SESSION TITLE: COPD QVA149 Posters
SESSION TYPE: Poster Presentations
PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM
PURPOSE: Exacerbations are the most frequent cause of hospitalization and death among patients with COPD. Combinations of long-acting bronchodilators maximize bronchodilation and may reduce the risk of exacerbations. QVA149, a once-daily dual bronchodilator containing the long-acting β2-agonist (LABA) indacaterol and long-acting muscarinic antagonist (LAMA) glycopyrronium, improves lung function, breathlessness and rescue medication use compared with twice-daily salmeterol/fluticasone combination (SFC), in patients with moderate-to-severe COPD.1
METHODS: In this 26-week, multicenter, double-blind study, patients ≥ 40 years with COPD (forced expiratory volume in 1 second [FEV1] ≥40% to <80% predicted and no history of exacerbations in the previous year) were randomized (1:1) to QVA149 110/50 µg or SFC 50/500 µg. In this post hoc analysis, we report the rate of mild, moderate or severe COPD exacerbations during 26 weeks of treatment with QVA149 or SFC.
RESULTS: Of 522 patients randomized [QVA149 (n=258), SFC (n=264); mean age: 63.3 years; mean post-bronchodilator FEV1: 60.2 % predicted], 82.6% completed. Rate ratio of QVA149 versus SFC [RR] of moderate or severe exacerbations was 0.80 (95% confidence interval [CI]: 0.41-1.56) and for all COPD exacerbations (mild, moderate, and severe), RR was 0.69 (95% CI: 0.44-1.07) (neither statistically significant).
CONCLUSIONS: The results demonstrate that the risk of exacerbations with once-daily QVA149 was numerically, but not statistically significantly, lower than twice-daily SFC in patients with moderate-to-severe COPD and no previous history of exacerbations.
CLINICAL IMPLICATIONS: The LABA/LAMA combination QVA149 has the potential to be an alternative to LABA/ICS in preventing COPD exacerbations. REFERENCE: 1. Vogelmeier et al. Lancet Respir Med 2013;1(1):50-60.
DISCLOSURE: Eric Bateman: Consultant fee, speaker bureau, advisory committee, etc.: Prof Eric Bateman has served on advisory boards for Boehringer Ingelheim, AstraZeneca, Elevation Pharma, Napp Pharma, Novartis, Almirall, Forest, and Merck and Takeda; has served as a consultant to Navigant Consulting, IMS consulting group, ALK-Abello, Almirall, Hoffman la Roche, and ICON; has been paid lecture fees by AstraZeneca, ALK-Abello, Chiesi, Boehringer Ingelheim, GlaxoSmithKline, Nycomed/Takeda, Novartis, Pfizer, and Indegene Lifesciences Ltd. Claus Vogelmeier: Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Janssen, Novartis, Pfizer, Almirall, Takeda, and Sterna Biologicals; has been paid lecture fees by AstraZeneca, Chiesi, GlaxoSmithKline, Janssen, Talecris, Novartis, Boehringer Ingelheim, Takeda, and Pfizer. Hungta Chen: Employee: Novartis Employee Donald Banerji: Employee: Novartis Employee
Clinical trial results of QVA149, combination of two approved products indacaterol and glycopyrronium, will be presented, QVA149 is in the late stage phase 3 trials prior to approval.