from www.theheart.org ZEE
"Rofecoxib {VIOXX} should be used with great caution in
patients with an already elevated risk of heart disease and
heart attack."
Apr 21, 2004
Rofecoxib increases MI risk, latest study published
Boston, MA - The latest study to show an increased risk of
acute 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 Daniel
Solomon (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).
Solomon, an epidemiologist, says: "Coxibs 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."
Patients taking celecoxib did not have increased risk of MI
As previously reported by heartwire, 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.
Adjusted association between coxibs and acute MI
Exposure/covariate Adjusted odds ratio p
Exposure (reference group)
-Rofecoxib (celecoxib)
1.24 .011
-Celecoxib (no current use) .93 .13
-Rofecoxib (no current use)
2.14 .054
-Celecoxib (naproxen) .95 .7
-Rofecoxib (naproxen)
3.17 .2
-Celecoxib (ibuprofen) .98 .9
-Rofecoxib (ibuprofen)
4.21 .2
-Celecoxib (other NSAID) .95 .4
-Rofecoxib (other NSAID)
5.17 .073
Covariate
-Race, white
6.20 <.001
-3+ comorbid conditions
7.42 <.001
-Diabetes
8.48 <.001
-Hypertension
9.15 <.001
-Previous MI
10.56 <.001
-Angina
11. 31
<.001
-Previous coronary revascularization .78 <.001
-Congestive heart failure
12.37 <.001
-Cerebrovascular accident
13.07 .014
-Use of statin
14.00 .7
-Use of HRT .88 .02
-Rheumatoid arthritis
15.16 .02
-Previous nonselective NSAID use .97 .3
Further work needed, but be careful with rofecoxib in those
at risk Solomon 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.
Rofecoxib should be used with great caution in patients with
an already elevated risk of heart disease and heart attack.
Solomon 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 heartwirethat 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.
Related links
16. Rofecoxib increases CV events in arthritis patients with
high BP [HeartWire > Hypertension; Mar 18, 2004 ]
17. COX-2 inhibitors: No thrombotic effect but worsening of
CHF? [HeartWire > News; Dec 16, 2003 ]
18. Rofecoxib has no effect on endothelial function, CRP in
patients with CAD [HeartWire > News; Nov 19, 2003 ]
19. Another analysis shows increased risk of AMI with
rofecoxib [HeartWire > News; Oct 29, 2003 ]
20. Experts clash again over safety of COX-2 inhibitors
[HeartWire > News; Oct 16, 2003 ]
21. Randomized study suggests rofecoxib increases 24-hour
mean systolic pressures [HeartWire > News; Jun 2, 2003 ]
22. No increase in MI risk with COX-2 inhibitors [HeartWire
Quoted message said:News; Feb 28, 2003 ]
Sources
23. Solomon DH, Schneeweiss S, Glynn RJ, et al. Relationship
between selective cyclooxygenase-2 inhibitors and acute
myocardial infarction in older adults. Circulation 2004
Apr 19😄OI:
24.1161/01.CIR.0000127578.21885.3E. Available at:
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