Rofecoxib, as a safe alternative for acetyl salicylic acid/nonsteroidal anti-inflammatory drug-intolerant patients.
BACKGROUND
Intolerance to acetylsalicylic acid (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) is a crucial problem in medical practice. There is therefore a need for safer NSAIDs in analgesic-intolerant patients.


OBJECTIVE
To assess the safety of rofecoxib, a selective COX-2 inhibitor, in ASA/NSAID-intolerant patients.


METHODS
A single blind, placebo-controlled oral challenge procedure was applied to 94 adult patients (M/F: 30/64, mean age: 39.2 +/- 11.9 yrs) with a reliable history of ASA/NSAID intolerance. 1/4 and 3/4 divided doses of placebo and rofecoxib were given with 2-hour intervals on consecutive days. During the challenge procedure, blood pressure, heart rate, nasoocular, pulmonary and cutaneous symptoms were monitored. Erythema, pruritus accompanied by erythema, urticaria/angioedema, rhinorrea, nasal obstruction, sneezing, dyspnea or cough associated with a decrease of at least 20% in the FEV1, and hypotension were considered as positive reactions.


RESULTS
None of the patients reacted to placebo. Only one patient (1.1%) presented urticarial-type cutaneous reaction to rofecoxib challenge. The remaining patients (98.9%) perfectly tolerated the drug challenge.


CONCLUSIONS
Rofecoxib can be used as a safe alternative drug for ASA/NSAID intolerant patients.
Bavbek
S
S
Dept. of Allergic Diseases, Ankara University School of Medicine, Ankara, Turkey. bavbek@medicine.ankara.edu.tr
Celik
G
G
Pasaoglu
G
G
Misirligil
Z
Z
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects*; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004342:Drug Hypersensitivity / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D001241:Aspirin