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The strength of
the analyses of Dr. Konstam, et al, was the pooling
of individual patient level data from randomized
trials that included both rofecoxib and the respective
comparators in the same trial. This type of combined
analysis with pooled individual data is preferable
to comparing absolute rates across different studies,
a method used by Mukherjee and colleagues in a
recently published article where comparison for
CV thrombotic event rates was made between 4 rofecoxib
and celecoxib trials and a placebo-group from
a meta-analysis of a differently designed trial
(aspirin primary prevention trials). That article
recently raised the concerns about CV safety profile
of COX-2 specific inhibitors.
Konstam and colleagues
added that comparing absolute event rates across
different studies in a manner adapted by Mukherjee
and colleagues is hazardous and considerably less
reliable than a prospective, randomized comparison
and assumes similar CV risks in the underlying
populations, as well as similarity in ascertainment
of study endpoints. It would therefore be difficult
to draw any conclusions from that article by Murherjee's
group.
In conclusion,
the report stated "The analysis provides no evidence
for an excess of cardiovascular events for rofecoxib
relative to either placebo or the non-naproxen
non-steroidal anti-inflammatory drugs (NSAIDs)
that were studied. Differences observed between
rofecoxib and naproxen are likely the result of
the antiplatelet effects of the latter agent."
Circulation is
a Houston-based peer-reviewed weekly journal of
the AHA intended for cardiologists, cardiovascular
surgeons, electrophysiologists, internists, nurses
and others interested in cardiovascular medicine.
It ranks first in among 63 journals in the Cardiac
and Cardiovascular Systems category, first among
60 journals in the Hematology category, and number
one among 45 journals in the Peripheral Vascular
Disease category.
Rofecoxib, is
a COX-2 specific (Cyclooxygenase-2) inhibitor
and belongs to a new class of medication known
as Coxibs. Rofecoxib is approved by the Bureau
of Food and Drugs (BFAD) for the relief of the
signs and symptoms of osteoarthritis and rheumatoid
arthritis, the relief of pain and treatment of
menstrual pain.
COX-2 specific
inhibitors like rofecoxib were designed specifically
to treat pain and inflammation while reducing
the incidence of gastric irritation and other
stomach problems commonly associated with traditional
NSAIDs (such as ibuprofen, diclofenac, naproxen,
nabumetone, etc). Rofecoxib is not a substitute
for aspirin for cardiovascular prophylaxis and
does not interfere with the effects of low-dose
aspirin on platelets.
It is best to
consult a physician for proper diagnosis and the
choice of the best treatment option for one's
condition.
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