STOCKHOLM, SWEDEN — June 19, 2002 —
The COX-2 inhibitor rofecoxib (Vioxx®) appears to be associated with fewer serious lower gastrointestinal (GI) events than the traditional non-steroidal anti-inflammatory (NSAID) agent naproxen in older patients with rheumatoid arthritis (RA).
The results of this study were presented here this week at the Annual European Congress of Rheumatology (EULAR). For the study, which was led by Dr. L. Laine of the department of gastroenterology at the University of Southern California in Los Angeles, United States, 8,076 RA patients 50 years or older or 40 years or older and taking corticosteroids were randomized to treatment with naproxen 500 mg BID or rofecoxib 50 mg once daily.
The researchers followed the patients up at six weeks, four months, and then every four months for a median follow-up time of nine months. The presence of serious lower GI events was defined as bleeding beyond the duodenum accompanied by a more than a 2 g/dl drop in hemoglobin or the need for hospitalization and hospitalization for intestinal perforation, obstruction, ulceration, or diverticulitis. Based on this definition, 24 patients taking naproxen experienced a serious GI event, compared to 11 taking rofecoxib.
This translates to a rate 0.89 per 100 patient years for serious lower GI events in patients taking naproxen, compared to 0.41 for those taking rofecoxib. Moreover, rates of all clinical upper GI events were 4.5 per 100 patient years for naproxen and 1.4 for rofecoxib. The authors conclude that serious lower GI events occurred in older patients taking rofecoxib at only 54 percent the rate of patients taking naproxen.
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