More News on Celebrex

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Title: EULAR: Celebrex Effective In RA, OA Without Affecting Platelet

Function, Clotting

URL: http://www.pslgroup.com/dg/105556.htm

Doctor's Guide

June 9, 1999

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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