EULAR: COX-2 Specific Inhibitors Will Replace Conventional NSAIDs
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EULAR: COX-2 Specific Inhibitors Will Replace Conventional NSAIDs

NICE, FRANCE -- July 10, 2000 -- "Now, in the 21st century, we can really do something for people with arthritis, a disease which affects 355 million people worldwide," said symposium chairman Roland W. Moskowitz, MD, of Case Western Reserve University, Cleveland, USA. "COX-2 specific inhibitors represent a major therapeutic advance -- and will replace conventional NSAIDs in the future.
Dr. Moskowitz made these statements at the XV European United League Against Rheumatism Congress (EULAR), in Nice, France.

Dr. Moskowitz was referring to the benefits of COX-2 specific inhibitors over NSAIDs, which include comparable efficacy to the maximum therapeutic doses of conventional NSAIDs and significant improvements in gastrointestinal (GI) safety.

A series of comparator- and placebo-controlled studies of the efficacy and safety of the COX-2 specific inhibitor celecoxib were presented by Frank McKenna, MD, of Trafford General Hospital, Manchester, UK.

"These findings confirm that celecoxib is a very potent agent in treating arthritis pain and inflammation -- as powerful as the most widely-used conventional NSAIDs in Europe," said Dr. McKenna. "They also show that celecoxib patients can get relief with fewer concerns about some of the serious treatment-related side effects typically associated with traditional non-selective agents."

"Importantly, patients demonstrate a similar upper gastrointestinal tolerability to celecoxib as placebo -- and this is significantly better than the conventional NSAIDs, naproxen and diclofenac, and the COX-2 specific inhibitor, rofecoxib," said Dr. McKenna.

Indeed, the percentage incidence of dyspepsia, abdominal pain and nausea seen in the comparative COX-2 specific inhibitor study were 10 percent for placebo, 11 percent for celecoxib and 34 percent for rofecoxib.

The efficacy of celecoxib in patients with chronic rheumatoid arthritis (RA) (mean disease duration approximately 10 years) has been confirmed in clinical trials. Celecoxib (200 mg twice daily) was compared to diclofenac (75 mg twice daily) in a 24-week, double-blind, randomized trial involving 655 patients with symptomatic adult-onset RA. The two drugs showed similar levels of efficacy in reducing pain and inflammation and the number of tender or painful and swollen joints.

In a randomized, double-blind, placebo-controlled, six-week trial of 600 patients, which was designed to compare the efficacy and safety of celecoxib (100 mg twice daily) and of diclofenac (50 mg three times a day) in osteoarthritis (OA) flare of the knee, primary efficacy measures were performed at baseline and at two and six weeks of treatment. The efficacy measures included patient’s assessment by APS (average pain in the last 24 hours), patient’s assessment of pain (100mm VAS scale) and the Western Ontario and McMaster OA Index (WOMAC) composite scores.

"There was no clinically significant difference between celecoxib and diclofenac in the relief of the symptoms of OA of the knee," said Dr. McKenna. "Significantly more patients taking diclofenac, however, experienced treatment-limiting gastrointestinal side effects (dyspepsia, diarrhea, abdominal pain, flatulence and nausea) than in the placebo or celecoxib-treated groups," he concluded.

In addition, two six-week, double-blind studies involving 1,404 patients with OA of the knee in flare who received celecoxib 100 mg twice daily, celecoxib 200 mg once daily, or placebo, showed that patients reported similar measures of efficacy for both dosing regimens.

Results from a six-week, head-to-head, placebo-controlled comparison of the two COX-2 specific inhibitors celecoxib (200 mg once-daily) and rofecoxib (25 mg once-daily) demonstrate equivalent efficacy for both treatment groups and significantly superior efficacy to placebo after six weeks of treatment. However, the incidence of upper GI adverse events (abdominal pain, dyspepsia and nausea) was significantly lower in celecoxib-treated patients compared with those in the rofecoxib group.

Dr. McKenna concluded that "Beyond efficacy, GI tolerability is crucial to the acceptance of NSAIDs and the predominant reason for discontinuation".

Related Link: celecoxib.

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