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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.

View products used for arthritis.


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