Efficacy and safety of NVA237versusplacebo and tiotropium in patients with COPD: the GLOW2 study

Abstract

NVA237 (glycopyrronium bromide) is a once-daily long-acting muscarinic antagonist (LAMA) in development for chronic obstructive pulmonary disease (COPD). The GLycopyrronium bromide in COPD airWays clinical Study 2 (GLOW2) evaluated the efficacy and safety of NVA237 in moderate-to-severe COPD over 52 weeks.Patients were randomised 2:1:1 to NVA237 50 μg, placebo or open-label tiotropium 18 μg for 52 weeks. Primary end-point was trough forced expiratory volume in 1 s (FEV1) at 12 weeks.1,066 patients were randomised, 810 completed the study. At week 12, trough FEV1 increased significantly by 97 mL with NVA237 (95% CI 64.6–130.2; p<0.001) and 83 mL with tiotropium (95% CI 45.6–121.4; p<0.001). Compared with placebo, NVA237 produced significant improvements in dyspnoea (Transition Dyspnoea Index at week 26; p=0.002) and health status (St George's Respiratory Questionnaire at week 52; p<0.001). NVA237 significantly reduced the risk of moderate-to-severe COPD exacerbations by 34% (p=0.001) and the use of rescue medication (p=0.039), versus placebo. NVA237-placebo and tiotropium-placebo differences were comparable for all outcomes. Safety profiles were similar across groups.NVA237 50 μg provided significant improvements in lung function, dyspnoea, health status, exacerbations and rescue medication use, versus placebo, and was comparable to tiotropium. NVA237 can potentially be an alternative choice of LAMA for COPD patients.

Addressing unmet needs in the treatment of COPD

“…Glycopyrronium has also demonstrated comparable efficacy and safety to blinded and open-label tiotropium, with a faster onset-of-action [72]. In the GLOW (GLycopyrronium Bromide in COPD Airways) 2 and GLOW5 studies, glycopyrronium provided comparable efficacy and safety to tiotropium, including similar improvements in lung function, dyspnoea, health status, rescue medication use and rate of exacerbations [72,74].…”

“…In the GLOW (GLycopyrronium Bromide in COPD Airways) 2 and GLOW5 studies, glycopyrronium provided comparable efficacy and safety to tiotropium, including similar improvements in lung function, dyspnoea, health status, rescue medication use and rate of exacerbations [72,74]. Additionally, glycopyrronium demonstrated rapid and early onset of bronchodilation from day 1, comparing favourably with tiotropium [72,74].…”

“…Significant improvements have been observed with glycopyrronium versus placebo in lung function and clinical end-points, such as health status, dyspnoea, rescue medication use, daily symptoms, exercise endurance time and rate of exacerbations in three major clinical trials [23,[71][72][73].…”

“…Triple therapy (the combination of a LABA/LAMA with an ICS, or an ICS/LABA with a LAMA) is a treatment option for patients in GOLD group D. The improvements in lung function and clinical end-points observed with glycopyrronium [71][72][73][74] suggest that the LAMA may be a suitable candidate for use in a loose triple combination with an ICS/LABA. To study the efficacy of glycopyrronium in this approach, the GLISTEN trial investigated the efficacy (non-inferiority) of glycopyrronium compared with blinded tiotropium when added to twice-daily SFC [75].…”

Van-e cardiovascularis mellékhatásuk az inhalációs antikolinerg szereknek?

“…A GLOW 1-5 vizsgálatokban [24,25,26] placebo, illetve tiotropium HandiHaler kontrollja mellett szignifi káns cardiovascularis mellékhatást nem észleltek. Jelentős QT-megnyúlást sem, csak kismértékűt.…”