LLY - Evista - Back fractures:
Monday September 14, 6:00 am Eastern Time
Company Press Release
SOURCE: Eli Lilly and Company
New Data Show Lilly's Evista
Significantly Reduces Spinal Fractures With Two Years of
Therapy
Medical Meeting to Highlight Results from the MORE Study
INDIANAPOLIS, Sept. 14 /PRNewswire/ -- Eli Lilly and Company's Evista(R) (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.
SOURCE: Eli Lilly and Company |
