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Feb. 27, 2006 — Celecoxib is as effective as naproxen or
diclofenac for osteoarthritis, but with significantly fewer serious
adverse upper gastrointestinal (UGI) tract effects, according to
the results of a multinational, randomized study reported in the
March issue of the American Journal of Medicine.
"Several questions remain about the safety advantage of COX-2
[cyclooxygenase-2]-specific inhibitors compared with nonspecific
NSAIDs [nonsteroidal anti-inflammatory drugs], including whether
they have a lower risk of serious gastrointestinal events and whether
their potential gastrointestinal advantage is negated by an increased
risk of thromboembolic complications," write Gurkirpal Singh, MD,
from Stanford University School of Medicine in California, and
colleagues. "In an attempt to answer some of these questions, we
present data from the SUccessive Celecoxib Efficacy and Safety
Study-1 (SUCCESS-1), a large, multinational, 'real-world,' randomized,
and controlled clinical trial in patients with osteoarthritis."
In this study, 13 274 osteoarthritis patients from 39 countries
were randomized to double-blind treatment with either 100 mg of
celecoxib twice daily, 200 mg of celecoxib twice daily, or nonselective
NSAID therapy (50 mg of diclofenac twice daily or 500 mg of naproxen
twice daily) for 12 weeks. Efficacy outcomes were standard validated
measures used to assess osteoarthritis, and 2 blinded, independent,
gastrointestinal events committees evaluated serious UGI tract
events.
For all primary efficacy endpoints, both dosages of celecoxib
were as effective as NSAIDs in treating osteoarthritis. Compared
with the celecoxib group, the nonselective NSAID group had significantly
more ulcer complications (0.8/100 patient-years vs 0.1/100 patient-years;
odds ratio [OR], 7.02; 95% confidence interval [CI], 1.46 - 33.80; P =.008).
There were fewer ulcer complications in the celecoxib group than
in the NSAID group, both in patients taking concomitant aspirin
and those not taking aspirin. However, the difference was statistically
significant only in the latter comparison. Cardiovascular thromboembolic
events were infrequent and not statistically different between
the groups (eg, myocardial infarction rates: celecoxib, 10 events
[0.55/100 patient-years] vs NSAIDs, 1 event [0.11/100 patient-years]; P =.11),
but the study lacked sufficient power to detect such differences.
"In the treatment of osteoarthritis, celecoxib is as effective
as the nonspecific NSAIDs naproxen and diclofenac, but has significantly
fewer serious upper gastrointestinal events," the authors write. "Celecoxib
100 mg twice daily and 200 mg twice daily were similar in efficacy."
Study limitations include lack of generalizability to patients
with higher cardiovascular risk and short treatment duration.
"Because current clinical osteoarthritis treatment guidelines
vary in their recommendations regarding the appropriate therapeutic
role of COX-2-specific inhibitors, clinicians should consider a
number of factors, including the risk for upper gastrointestinal
events, duration of therapy, as well as costs, before deciding
upon individual patient treatment," the authors write.
Pharmacia/Pfizer employs 2 of the authors. Several other authors
have disclosed having relevant financial relationships with Searle,
Pharmacia, Pfizer, Merck, Boehringer Ingelheim, TAP Pharmaceuticals,
Wyeth, Altana, Glaxo Smith Kline, Novartis, Centocor, Aventis,
Astra-Zeneca, Janssen and Schering-Plough.
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