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Hormone Therapy: Heartening News
June 20, 2007 - Estrogen protects the hearts of women who take the hormone early in menopause, new data from the Women's Health Initiative (WHI) suggest.
"This is another level of evidence for younger women that estrogen does not harm the heart and may have a heart benefit," study researcher JoAnn E. Manson, MD, PhD, chief of preventive medicine at Harvard's Brigham and Women's Hospital, tells WebMD.
During menopause, a woman's ovaries stop making estrogen. Many women develop life-disrupting symptoms such as hot flashes and night sweats. Estrogen replacement is the most effective treatment for these symptoms. Women with an intact uterus risk uterine cancer from this treatment unless estrogen is balanced with another hormone, progestin.
The new findings come from a WHI substudy of women who had had a hysterectomy and thus received estrogen-only hormone treatment (Premarin, in the WHI study). But Michelle Warren, MD, says that women taking combination hormone therapy do not need to worry about increased risk of heart disease -- provided they start treatment soon after menopause.
"I don't think that women with or without a uterus need to worry about this issue [of heart disease risk]," Warren said at a news conference.
Warren, medical director of the Columbia University Center for Menopause, Hormonal Disorders, and Women's Health, has studied the timing of menopausal hormone therapy but was not involved in the WHI. The news conference was sponsored by Wyeth, which makes Premarin and Prempro (combined estrogen and progesterone), the two drugs studied in the WHI.
Despite the findings, Manson stresses the fact that hormone therapy is intended only for the short-term relief of menopausal symptoms and not as a long-term treatment to prevent heart disease. An editorial accompanying her report in the June 21 issue of the Journal of the American Medical Association agrees.
"It remains important ... to continue to emphasize that hormone replacement therapy should not be considered as a strategy to prevent cardiovascular disease in women," write Michael E. Mendelsohn, MD, and Richard H. Karas, MD, PhD, of Tufts University in Boston.
But Mendelsohn and Karas also agree with Warren, who says that the initial reports from the WHI unduly frightened younger menopausal women.
"Unfortunately, the initial WHI results were unfairly generalized, creating widespread concern that hormone replacement therapy is neutral or even harmful, with respect to cardiovascular disease, in all women," Mendelsohn and Karas write. "[The current study] and other recent studies support the hypothesis that estrogen can reduce the risk of coronary heart disease in women 50 to 59 years old, which should help clarify this confusion."
Hormone Therapy: Timing Key to Benefit
The WHI trial was designed to see whether long-term treatment with combined estrogen plus progestin (Prempro) (or, for women who have had hysterectomies, estrogen alone (Premarin)) offered health benefits after menopause. The study enrolled women up to age 79.
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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