VIOXX UPDATE

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Rofecoxib = " Vioxx "

Long-Term Use of High-Dose Rofecoxib Tied to Increased Risk of Coronary

Disease

By J. Brown, MD

NEW YORK (Reuters Health) Oct 04 - Patients on 50 mg/day of rofecoxib

for longer than 5 days are 70% more likely to develop coronary heart

disease (CHD) than nonusers, according to a report published in the

October 5th issue of The Lancet.

In their introduction, the authors note that findings from a large

clinical trial published in 2000 first suggested a link between

high-dose rofecoxib use and CHD. However, the control group in that

study received naproxen, not placebo. Therefore, it was unclear if

rofecoxib increased the risk of CHD or if naproxen had a protective

effect.

To investigate further, Dr. Wayne A. Ray and colleagues from Vanderbilt

University in Nashville, Tennessee, analyzed data on more than 375,000

subjects who were registered in the Tennessee Medicaid program.

The study group included 202,916 people who did not use non-steroidal

antiinflammatory drugs (NSAIDs), 24,132 who used rofecoxib, and 151,728

who used other NSAIDs. All of the subjects were 50 to 84 years of age,

lived in a community setting, and did not have any life-threatening

non-cardiovascular diseases.

" With the exception of rofecoxib 50 mg, none of the NSAIDS, including

celecoxib, were associated with an increased risk of serious CHD, " Dr.

Ray told Reuters Health.

He and his colleagues report in the Lancet paper that the incidence rate

ratio for CHD associated with 50-mg rofecoxib was 1.70 relative to

nonusers of NSAIDS. The 25-mg dose was not associated with increased CHD

risk (IRR, 1.03).

" The current findings suggest that the results of [the earlier trial]

were due to an adverse effect of rofecoxib, not a beneficial effect of

naproxen, " Dr. Ray noted.

" The 50-mg dose of rofecoxib is not indicated for use for longer than 5

days, " he pointed out. In fact, Merck, the company that markets

rofecoxib under the trade name Vioxx, actually includes this in the

drug's prescribing information, he added. " Still, I think a lot of

physicians are unaware of this. "

Dr. Ray said the lack of an association between CHD and celecoxib, a

COX-2 inhibitor similar to rofecoxib, " may be because celecoxib does not

have the acute pain indication that rofecoxib does and, therefore, is

less likely to be used at high doses. "

Lancet 2002;360:1071-1073.

~ Vicki ~ Myositis Info Links