Huang, Tsan-Ming, Kuo, Kuan-Chih, Wang, Ya-Hui, Wang, Cheng-Yi, Lai, Chih-Cheng, Wang, Hao-Chien, Chen, Likwang, Yu, Chong-Jen, On the behalf of Taiwan Clinical Trial Consortium for Respiratory Diseases (TCORE), Perng, Diahn-Warng, Cheng, Shih-Lung, Hsu, Jeng-Yuan, Hsu, Wu-Huei, Tsai, Ying-Huang, Hsiue, Tzuen-Ren, Lin, Meng-Chih, Lin, Hen-I, Chang, Yeun-Chung, Yang, Ueng-Cheng, and Lin, Cing-Syong
Objectives: To investigate the incidence of active tuberculosis (TB) among COPD patients using fluticasone/salmeterol or budesonide/formoterol, and to identify any differences between these two groups of patients.Methods: The study enrolled COPD patients from Taiwan NHIRD who received treatment with fluticasone/salmeterol or budesonide/formoterol for > 90 days between 2004 and 2011. The incidence of active TB was the primary outcome.Results: Among the intention-to-treat population prior to matching, the incidence rates of active TB were 0.94 and 0.61% in the fluticasone/salmeterol and budesonide/formoterol groups, respectively. After matching, the fluticasone/salmeterol group had significantly higher rates of active TB (adjusted HR, 1.41, 95% CI, 1.17-1.70) compared with the budesonide/formoterol group. The significant difference between these two groups remained after a competing risk analysis (HR, 1.45, 95% CI, 1.21-1.74). Following propensity score matching, the fluticasone/salmeterol group had significantly higher rates of active TB compared with the budesonide/formoterol group (adjusted HR, 1.45, 95% CI, 1.14-1.85). A similar trend was observed after a competing risk analysis (HR, 1.44, 95% CI, 1.19-1.75). A higher risk of active TB was observed in the fluticasone/salmeterol group compared with the budesonide/formoterol group across all subgroups, but some differences did not reach statistical significance.Conclusion: Fluticasone/salmeterol carried a higher risk of active TB compared with budesonide/formoterol among COPD patients. [ABSTRACT FROM AUTHOR]