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.
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products used for arthritis.
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