Therapeutic Research

Abstract

Objectives：This investigation was conducted to evaluate the long‒term safety and effectiveness of vilanterol/fluticasone furoate dry powder inhaler（FF/VI）in patients with chronic obstructive pulmonary disease（COPD）in routine clinical practice. 　　Methods：The subjects were patients diagnosed with COPD and previously untreated with FF/VI, and the observation period per patient was one year from the start of treatment with FF/VI. The safety was evaluated based on the incidences of adverse drug reaction （ADRs）, and the effectiveness was evaluated based on the investigator’s global assessment according to the courses of patient‒reported symptoms and of clinical symptoms, COPD exacerbations, and the time courses of respiratory function test values and the COPD Assessment Test（CAT）score and such. 　　Results：ADRs were reported in 43（4.4％）of 968 patients in the safety analysis set of this investigation. The most common ADRs were pneumonia in 9 patients（0.9％）, dysphonia in 9（0.9％）, COPD in 8（0.8％）, and oral candidiasis in 4（0.4％）. 　　Among 889 patients in the effectiveness analysis set, the proportion of responders based on the global assessment was 89.3％（794/889）；decreases in the number of COPD exacerbations and increases in respiratory function test values（FEV1, FVC）were observed. 　　Conclusion：The results of this investigation revealed no new safety issues, suggesting the safety and effectiveness of long‒term FF/VI treatment in routine clinical practice.