The JAMA paper reports on the HERS study, designed to determine whether hormone replacement therapy (HRT) reduces risk for non-fatal heart attack or death from coronary heart disease in post-menopausal women with established heart disease. Participating in the study were 2,763 women, average age 67, who already had suffered a heart attack, had undergone cardiac surgery, or had angiographic evidence of severe atherosclerosis. They were randomly assigned to two groups: those who received HRT (estrogen and progestin) and those who were "untreated."
The average follow-up was four years and two months. During the first year, more deaths occurred in the HRT treated group than in the "untreated" group. In the third and fourth years of the study, more deaths from heart disease and more heart attacks occurred in the "untreated" group. At the end of the study, there were no statistically significant differences between the two groups in the number of women who had a heart attack or who died from heart disease.
The American Heart Association says the HERS results:
- should help guide physicians in their treatment of older women with heart disease
- are relevant to the medical care of older, post-menopausal women with advanced coronary heart disease
- should not be generalized to women who are healthy (without heart disease)
- should stimulate more research about women in heart disease
- reinforces the need for all women to talk with their physician about what they can do to reduce their risk for heart disease, which claims more women's lives than any other disease.
Note to reporters: American Heart Association spokespersons are available to speak with reporters about this study. Please contact AHA's News Media Relations office at (214) 706-1135 or 1279, or (212) 878-5940.
Comments from AHA spokespersons:
"This study indicates that care should be taken by doctors in their decisions about whether to initiate hormone replacement therapy in older women who already have advanced heart disease," said Rodman Starke, M.D., executive vice president for science and medicine at the American Heart Association. "Women with heart disease who already are taking HRT should talk with their doctor about continuing the treatment. But, if they have been taking HRT for several years, they may be past the period of time when adverse events are more likely to occur according to the study."National Institutes of Health-sponsored research is underway to answer the question of whether HRT prevents heart disease in postmenopausal women who are healthy -- without heart disease.
Elizabeth Ross, M.D., a Washington, D.C., based cardiologist, pointed out that deciding whether to prescribe, or continue, HRT is a "complex decision." "There may be a compelling reason, other than the prevention or reduction of heart disease, for HRT." One reason may be the individual's high risk for osteoporosis.
"Regardless of the results, it is important to note that many established therapies are effective in treating heart disease in older women," said Sidney Smith, M.D., former president of the AHA and chief of cardiology at the University North Carolina at Chapel Hill. These medical, surgical and lifestyle interventions focus on relief of symptoms and the major risk factors for heart disease that have been identified by AHA: obesity, high blood pressure, high blood levels of cholesterol, cigarette smoking and physical inactivity.
"Obviously, these results raise a lot of questions that should be addressed in research," said Martha Hill, R.N., Ph.D., co-chairman of the AHA's women's health campaign that is designed to encourage women to reduce their risk factors for heart disease and stroke. Dr. Hill, immediate past president of AHA and director, Center for Nursing Research at Johns Hopkins University, added, "What caused the increased deaths in the group treated with HRT during the first year is one obvious question."
"The follow-up time period in this study is too brief to make definitive answers," said Valentin Fuster, M.D., Ph.D., president of AHA. Because the follow-up was relatively brief, "the answers are still not in."
The American Heart Association's "Each One, Reach One" campaign provides information to help women reduce their risk for heart attack and stroke. For information, telephone 1-888-MY HEART or internet: http://www.women.amhrt.org.