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

[Guest guest]

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.