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Rofecoxib, as a safe alternative for acetyl salicylic acid/nonsteroidal anti-inflammatory drug-intolerant patients.
J Investig Allergol Clin Immunol. 2006; 16(1):57-62.JI

Abstract

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.

CONCLUSION

Rofecoxib can be used as a safe alternative drug for ASA/NSAID intolerant patients.

Authors+Show Affiliations

Bavbek S
Dept. of Allergic Diseases, Ankara University School of Medicine, Ankara, Turkey. bavbek@medicine.ankara.edu.tr
Celik G
No affiliation info available
Pasaoglu G
No affiliation info available
Misirligil Z
No affiliation info available

MeSH

AdultAnti-Inflammatory Agents, Non-SteroidalAspirinCyclooxygenase 2 InhibitorsDrug HypersensitivityFemaleHumansLactonesMaleMiddle AgedSingle-Blind MethodSulfones

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16599250

Citation

Bavbek, S, et al. "Rofecoxib, as a Safe Alternative for Acetyl Salicylic Acid/nonsteroidal Anti-inflammatory Drug-intolerant Patients." Journal of Investigational Allergology & Clinical Immunology, vol. 16, no. 1, 2006, pp. 57-62.
Bavbek S, Celik G, Pasaoglu G, et al. Rofecoxib, as a safe alternative for acetyl salicylic acid/nonsteroidal anti-inflammatory drug-intolerant patients. J Investig Allergol Clin Immunol. 2006;16(1):57-62.
Bavbek, S., Celik, G., Pasaoglu, G., & Misirligil, Z. (2006). Rofecoxib, as a safe alternative for acetyl salicylic acid/nonsteroidal anti-inflammatory drug-intolerant patients. Journal of Investigational Allergology & Clinical Immunology, 16(1), 57-62.
Bavbek S, et al. Rofecoxib, as a Safe Alternative for Acetyl Salicylic Acid/nonsteroidal Anti-inflammatory Drug-intolerant Patients. J Investig Allergol Clin Immunol. 2006;16(1):57-62. PubMed PMID: 16599250.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rofecoxib, as a safe alternative for acetyl salicylic acid/nonsteroidal anti-inflammatory drug-intolerant patients. AU - Bavbek,S, AU - Celik,G, AU - Pasaoglu,G, AU - Misirligil,Z, PY - 2006/4/8/pubmed PY - 2006/8/17/medline PY - 2006/4/8/entrez SP - 57 EP - 62 JF - Journal of investigational allergology & clinical immunology JO - J Investig Allergol Clin Immunol VL - 16 IS - 1 N2 - 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. CONCLUSION: Rofecoxib can be used as a safe alternative drug for ASA/NSAID intolerant patients. SN - 1018-9068 UR - https://www.unboundmedicine.com/medline/citation/16599250/Rofecoxib_as_a_safe_alternative_for_acetyl_salicylic_acid/nonsteroidal_anti_inflammatory_drug_intolerant_patients_ DB - PRIME DP - Unbound Medicine ER -