The US Food and Drug Administration (FDA) has approved a novel estrogen-based drug for women for the treatment of moderate-to-severe vasomotor symptoms and osteoporosis associated with menopause. Duavee (Wyeth Pharmaceuticals) is a once-a-day tablet containing a combination of conjugated estrogens and bazedoxifene, an estrogen agonist/antagonist.
Ever since 2002 when several large-scale studies called into question the safety of long-term hormone replacement therapy (HRT), there has been confusion and conflicting opinions regarding the management of menopausal symptoms. Initially there was a movement to avoid HRT altogether; now it is becoming clearer that certain women may safely use and benefit from hormonal interventions.
The FDA will require Yaz, Yasmin and several other newer oral contraceptives to carry new warning labels that detail the potential risk of venous thromboembolism (VTE or blood clots). All oral contraceptives increase the risk of blood clots; however, recent studies have suggested that birth control pills containing drospirenone, a synthetic form of the hormone progesterone, may carry a slightly increased risk of VTE, compared with older birth control pills. The FDA estimates that over a one year period, 10 in 10,000 women taking an oral contraceptive with drospirenone would develop a blood clot , as compared to about 6 in 10,000 women taking older contraceptives.
In increasing numbers, women who are candidates for hormonal replacement therapy are requesting “bioidentical” rather than synthetic hormones. Although there is a tendency to think of bioidentical hormones as “all-natural”, they, like synthetic hormones, are manufactured in the laboratory. In contrast to synthetic hormones, they are chemically identical to the hormones produced by the human body; synthetic hormones are structurally different yet are designed to have similar biological effects as naturally produced hormones.
Many women report vasomotor symptoms, including hot flushes and night sweats, during the menopausal transition. While estrogen is clearly one of the most effective treatments for vasomotor symptoms, recent concerns regarding the use of hormone replacement therapy (HRT) have made treaters much more reluctant to recommend HRT, even for short-term management of vasomotor symptoms. A recent study has demonstrated that acupuncture may be an effective non-hormonal treatment for vasomotor symptoms.
As a result of dramatically increased life expectancies in industrialized countries, healthy women today expect to spend nearly 40% of their lives after menopause. For these postmenopausal women, lack of estrogen may contribute to long-term adverse effects, including cardiovascular disease and osteoporosis. Many postmenopausal women might benefit from hormone replacement therapy (HRT) with estrogens and progestins; however, a number of recent studies in the USA and Europe suggest that the potential risks of hormonal replacement therapy may sometime exceed the expected benefits. Thus, many treaters now avoid the use of hormone replacement therapy in peri- and postmenopausal women.
