestrogens 0.45mg / bazodoxifene 20mg) available in the UK market to treat oestrogen-deficiency symptoms in post-menopausal women with a uterus.
Duavive is the first tissue-selective oestrogen complex (TSEC) licensed for the treatment of oestrogen-deficiency symptoms in post-menopausal women with a uterus (with at least 12 months since the last menses), for whom progestogen-containing therapy is not suitable.
The drug is used as a new hormone replacement therapy (HRT) treatment and combines conjugated oestrogens (HRT) with bazedoxifene (BZA), a selective oestrogen receptor modulator (SERM).
The conjugated oestrogens help reduce menopausal symptoms, but as oestrogens support the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia, as well as cancer.
BZA performs the role of an oestrogen receptor antagonist in the uterus, and upon adding this, the oestrogen-induced risk of endometrial hyperplasia is reduced in non-hysterectomised women.
Approximately 20% of women receiving HRT fail to take progestogen, with about half this number having adverse effects that include bloating, weight gain and migraine.
Royal Brompton Hospital London consultant physician and endocrinologist, and Imperial College London Metabolic Medicine reader Dr John Stevenson said: “The tissue-selective, oestrogen complex concept represents a new paradigm in menopause management.
“For most women, any problems that arise from HRT result from the progestogen component, and this new HRT dispenses with progestogens.”
Post-menopausal women with a uterus face a common symptom of breakthrough bleeding in the early months of HRT treatment and the bleeding unpredictability is a major reason for discontinuing the therapy.
The average age of menopause in the UK is 51, but with exceptions where one in 100 women experiences premature ovarian insufficiency, that is, menopause occurring before the age of 40.