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Safety of selective cyclooxygenase-2 inhibitor rofecoxib in patients with NSAID-induced cutaneous reactions

2002; Elsevier BV; Volume: 89; Issue: 1 Linguagem: Inglês

10.1016/s1081-1206(10)61912-6

1534-4436

J. Quiralte, Blanca Sáenz de San Pedro, J. José Fernando Florido,

Urticaria and Related Conditions

Background Controlled oral challenge with nonsteroidal anti-inflammatory drugs (NSAIDs) is the only definite way to diagnose the different clinical manifestations of NSAID sensitivity. Objective To evaluate the safety of selective cyclooxygenase-2 inhibitor rofecoxib in a patient population with NSAID-induced skin reactions. Methods We prospectively conducted single-blind, placebo-controlled, oral challenges (SBPCOCs) with rofecoxib in 15 patients with challenge-proven NSAID-induced cutaneous reactions. Results Fifteen patients (9 men and 6 women, ranging in age from 14 to 60 years) had positive SBPCOC response to at least one of the following NSAIDs: aspirin (in 46.7% of cases), nimesulide (in 40% of cases), and diclofenac (in the remaining 13.3% of cases). During controlled challenges, 8 patients (53.3%) had urticaria (1 of them with associated angioedema); 6 (40%) had facial angioedema; and 1 (6.6%) had nonurticarial rash. Controlled oral challenge with rofecoxib were well tolerated in all patients. Conclusion Rofecoxib did not cross-react with aspirin and other NSAIDs in patient with NSAID-induced skin reactions. A tolerance observed to this drug during SBPCOCs will indicate a safe alternative in this patient-group. Controlled oral challenge with nonsteroidal anti-inflammatory drugs (NSAIDs) is the only definite way to diagnose the different clinical manifestations of NSAID sensitivity. To evaluate the safety of selective cyclooxygenase-2 inhibitor rofecoxib in a patient population with NSAID-induced skin reactions. We prospectively conducted single-blind, placebo-controlled, oral challenges (SBPCOCs) with rofecoxib in 15 patients with challenge-proven NSAID-induced cutaneous reactions. Fifteen patients (9 men and 6 women, ranging in age from 14 to 60 years) had positive SBPCOC response to at least one of the following NSAIDs: aspirin (in 46.7% of cases), nimesulide (in 40% of cases), and diclofenac (in the remaining 13.3% of cases). During controlled challenges, 8 patients (53.3%) had urticaria (1 of them with associated angioedema); 6 (40%) had facial angioedema; and 1 (6.6%) had nonurticarial rash. Controlled oral challenge with rofecoxib were well tolerated in all patients. Rofecoxib did not cross-react with aspirin and other NSAIDs in patient with NSAID-induced skin reactions. A tolerance observed to this drug during SBPCOCs will indicate a safe alternative in this patient-group.