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KMID : 1011320170090010011
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Journal of Pharmacoepidemiology and Risk Management
2017 Volume.9 No. 1 p.11 ~ p.17
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A Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Fluticasone Furoate Nasal Spray in Korean with Seasonal and Perennial Allergic Rhinitis
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Cho Jung-Eun
Min Soung-Jun
Lee Yil-Seob
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Abstract
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Objective: The aim of this study was to evaluate the safety and effectiveness of Fluticasone Furoate nasal spray in Korean patients with seasonal and perennial allergic rhinitis.
Methods: A total of 3,244 patients were enrolled consecutively in 154 hospitals, by 179 physicians. Subjects who were administered Fluticasone Furoate nasal spray at least once and were monitored for safety, effectiveness were included in the analysis. Primary endpoint was the incidence of adverse events (AEs) among the Korean subjects administered Fluticasone Furoate nasal spray according to the prescribing information in real world practice. For the secondary end point, effectiveness was assessed through overall evaluation by physicians.
Results: The safety assessment group was 3,218; male 1,721 (53.5%), female 1,497 (46.5%). The mean age of subjects was 32.5±20.1 years. The overall incidence of AEs was reported 2.3% (75 patients, 81 cases). The most frequent AEs reported were epistaxis (0.6%), followed by cough (0.6%) and headache (0.3%). Among 81 AE reports, 32 AEs (29 patients, 0.9%) were reported to be related with the use of Fluticasone Furoate nasal spray. There were 3 cases of serious AEs (SAEs). Most subjects (2,823 patients 92.6%) showed overall improvement of disease after treatment of Fluticasone Furoate nasal spray.
Conclusion: The results suggest that Fluticasone Furoate nasal spray administered to Korean subjects according to the prescribing information was well tolerated.
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KEYWORD
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Fluticasone, Nasal Sprays, Drug-Related Side Effects and Adverse Reactions, Rhinitis, Allergic
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