Lack of clinically relevant differences between combination therapy and monotherapy in COPD

Abstract

From the authors: We would like to thank B.J. Lipworth for his letter and interest in the SHINE study. B.J. Lipworth incorrectly describes the conclusion of the SHINE study article. Nowhere in the article is it stated that QVA149 “demonstrated clinically relevant superiority versus its respective monotherapy components in COPD”. Rather, we concluded that “dual bronchodilation with once-daily QVA149 demonstrated superior and clinically meaningful outcomes versus placebo and superiority versus treatment with a single bronchodilator” [1]. The conclusion on QVA149 versus placebo is justified by improvements in trough forced expiratory volume in 1 s (FEV1) being twice the accepted minimal clinically important difference (MCID) of 100 mL [2] and that for the transition dyspnoea index (TDI) exceeding the MCID of >1 unit improvement [3]. …