|
Also Celebrex Safer Than Conventional
NSAIDS
The drug Celebrex (celecoxib) is less likely to cause ulcers, gastrointestinal
bleeding, and other toxic effects, than conventional nonsteroidal
anti-inflammatory drugs (NSAIDs) report researchers in a new study.
-
The report is part of the Celecoxib Long-term Arthritis Safety
Study (CLASS), a double-blind, randomized controlled trial,
funded by the drug's manufacturer Pharmacia, conducted from
September 1998 to March 2000.
-
Researchers analyzed data, on patients with either osteoarthritis
(OA) or rheumatoid arthritis (RA), from 386 clinical sites in
the US and Canada.
-
Of the 8059 patients originally enrolled in the study, 7968
received at least 1 dose of study drug, and 4573 patients (57%)
received treatment for 6 months.
-
Patients were randomly assigned to receive celecoxib, 400 mg
twice per day; ibuprofen, 800 mg 3 times per day; or diclofenac
(another NSAID), 75 mg twice per day.
-
Patients were also permitted to take a daily dose of aspirin
use for cardiovascular prophylaxis (325 mg/d).
-
The researchers note that "Conventional nonsteroidal anti-inflammatory
drugs (NSAIDs) are associated with a spectrum of toxic effects,"
something which many patients are likely unaware of.
The results of the study revealed annual incidence rates of upper
GI ulcer complications alone (1st figure) and combined with symptomatic
ulcers (2nd figure) for celecoxib vs. NSAIDs as follows:
Totals:
Celebrex - 0.76% vs. 1.45%
NSAIDs - 2.08% vs 3.54%
Non-Aspirin Users:
Celebrex - 0.44% vs. 1.27%
NSAIDs - 1.40% vs. 2.91%
Aspirin Users:
Celebrex - 2.01% vs. 2.12%
NSAIDs - 4.70% vs. 6.00%
The most obvious and striking thing about
these results is the tremendous rise in risk of aspirin users. For
patients taking Celebrex, daily aspirin use raised the GI complication
risks up to 450%. For patients taking NSAIDs, daily aspirin use
raised the risks up to 335%.
Additionally, fewer celecoxib-treated patients than NSAID-treated
patients experienced chronic GI blood loss, GI intolerance, liver
toxicity, or kidney damage.
The authors note that "No difference was noted in the incidence
of cardiovascular events between celecoxib and NSAIDs, irrespective
of aspirin use."
JAMA September 13, 2000;284:1247-1255
|