SESSION TITLE: COPD Posters V
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 treatment of patients with COPD. Glycopyrronium (GLY) 50 µg once daily is a LAMA 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. To assess the safety profile of twice-daily GLY, safety data from the GEM1, GEM2, FLIGHT1 and FLIGHT2 studies were pooled and evaluated along with the patient level safety data.
METHODS: GEM1/GEM2 and FLIGHT1/FLIGHT2 were 12-week, multicenter, double-blind, parallel-group, placebo- and active-controlled studies that randomized patients with moderate-to-severe COPD. The pooled data from the twice-daily GLY 12.5 µg and placebo (PBO) treatment arms were analyzed. Safety over 12 weeks was assessed in terms of adverse events (AE), serious AEs, premature discontinuation of study treatment, laboratory results, vital signs and independent adjudication of deaths.
RESULTS: A total of 1889 patients [GLY (N=951) and PBO (N=938)] were included in this pooled analysis. The overall incidence of AEs was comparable for GLY (n=420, 44.2%) and placebo (n=399, 42.5%). Incidences of serious AEs (GLY, n=40 [4.2%] and PBO, n=38 [4.1%]) and AEs leading to premature discontinuation of study treatment (GLY, n=24 [2.5%] and PBO, n=38 [4.1%]) were also comparable between groups. The most common AEs were COPD exacerbations (GLY 16.5%, PBO 18.9%) and upper respiratory tract infection (GLY 3.4%, PBO 2.4%). Among the SAEs, COPD exacerbation was the only SAE reported in at least 1% of patients which was similar between groups (GLY 1.5% and PBO 1.7%). Five deaths were reported (GLY, n=3; PBO, n=2) and none of those were related to study treatment. Laboratory parameters and clinically notable vital sign findings were similar between treatments.
CONCLUSIONS: Pooled data from these four clinical trials in patients with moderate-to-severe COPD demonstrates that the overall safety profile of glycopyrronium 12.5 µg twice daily is comparable with placebo.
CLINICAL IMPLICATIONS: These findings add to the existing evidence of the safety of glycopyrronium, approved at a dose of 50 µg, and support its usage at 12.5 µg twice daily as a safe and well-tolerated treatment in patients with moderate-to-severe COPD.
DISCLOSURE: Edward Kerwin: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Kerwin has served on advisory boards, speaker panels, or received travel reimbursement for Amphastar, Astra Zeneca, Forest, Ironwood, Merck, Mylan, Novartis, Pearl, Pfizer, Sanofi Aventis, Sunovion, Targacept, Teva and Theravance. He has conducted multicenter clinical research trials for approximately seventy pharmaceutical companies. Andrew Pedinoff: Other: Dr. Pedinoff has participated in multiple clinical trials including Novartis. He has no other financial agreements with any pharmaceutical companies. He takes no speaker fees. S. David Miller: Grant monies (from industry related sources): Research grant from Novartis Brigitte Franke-Bray: Employee: Employee of the study sponsor company (Novartis) and no other conflicts Robert Di Giovanni: Employee: Employee of the study sponsor company (Novartis) and no other conflicts Michelle Henley: Employee: Employee of the study sponsor company (Novartis) and no other conflicts Peter D’Andrea: Employee: Employee of the study sponsor company (Novartis) and no other conflicts
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