The drug Duavive arrives on the Brazilian market in the coming months, for the treatment of moderate and severe vasomotor symptoms of menopause, also known as hot flashes or hot flushes. The new drug is a combination of two active ingredients: conjugated estrogens and bazedoxifene acetate. O The product was recently approved by the National Health Surveillance Agency (Anvisa).
The first compound, used for years Replacing the estrogen that is no longer produced by women alleviates vasomotor symptoms. The second age in the estrogen receptors of the cells of the breasts and uterus, inhibiting the effects of the isolated use of estrogen, normally adopted in classic hormonal therapy (HT).
According to the professor at the Faculty of Medical Sciences (FCM) Lucia Costa Paiva, director of the Gynecology Division of the Women's Hospital - Caism at Unicamp and head of the Menopause Outpatient Clinic, Although estrogen has a beneficial effect on menopausal symptoms, if it is used alone it may increase the risk of endometrial cancer. In general, it is then recommended to combine it with progesterone (progestogen or progestogen), another protective hormone against endometrial cancer. It turns out that progesterone increases the risk of breast cancer, metabolic changes and cholesterol.
The new medicine is an interesting proposal, according to Lúcia Costa, due to the fact that it does not use progestogen. With this, estrogen and bazedoxifene acetate are administered as a single medication. A teacher explains that o Duavive is a new generation of TH that treats the signs and symptoms of menopause due to the drop in estrogen, a situation that can cause discomfort to women. This hormonal therapy has virtually no adverse effects.
This class of medication is called tissue-selective estrogen complex (TSEC): depending on the tissue, it will have an estrogenic action, whereas, in other tissues, it will have a neutral or antagonistic action. OThe five clinical studies carried out so far, she says, were favorable to the improvement of symptoms, showed no vaginal bleeding, had a protective effect on breast density and did not suggest significant complaints of mastalgia.
Lúcia Paiva also states that Duavive is the most recent hormonal therapy with low-dose estrogens. A Recommended dose is one tablet of 0,45 mg of conjugated estrogens and 20 mg of bazedoxifene per day. “But this medicine, like any hormonal therapy”, she emphasizes, “should be taken when necessary and for the shortest time necessary".
Effectiveness
According to FCM professor Adriana Orcesi Pedro, also a gynecologist at Caism and specialist in menopause, the most common side effects in hormonal therapy with estrogen and progestogen are breast pain, which can occur in up to 20% of cases; and bleeding, in up to 60%. As Duavive does not act on the breast, the woman does not experience breast pain, tenderness or increased breast density during the mammogram examination, which could interfere with the mammographic analysis. Also, as the medication has no action on the endometrium, it does not cause bleeding when the woman starts HT. Duavive is used after menopause in women who still have a uterus and whose last natural menstrual period was recorded more than 12 months ago.
This therapy is also effective for treating psycho-emotional, urogenital and bone mass symptoms, which are also treated in classical therapy, but with fewer side effects. It also exhibits lower rates of estrogen-related diseases in the uterus, such as endometriosis and fibroids, as they are not stimulated.
The use of estrogen can cause edema, abdominal distension and mood lability, unlike the action of bazedoxifene which, above all, protects the endometrium in the same way as progestogen, but with the advantage of having no side effects. The main indication for Duavive would be the same as HT for women with symptoms related to menopause, such as hot flashes, psycho-emotional changes, vaginal dryness, pain during sexual intercourse, genital atrophy, bone loss and fractures due to osteoporosis.
Early menopause also requires HT at least until the age at which the woman would enter menopause. Doses should be similar to those taken by women in their reproductive phase, between 30 and 40 years old, advises Adriana Orcesi. Absolute contraindications to HT are breast and endometrial cancer, history of thromboembolism and active liver disease. There is also a contraindication for women with cardiovascular risk factors, sedentary lifestyle, obese women, smokers – all in the same woman. If she only has controlled hypertension, she can take HT. If she only smokes, she can too. “Regarding age and time of menopause, it is important to start HT in the 'window of opportunities', that is, under 60 years of age, because the advantages of this therapy are greater in preventing diseases at this stage of life”, reveals Adriana Orcesi.
