New Data Show Lilly's Evista® Significantly Reduces Spinal Fractures With Two
Years of Therapy
Medical Meeting To Highlight Results From the MORE Study
Eli Lilly and Company's Evista® (raloxifene hydrochloride), the newest osteoporosis preventive, significantly reduced by about half the risk of new spinal fractures among postmenopausal women after two years of treatment, according to data presented today. These interim data were reported by Bruce Ettinger, M.D., senior investigator, division of research, Kaiser Permanente Medical Care Program, at the annual meeting of the European Congress on Osteoporosis in Berlin, Germany.
"These data are the first to show that a selective estrogen receptor modulator can significantly reduce the risk of spinal fracture," said August M. Watanabe, M.D., Lilly executive vice president, science and technology. "The results from this interim analysis provide further support that Evista protects a woman's bones and may address other health concerns important after menopause."
Two-year results from osteoporosis treatment studies
Ettinger's report analyzes 7,705 postmenopausal women enrolled in the ongoing
Multiple Outcomes of Raloxifene Evaluation (MORE) study, a double-blind,
placebo-controlled, randomized clinical trial designed primarily to evaluate the
effect of daily Evista therapy on bone mineral density (BMD) and spinal
fractures in women who have osteoporosis.
Women in the MORE study were on average 66 and one-half years old upon entry into the trial and have osteoporosis. The two-year analysis demonstrates that women taking Evista who had no spinal fractures upon entry into the study were 52 percent less likely to have a first spinal fracture and women with a previous spinal fracture were 38 percent less likely to have new spinal fractures when compared with their counterparts taking placebo supplemented with calcium and vitamin D.
"These findings demonstrate that Evista may provide women with a safe new choice for the treatment of osteoporosis," said Ettinger. "If a woman's bone mass deteriorates to the point where she has one fracture, she has a very high risk for sustaining another fracture. By intervening, we can prevent the progression of the osteoporotic condition and multiple fractures that lead to pain, chronic disability and deformity."
Spinal fractures are the most common osteoporosis-related fracture. According to the National Osteoporosis Foundation, one in three women older than 50 years of age will suffer a spinal fracture.
Interim results from ongoing Evista osteoporosis prevention studies involving 601 healthy women aged 45-60 were also presented at the meeting. These data showed that Evista maintained favorable effects on BMD at the spine, hip and total body and lowered total and LDL or "bad" cholesterol levels without stimulating uterine tissue after three years of follow-up.
MORE study evaluates benefits and risks beyond bone
A selective estrogen receptor modulator (SERM), Evista has demonstrated the
ability to act like estrogen in some tissues but not others. The ongoing MORE
osteoporosis treatment study, which began in 1994, was also designed to evaluate
the effects of Evista therapy on a number of secondary endpoints, including
cardiovascular events, cognitive function, quality of life, lipid metabolism,
and the incidence of breast and endometrial cancer.
"To achieve any benefits with osteoporosis drug treatment requires long-term continuation," Ettinger said. "With Evista, there is no vaginal bleeding and no breast tenderness, which may result in women continuing therapy over the longer term."
In studies up to 39 months, Evista did not stimulate reproductive tissue or increase breast or endometrial cancer risks. The first interim MORE findings were presented earlier this year at the American Society of Clinical Oncology meeting and demonstrated that Evista-treated postmenopausal women had 70 percent fewer cases of newly diagnosed invasive breast cancers than those women taking placebo with approximately 33 months of follow-up. These effects will be followed over the longer term. In addition, Lilly will partner with the National Surgical Adjuvant Breast and Bowel Project and the National Cancer Institute to support the upcoming Study of Tamoxifen and Raloxifene (STAR trial), a breast cancer prevention study that will enroll 22,000 women at increased risk for the disease to directly compare the benefits and risks of tamoxifen and Evista therapies.
As with most drugs, Evista therapy is associated with some side effects, the majority of which were reported as mild. The most commonly reported side effects in this clinical trial were hot flashes (5.4 percent incidence in the placebo group and 8.7 percent in the Evista group) and leg cramps (2.4 percent incidence in the placebo group and 5 percent incidence in the Evista group), although most women did not find these events serious enough to discontinue therapy. A rare but serious side effect is blood clots in the veins, which occurred in clinical trials at a rate similar to that reported in women receiving long term estrogen replacement therapy. Evista is contraindicated in women who are or may become pregnant because preclinical data suggest Evista can cause fetal harm.
Evista, currently FDA-approved for the prevention of postmenopausal osteoporosis in the U.S., has also received marketing approval in 27 other countries worldwide.
Lilly is a global, research-based pharmaceutical corporation headquartered in Indianapolis, Ind., dedicated to creating superior health care solutions in order to help people live longer, healthy and more active lives. Women's health is a key area in which the company is focusing its efforts. Full prescribing information for Evista is available at www.evista.com.