Safety of rofecoxib in subjects with a history of adverse cutaneous reactions to aspirin and/or non-steroidal anti-inflammatory drugs.
BACKGROUND
Adverse reactions to non-steroidal anti-inflammatory drugs (NSAID)s are frequent, and the need to identify a safe alternative drug is a common problem in clinical practice.


OBJECTIVE
To assess the tolerability of rofecoxib, a drug that specifically inhibits COX-2, in a group of NSAID-sensitive patients.


METHODS
One-hundred and four subjects (29 males and 75 females, mean age 35.6 +/- 14.1) were enrolled. All subjects had experienced one or more episode characterized by cutaneous symptoms (erythema, and/or urticaria angioedema) following the assumption of NSAIDs; 92 subjects experienced reactions to only one NSAID (single intolerance: SI) and 12 subjects had reactions to multiple NSAIDs (multiple intolerance: MI). Rofecoxib was challenged at the following dosages: 1/4 of 25 mg (6.25 mg), 1/4 of 25 mg, and 1/2 of 25 mg (12.5 mg), at intervals of 1 h if no symptoms had developed with the previous administration, in order to reach a cumulative dose of 25 mg. All subjects underwent two double-blind, placebo-controlled challenges in two consecutive days.


RESULTS
No reactions against placebo were observed. Similarly, no reactions were observed in all subjects both after the first and after the second challenge to rofecoxib.


CONCLUSIONS
The present study demonstrated that rofecoxib does not have cross-reactivity to NSAIDs. Rofecoxib is a safe alternative in subjects with previous adverse cutaneous reaction to NSAIDs.
Pacor
M L
ML
Department of Clinical and Experimental Medicine, University of Verona, Verona, Italy. marisa+pacor@yahoo.it
Di Lorenzo
G
G
Biasi
D
D
Barbagallo
M
M
Corrocher
R
R
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use*; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004341:Drug Evaluation; D004342:Drug Hypersensitivity / Q000209:etiology; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000187:drug effects; D007558:Italy; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012871:Skin Diseases / Q000139:chemically induced*; D013450:Sulfones; D016896:Treatment Outcome; D014581:Urticaria / Q000139:chemically induced
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D007073:Immunoglobulin E; D001241:Aspirin