Evista Approved In Canada For Postmenopausal Osteoporosis
SASKATOON, SK -- Nov. 24, 1998 -- The Health Protection Branch of
Health Canada has approved Eli Lilly Canada's Evista(TM) (raloxifene
hydrochloride), among the first of a new class of drugs called selective estrogen
receptor modulators (SERMS), for the prevention of postmenopausal
osteoporosis.
This once-daily tablet offers Canadian women a new choice in preventing the
debilitating bone loss that often occurs after menopause. The drug builds bone
mass and prevents vertebral fractures. Also in clinical trials, Evista was found to
significantly reduce the incidence of breast cancer and lower cholesterol, without
stimulating activity in uterine tissue.
"Evista offers an new and different non-hormonal option for postmenopausal
women searching for a means of preventing postmenopausal diseases. Evista is a
SERM as it mimics estrogen's effects in some tissue while blocking estrogen's
effects in other tissues," explained Dr. Wojciech Olszynski, clinical associate and
professor of medicine at the University of Saskatchewan and director of the
Saskatoon Osteoporosis Centre. "Evista offers the benefits that estrogen can
have in the bones and heart while it blocks estrogen's potentially negative impact
on the uterus and breast."
During menopause, which usually occurs around age 50, women's ovaries start
to slow the production of estrogen. This depletion of estrogen is responsible for
the dramatic increase in the risk of diseases such as osteoporosis and heart
disease among postmenopausal women. One in four Canadian postmenopausal
women has osteoporosis, one of the major causes of disability and death. Heart
disease and stroke is the leading cause of death in women over age 50 in
Canada.
"Although many women are presently seeking health care treatment for
symptoms such as hot flushes, night sweats, mood swings or vaginal dryness that
often occur the early stages of menopause, most do not continue to pursue
treatment," Dr. Olszynski said. "Due to a lack of public education, women
remain unaware of the health risks that often come after menopause."
The estrogen produced by a woman's body plays an essential role in maintaining
healthy bone when estrogen levels fall, the bone remodelling process is impaired.
The loss of estrogen is an important risk factor for osteoporosis -- the thinning
and weakening of bone that increases the risk of fractures in the hip, spine and
wrist.
"One in four Canadian women develop osteoporosis, a condition that robs
women of their quality of life and potentially their life due to the complications
associated with bone fractures," Dr. Olszynski explained. "Evista is an important
new option for preventing osteoporosis. It adds safety into the options we have
presently.
"There are some concerns about the long term use of estrogen. Evista provides
the advantages of estrogen, but can also offer long term safety."
The clinical research program to evaluate the safety and efficacy of Evista is the
largest single program ever undertaken in Eli Lilly and Co.'s history. To date,
more than 12,800 postmenopausal women in 25 countries -- including Canada
-- have participated in studies. Additional studies to further assess potential
benefits of the drug in the heart and breast are currently enrolling patients or are
planned.
In clinical trials, Evista increased bone mineral density in the spine, hip and whole
body. It also reduced the incidence of vertebral fractures by up to 52 per cent in
postmenopausal women with osteoporosis. Studies also show that the drug
significantly reduced cholesterol levels which, when increased, can lead to a
greater risk of heart disease.
Safety information from numerous studies assessed the effects of Evista on breast
and uterine tissues. In ongoing trials, the drug has shown a reduction of 54 per
cent in the incidence of newly diagnosed breast cancer in women taking it for up
to 39 months. Evista showed no effect on uterine tissue or vaginal bleeding
compared to placebo, unlike hormone replacement therapy which caused
increased spotting and bleeding.
The most commonly reported side effects in clinical trials included hot flushes and
leg cramps, although most women did not find these events bothersome enough
to discontinue therapy. A rare, but more serious side effect was a blood clot in
the veins of the leg (venous thromboembolic events) which occurred at a rate
similar to that reported for hormone replacement therapy.
"In order to ensure long-term health and quality of life, women should talk to
their physician about their personal risk factors for osteoporosis and discuss
appropriate prevention options," Dr. Olszynski said. |
