Women's health study targets heart disease and hormone therapy

February 16, 1993|By Jonathan Bor | Jonathan Bor,Staff Writer

Heart disease often gets lost in discussions of women's health because it strikes men at an earlier age, but experts are quick to point out that it ultimately kills as many women as it does men.

It also kills as many women as do all cancers combined. And taken together, the related diseases of heart disease and stroke kill about a half million women each year -- twice the number killed by cancer.

This is why Dr. Trudy Bush, an associate professor of epidemiology at the Johns Hopkins School of Medicine, speaks passionately about a coming study that will test the theory that hormone replacement therapy can dramatically reduce heart-related deaths in post-menopausal women with histories of heart disease.

"I think this is probably the most important study for women's health that we will have for the next decade," she said. "Heart disease is totally understudied in women. We know an awful lot about men, but we don't know what works in women."

The study, she said, "will be very important to the 43 million women who are at or nearing menopause." Between the ages of 45 and 64, one in nine women will have some form of heart disease, she said. But for those over 65, the figure jumps to one in three.

Strict eligibility rules have made it difficult to find eligible volunteers. To qualify, a woman must be post-menopausal, under the age of 75, have a documented history of heart disease, and must not have undergone a hysterectomy. She must also not be taking hormones.

All told, Hopkins and 14 other institutions across the country are trying to recruit 2,500 women for the five-year study that will begin in January. At Hopkins, recruiters have enrolled just 20 of the 160 women they hope to enlist.

"We're having a hard time finding women who are eligible," said Alice McKenzie, who is in charge of recruitment at Hopkins. "One of the problems is that hysterectomy is an exclusion and a lot of women in this age have had a hysterectomy."

To volunteer at Hopkins, women should call 825-1841.

The participants will be divided into two "double-blind" groups -- one that will take a placebo, and the other a pill that combines the female hormones, estrogen and progestin. The progestin is added to counteract the risk that estrogen, when taken alone, could increase a woman's risk of uterine cancer.

Hormone replacement therapy has long been accepted as a treatment to help women through the difficulties of menopause. And it has gained favor as a long-term treatment for the prevention of heart disease and osteoporosis, a bone-weakening disease.

But the proposition that hormone replacement is capable of preventing deaths due to heart disease has only been observed across broad populations of women. Never has it been tested in the time-honored method of a controlled clinical trial, which gives scientists the opportunity to compare its value against a placebo's in a group of volunteers with similar health histories.

The observational studies were encouraging. "Looking at women who have estrogen and those who don't take them, healthy women had a 30 to 50 percent reduction in their heart disease risk," Dr. Bush said. "But women who already have some cardiovascular disease seem to have a 40 to 70 percent reduction.

"This looks like a very promising study."

Another study already under way is testing the value of hormone replacement therapy for healthy women. Called Heart and Estrogen-Progestin Replacement Study, it will be the first to focus exclusively on women with histories of heart disease.

Specifically, the study will evaluate whether women with heart disease who receive the hormones have fewer heart attacks and heart attack deaths than do women in the placebo group. It will also assess whether the hormone-receiving group is less likely to need bypass surgery, angioplasty and other treatments for heart disease.

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