フェキソフェナジン塩酸塩60 mg/フェニレフリン塩酸塩10 mg 配合剤（FEX60/PE10 錠）のアレルギー性鼻炎患者に対する有効性および安全性の検討―多施設共同，オープンラベル試験―

Background：Treatment with histamine H1 receptor agonists tends to be less effective for nasal congestion than for the other two primary symptoms of allergic rhinitis （repeated sneezing and rhinorrhea）. We thus explored the efficacy and safety of a fixed dose combination（FDC）of 60 mg fexofenadine hydrochloride（FEX）, a second‒generation antihistamine known for its good safety profile, and 10 mg phenylephrine（PE）, an α1 receptor agonist effective against nasal congestion. Methods：A multicenter open‒label study comparing the effectiveness before and after 2‒week twice‒daily administration of oral FEX60/PE10 FDC tablets for at least 1 year in patients aged 15 years and older with allergic rhinitis. The primary endpoint was mean change from baseline in nasal congestion score. The secondary endpoints were mean change from baseline in daily, daytime, and nighttime scores for the following：combined scores for sneezing, rhinorrhea, and nasal congestion；individual scores for sneezing, rhinorrhea, and impact on daily activities；change in nasal cavity findings；patient impressions；and change in symptom severity. Results：This 3‒center study was conducted from March to July 2015 in Japan. The intent‒to‒treat population was 105 patients with a mean age of 38.9 years；all were included in safety analysis and in the modified intent‒to‒treat group. Slightly more subjects were male（56 subjects, 53.3％）. The allergy diagnosis was seasonal allergic rhinitis in 48 subjects（45.7％）, perennial allergic rhinitis in 25 （23.8％）, and mixed allergic rhinitis in 32（30.5％）. Mean improvement in nasal congestion score was statistically significant（－0.798；95％CI －0.91 to －0.68；p＜0.001）. Secondary endpoints also improved significantly. Patient impressions were favorable, and physician assessment tended toward improvement for all symptoms. Adverse events were noted in 7 patients （6.67％）；the most common was rhinopharyngitis in 4 patients（3.81％）. Adverse drug reactions were 1 case of aggravated preexisting hepatic steatosis and 1 case of somnolence（0.95％ each）. The hepatic steatosis was confirmed to have been relieved, and the other adverse events were confirmed resolved. No serious adverse events were reported. Conclusion：FEX60/PE10 tablets were effective against nasal congestion, and also improved other rhinitis symptoms and reduced the impact of those symptoms on daily activities. The drug was generally well‒tolerated.