Tolerability of three selective cyclo-oxygenase-2 inhibitors, meloxicam, celecoxib and rofecoxib in NSAID-sensitive patients.

BACKGROUND: Patients with aspirin-sensitive respiratory and cutaneous diseases experience cross reactions to all nonsteroidal anti-inflammatory drugs (NSAIDs) which inhibit cyclo-oxigenase (COX) enzymes. As are now available drugs which selectively inhibit COX-2, questions are raised whether cross-reactivity occurs between aspirin and these COX 2 inhibitors.

OBJECTIVE: The aim of this study was to evaluate the tolerability of three COX-2 inhibitors (meloxicam, celecoxib and rofecoxib) in subjects with previous pseudoallergic respiratory and cutaneous reactions to NSAIDs.

METHODS: 76 subjects with documented previous cutaneous and respiratory pseudoallergic reactions to aspirin and/or other NSAIDs underwent a single blind challenge with celecoxib, meloxicam and rofecoxib.

RESULTS: All subjects with previous respiratory reactions tolerated all drugs. Three subjects with multiple-drug induced urticaria complained of a generalized reaction after challenge (Two due to celecoxib and one due to meloxicam). Among the group of patients with NSAIDs-induced urticaria five complained of a relapse of the disease due to rofecoxib (one subject), celecoxib (two subjects and meloxicam (two subjects).

CONCLUSIONS: According to these results the cross-reactivity between aspirin and these COX-2 inhibitors does not occur in subjects with previous respiratory pseudoallergic reactions. A good safety profile was also demonstrated in patients with cutaneous reactions, being few reactions observed. However for this reason a controlled oral challenge with these drugs is useful for the proper management of patients sensitive to classic NSAIDs.