Eli Lilly's
osteoporosis drug Evista (raloxifene) does not appear to offer heart protection
in postmenopausal women with a history of heart problems or who at high
cardiac risk -- and the drug may even increase the risk for blood clots
and fatal strokes, said researchers this week.
In major new study, to be published Thursday
in the New England Journal of Medicine, doctors found that while raloxifene
reduces the risk of fractures -- a condition that can be deadly in older
women -- and also appears to reduce the risk of breast cancer, those benefits
are offset by increases in strokes and blood clots.
"Raloxifene did not significantly affect
the risk of coronary heart disease," Elizabeth Barrett-Connor, professor
of family and preventive medicine at the University of California at Los
Angeles, reported in the journal.
The Raloxifene Use for The Heart (RUTH) study
showed that "the benefits of raloxifene in reducing the risks of invasive
breast cancer and vertebral fracture should be weighed against the increased
risk of venous thromboembolism (clots) and fatal stroke," she said.
Women's health experts said the study's findings
highlight the need to weigh each individual patient's risk factors when
deciding on raloxifene therapy.
"This study offers us a chance to look at
the big picture of women's health," Lori Mosca, director of preventive
cardiology at New York Presbyterian Hospital/Columbia University, told
UPI. "Raloxifene affects at least four disease states in women -- in different
directions.
Clearly, however, raloxifene is not a viable
option for treating patients simply for cardiovascular disease."
Mosca, a co-author of RUTH, added, "The study
results support the need for women who are considering raloxifene therapy
to discuss the benefits and risks with their doctors.
This study underscores the concept that one
size does not fit all patients."
The data also suggest that women at higher
cardiac risk should consider whether a breast cancer prophylactic is worth
the added dangers.
"A woman who has had a heart attack or has
heart disease precursors would be better off concentrating on lowering
cholesterol, getting blood pressure under control, controlling blood sugars,
losing weight and getting more exercise than taking drugs that protect
against breast cancer," Marcia Stefanick, professor of medicine at Stanford
University School of Medicine in California, said Wednesday in commenting
on the study.
"Preventing a second heart attack should
be of more concern," she told United Press International, "than breast
cancer in this group of women who were at relatively low risk for cancer."
In an editorial that accompanied Barrett-Connor's
article, Stefanick said, "Right now, there is no magic bullet that can
reduce the risks of major health problems related to estrogens and aging
without introducing other potentially serious health concerns."
The RUTH investigators enrolled 10,101 women
in the study, following them for more than five years. Over the course
of the study, 595 women out of 5,044 taking placebo died, compared with
554 women out of 5057 taking 60 milligrams of raloxifene a day.
Another 483 women on placebo and 430
women on raloxifene dropped out of the study that was supported by Eli
Lilly, based in Indianapolis, Ind.
Barrett-Connor reported that:
-
-- A total of 533 women on raloxifene suffered an adverse
coronary event compared with 553 women on raloxifene. The difference did
not reach statistical significance.
-
-- A total of 249 women on raloxifene suffered a stroke
compared with 224 women on placebo. That difference was not significant.
-
-- A total of 103 women on raloxifene experienced a
blood clot, compared with 71 women on placebo -- a difference that was
statistically significant.
-
-- A total of 40 women on raloxifene and 70 women on
placebo developed invasive breast cancer, also a significant difference.
Overall, 52 women on raloxifene and 75 women on placebo developed any form
of breast cancer, a difference that was still significant in favor of raloxifene.
-
-- Overall, there were no differences in fractures
among the women, with 428 clinical fractures reported among women on raloxifene
and 438 among women on placebo.
However, vertebral fractures -- painful and
sometimes debilitating fractures to back -- occurred significantly more
often among the women on placebo. There were 97 vertebral fractures among
the women on placebo compared with 64 such fractures that occurred in the
women on raloxifene.
Stefanick said that there might be some groups
of heart disease patients for whom raloxifene would be useful, such as
women with osteoporosis who are at high risk of fracture.
"When considering the use of raloxifene in
a postmenopausal woman," said Barrett-Connor, "the clinician should
take into account the individual woman's risk of disease and per personal
preferences and weigh potential benefits against risks and against the
availability of alternative interventions."
Mosca said that if a woman with heart disease
was on medication that controlled cholesterol and other risk factors and
she also had a family history of breast cancer and was at risk for osteoporosis
-- as are most postmenopausal women -- then she could be a candidate for
raloxifene.
"We have a lot of options for treatment of
these women," she told UPI.
--
