Safety of meloxicam in aspirin-hypersensitive patients with asthma and/or nasal polyps. A challenge-proven study.
BACKGROUND
The anti-inflammatory actions of acetylsalicylic acid (ASA)/non-steroidal anti-inflammatory drugs (NSAIDs) are thought to be due to inhibition of COX-2, whereas the side effects such as gastric damage and aspirin-induced asthma are mediated through inhibition of COX-1. Therefore, a new class of drugs with COX-2 selectivity may be well tolerated by patients with ASA/NSAIDs hypersensitivity.


OBJECTIVE
We investigated whether subjects with asthma and/or nasal polyps (NP) and analgesic intolerance proven by oral ASA provocation test tolerated the selective COX-2 inhibitor, meloxicam.


METHODS
All subjects were first challenged with ASA using a 2-day, single-blind, placebo-controlled oral provocation test. Thereafter, the subjects showing positive response to ASA provocation underwent a single-blind, placebo-controlled challenge with a cumulative dose of 7.5 mg of meloxicam on 2 separate days. One and three fourths of the divided doses of placebo and the active drug were given at 1-hour intervals. Clinical symptoms, lung function, and blood pressure were monitored during these challenge protocols.


RESULTS
Twenty-one patients with asthma and/or NP (10 males and 11 females; mean age: 38.4 +/- 2.9 years) who reacted to ASA challenges were enrolled in the study. Response to ASA provocation was rhinitis + bronchospasm in 13, and extrabronchial reactions in 8 (isolated rhinitis in 3) patients. Mean PD(20) was 163.4 +/- 39.9 mg ASA among patients who reacted with bronchospasm to ASA. Only 1 patient reacted to meloxicam challenge at a cumulative dose of 7.5 mg.


CONCLUSIONS
This study indicates that 7.5 mg of meloxicam is a safe alternative treatment for ASA-hypersensitive asthma and/or NP patients with proven hypersensitivity via oral ASA challenges.
Bavbek
Sevim
S
Department of Allergic Diseases, Ankara University School of Medicine, Ankara, Turkey.
Dursun
A Berna
AB
Dursun
Engin
E
Eryilmaz
Adil
A
Misirligil
Zeynep
Z
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects*; D001249:Asthma / Q000150:complications / Q000188:drug therapy*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004342:Drug Hypersensitivity / Q000150:complications / Q000209:etiology; D006801:Humans; D000077239:Meloxicam; D008875:Middle Aged; D009298:Nasal Polyps / Q000150:complications / Q000188:drug therapy*; D013843:Thiazines / Q000009:adverse effects / Q000627:therapeutic use*; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D013843:Thiazines; D013844:Thiazoles; D001241:Aspirin; D000077239:Meloxicam