EULAR: Celebrex Effective In RA, OA Without Affecting Platelet Function, Clotting
GLASGOW, SCOTLAND -- June 9, 1999 -- In
separate clinical studies presented at the 14th meeting of
the European League Against Rheumatism (EULAR) in
Glasgow, celecoxib -- a compound developed for the
treatment of arthritis pain and inflammation -- was shown
to effectively treat adult rheumatoid arthritis (RA),
osteoarthritis (OA) of the hip and have no significant
effect on platelet function or normal blood clotting.
Additionally, data was presented demonstrating that G.D.
Searle & Co.'s and Pfizer Inc.'s Celebrex (celecoxib)
provides equivalent relief of osteoarthritis symptoms
when taken either in a once-daily dose of 200mg or a
twice-daily dose of 100mg.
In the first study, more than 1,100 patients with RA in a
flare state and with a Functional Capacity Classification
of I-III (age range: 21 to 84) were randomised to receive
celecoxib (100mg BID, 200mg BID, or 400mg BID),
placebo, or a widely prescribed non-steroidal
anti-inflammatory drug (NSAID), naproxen (500mg
BID). All study participants received multiple clinical
evaluations of their arthritis condition and regular physical
examinations and laboratory tests during the 12 week
study.
At all time points, the efficacy of celecoxib in the 100mg
BID, 200mg BID, and 400mg BID treatment groups
were similar in reducing the signs and symptoms of RA as
demonstrated by ACR-20, Patient and Physician Global
Assessments, number of tender/painful joints and number
of swollen joints. By these same measures, all doses of
celecoxib were comparable to naproxen and statistically
superior to placebo. When tested at Week 12, the
celecoxib treatment groups and the naproxen group
demonstrated improvements in the HAQ Functional
Disability Index with the improvement of each of the
groups being statistically different from placebo. All doses
of celecoxib were well tolerated and the incidences of
adverse events in the celecoxib groups were similar to
those in the placebo group.
In a second study, more than 1,000 patients with OA of
the hip (age range: 28 to 93) with a Functional Capacity
Classification of I-III were randomised to receive
celecoxib (50mg BID, 100mg BID, or 200mg BID),
naproxen (500mg BID) or placebo for up to 12 weeks.
Using both patient and physician arthritis assessments,
including Patient and Physician Global Assessments,
Patient Assessment of Pain and the Osteoarthritis
Severity Index, 100mg BID and 200mg BID doses of
celecoxib were highly efficacious in treating the signs and
symptoms of OA of the hip. These doses of celecoxib
were statistically superior to placebo and comparable to
naproxen at weeks two, six and 12. As with the RA
study, celecoxib therapy was well tolerated by patients in
the trial. Together with previously reported results, these
data demonstrate that celecoxib is highly effective for
relieving the signs and symptoms of OA whether it occurs
in the knee or hip.
In another clinical study presented at EULAR, healthy
male and female volunteers (age range: 19 to 53 years)
received single doses of either celecoxib, at up to double
the total-daily arthritis dose (100mg, 400mg or 800mg),
or ibuprofen at the standard arthritis dose (800mg).
Normal blood-clotting ability in the study was assessed
by collagen- and arachidonate-induced platelet
aggregation and serum thromboxane B2 (TxB2) levels in
the blood that indicate normal platelet function.
When tested three hours after dosing, platelet function in
the celecoxib treatment groups was statistically
indistinguishable from the placebo group. In contrast, the
ibuprofen treatment group demonstrated
clinically-significant impairment of platelet function. Blood
levels of serum TxB2 were also reduced three to four
times more in the ibuprofen group than in the celecoxib or
placebo groups. This difference was also statistically
significant.
A final study presented at the meeting demonstrated that
celecoxib effectively relieved OA pain and inflammation
when taken in either once-daily or twice-daily doses. In
this study, nearly 700 patients with OA of the knee in a
flare state (age range: 29 to 88 years) and with a
Functional Capacity Classification of I-III were
randomised to receive celecoxib (100mg BID or 200mg
QD) or placebo for six weeks. Arthritis assessments and
laboratory tests were completed at baseline and at
Weeks two and six. At both the two and six-week time
points, the efficacy of a once-daily dose of 200mg was
equally effective as a twice-daily dose of 100mg in
relieving OA pain and inflammation in the knee.
Additionally, both celecoxib dosing regimens were
equally well tolerated.
The most common side effects of celecoxib were
dyspepsia, diarrhoea and abdominal pain, which were
generally mild to moderate. Although celecoxib has a low
potential for stomach ulcers, serious GI tract ulcerations
can occur without warning. Physicians and patients
should remain alert for signs of GI bleeding. Patients who
have a known allergic reaction to celecoxib,
sulfonamides, aspirin or NSAIDs should not use
celecoxib.
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