SESSION TITLE: COPD Posters V
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Cardio- and cerebrovascular (CCV) diseases are common comorbidities in patients with COPD.1 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. Here we present the pooled cardiovascular safety data for GLY 12.5 µg b.i.d from four 12-week studies.
METHODS: GEM1, GEM2, FLIGHT1 and FLIGHT2 studies assessed the 12-week efficacy and safety of GLY 12.5 µg b.i.d compared with placebo (PBO), all delivered via the NeohalerTM device. The studies included male and female patients (aged ≥40 years with a smoking history of ≥10 pack-years) with moderate-to-severe COPD. Cardiovascular safety was assessed through independent adjudication of major adverse cardiovascular events (MACE), cardiovascular death, atrial fibrillation/flutter events, and newly occurring and worsening of ECG evaluations over 12 weeks.
RESULTS: A total of 1889 patients (GLY, N=951; PBO, N=938) from the GEM1, GEM2, FLIGHT1 and FLIGHT2 studies were included in the safety analysis. In this 12-week pooled safety database (S-db), the frequency of MACE events was low and similar between GLY (n=4, 0.4%) and PBO (n=6, 0.6%). There were 3 cardiovascular deaths (GLY, n=1; PBO, n=2) in the 12-week S-db and none of the deaths was considered treatment-related by the investigators. The frequency of new-onset atrial fibrillation/flutter events was low (<1%) in both treatment arms. New-onset atrial fibrillation/flutter did not result in stroke or transient ischemic attack in any of the patients. Newly occurring or worsening QTcF values did not indicate any clinically meaningful differences between treatment groups. Newly occurring or recurrent ECG abnormalities were infrequent and the differences were not clinically relevant.
CONCLUSIONS: The cardiovascular safety of glycopyrronium 12.5 µg b.i.d in patients with moderate-to-severe COPD was comparable with placebo in the 12-week studies.
CLINICAL IMPLICATIONS: Glycopyrronium has a cardiovascular safety profile similar to that observed with placebo and can be a safe treatment option in patients with moderate-to-severe COPD.
DISCLOSURE: Edward Kerwin: Consultant fee, speaker bureau, advisory committee, etc.: Have 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. Craig Laforce: Consultant fee, speaker bureau, advisory committee, etc.: A principal investigator and a consultant with Novartis Andrew Pedinoff: Grant monies (from industry related sources): Participate in clinical trials for Novartis Robert Di Giovanni: Employee: Employee of the study sponsor, Novartis, and no other conflicts Nicola Jessop: Employee: Employee of the study sponsor, Novartis and no other conflicts Michelle Henley: Employee: Employee of the study sponsor, Novartis, and no other conflicts Peter D’Andrea: Employee: Employee of the study sponsor, Novartis, and no other conflicts
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