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Evista, Eli Lilly & Co.'s osteoporosis drug, has been something of a disappointment since it hit the U.S. market in 1998. But new research now suggests the drug could find a second commercial life as a prevention of more-serious illnesses in post-menopausal women.

A study published Wednesday in the Journal of the American Medical Association indicates women at high risk for heart attack and stroke had 40% fewer such cardiac events when taking Evista compared with high-risk women on a placebo.

The research follows evidence pointing to a possible reduction in the occurrence of breast cancer in older women taking Evista. Other recent research suggests that estrogen-replacement therapy -- long thought to have both cardiac benefits for menopausal women -- may actually fail to protect against heart disease and may even promote breast cancer.

Paradoxically, Lilly isn't allowed to breathe a word to promote Evista as a preventive drug for heart disease or breast cancer, because it is approved by the Food and Drug Administration only for the prevention and treatment of osteoporosis, a thinning and fracture of bones primarily in older women.

That's too bad, says Carl Seiden, a J.P. Morgan medical analyst. "If I were giving advice to a loved one, this looks like the best collection of attributes of anything on the market," he says. Evista is "a remarkably promising compound whose growth has been slowed down because it's promoted only for osteoporosis benefits."

New uses for Evista would be highly welcome at Indianapolis-based Lilly, which is scrambling to replace Prozac sales it has lost since the antidepressant went off patent. In 2001, Evista generated $665 million in sales, far behind the $1.76 billion racked up by Fosamax, Merck & Co.'s osteoporosis drug.

The JAMA article is based on a study of Evista, generically called raloxifene, at the University of California at San Diego and elsewhere. Elizabeth Barrett-Connor, a co-author of the study and the chief of epidemiology in UCSD's department of family and preventive medicine, concludes that Evista "might be a very good drug" for older women at moderate risk of heart disease. "For those women who don't already have osteoporosis and for whom menopausal symptoms aren't a big issue, raloxifene fills a very important niche," she says.

Evista is a so-called designer estrogen, or "selective estrogen-replacement modulator," designed to do some of the positive things that estrogen does, such as protecting bones, without doing negative things such as possibly promoting cancer of the breast and uterus. A big question for Lilly now is whether Evista's growth can surge even without corporate promotion of the possible breast-cancer and cardiac benefits.

"The public is going to see this and react to it, even though Lilly can't promote it," predicts Dr. Barrett-Connor. "Women and doctors are much smarter than they were 10 years ago." A number of Web sites, for example, disseminate information about drugs available for women after menopause, she says.

In the mid-1990s, researchers looked at 7,705 osteoporotic women with a mean age of 67 as part of a study of Evista that wasn't originally intended as a cardiovascular study. As Dr. Barrett-Connor puts it, "The possibility that the drug would actually reduce the risk [of cardiac events] wasn't even considered" when the study began.

In fact, Evista didn't significantly reduce cardiac risk in the overall study population. But when researchers at UCSD and elsewhere looked at the subset of 1,035 women at high risk for cardiac disease, they found Evista "did significantly lower the risk of cardiovascular events." Now, scientists at Emory University in Atlanta and elsewhere are working on larger studies focused on Evista's cardiovascular effects.

The research on Evista and breast cancer isn't considered definitive, and more research is under way. Still, Larry Norton, medical director for breast cancer at New York's Memorial Sloan-Kettering Cancer Center, says Evista "clearly reduces the risk of breast cancer."

In 2001, an American Heart Association panel found "no overall cardiovascular benefit and a possible early increased risk of cardiovascular events" for high-risk women on hormone-replacement therapy, based on a major clinical trial. Other recent research, including a study at the University of Washington in Seattle, suggests a higher risk of breast cancer from the hormone therapy.

American Home Products Corp., whose Premarin line is the leading estrogen-replacement medicine, says studies of large numbers of women over several years are needed before drawing conclusions about cardiac disease and breast cancer. The average age of women in the estrogen-replacement cardiac trial was 67, the company notes, while many women taking estrogen are between 48 and 52 and take it to relieve symptoms such as hot flashes and night sweats.

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