Dec. 18, 2002 -- Evidence is mounting that a class of drugs known as "designer estrogens" may fulfill the broken promises of hormone replacement therapy, but experts warn that it is too soon to know for sure.
Selective estrogen receptor modulators (SERMs) have been proved to be effective in preventing bone loss in older women, and early studies suggest they may also protect against stroke, heart disease, breast cancer, and even Alzheimer's.
The downside? SERMs like the drug Evista (raloxifene), which is widely prescribed for the prevention and treatment of osteoporosis, do nothing to lessen the symptoms associated with menopause, and may even bring on hot flashes and mood swings, especially when given close to the menopausal transition period. But Evista appears to be an increasingly popular choice for women who once took hormones to prevent the diseases of aging.
"Although SERMs already are in clinical use, the preventive and therapeutic potential of this class of drugs has only begun to be unraveled," researcher Evanthia Diamanti-Kandarakis, MD, and colleagues wrote in the Jan. 1 issue of the American Cancer Society publication Cancer.
SERM researcher Elizabeth Barrett-Connor, MD, agrees, but says the definitive study assessing the benefits of Evista is ongoing. The trial involves just over 10,000 women who are at increased risk for heart disease, and findings are expected in 2006.
"Women and their doctors got a big surprise a few months ago with regard to hormone replacement therapy (HRT)," Barrett-Connor tells WebMD. "We have to be very careful at this point not to recommend [SERMs] for unproven indications so they don't get another one."
Evista has been approved for the prevention and treatment of osteoporosis, but not for other diseases. In a trial involving 7,000 women, Barrett-Connor and colleagues found that the drug is not associated with an increased risk of cardiovascular disease. Although the results suggest the drug can lower "bad" LDL cholesterol, it had no effect on "good" HDL cholesterol. Just last month they reported that it significantly reduced the risk of stroke in the same study population, and earlier findings showed a dramatic reduction in breast cancer risk.
"At this point, I don't think physicians can say to patients that this drug will reduce your risk of breast cancer by 70% and your risk of stroke by 60%, even though that is what we found in this one study," she says. "What they can say is that this drug is not like estrogen. It definitely does not increase the risk of breast cancer and stroke. From a safety point of view these data are quite convincing."
Preliminary findings from a separate study, reported late last July, suggest that Evista may help prevent the memory loss and dementia associated with Alzheimer's disease. Researchers hope to confirm the findings when data from the more than 5,300 women taking part in the study are analyzed.
North American Menopause Society executive director Wulf H. Utian, MD, PhD, says HRT is still the best option for the treatment of menopausal symptoms. He says studies suggest that taking estrogen or estrogen plus progestin for five years or less is perfectly safe for most women, but women on HRT should be re-evaluated annually to determine if they need to remain on it.
"My message to women is don't rule out hormones for short-term use," he tells WebMD. "There are different options for prevention of disease, and raloxifene is definitely among them. It is important to educate yourself about what they are and discuss them with your physician."