Obstructive Lung Diseases |

Safety Profile of Glycopyrronium Compared With Once-Daily Indacaterol in Patients With COPD With Moderate-to-Severe Airflow Limitation: The GEM3 Study FREE TO VIEW

Donald Mahler, PhD; Alex Gifford, MD; Aditi Satti; Nicola Jessop; Joerg H. Eckert; Peter D’Andrea; Rudrani Banerjee
Author and Funding Information

Geisel School of Medicine at Darmouth, Hanover, NH; Temple University College of Medicine, Philadelphia, PA; Novartis Pharma AG, Basel, Switzerland; Novartis Pharmaceuticals Corporation, East Hanover, NJ; Novartis Healthcare Pvt Ltd, Hyderabad, India

Chest. 2015;148(4_MeetingAbstracts):734A. doi:10.1378/chest.2228025
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SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM

PURPOSE: Glycopyrronium (GLY) 50 µg once daily is approved for maintenance bronchodilator treatment in patients with COPD in more than 80 countries including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia. The GEM3 (Glycopyronium Effect on syMptoms and lung function) study assessed the long-term safety of GLY 12.5 µg b.i.d compared with indacaterol (IND) 75 µg q.d. in COPD patients with moderate-to-severe airflow limitation.

METHODS: In this multicenter, double-blind, 52-week study, patients with COPD who met the following criteria were randomized to GLY 12.5 µg b.i.d or IND 75 µg q.d: post-bronchodilator predicted FEV1 ≥30% and <80%, FEV1/ FVC <0.70, a smoking history of ≥10 pack years and mMRC grade of ≥2.The primary endpoint was the adverse event (AE) reporting rate. Other assessments included the time to first moderate or severe COPD exacerbation, rescue medication use and lung function parameters (pre-dose FEV1 and FVC).

RESULTS: Of the 511 patients randomized (GLY, n=254; IND, n=257), 81.6% completed the study. The overall incidence of AEs (GLY 77.3%, IND 77.0%) and serious AEs (GLY 13.1%, IND 13.3%) was comparable between the groups. COPD exacerbation was the most commonly reported AE in both groups (GLY 3.6%, IND 2.0%). The incidence of MACE events was low and comparable between the groups (GLY, n=4 [1.6%]; IND, n=5 [2.0%]). New-onset atrial fibrillation/flutter events occurred in 1 (0.4%) patient in the GLY and 2 (0.8%) patients in the IND group. Three deaths were reported (GLY, n=2; IND, n=1) and none of these was deemed drug-related. No significant differences were observed between treatment groups in time-to first-moderate or severe COPD exacerbation (Hazard ratio = 0.92; 95% CI 0.64, 1.31; p=0.636). Both GLY and IND showed reduction in rescue medication use over the 52 weeks with no significant difference between the groups. GLY showed improvements in pre-dose FEV1 and FVC from baseline and was comparable with IND.

CONCLUSIONS: The safety profile of glycopyrronium 12.5 µg b.i.d. was similar to indacaterol 75 µg q.d. The data support the safety and efficacy of glycopyrronium 12.5 µg b.i.d as a treatment option for COPD.

CLINICAL IMPLICATIONS: The study provides long-term safety data for glycopyrronium 12.5 µg twice daily regimen and demonstrates safety comparable to an approved LABA in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation.

DISCLOSURE: Donald Mahler: Consultant fee, speaker bureau, advisory committee, etc.: Was on Advisory board for Novartis Alex Gifford: Grant monies (from industry related sources): Recieved a non-salary research support from Novartis Pharmaceuticals Aditi Satti: Grant monies (from industry related sources): Received research grant from Novartis Nicola Jessop: Employee: Novartis Pharma AG Joerg H. Eckert: Employee: Novartis Pharma AG Peter D’Andrea: Employee: Novartis Pharmaceuticals Corporation Rudrani Banerjee: Employee: Novartis Healthcare Pvt.Ltd

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