Safety of a cyclooxygenase-2 inhibitor in patients with aspirin-sensitive asthma.

BACKGROUND: In 5 to 10% of adult patients with asthma, aspirin (acetylsalicylic acid [ASA]) and most other nonsteroidal anti-inflammatory drugs (NSAIDs) precipitate acute asthmatic attacks. Therefore, choosing an alternative anti-inflammatory agent for patients with adverse reactions to an NSAID is a common problem in clinical practice. The discoveries that cyclooxygenase (COX)-2 is an inducible form of COX that is involved in inflammation and that COX-1 is the major isoform responsible for the production of prostaglandins have provided a reasonable basis for the development of specific COX-2 inhibitors as a new class of anti-inflammatory agents. OBJECTIVE: The purpose of this study was to demonstrate that rofecoxib, a specific inhibitor of COX-2, does not cause asthmatic attacks in patients with ASA and/or other NSAID-induced asthma. METHODS: We studied 40 patients, all of whom had experienced asthma induced by at least two different NSAIDs. The patients were challenged in a single-blind manner with different doses of rofecoxib on 3 different days, until either the therapeutic dose of 25 mg or intolerance was reached. Each patient was rechallenged with 25 mg of rofecoxib 7 days later if no evidence of intolerance had been observed previously. RESULTS: Rofecoxib, 25 mg, was proven to be well tolerated in all 40 patients with ASA-induced and NSAID-induced asthma. CONCLUSION: Our study appears to demonstrate that rofecoxib is a suitable NSAID for treatment of patients with ASA and/or other NSAID-induced asthma.