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Title: Women Taking Evista (Raloxifene) For Osteoporosis Show Significant Lower Risk For Breast Cancer

"Women Taking Evista (Raloxifene) For Osteoporosis Show Significant Lower Risk For Breast Cancer"

TORONTO, ON -- February 13, 2001 -- Findings to be published in the upcoming issue of Breast Cancer Research and Treatment show that postmenopausal women with osteoporosis who used Evista® (raloxifene HCl) continued to show significantly lower risk of breast cancer through four years of treatment. Evista, a selective estrogen receptor modulator (SERM), is the only drug approved in the United States for the prevention and treatment of osteoporosis in women past menopause that is also being studied for its ability to reduce a postmenopausal woman's risk of breast cancer. These new 48-month data from Eli Lilly and Company's Multiple Outcomes of Raloxifene Evaluation (MORE) trial demonstrate that Evista reduced the risk of newly diagnosed invasive breast cancer by 72 percent and estrogen-receptor- positive invasive breast cancer-the most common type occurring in women past menopause-by 84 percent. The data represent the final breast cancer findings from the trial, a multicenter osteoporosis study in which breast cancer risk reduction was a pre-planned secondary endpoint. Women enrolled in MORE were not required to be at high risk for breast cancer in order to participate in the trial. "This highly significant sustained reduction in the risk of breast cancer seen with Evista through four years of treatment builds on the three-year results previously published in the Journal of the American Medical Association," said Leo Plouffe, Jr., M.D., Lilly U.S. medical director of women's health. "Based on these encouraging findings, Lilly is eager to collect further data for Evista through ongoing large-scale clinical trials that may lead to regulatory submissions for a breast cancer risk reduction indication." In MORE, a total of 2,557 women received raloxifene 60mg/day (Evista); 2,572 received raloxifene 120mg/day; and 2,576 received placebo. Patients underwent routine mammograms during the trial and an independent oncology review board confirmed any reported breast cancers. Key findings at the conclusion of the trial include: - Thirty-nine invasive breast cancers were reported and confirmed in the placebo group of 2,576 women, compared with 22 invasive breast cancers reported and confirmed in the 5,129 women taking raloxifene. This translated into a 72 percent reduction in risk for invasive breast cancer among the raloxifene groups compared with placebo. - Thirty-one estrogen-receptor-positive invasive breast cancers were reported and confirmed in the placebo group, compared with 10 estrogen- receptor-positive invasive breast cancers in the combined raloxifene groups. This resulted in an 84 percent reduction in risk for estrogen-receptor-positive invasive breast cancer among women taking raloxifene compared with placebo. "More than 180,000 new cases of breast cancer occur in women each year in the United States; about half of these occur in women over the age of 65," said Jane Cauley, M.D, a MORE investigator from the University of Pittsburgh and lead author of the Breast Cancer Research and Treatment report. "Invasive breast cancer ranks as the second most deadly cancer occurring in women, and estrogen-receptor-positive breast cancer is the most common form in women past menopause." MORE, a prospective, long-term, randomized, placebo-controlled osteoporosis treatment study that concluded in 1999, involved 7,705 postmenopausal women with osteoporosis. Overall, MORE has yielded important data demonstrating the fracture efficacy of Evista, its favorable lipid profile and its continued safety in the breast and uterus. Additional new data published in the Jan. 3 issue of the Journal of the National Cancer Institute showed that Evista did not increase breast density after two years of treatment. According to the study authors, this finding is important because Evista did not impede and may, in fact, facilitate mammographic detection of new breast cancers. Evista is not for everyone. If you are or still can become pregnant, are nursing, have severe liver problems, or have had blood clots that required a doctor's treatment, you cannot take Evista. An infrequent but serious side effect of Evista is blood clots in the veins - being immobile for a long time may add to the risk. The most commonly reported side effects were hot flashes and leg cramps. Side effects with Evista have usually been mild, and most women didn't find them serious enough to stop taking it. You may be at increased risk for osteoporosis if you are Caucasian (white) or Asian, have a slender build, don't exercise, or have a family history of the disease. If you don't get enough calcium and/or vitamin D in your diet, you should also take these supplements. Related Link: [Evista® (raloxifene HCl).

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