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Lower Rofecoxib Doses Raise Heart Disease Risk Compared With Celecoxib
Lower Rofecoxib Doses Raise Heart Disease Risk Compared With Celecoxib -- Posted by Roman Bystrianyk on 01-25-05 17:55
http://www.healthsentinel.com/news.php?event=news_print_list_item&id=568
"Lower Rofecoxib Doses Raise Heart Disease Risk Compared With
Celecoxib", Medscape, January 24, 2005,
Link: http://www.medscape.com/viewarticle/498093
Even when used at standard doses, rofecoxib (Vioxx) increases the risk
of serious heart disease compared with celecoxib (Celebrex), according
to a report in the January 25th online issue of The Lancet. The
findings also indicate that naproxen use does not reduce this risk.
Vioxx was withdrawn from the pharmaceutical market at the end of
September 2004 after use of the drug was tied to adverse cardiac
effects. Since then, however, questions remain, such as whether there
is a safe dose of rofecoxib and if all COX-2 inhibitors share these
harmful effects.
In the new study, Dr. David J. Graham, from the US Food and Drug
Administration in Rockville, Maryland, and colleagues analyzed data
from Kaiser Permanente in California to determine the risk of MI and
sudden cardiac death associated with the use of COX-2 selective and
non-selective NSAIDs. The data included more than 2.3 million
person-years of follow-up.
Between 1999 and 2001, a total of 8143 cases of serious heart disease
were recorded, including 2210 that were fatal, the authors note.
Compared with celecoxib use, treatment with high-dose rofecoxib (>25
mg/day) increased the risk of serious heart disease by 3.58-fold (p =
0.016). However, even users of lower-dose rofecoxib were 47% more
likely to experience MI or sudden cardiac death than celecoxib users (p
= 0.054).
In contrast to what has been seen in some studies, naproxen use did not
provide cardioprotection compared with other NSAIDs, the researchers
note.
"An estimated 88,000 to 140,000 excess cases of serious coronary heart
disease probably occurred in the USA over the market-life of
rofecoxib," the authors conclude.
In a related editorial, Dr. David J. Webb and Dr. Simon R. J. Maxwell,
from the University of Edinburgh in the UK, comment that "it now falls
to the manufacturers, under the careful review of the regulatory
authorities, to provide the evidence that this class of drugs is safe,
if necessary including studies that directly address cardiovascular
morbidity as a primary outcome."
Lancet 2005.
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