Therapeutic Research

Abstract

Background：A combined fexofenadine/pseudoephedrine（FEX/PSE）tablet is approved in Japan for treatment of allergic rhinitis. The FEX/PSE package insert was recently amended to avoid misunderstanding of treatment duration, particularly when prescribed for ＞2 weeks. Objective：To assess whether FEX/PSE treatment duration in clinical practice is appropriate. Methods：In this post hoc analysis of the post‒marketing DEPARTURE drug use‒results survey, we analyzed the time course of discontinuation, incidence of adverse drug reactions（ADRs）, physician‒assessed efficacy, and patient‒reported outcomes （PRO） in 3 cohorts. Cohort A included patients who discontinued because of improvement or continued treatment for ≧8 weeks（n＝607）, Cohort B included patients who discontinued because of inefficacy or an ADR（n＝103）, and Cohort C included patients who discontinued for other reasons（n＝202）. Results：Median（interquartile range）treatment duration was 44（21‒63）, 15（13‒28）, and 23.5（15‒38）days in Cohorts A, B, and C, respectively. Cohort A exhibited 2 peaks of discontinuation（2‒3 weeks；9‒10 weeks）, likely reflecting early efficacy and pollinosis duration, and had significant improvements in efficacy and PRO. ADRs were infrequent（2.0％）and not associated with prolonged treatment. In Cohort B, FEX/PSE was appropriately discontinued early after an ADR or inefficacy. The ADR incidence was high（40.8％）, with minimal improvements in symptoms and PRO. In Cohort C, 94.6％ of discontinuations could not be medically justified. Cohort C had moderate improvements and ADRs were infrequent（1.5％）. Conclusion：FEX/PSE treatment duration is adjusted appropriately in most Japanese patients with allergic rhinitis, although one‒fifth of early discontinuation could not be medically justified.