Experts Split on -2 Arthritis Drug Safety Data

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Experts Split on -2 Arthritis Drug Safety Data

Fri Jun 14, 8:35 AM ET

By Woodman

STOCKHOLM (Reuters) - Drugmakers and rheumatologists were split on Friday

over how to interpret key data comparing the cardiovascular safety of new

-2 inhibitor painkillers against traditional aspirin-like drugs.

The issue has been a hot topic ever since a clinical trial comparing Merck

and Co's arthritis drug Vioxx against naproxen showed that patients on the

older anti-inflammatory medicine suffered fewer blood clots than those

taking Vioxx.

It was rekindled at the annual meeting of the European League Against

Rheumatism in Stockholm which discussed recent findings showing that the

same is true with Merck's follow-on drug Arcoxia for the treatment of acute

pain.

The meeting heard that the rate of serious cardiovascular thrombotic events

in a study involving 1,171 patients was about 1.5 per cent per 100 patient

years for those patients on Arcoxia -- twice the rate observed for those

taking naproxen.

But the rate of adverse events with Arcoxia was no worse than that seen in

patients on placebo, adding apparent weight to the theory that naproxen has

a cardio-protective effect similar to aspirin.

Curtis, director of clinical research at Merck, said in an interview

that the findings with Arcoxia were " very consistent " with what had been

seen with Vioxx.

" What you see is that there is no evidence of a difference against placebo

whereas when you compare it against naproxen there is approximately a

two-fold difference, " he said.

" The data support the hypothesis that due to a potent and sustained

anti-platelet effect, naproxen is acting like an aspirin and has a

cardioprotective effect. "

However, Merck announced earlier this week that U.S. regulators had

requested extra data, including cardiovascular safety data, on Arcoxia and

that it did not now plan to refile the drug until the second half of 2003.

The U.S. company has been in talks with the Food and Drug Administration (

news - web sites) since the withdrawal of the original U.S. application for

Arcoxia on March 15. It is now carrying out further trials involving 6,000

patients to answer the safety concerns.

Meanwhile, other researchers told the meeting that their findings refuted

the theory that naproxen has a cardioprotective effect and warned that the

drug should not be used for this purpose.

Scientists at Stanford University Medical Center at Palo Alto in the U.S.

said they had found no protective effect from naproxen in patients with

rheumatoid arthritis who were not already on aspirin.