Monday, April 22, 2013

Novartis once-daily QVA149 shows superior efficacy in reducing exacerbations, improving lung function and quality of life in COPD patients

  • QVA149 significantly reduced the rate of all COPD exacerbations compared to open-label tiotropium 18 mcg and glycopyrronium. As far as moderate to severe exacerbations are concerned it was statistically significant compared to glycopyrronium, while in comparison to tiotropium though it was numerically lower but  did not reach statistical significance 
  • QVA149 also demonstrated significant improvements in lung function and health-related quality of life
 Results from the 64-week SPARK study published today in Lancet Respiratory Medicine showed that investigational once-daily dual bronchodilator QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) was more effective at reducing all chronic obstructive pulmonary disease (COPD) exacerbations compared to glycopyrronium 50 mcg and open-label (OL) tiotropium 18 mcg a treatment with established efficacy in preventing exacerbations. This is the first study to evaluate the effect on exacerbations of dual bronchodilation with a fixed-dose combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), versus single LAMA therapies.
 SPARK was a 64-week, multi-center, double-blind, parallel-group, active controlled study with the primary objective to show superiority of QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) versus glycopyrronium 50 mcg for the rate of moderate to severe COPD exacerbations in 2,224 patients with severe to very severe COPD. The key secondary objective was to show superiority of QVA149 compared with OL tiotropium 18 mcg with respect to the rate of moderate or severe COPD exacerbations during the treatment period. Patients aged >=40 years with >=1 COPD exacerbation in the year before were randomized to receive either once-daily QVA149, glycopyrronium or OL tiotropium 18 mcg.

The study met its primary endpoint demonstrating that QVA149 significantly reduced the rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium (p=0.038). The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18 mcg. The rate of all (mild, moderate, and severe) exacerbations was significantly reduced by 15% with QVA149 compared to glycopyrronium (p=0.0012) and by 14% compared with OL tiotropium 18 mcg (p=0.0017). All treatments had an acceptable safety profile, and there was no meaningful difference between the treatment groups in the incidence of adverse and serious adverse event reporting. Novartis has previously released the First Interpretable Results (FIR) for SPARK.

SPARK also demonstrated that the dual bronchodilator effect of QVA149 resulted in substantially improved lung function. During the 64-week study, results showed that lung function, as measured by trough FEV1 was significantly higher with QVA149 compared to glycopyrronium (p<0 .0001="" 18="" and="" assessment="" at="" during="" each="" mcg="" ol="" p="" period.="" span="" the="" tiotropium="" treatment="">






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