Advisory issued on HRT and heart disease

 Patients may be asking questions about hormone replacement therapy (HRT) following the July 2001 release of a scientific advisory from the Dallas-based American Heart Association.

The advisory recommends that HRT should not be initiated for the prevention of future coronary events in postmenopausal women with cardiovascular disease (CVD).1 For HRT use as a primary prevention tool in women without pre-existing CVD, the advisory notes that current data are inconclusive regarding possible coronary benefits or risks. In these women, the association says the decision to start or continue HRT should be based on noncoronary benefits and risks, and patient preference.

"The American Heart Association document basically defines that currently there is no good evidence from randomized, controlled trials, which are the strictest evidence, for benefit of hormone therapy for cardiac protection," states Nanette Wenger, MD, professor of medicine in the division of cardiology at the Emory University School of Medicine and chief of cardiology at Grady Memorial Hospital, both in Atlanta. Wenger served as a co-author of the advisory.

Rather than prescribing HRT solely for cardiac prevention, providers can look to lifestyle interventions, such as smoking cessation, weight control, healthy diet, and exercise, says Wenger. Pharmacotherapy for lipid lowering and blood pressure control may be used when such lifestyle interventions do not meet desired targets, she adds.

For patients who do not have cardiovascular disease and are taking HRT for noncoronary benefits, reassure them that they do not need to change their treatment, the advisory states.

For women who do not have CVD and are considering HRT for other reasons, review the drug therapy’s noncoronary benefits, such as treatment of hot flashes and prevention of osteoporosis, the advisory notes. Explain that the current data are inconclusive regarding possible coronary benefits or risks for women without cardiovascular disease.

Women who have cardiovascular disease and have used HRT for many years may continue use of the drug for noncoronary benefits. However, for those women who do have cardiovascular disease and are not currently taking HRT, do not prescribe the drug regimen solely for the prevention of future coronary events, the advisory states.

Waiting on study results 

Providers are looking to the Women’s Health Initiative to offer definitive information on the issue of HRT and cardiovascular disease, but the results of this trial are at least five years away. The Bethesda, MD-based National Institutes of Health established the initiative, one of the largest U.S. prevention studies of its kind, to address the most common causes of death, disability, and impaired quality of life in postmenopausal women. The HRT component of the study is examining the effects of HRT on heart disease, osteoporosis-related bone fractures, and breast and endometrial cancer.

In 2000, the Initiative reported a small increase in the number of heart attacks, strokes, and blood clots in those taking active hormones during the first two years of the national study.2 The Initiative update came on the heels of two clinical trials that challenged the belief that postmenopausal hormone therapy protects against coronary heart disease.3,4 (Contraceptive Technology Update reported on the update in its June 2000 issue, p. 68.)

It is important for clinicians to understand that the advisory follows similar statements from other scientific organizations, says Wulf Utian, MD, PhD, executive director of the Cleveland-based North American Menopause Society.

Similar information has come from both the Brussels, Belgium-based International Menopause Society5 as well as from the North American Menopause Society,6 he states. All three organizations appear to have a concordant point of view, observes Utian.

According to information presented in the North American Menopause Society’s 2000 publication, there is some evidence that there may be a primary preventive role for HRT in CVD, notes Utian. Until this evidence is confirmed through a randomized, prospective trial, such as the Women’s Health Initiative, HRT should not be prescribed with the only indication being primary protection against CVD.

However, if a patient is considering HRT for menopausal symptom relief, and there may be an added benefit for cardiovascular protection, then providers should proceed, says Utian.

"If there’s no reason to prescribe, the simple concept to be taking to prevent cardiovascular disease does not hold at this point in time because it’s an unproven case," he states.

Emphasize safe indications

The important news to stress with patients is that HRT is safe for such indications as relief of hot flashes and reducing the risk of osteoporosis, says Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health.

"What concerns me is that the recent headlines have lead to a tremendous amount of confusion in which the approved benefits of HRT — the treatment of [menopausal] symptoms, prevention of osteoporosis, and the prevention of vaginal dryness and atrophy — are almost completely lost," Wysocki reflects. "If HRT is eventually shown to have a role in the prevention of cardiovascular disease, women who might have benefited may have stopped using the HRT they were taking for other reasons because of this confusion."

References

1. Mosca L, Collins P, Herrington DM, et al. Hormone replacement therapy and cardiovascular disease: A statement for healthcare professionals from the American Heart Association. Circulation 2001; 104:499-503.

2. Women’s Health Initiative. What you should know about hormones and cardiovascular health. WHI HRT Update

3. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA 1998; 280:605-618.

4. Herrington D. The Estrogen Replacement and Atherosclerosis (ERA) trial. Presented at the American College of Cardiology Scientific Session 2000. Anaheim, CA; March 2000.

5. Genazzani AR, Gambacciani M. Cardiovascular disease and hormone replacement therapy. International Menopause Society Expert Workshop. Climacteric 2000; 3:233-240.

6. North American Menopause Society. Menopause Core Curriculum Study Guide. Cleveland; June 2000.