Study
Focuses on Arthritis Drugs
NEW YORK (AP) - Patients taking the anti-arthritis drug Vioxx are more
likely to suffer high-blood pressure and swelling than patients taking
Celebrex, a competing product, according to a new study.
The findings being presented at a medical meeting Friday affirmed an
earlier
study commissioned by Celebrex manufacturer Pharmacia Corp. The new
study -
also done by Pharmacia - is potentially significant, however, because
the
Food and Drug Administration requires two investigations
before it will consider allowing a company to claim superiority over a
competitor's product.
About
43 million patients
suffer from the type of arthritis Celebrex and
Vioxx are designed to treat; of that total, about 42 percent suffer
from
high blood pressure, according to Peapack, N.J. based Pharmacia. The
drugs
target the most common from of arthritis known as osteoarthritis, which
wears down the cartilage between the joints.
Vioxx
is Whitehouse Station,
N.J.-based Merck and Co.'s second-largest selling
drug, with revenues totaling $2.2 billion last year - about 10 percent
of
Merck's global sales.
Celebrex
is still the market
leader, however. Introduced in January 1999 -
six months before Vioxx - Celebrex has annual revenues of $2.6 billion,
making it Pharmacia's best-selling drug.
Pharmacia, which co-markets the drug with Pfizer Inc., is in the
process of
filing the studies with the FDA, spokeswoman Judy Glova said.
Merck
spokeswoman Christine
Fanelle countered that the FDA will only
consider ``well-supported, well-designed'' clinical trails and said
Pharmacia's study was flawed because the Vioxx dose was twice as much
as
should be used in patients beginning treatment.
She
said doctors treating
patients at risk of high blood pressure are
instructed to give patients 12.5 milligrams of Vioxx. However, most
prescriptions written are for 25 milligrams, the amount used in the
Pharmacia study.
Fanelle added that Merck conducted its own study of 382 patients last
year
that found no difference in the incidence of high blood pressure and
swelling between patients using Celebrex or Vioxx.
Banc of
America Securities
analyst Len Yaffe didn't expect the new study to
affect prescribing patterns because doctors were already aware of the
side
effects.
``This
isn't new, and all
because Pharmacia takes the studies to the FDA
doesn't mean the FDA will accept them,'' said Yaffe. He added it should
be a
moot point by next year because Pharmacia is expected to introduce a
new
product that is likely to be more effective than either Vioxx or
Celebrex.
The
study is likely to add
further grist to an expensive battle between the
two drug companies. In the ten months ended October 2000, Merck poured
$145
million into consumer advertising for Vioxx, the most spent on any
drug,
according to IMS Healthcare Market Research. Over the same period,
Pharmacia
pumped $60.5 million for Celebrex.
In the
first study of 810
patients, 16.5 percent of patients taking Vioxx
experienced high blood pressure versus 10 percent of those taking
Celebrex.
In the second study of 1,100, patients 14.9 percent of patients taking
Vioxx
demonstrated higher blood pressure compared to 6.9 percent of Celebrex
patients.
In the
first study 9.4
percent
of Vioxx-treated patients experienced an
increase in swelling, compared to 4.9 percent of Celebrex-treated
patients.
In the replicate study, 7.7 percent of Vioxx-treated patients
experienced
swelling, compared to 4.6 percent of patients in the Celebrex group.
The new
study is being
presented at the American Geriatric Society meeting
in Chicago.
Some of you may want to know
what I take. It is
called B-Safe.
It has Green
tea extract in it. B-Safe also has grape skin extract and
many
other great stuff. I have been taking B-Safe for 2 years now. It has
made
the pain and swelling in my hands (from RA) go completely away. When I
miss
taking B-Safe for a few days. I really know it. My hands start hurting
and
swelling again. "Trish Koch"
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