[Tolerability of a selective cyclooxygenase-2-inhibitor (rofecoxib) in patients with intolerance reactions to nonsteroidal anti-inflammatory agents].

OBJECTIVE

Pseudoallergic reactions triggered by nonsteroidal anti-inflammatory drugs (NSAIDs) are common and caused by inhibition of the enzyme cyclooxygenase-1, whereas their therapeutic effects are mediated by inhibition of cyclooxygenase-2. This study analyzed the tolerability of the selective cyclooxygenase-2-inhibitor rofecoxib in patients who encountered pseudoallergic reactions to NSAIDs.

METHODS

37 patients (12 males, 25 females, mean age 35 years [15-75 years]) with a history of pseudoallergic reactions to NSAIDs underwent standardized skin prick, scratch and patch tests along with oral placebo-controlled blinded exposure to rofecoxib (maximum single dose 12.5 mg, cumulative dose 25 mg).

RESULTS

23 patients had skin reactions, 4 times respiratory symptoms were documented, and in 10 cases cutaneous as well as respiratory symptoms were reported. Salicylic acid was identified as the most common trigger for a pseudoallergic reaction (n = 28). In 9 cases several non-steroidal antiphlogistics of different chemical groups caused symptoms. All skin tests showed negative results. Oral challenge with rofecoxib was tolerated by all 37 patients without adverse effects.

CONCLUSIONS

Given the high incidence of pseudoallergic reactions to NSAIDs the use of selective cyclooxygenase-2-inhibitors represents a therapeutic alternative as well as a means of prevention of the described reactions.