SESSION TITLE: COPD I
SESSION TYPE: Slide Presentations
PRESENTED ON: Sunday, March 23, 2014 at 04:15 PM - 05:15 PM
PURPOSE: QVA149 is a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (indacaterol) and long-acting muscarinic antagonist glycopyrronium, for the treatment of COPD. We evaluated the overall rate of exacerbations and the health status with QVA149 in comparison with glycopyrronium and tiotropium.
METHODS: In this 64-week multicenter study, patients aged ≥40 yrs with severe-to-very severe COPD were randomized to receive once-daily, double-blind QVA149 110/50 μg, glycopyrronium 50 μg, or open-label tiotropium 18 μg. Overall exacerbation rates and health status via the St George’s Respiratory Questionnaire (SGRQ) scores were determined.
RESULTS: Of 2224 patients randomized, 75% of patients completed the study. QVA149 resulted in a rate reduction of 15% versus glycopyrronium (Rate ratio [RR] 0.85; 95% CI 0.77-0.94; p=0.001) and 14% versus tiotropium (RR 0.86; 95% CI 0.78-0.94; p≤0.01). SGRQ total score was significantly improved with QVA149 at Week 64 compared with both glycopyrronium (mean difference - 2.07; p<0.01) and tiotropium (mean difference -2.69; p<0.001). SGRQ symptoms, activity and impacts component scores also showed greater improvement with QVA149 than with glycopyrronium or tiotropium at all visits.
CONCLUSIONS: Once-daily QVA149 was superior to glycopyrronium and tiotropium in lowering the rate of exacerbations and similarly provided significant and clinically meaningful improvements in health status (SGRQ) in patients with severe-to-very severe COPD.
CLINICAL IMPLICATIONS: QVA149 is a better alternative to glycopyrronium and tiotropium in improving respiratory health-related quality of life and lowering exacerbation rates in management of COPD.
DISCLOSURE: Jadwiga Wedzicha: Consultant fee, speaker bureau, advisory committee, etc.: JW has received speaking fee and/or for advisory boards from GlaxoSmithKline, AstraZeneca, Novartis, Bayer, Boehringer Ingelheim, Nycomed. Chiesi and Respifor as well as travel reimbursements from Boehringer Ingelheim. JW has received research grants from GlaxoSmithKline, AstraZeneca, Chiesi and Novartis. Joachim Ficker: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Ficker has received speaker fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Pfizer, Nycomed, Almirall, Berlin-C hemie, Takeda and Novartis, consulting fees from AstraZeneca, Boehringer Ingelheim, and Novartis. Angel FowlerTaylor: Employee: The author is an employee of Novartis Pharmaceuticals Corporation Peter D'Andrea: Employee: The author is an employee of Novartis Pharmaceuticals Corporation Christie Arrasate: Employee: The author is an employee of Novartis Pharmaceuticals Corporation Hungta Chen: Employee: The author is an employee of Novartis Pharmaceuticals Corporation Donald Banerji: Employee: The author is an employee of Novartis Pharmaceuticals Corporation
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