TY - JOUR T1 - Safety profile of glycopyrronium in patients with COPD: An innovative approach to analyse data from post-marketing surveillance (PMS) JF - European Respiratory Journal JO - Eur Respir J VL - 44 IS - Suppl 58 SP - P890 AU - Robert Di Giovanni AU - Peter D'Andrea AU - Huilin Hu AU - Pankaj Goyal AU - Vikas Joshi Y1 - 2014/09/01 UR - http://erj.ersjournals.com/content/44/Suppl_58/P890.abstract N2 - IntroductionGlycopyrronium (GLY) is a once-daily approved LAMA with rapid onset of action, for maintenance treatment of patients (pts) with COPD. Based on GLYs cumulative worldwide sales since its launch (upto 28 Sep 2013), patient exposure to GLY is estimated to be about 70727 patient treatment yrs. We evaluated the cardiac safety of GLY from the PMS.MethodsSpontaneous voluntary reports of cardiac events were evaluated using the Empirica™ Signal System (ESS), a safety data mining application applied to Novartis global safety database (ARGUS) for automated signal detection and calculating disproportionality scores. ESS utilized the multi-item gamma poisson shrinker (MGPS) algorithm to calculate an estimate of the reporting ratio (EBGM- Empirical Bayes Geometric Mean) of cardiac events considered to be potential risks for the drug. The lower 90% confidence interval limit of EBGM (denoted as EB05) was used. EB05 ≥2 was considered “signalled by MGPS” based on the threshold (Szarfman A, et al. Drug Saf. 2002;25:381-92). Limitation of our method includes potential under reporting and selection of ARGUS database as background.ResultsBased on this innovative signal detection method, GLY did not increase the risk of selected cardiovascular adverse events (AEs) and serious AEs in pts with COPD (Table).View this table:Statistical scores for cardiac safety of GLY during PMSConclusionPost marketing data suggests that cardiac safety profile of GLY (50µg OD) is consistent with its current label with an acceptable overall safety profile. ER -