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Hormone Therapy Not for Older Women
July 11, 2007 - If started long after menopause, hormone therapy carries serious risks for older women, a study from the U.K., Australia, and New Zealand shows.
The study, called the WISDOM (Women's International Study of Long Duration Oestrogen after Menopause), was very like the Women's Health Initiative (WHI) study:
- Both studies looked at Prempro (combined estrogen plus progesterone) or, for women who had hysterectomies, Premarin (estrogen alone).
- Both studies tested whether hormone therapy could be used to prevent disease in older women.
- Neither study tested hormone therapy for relief of menopausal symptoms.
- Women in both studies started or restarted hormone therapy years after menopause.
- Both studies were stopped when safety concerns became apparent in the Prempro arm of the WHI.
Because of it's early halt, the WISDOM trial followed women only for about a year after starting hormone therapy. Nevertheless, the trial found that hormone therapy has serious risks for older women (the average age of the 5,692 women in the trial was 63).
Researcher Janet H. Darbyshire, MB, is director of the clinical trials unit of the U.K. Medical Research Council, which sponsored the trial.
"There was no evidence of benefit, which we hoped there would be," Darbyshire tells WebMD. "Instead, there was an increase in risk of cardiovascular events."
Within the first year of the trial, 11 women had "cardiovascular events" -- that is, angina (chest pain), nonfatal heart attack, or sudden cardiac death. All of these women were assigned to hormone therapy. None of these serious events occurred among women receiving inactive placebo treatment.
By itself, the brief trial proves very little. But the findings are identical to those seen over seven years in the WHI study, Darbyshire says.
That's true, says JoAnn Manson, MD, DrPH, chief of preventive medicine at Harvard's Brigham and Women's Hospital in Boston. Manson is one of the principal researchers for the WHI and is co-author of the book Hot Flashes, Hormones, and Your Health.
"These findings from WISDOM are consistent with WHI," Manson tells WebMD. "In older women using these hormone formulations, the risk outweighs the benefits. There was evidence of increased cardiovascular disease and blood clots."
The bottom line, Manson and Darbyshire agree, is that hormone therapy should not be used for disease prevention.
Both experts also agree that the findings do not apply to the main use for hormone therapy: relief of severe menopausal symptoms.
"There is no one-size-fits-all solution to hormone therapy," Manson says. "The answer depends on the presence of menopausal symptoms that interfere with sleep and disrupt quality of life. And it depends on whether a woman is at risk of heart disease or stroke. If so, there is increased risk with hormone therapy."
For women not already at risk of heart disease, hormone therapy may actually protect the heart.
"Hormone therapy is a two-edged sword. It seems to help the earliest stages of heart disease, but may increase the risk of blood clots and arterial plaque rupture if continued into older age," Manson says.
The WISDOM results appear in the July 11 online issue of the British medical journal BMJ.
- Whether you’re just entering perimenopause or already deep into the world of hot flashes and night sweats, you can find friends, support, and information on WebMD’s Menopause Support Group message board.
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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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