S Bavbek1, G Celik, G Pasaoglu, Z Misirligil. 1. Dept. of Allergic Diseases, Ankara University School of Medicine, Ankara, Turkey. bavbek@medicine.ankara.edu.tr
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.
RCT Entities:
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: Mohammad Bakhriansyah; Ronald H B Meyboom; Patrick C Souverein; Anthonius de Boer; Olaf H Klungel Journal: Fundam Clin Pharmacol Date: 2019-04-22 Impact factor: 2.748