Glycopyrronium Improved Health Status, Dyspnea, and Reduced Rescue Medication Use in Patients With Moderate-to-Severe COPD: Pooled Analysis From GEM1 and GEM2 Studies

Abstract

SESSION TITLE: COPD Posters IV SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM PURPOSE: Long-acting bronchodilators including muscarinic antagonists are central to the management of symptoms in patients with COPD. Glycopyrronium (GLY) 50 μg q.d. is approved for maintenance bronchodilator treatment in patients with COPD in more than 80 countries including countries within the EU and Japan, Canada, Switzerland and Australia. Here, we present the results of patient reported outcomes from the pooled analysis of GEM1 and GEM2 studies. METHODS: GEM1 and GEM2 were 12-week, multicenter, double-blind, placebo-controlled, replicate studies, designed to assess efficacy and safety of GLY 12.5 μg b.i.d compared with placebo (both delivered via the NeohalerTM device). Change in health status, dyspnea, and rescue medication use were measured by St. George's Respiratory Questionnaire [SGRQ] total score, Transition Dyspnea Index [TDI] focal score, and puffs/day of rescue medication, respectively. RESULTS: Data from 867 patients from the GEM1 and GEM2 studies (GLY, n=437, placebo, n=430) were included in this analysis. Baseline patient demographics were comparable between the two treatment groups. At week 12, compared with placebo, GLY showed a significant reduction in the SGRQ total score [Least Square Mean treatment difference (LSMTD) (95% CI): -4.0 units (-5.6, -2.3), p<0.001] which reached the minimal clinically important difference (MCID) of ≥4 units decrease in SGRQ total score from baseline. GLY also showed a significant improvement in TDI focal score [LSMTD (95% CI): 0.70 units (0.28, 1.12); p=0.001] at week 12 compared with placebo. The proportion of patients achieving the MCID for the SGRQ total score (≥4 units decrease) and TDI focal score (≥1 unit) at week 12 were significantly higher with GLY compared with placebo (SGRQ: GLY, 52%, placebo, 42%, Odds ratio (95%CI) 1.59 (1.19,2.12), p=0.002; TDI: GLY, 54%; placebo, 41%, Odds ratio (95%CI), 1.75 (1.30, 2.36), p<0.001]. The change from baseline in rescue medication use over 12 weeks was significantly lower with GLY compared with placebo [LSMTD (95% CI): -0.66 puffs/day (-0.97, -0.36); p<0.001]. CONCLUSIONS: In COPD patients with moderate-to-severe airflow limitation, treatment with glycopyrronium 12.5 μg b.i.d. improves health status and dyspnea, and reduces rescue medication usage. CLINICAL IMPLICATIONS: Glycopyrronium 12.5 μg twice daily can be an effective treatment option to reduce COPD symptoms and improve quality of life in patients with COPD with moderate-to-severe airflow limitation. DISCLOSURE: Craig Laforce: Consultant fee, speaker bureau, advisory committee, etc.: Consultant to Novartis, Grant monies (from industry related sources): the principal investigator on trials with the following pharmaceutical companies including Novartis Edward Kerwin: Consultant fee, speaker bureau, advisory committee, etc.: Has served on advisory boards, speaker panels, or received travel reimbursement for Novartis Pharmaceuticals, Grant monies (from industry related sources): He has conducted multicenter clinical research trials for approximately forty pharmaceutical companies including Novartis. Selwyn Spangenthal: Consultant fee, speaker bureau, advisory committee, etc.: Has received honoraria from AstraZeneca, Forest, Mylan Labs, and Novartis Peter D'Andrea: Employee: Employee of the study sponsor, Novartis, and no other conflicts Joerg H. Eckert: Employee: Employee of the study sponsor, Novartis, and no other conflicts Michelle Henley: Employee: Employee of the study sponsor, Novartis, and no other conflicts Francesco Patalano: Employee: Employee of the study sponsor, Novartis and no other conflicts No Product/Research Disclosure Information