RT Journal Article
SR Electronic
T1 Once-daily NVA237 improves lung function in COPD patients: Pooled results of the GLOW1 and GLOW2 studies
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P2102
VO 40
IS Suppl 56
A1 Donald Banerji
A1 Vijay Alagappan
A1 Carmen Martin
A1 Ellie He
A1 Hungta Chen
A1 Tim Overend
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P2102.abstract
AB IntroductionNVA237 (glycopyrronium bromide) is safe and effective once-daily (QD) inhaled long-acting muscarinic antagonist for maintenance treatment of COPD.Methods This pooled analysis of the GLOW1 and 2 studies assessed the efficacy of NVA237 50µg QD vs placebo (PBO) and open-label tiotropium (TIO) 18µg QD over 26 to 52 wks in patients with moderate-to-severe COPD. Results include trough forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) at Day 1 and Wks 12, 26 and 52, 24-hr serial spirometry in a subset of patients, and FEV1 AUC.Results1888 subjects were randomized, 98.2% analyzed (NVA237=1059, TIO=267, PBO=528); male: 71.5%, mean age: 63.9yr, mean post-bronchodilator FEV1: 55.5% predicted. All trough FEV1 and FVC values for NVA237 and TIO were significantly greater than PBO (p<0.001) and NVA237 was numerically higher than TIO at all-time points (Table).View this table:Table: Trough FEV1 and FVC least square mean treatment difference (SE) from PBO (mL)The improvement in FEV1 with NVA237 was seen immediately after the first dose on Day 1 (90mL at 5min and 144mL at 15min versus PBO, p<0.001) and sustained throughout the 52 Wk period. FEV1 AUC for 0-4h, 0-12h, 0-24h and 12-24h for NVA237 was significantly greater than PBO (p<0.05) and numerically greater than TIO on Day 1, Wk 12, 26 and 52.ConclusionNVA237 50μg QD provided rapid, sustained and clinically meaningful bronchodilation over 52 wks with efficacy similar to tiotropium.