"We have expanded the main objective of RUTH to now look at two of today's most important areas in postmenopausal women's health: heart disease and breast cancer," said Elena Moscarelli, M.D., Lilly senior clinical research physician for RUTH. "RUTH is among the largest prospective trials of its kind for women. As a physician and a woman, I am encouraged by this increased emphasis on preventive strategies for those diseases that differently affect, or more frequently affect, women than men."

Beyond its two primary objectives, RUTH will also assess the effect of Evista on a variety of other important measures, including all-cause death, acute coronary syndromes treated in the hospital, coronary angioplasty, bypass surgery, surgical and non surgical treatment of peripheral artery disease, stroke, fractures and all-cause hospitalization. Outcomes in women taking Evista will be compared with those in women taking placebo.

Enrollment for RUTH began in June 1998. With 10,101 women participating at nearly 200 sites in 26 countries, enrollment is now complete. Five hundred and thirty-nine women from the United States are participating at trial sites in California, Georgia, Michigan, Minneapolis, North Carolina, Pennsylvania and Washington. To qualify for the study, women had to be postmenopausal, over the age of 55 and at risk for heart attack and/or coronary disease. Early results from RUTH may be available in approximately five years.

Lilly's Commitment to RUTH and Women's Health

Lilly is significantly investing in evidence-based research -- including large-scale, placebo-controlled, randomized, double-blind clinical trials such as RUTH -- early in the life cycle of Evista to find answers to medical questions that matter most to women.

Lilly's Multiple Outcomes of Raloxifene Evaluation (MORE) -- a study involving 7,705 postmenopausal women with osteoporosis -- reached its planned objectives in 1999. Data collected from the MORE  trial suggested Evista may have potential beneficial effects on a number of cardiovascular risk factors, such as cholesterol and serum fibrinogen (a factor in clotting). Additional data suggested that Evista may significantly reduce the risk of invasive breast cancer -- including estrogen-receptor-positive invasive breast cancers, the most commonly occurring type of breast cancer among postmenopausal women.

"Based on these results, Lilly is focused on fully exploring the potential cardiovascular and breast cancer effects of Evista through RUTH," said Pamela Wang Anderson, M.D., Lilly senior clinical research physician. "Our investment in this prevention trial reflects the company's ongoing commitment to women's health. When RUTH is completed, we will have relevant data on whether Evista can reduce a postmenopausal woman's risk of heart attack and invasive breast cancer."

The impact and burden of heart disease and breast cancer among women are immense, underscoring the need for effective preventative therapeutic options. In the United States, a woman's risk for heart attack and breast cancer rises steadily with age (1,2). Every year, more than 350,000 women over the age of 65 experience a diagnosed heart attack (1). Invasive breast cancer ranks as the second most deadly cancer in women, with an estimated 178,000 new cases occurring in 1998 (2). 

Important safety information about Evista

Evista is not for everyone. Evista is contraindicated for women who are or can become pregnant, are nursing, have severe liver problems, or have had blood clots that have required a doctor's treatment. These women have been excluded from the RUTH trial. An infrequent but serious side effect of Evista is blood clots in the veins. If such an event occurs, therapy must be discontinued. In clinical trials, the most commonly reported side effects were hot flashes and leg cramps. However, most women taking Evista did not experience these side effects. Full prescribing information is available at http://www.evista.com/ or via fax by calling 1-800-753-0352, extension 708.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers-through medicines and information-for some of the world's most urgent medical needs.

For detailed information about Evista, visit Lilly's website at http://www.evista.com/.

References:

1. American Heart Association, Heart and Stroke Statistical Update. 1999, 2 & 11.

2. American Cancer Society, Cancer Facts & Figures. 1998, 8.

Evista® (raloxifene hydrochloride, Lilly)
Evista is a registered trademark of Eli Lilly and Company
RA-18915 PRINTED IN USA 10167906

SOURCE: Eli Lilly and Company

WEB SITE: http://www.evista.com/

WEB SITE: http://www.lilly.com/