Vioxx increases myocardial infarction risk, latest study published

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Rheumawire

Apr 22, 2004

Rofecoxib increases myocardial infarction risk, latest study published

Boston, MA - The latest study to show an increased risk of acute

myocardial infarction (MI) in users of the COX-2 inhibitor rofecoxib

(Vioxx®, Merck & Co) has been published April 19, 2004 in a rapid access

issue of Circulation [1].

The research, first reported by lead author Dr (Brigham

and Women's Hospital, Boston, MA) at the American College of

Rheumatology meeting in October 2003, showed that those taking rofecoxib

for osteoarthritis had a 24% higher risk of MI than similar patients

taking the other main COX-2 inhibitor, celecoxib (Celebrex®, Pfizer).

, an epidemiologist, says: " ibs are the most common treatment

for arthritis, with more than 41 million prescriptions filled in the US

in 2002. It is important for physicians and patients to note that

rofecoxib was shown to increase the risk of heart attack in this study,

and its use should be weighed against this potential risk. "

As previously reported by rheumawire, the study followed 54 475 patients

65 years or older who were treated with a coxib, a traditional

nonsteroidal anti-inflammatory drug (NSAID), or neither. In this study

group, patients taking either rofecoxib or celecoxib shared similar

baseline risk factors for MI, such as diabetes, hypertension, and prior

heart disease. As well as the 24% percent increase in MI risk in those

taking rofecoxib compared with celecoxib, the researchers found that the

risk of MI was highest in those taking more than 25 mg daily of

rofecoxib during the first 60 days of use. Those patients taking

celecoxib did not experience an increased risk of MI. They also found

that rofecoxib, in comparison with NSAIDs such as ibuprofen, elevated MI

risk by 17% and by 14% compared with patients not taking

anti-inflammatory medications.

et al say that several biological pathways could underlie a

potential association between selective COX-2 inhibitors and coronary

events. For example, in rat models of hypertension, celecoxib but not

rofecoxib may be associated with improvements in endothelial function

and oxidative stress, they say.

says there are several limitations to the research, so " further

study is necessary to help the medical community determine in which

patients the benefits of rofecoxib outweigh the potential risks. "

He told rheumawire that Merck & Co has told him it is performing several

randomized controlled trials in this area but that it has not been any

more specific. His group is also continuing to do further observational

work. " We're looking in greater detail at, for example, patient

subgroups and time until events, " he noted.

" In the meanwhile, this information, combined with what we have learned

through trials such as VIGOR, provide physicians with evidence that

rofecoxib should be used with great caution in patients with an

already-elevated risk of heart disease and heart attack, " he concludes.

Nainggolan

Source

1. DH, Schneeweiss S, Glynn RJ, et al. Relationship between

selective cyclooxygenase-2 inhibitors and acute myocardial infarction in

older adults. Circulation [DOI: 10.1161/01.CIR.0000127578.21885.3E].

2004 Apr 19. Available at: http://circ.ahajournals.org.

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Mayo Clinic in Rochester

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s Hopkins Medicine

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