Etoricoxib Outperforms Naproxen as Treatment for RA

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Etoricoxib Outperforms Naproxen As Treatment For Rheumatoid Arthritis

NEW YORK (Reuters Health) Sept 04 - Etoricoxib, a highly selective

cyclooxygenase-2 inhibitor (CSI), appears to be a more effective treatment

for rheumatoid arthritis (RA) than naproxen, according to a report published

in the August issue of the Journal of Rheumatology.

Etoricoxib, produced by Merck and Co., Inc. under the trade name Arcoxia,

was submitted to the US Food and Drug Administration for approval last year.

But Merck withdrew the application in March 2002 so that it could add data

supporting the drug's use in ankylosing spondylitis. Since then, the FDA has

requested additional cardiovascular safety data in comparison to drugs other

than naproxen.

In the current study, underwritten by Merck Research Laboratories, Dr. Alan

K. Matsumoto, from s Hopkins Medical Institutions in Baltimore,

land, and colleagues assessed the outcomes of 448 RA patients who were

randomized to receive etoricoxib 90 mg once daily, naproxen 500 mg twice

daily, or placebo for 12 weeks.

Treatment with etoricoxib or naproxen was associated with significant

improvements in disease activity and joint swelling and tenderness compared

with placebo (p < 0.01), the authors note. Furthermore, the improvements

observed were significantly greater with etoricoxib than with naproxen (p <

0.05).

The percentage of patients who experienced a treatment response based on

American College of Rheumatology Criteria was 52.6%, 39.1%, and 20.8% with

etoricoxib, naproxen, and placebo, respectively.

The number of patients who discontinued etoricoxib due to lack of efficacy

was significantly lower than for naproxen or placebo.

In general, etoricoxib was well tolerated, the researchers write. The only

two cardiovascular events, a transient ischemic attack and a non-Q wave

myocardial infarction, occurred in the etoricoxib-treated group, but " were

both considered definitely not drug related by the investigator, " according

to the report.

" These data support the addition of etoricoxib to the available therapeutic

options in the management of patients with RA, " the investigators state.

" We now need large, event-driven, properly powered, randomized, controlled

clinical trials of etoricoxib and other CSI using maximal clinically

relevant doses versus conventional non-steroidal anti-inflammatory drugs not

only to prove gastrointestinal but also cardiovascular safety, " Dr.

Day, from St. 's Hospital in Sydney, Australia, comments in a related

editorial.

J Rheumatol 2002;29:1581-1582,1623-1630.