INDIANAPOLIS, Aug. 9, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data on EVISTA® (raloxifene HCl tablets) therapy for more than three years was published online in Current Medical Research & Opinion. The review includes summaries of previously published information; new, previously unpublished observations; and new data on EVISTA use. EVISTA is indicated for the treatment of osteoporosis in postmenopausal women and reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
The majority of available data came from the Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the Continued Outcomes of Raloxifene Evaluation (CORE) trial. In these trials, patients were evaluated for up to eight years. While available information is supportive of EVISTA use for more than three years, the optimum duration of EVISTA therapy is not known.
"Because of the chronic nature of postmenopausal osteoporosis and the risk of invasive breast cancer associated with the disease in postmenopausal women with osteoporosis, it is critical to evaluate medications that treat these conditions that require therapy over a prolonged period of time," said lead author Robert Recker, M.D., professor of medicine, chief, division of endocrinology, director, Osteoporosis Research Center, Creighton University School of Medicine.
Use of EVISTA was evaluated by changes in vertebral fracture risk reduction, bone mineral density (BMD), markers of bone turnover, iliac crest bone biopsies, and invasive breast cancer risk reduction:
Study safety findings included:
"Lilly is committed to providing information regarding our therapies to help healthcare professionals and their patients engage in more informed discussions about available treatment options for postmenopausal osteoporosis," said co-author John Krege, M.D., medical fellow, Eli Lilly and Company.
About the Review"Long-term Raloxifene for Postmenopausal Osteoporosis" is a literature review of available information concerning EVISTA use for greater than three years for the treatment of postmenopausal osteoporosis and invasive breast cancer risk reduction in postmenopausal women with osteoporosis. Two reviewed studies were the Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the Continued Outcomes of Raloxifene Evaluation (CORE) trial. The review includes summaries of previously published information, as well as a number of previously unpublished observations from analyses of the clinical study databases. In addition, new data from three patients who underwent iliac crest bone biopsies after eight years of EVISTA therapy were reported.
About EVISTA® (raloxifene HCl tablets)EVISTA is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM), which appears to act like estrogen in bone and to block the effects of estrogen in some tissues. It is an osteoporosis therapy for postmenopausal women that also reduces the risk of invasive breast cancer in postmenopausal women with osteoporosis.
EVISTA is approved by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of osteoporosis in postmenopausal women. EVISTA is also indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. There are Important Limitations of Use for breast cancer risk reduction:
EVISTA 60 mg tablets are taken once daily and can be taken with calcium and vitamin D supplements, with or without food.
Important Safety Information about EVISTA® (raloxifene HCl tablets)What is the most important information patients should know about EVISTA?Patients should not take EVISTA if they have had or are at risk for getting blood clots in the legs, lungs or eyes, as it may increase the risk of blood clots. Patients should stop taking EVISTA and call their doctor if they have leg pain or warmth, swelling of the legs, hands or feet, chest pain, shortness of breath or a sudden vision change, as these may be signs of a blood clot. Being unable to move around for long periods may increase this risk. If patients will need to be still for a long time, they should talk to their doctor about ways to reduce the risk of blood clots.EVISTA does not increase the risk of a heart attack or stroke in women who have had or are at risk for a heart attack; however, EVISTA increases the likelihood of dying from stroke in these women, should one occur. Before taking EVISTA patients should tell their doctor if they have had a stroke, a mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or believe they have other risk factors for stroke or a heart attack.EVISTA is not right for everyone. Patients should not take EVISTA if they:
What should patients tell their doctor before taking EVISTA?
Patients should talk to their doctor about all their medical conditions including:
What are the possible side effects of EVISTA?
What are the possible drug interactions with EVISTA?
For more information about EVISTA, please see the Full Prescribing Information (http://pi.lilly.com/us/evista-pi.pdf) including Boxed Warning, and Medication Guide (http://pi.lilly.com/us/evista-ppi.pdf).
RA Media ISI 01AUG2011
About Eli Lilly and CompanyEli Lilly and Company, a leading innovation-driven company, is developing a growing portfolio of 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. Information about Lilly is available at www.lilly.com. P-LLY
EVISTA® is a registered trademark of Eli Lilly and Company.
|SOURCE Eli Lilly and Company|
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