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For decades, women opted for hormone replacement therapy, not only because it reduced the severity of post-menopausal symptoms, but because it might help protect their hearts. Until the late 1990s, research supported HRT's role in preventing heart disease. New clinical studies, however, cast serious doubt on its heart-protective benefits. To find out more about the ongoing investigation into HRT and heart disease, Medical Update interviewed Dr. Nanette Wenger, a leading advocate for women's health and professor of medicine (Division of Cardiology) at the Emory University School of Medicine.
Q: Does hormonal replacement therapy help prevent heart attack and strokes?
A: We don't have final data to answer this question. The expert statement from the American Heart Association last year identified that the very stringent clinical trial information available for women who already have coronary heart disease shows that there is no preventive benefit of hormone therapy, and that there may even be an increased early risk. Hormone therapy is not recommended for secondary prevention--to prevent a recurrent coronary episode.
The data are far less robust for the healthy woman. We are waiting for results of ongoing clinical trials. The healthy woman should first try the many other proven treatments that will decrease the risk of heart attack. These are simple, inexpensive lifestyle changes, such as smoking cessation, weight control, physical activity, and a healthy diet.
We also have an abundance of clinical trials that show that for women who can't control their cholesterol with diet, statin drugs can improve clinical outcomes. That occasioned a major change in this decade. Ten years ago, the American Heart Association, the National Cholesterol Education Program, and the American College of Cardiology coronary guidelines recommended hormones as first-line therapy for lipid-lowering in women. That has totally changed. The Heart Association and the National Cholesterol Education Program in its most recent iteration define statins as the first-line therapy to lower cholesterol for both men and women. This is not because hormones don't lower lipids, but because statins can do so better, result in better clinical outcomes, and entail less risk than hormone therapy.
Q: Is that message reaching the public?
A: The message is beginning to get out. For many years, menopausal hormones were the only preparations available for lipid lowering and osteoporosis prevention. Only in this decade have several very powerful clinical trials of lipid lowering documented benefit for women with statins. Even though the representation of women in these trials has been only 15 to 30 percent, there were enough data to document benefit for women.
All of the national organizations have signed onto this recommendation. Remember also that for many years, hormones were the only preparations available for the prevention and treatment of osteoporosis. The FDA licensed estrogen for the prevention and treatment of osteoporosis because it was the only drug class available. Since new drugs in this decade--the bisphosphonate drugs and the selective estrogen receptor modulators such as raloxifene--have proved effective in the prevention and treatment of osteoporosis, the FDA removed the indication for treatment of osteoporosis from estrogen. Estrogen is licensed only for osteoporosis prevention.
Q: Should women taking HRT to treat hot flashes discontinue therapy?
A: There are no guidelines because of emerging information. There is no question that hormones are overwhelmingly the most effective therapy for the management of menopausal symptoms. They have no peer. The question is, beyond symptoms and prevention of osteoporosis, are there other indications? We have none thus far.
Estrogen is being examined for prevention of colon cancer and effects on cognition, but none of the studies reported to date have shown benefit. With hormone therapy, there is an increased risk of deep vein thrombosis and blood clots to the lung. Women who take hormones have a 40 percent increase in gallbladder disease. There was a general belief that hormones improved urinary incontinence, a very serious problem for women. Now two trials show that urge incontinence is increased, not decreased, with hormone therapy. There must be examination of benefit and risk for the individual woman.
Q: Many MU readers participate in clinical trials.
A: Women who enroll in clinical trials are very special people, and they deserve commendation. The Society for Women's Health Research has had a motto: "There are some things only a woman can do." One of these things is to participate in clinical trials that will give information for the health of women.
Q: What is the main message about HRT in regard to coronary heart disease?
A: Not all the answers are yet available. Currently, menopausal hormone therapy is not recommended for preventing recurrent events in women who have had a heart attack or coronary bypass surgery. We are uncertain about the role in primary prevention. If women are interested in preventing coronary heart disease, I suggest that they prioritize the proven preventive interventions--smoking cessation, physical activity, healthy diet and weight control, controlling blood pressure, and statins for controlling cholesterol levels.
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