The Bloomberg version of the news and some additional information in the second half of the article:
Lilly's Evista Cuts Heart Risks, Though Not
as Much as Hormones
Bloomberg News
May 12, 1998, 1:40 p.m. PT
Lilly's Evista Cuts Heart Risks, Though Not as Much as Hormones
Chicago, May 12 (Bloomberg) -- Eli Lilly & Co.'s new
osteoporosis drug Evista appears to reduce a woman's risk of
heart disease, although perhaps not as much as competing
treatment with hormone replacement, a new study shows.
Evista lowered a wide range of conditions linked to heart
disease, such as high cholesterol and liproprotein levels,
although hormone replacement therapy generally was more powerful
in the study of 390 healthy postmenopausal women. The research,
from Lilly, Brigham and Women's Hospital in Boston, and others,
is in tomorrow's Journal of the American Medical Association.
In a mixed bag of results, however, Evista outperformed
hormones with a greater reduction in the clot-forming protein
fibrinogen, without an increase in trigylcerides, a form of fat,
the study found. Overall, the researchers concluded that Evista's
impact paralleled hormone replacement, a market dominated by
American Home Products Corp.'s Premarin, although it didn't have
the same magnitude of effect.
''We can safely say that Evista has great potential to
reduce the risk of heart disease,'' said Dr. Brian Walsh, the
lead researcher and director of the menopause center at Brigham
and Women's hospital. Moreover, the only side effect of the drug
was hot flashes, which didn't stop patients from taking it.
A statistical analysis found Evista may reduce heart disease
and other cardiac problems by 39 percent or more, the researchers
hypothesized, while some research has placed hormone's heart-
disease reduction rate as high as 50 percent. Another study
looking specifically at heart disease and death rates is needed
before the cardiac benefits of Evista can be confirmed, the
researchers said.
Clinical Research
Lilly is starting just such a study next week, although it
could take seven years to finish, said Dr. Pamela W. Anderson, a
clinical research physician at Lilly who worked on the study.
Since none of the studies into osteoporosis treatments include
both hormones and drug therapy, however, a direct comparison
might never be available.
Heart disease is the leading killer of women, accounting for
more than 473,000 deaths in those aged 55 and older each year.
While many experts believe estrogen can prevent heart
disease, a conclusive clinical trial hasn't yet proved the
theory, said Drs. Basil Rifkind and Jacques Rossouw from the
National Heart, Lung and Blood Institute in an editorial. ''The
uncertainties about the cardioprotective effect of estrogens
apply doubly to raloxifene,'' the chemical name for Evista, they
wrote.
Evista, a so-called designer estrogen, was developed to have
the benefits of hormone replacement therapy without the side
effects. Indianapolis-based Lilly's shares have fallen in recent
days amid concern that Evista's sales won't grow as quickly as
previously thought, although a study expected next week showing
it may reduce the risk of developing breast cancer could enliven
expectations for the drug.
Side Effects
American Home's Premarin, which dominates the $1 billion
estrogen replacement market, is used to prevent and treat the
bone-thinning disease osteoporosis and lessen the symptoms of
menopause. While studies show hormones can lower the risk of
heart disease and may help ward off dementia, almost half those
who take it stop within a year because of side effects like
vaginal bleeding or fears about increased risk of breast and
uterine cancer.
The concerns led companies like Lilly and Denmark's Novo
Nordisk A/S to design drugs that work like estrogen where it's
beneficial and block it in the breast and other tissue where it
may cause harm.
Because the newer drugs don't have side effects of estrogen,
''it therefore appears the long-term compliance could be greater
for treatment with Evista than is currently the case'' with
hormones, the researchers said.
On the other hand, if Evista's reduced impact on cholesterol
translates into less heart protection, a significant number of
women would put themselves at risk by taking it instead of
estrogen, said Drs. Rifkind and Rossouw.
Until clinical trials show the benefits of Evista for heart
disease and cancer, it ''may be viewed as a designer drug, not
yet suitable for everyday wear,'' they said. ''Or, ultimately, it
may prove to be a magic bullet in search of its target.''
--Michelle Fay Cortez in Ithaca, New York (607) 272-1174, through |
