D. Quaratino et al., Tolerability of meloxicam in patients with histories of adverse reactions to nonsteroidal anti-inflammatory drugs, ANN ALLER A, 84(6), 2000, pp. 613-617
Background: Adverse reactions to nonsteroidal anti-inflammatory drugs (NSAI
Ds) are frequent, particularly among patients with chronic urticaria or ast
hma. The need to identify an alternative drug that is safe and reliable is
a common problem in clinical practice.
Objective: To assess the tolerability of meloxicam, a new NSAID that select
ively inhibits the inducible isoform of cyclooxygenase, in a group of NSAID
-sensitive patients.
Patients and Methods: We studied 177 patients who had suffered adverse reac
tions to one or more NSAIDs. Cutaneous reactions were reported by 83.1% of
the subjects (urticaria in 55, angioedema in 52, urticaria/angioedema in 39
, and maculopapular rash in 1), respiratory symptoms by 3.9%, both cutaneou
s and respiratory symptoms by 9%, Stevens-Johnson's syndrome by 2.3%, and a
naphylactoid reactions by 1.7%. All subjects underwent a single-blind, plac
ebo-controlled oral challenge with divided therapeutic doses of meloxicam (
1.9 mg + 5.6 mg 1 hour later = cumulative dose 7.5 mg),
Results: Positive reactions were observed in only two cases (1.1%), both ma
nifested exclusively by cutaneous symptoms (urticaria/angioedema in one cas
e and maculopapular rash/facial edema in the second).
Conclusion: Meloxicam seems to be well tolerated by NSAID-sensitive subject
s whose reactions are manifested by urticaria/angioedema. Additional study
is needed for a more complete assessment of its tolerability in patients wi
th aspirin-induced asthma and other severe manifestations of NSAID sensitiv
ity.