Evista Reduces Breast Cancer Incidence In Postmenopausal Women
INDIANAPOLIS, IN -- Dec. 11, 1998 -- Eli Lilly and Co.'s osteoporosis drug
Evista(R) (raloxifene hydrochloride) appears to reduce the incidence of
newly-diagnosed invasive breast cancer, potentially the most serious type of
breast cancer, by 63 percent among postmenopausal women taking the therapy
for more than three years.
Additional three-year findings from the largest of these placebo-controlled
studies show that Evista also has significant benefits on vertebral (spinal)
fractures and cholesterol levels.
The new breast cancer data will be reported tomorrow (Dec. 12) at the 21st
San Antonio Breast Cancer Symposium by V. Craig Jordan, Ph.D., director,
Lynn Sage Breast Cancer Research Program, Robert Lurie Comprehensive
Cancer Center, Northwestern University and chairman of the Evista Oncology
Advisory Board.
"This is a significant breakthrough in women's health," Jordan said. "Not only is
Evista helping a woman prevent bone loss and the development of vertebral
fractures after menopause, but it's also continuing to reduce her risk of breast
cancer over time. The reductions in breast cancer risk seen to date in these trials
are extremely important and provide invaluable information for the additional
large-scale testing of Evista in the prevention of breast cancer."
These data, an update from those presented earlier this year at the American
Society of Clinical Oncology, were gathered from 10,575 postmenopausal
women enrolled in 10 randomised, double-blind, placebo-controlled
osteoporosis studies. The women, who ranged in age from 31 to 80, were taking
daily Evista therapy for a median follow-up of 40 months and a maximum
follow-up of 55 months. Overall, there was a 55 percent reduction in risk for all
types of breast cancer among postmenopausal women taking Evista.
Approximately 7,700 of these women are participating in the six-year Multiple
Outcomes of Raloxifene Evaluation (MORE), an ongoing osteoporosis treatment
study. The remainder are healthy postmenopausal women enrolled in
osteoporosis prevention trials. Women were not enrolled in these trials based on
breast cancer risk.
Mammograms were routinely performed on an annual or biannual basis in all
placebo-controlled trials of at least 12 months in duration.
Data from the three-year analysis of the MORE study confirms additional
benefits with Evista therapy. As observed earlier, women taking Evista were no
more likely to have vaginal bleeding than those taking placebo. Vaginal bleeding
is a side effect common to conventional hormone replacement therapies. In
addition, Evista did not increase endometrial cancer risks. Estrogen therapy
alone has been linked to an increased risk of endometrial cancer and
postmenopausal women with a uterus must usually take a progestin drug along
with the estrogen to reduce this risk. Evista does not require concurrent use of
any progestin drug.
Women taking Evista continued to realise significant reductions in total
cholesterol (about eight percent), LDL (more than 12 percent) and fibrinogen
(more than 12 percent). Evista had a neutral effect on triglycerides and HDL.
By three years of treatment, Evista therapy supplemented with calcium and
vitamin D reduced an osteoporotic woman's risk of a first spinal fracture by 55
percent and an osteoporotic woman's risk of second or subsequent spinal
fractures by 30 percent compared with women receiving only placebo
supplemented with calcium and vitamin D. Spinal fractures are the most common
of all osteoporosis-related fractures and tend to strike women at a younger age
than fractures of the hip, wrist and ankle.
"This finding should send a strong message to women that mineral supplements
alone may not be enough to protect your bones if you are at risk for
osteoporosis after menopause," Jordan said. "Taken together, Evista data
validate the potential of SERMs to prevent osteoporosis and reduce the
likelihood of fractures, and at the same time, reduce the incidence of breast
cancer," he added.
Evista is currently indicated for the prevention of postmenopausal osteoporosis.
Evista is the only selective estrogen receptor modulator (SERM) available in the
U.S. to protect postmenopausal women against the rapid loss of bone that
occurs after menopause and often leads to thinning bones, osteoporosis and
fractures. Evista is approved for marketing in 36 countries world-wide.
As with most therapies, Evista is associated with some side effects, the majority
of which were reported as mild. A rare but serious side effect is blood clots in
the veins, which occurred in clinical trials at a rate similar to that reported for
current users of estrogen or hormone replacement therapy. The most-commonly
reported side effects in clinical trials were hot flashes and leg cramps, although
most women did not find these events serious enough to discontinue therapy.
Evista is contraindicated in women who are or may become pregnant because
preclinical data suggest Evista can cause fetal harm. |
