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As reported in Medical Update, the prescription drug Evista builds bone and helps prevent fractures in women with osteoporosis. Ongoing research suggests that the drug, manufactured by Eli Lilly and Company, may promote cardiovascular health as well. To learn more about the exciting possibilities of the drug, we spoke with Dr. Leo Plouffe, Jr., U.S. medical director of women's health and medicine at Eli Lilly, about recent research on Evista.
"The clinical trials of Evista for prevention of osteoporosis involved over 2,000, while the trial for the treatment of osteoporosis involved over 7,700 women," Dr. Plouffe told us. "You are looking at over 10,000 women who were studied in the osteoporosis trial that showed Evista helped maintain bone mineral density, which was one measure of bone health. More important, the studies show clearly that Evista is effective in lowering the risk of fracture that is associated with osteoporosis."
As a result of the Women's Health Initiative (WHI) trial and the findings on hormone replacement therapy, many women want to know if a medication such as Evista poses an increased risk of breast cancer or heart disease.
"We can state very clearly right now, as compared to hormone replacement therapy, there is no increased risk of breast cancer with Evista," Dr. Plouffe explained. "There is also no evidence of increased risk of either heart attack or stroke with Evista. In the large MORE [Multiple Outcomes of Raloxifene Evaluation] clinical trial, the risk of breast cancer was 50 percent lower in women treated with Evista. The same MORE trial showed that in women at high risk for heart disease, there was a 40 percent lower risk of combined stroke and heart attack.
"Those data are really prompting us to further study that potential. One such study is a large ongoing trial known as the RUTH [Raloxifene Use for the Heart] trial of 10,000 women around the world, looking at both heart disease and breast cancer. The RUTH trial is an extension of the MORE trial to study whether Evista could demonstrate potential heart benefit, as opposed to previous trials where the benefit was suggested."
The osteoporosis drug has also demonstrated a positive effect on lowering certain parameters of cholesterol.
"A number of prior studies have shown the benefits of Evista in terms of lowering total cholesterol and lowering LDL, or bad, cholesterol," Dr. Plouffe said. "HDL cholesterol and triglycerides are not modified by Evista, so they are unaffected. Nonetheless, this is felt to be a favorable profile. The more important area of investigation has really occurred during the past three years. With the understanding first from the Heart and Estrogen-Progestin Replacement Study [HERS] trial and now with the WHI trial, there seems to be an increase in cardiovascular events with preparations like Prempro.
"Some preparations of hormones have potential to stimulate inflammatory markers and substances in the body. One of these is called C-reactive protein, which is markedly increased--about 80 percent--by compounds like Premarin, Prempro, and other estrogen preparations. Other preparations, such as Evista, do not affect these inflammatory markers. That is a possible mechanism in terms of explaining the difference between these factors."
The news to date has been good for Evista, and researchers look forward to further studies of its potential in heart and other diseases that affect postmenopausal women.
"We are totally convinced--and many people agree strongly with us--that in terms of providing osteoporosis treatment and prevention, Evista is as good an agent as any of the top-line agents out there," Dr. Plouffe concluded. "In addition, we think Evista holds a lot of promise for other dimensions. It clearly does not increase risk of breast cancer or cardiovascular events in terms of coronary or stroke, But we think, in the long term, we will be able to show the benefits in these other areas."
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