Therapeutic Research

Abstract

Background：Tiotropium Respimat®（Tio‒R）is a first long‒acting muscarinic antagonist with bronchial asthma indications in Japan. Objective：To evaluate the safety and effectiveness of Tio‒R in severe persistent asthmatics under general clinical practice. Method：The PMS was conducted over a 52‒week observation period in 359 patients enrolled with severe persistent asthma, aged≧15 years, who were naive to Tio‒R and received Tio‒R for the first time for treatment of bronchial asthma on top of at least inhaled corticosteroid treatment（NCT02489981）. The primary outcome was the incidence of patients with adverse drug reactions（ADRs） over a 52‒week observation period. The secondary outcome was the change from baseline in asthma control status at Week 52. Asthma control status at each visit was determined according to the Japanese guideline for adult asthma. Another outcome was the change from baseline in the Asthma Control Questionnaire（ACQ‒6）score at Week 52. Results：Of 340 patients in the safety set, the incidence of patients with ADR was 5.59％（19/340 patients）. The most frequent ADRs were thirst, cough, dry mouth and dysphonia；each event was reported in 3 of 340 patients［0.88％（3/340 patients）］. Potential factor affecting the incidence of ADR was sex｛2.55％ in male and 8.20％ in female, and odds ratio＝3.42［, 95％ confidential interval（CI）；1.11, 10.51］｝. Regarding the asthma control status at Week 52, for those with insufficient control at baseline, 58.12％（68/117 patients） improved, and for those with poor control at baseline, 57.66％ （64/111 patients） improved. Change from baseline to Week 52 in the ACQ 6 score was－1.59（95％ CI；－1.91, －1.26）, which was statistically significant. Conclusion：The survey supported the effectiveness of long‒term use of Tio‒R（a dose of 5μg once daily） in severe persistent asthmatics and did not discover any clinically relevant safety issue.