Obstructive Lung Diseases: COPD Pharmacotherapy |

Evaluation of Glycopyrronium Therapy in Chinese Patients Versus Predominantly Caucasian Populations in Patients With Moderate-to-Severe COPD: Comparison of Clinical Data FREE TO VIEW

Chen Wang, MD; Tieying Sun, MD; Yijiang Huang, MD; Michael Humphries, MD; Lingyan Bai, MD; Lilly Li, MD; Qian Wang, MD; Zi Lin, MD; Peter D'Andrea, MD; Pablo Altman, MD
Author and Funding Information

China-Japan Friendship Hospital, Beijing, China

Copyright 2016, American College of Chest Physicians. All Rights Reserved.

Chest. 2016;149(4_S):A390. doi:10.1016/j.chest.2016.02.405
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SESSION TITLE: COPD Pharmacotherapy

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Saturday, April 16, 2016 at 11:45 AM - 12:45 PM

PURPOSE: Glycopyrronium (GLY) is a once daily (od) long-acting muscarinic antagonist (LAMA) for maintenance treatment for patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The GLOW7 study studied the efficacy and safety of GLY 50µg od in Asian (predominantly Chinese) patients. We report here a comparison of the efficacy and safety of GLY in the Chinese cohort in the GLOW7 study vs results in predominantly Caucasian populations (GLOW1 and GLOW2 studies) with similar severity of COPD.

METHODS: The GLOW1, 2 and 7 studies were randomized double-blind placebo (PLA) controlled phase 3 studies in symptomatic adult patients aged 40 years or older with moderate-severe COPD (post-bronchodilator forced expiratory volume in one second (FEV1) of <80% and ≥30% of predicted normal and post-bronchodilator FEV1/FVC ratio of <0.7), smoking history 10 pack-years. Key parameters assessed at baseline and at Week 26 included lung function as FEV1, Transition Dyspnea Index (TDI) and St. George’s Respiratory Questionnaire (SGRQ).

RESULTS: The efficacy and safety of GLY in the Chinese cohort of GLOW7 was found to be comparable to predominantly Caucasian patients in GLOW1 and 2. For FEV1 at Week 26 in GLOW7, GLY was superior to PLA (LSM 0.138; p<0.001) similar to GLOW1 and 2, (LSM 0.113 and 0.134 L; p<0.001) respectively. The TDI score at Week 26 for GLY was superior to PLA (LSM 1.1; p<0.001) similar to GLOW1 and 2 (LSM 1.04; p<0.001 and LSM 0.81; p<0.01), respectively. Regarding health status, for SGRQ in GLOW7, GLY was superior to PLA (LSM -4.57; p<0.01), similar to GLOW1 and 2 (LSM -2.81, and -3.38; both p<0.001), respectively. For TDI and SGRQ, the numerical trends were greater in GLOW7 than GLOW1 and 2. Adverse events were comparable across all three studies. There were four deaths in the GLY arm in predominantly Chinese patients unrelated to study medication.

CONCLUSIONS: Glycopyrronium improved lung function, dyspnea and health status at Week 26 when added to routine therapy compared to placebo in predominantly Chinese patients with moderate-to-severe COPD with comparable results to predominantly Caucasian patients.

CLINICAL IMPLICATIONS: Glycopyrronium may prove to be an effective and well tolerated therapy option for Chinese patients with moderate-to-severe COPD.

DISCLOSURE: Michael Humphries: Employee: Beijing Novartis Pharma Co. Ltd., Shanghai, China Lingyan Bai: Employee: Beijing Novartis Pharma Co. Ltd., Shanghai, China Lilly Li: Employee: Beijing Novartis Pharma Co. Ltd., Shanghai, China Qian Wang: Employee: Beijing Novartis Pharma Co. Ltd., Shanghai, China Zi Lin: Employee: Beijing Novartis Pharma Co. Ltd., Shanghai, China Peter D'Andrea: Employee: Novartis Pharmaceuticals Corp, East Hanover, USA Pablo Altman: Employee: Novartis AG, Basel, Switzerland The following authors have nothing to disclose: Chen Wang, Tieying Sun, Yijiang Huang

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