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Published on 24 April 2013

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Novartis once-daily QVA149 in reducing exacerbations in COPD

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Results from the 64-week SPARK study published today in Lancet Respiratory Medicine showed that investigational once-daily dual bronchodilator QVA149 (indacaterol maleate 110mcg/glycopyrronium 50mcg) was more effective at reducing all chronic obstructive pulmonary disease (COPD) exacerbations compared to glycopyrronium 50mcg and open-label (OL) tiotropium 18mcg[1] a treatment with established efficacy in preventing exacerbations.[2–5] 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.
“We are delighted that results from SPARK demonstrated that QVA149 reduced the overall rate of exacerbations in patients with severe and very severe COPD. For physicians and their patients, these findings offer hope of a new effective treatment to prevent debilitating COPD exacerbations and improve health-related quality of life,” said Tim Wright, Global Head of Development at Novartis Pharma AG.
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 110mcg/ glycopyrronium 50mcg) versus glycopyrronium 50mcg 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 randomised to receive either once-daily QVA149, glycopyrronium or OL tiotropium 18 mug.[1]
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 18mcg. 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 18mcg (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.[1] 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) and OL tiotropium 18mcg (p<0.0001) at each assessment during the treatment period.
Additionally, QVA149 showed significant differences in health-related quality of life during the study as demonstrated by lower St George’s Respiratory Questionnaire (SGRQ) total scores of QVA149 versus glycopyrronium (p<0.01), and OL tiotropium 18 mcg (p<0.05). Percentages of patients achieving the minimum clinically important (>=4 unit) improvement in SGRQ total scores were higher with QVA149 compared to glycopyrronium (p=0.055) or OL tiotropium 18 mcg (p=0.051), even up to Week 64.[1]
The effective management of COPD exacerbations is very important to both patients and physicians, as exacerbations can impose a significant burden of morbidity, mortality, reduced quality of life and increased healthcare costs.[6,7] Frequent exacerbations are linked to an accelerated decline in lung function[8,9] and patients are also known to have a poorer quality of life.[10] Admissions to hospital due to exacerbations are increasing[11] and patients with more severe underlying disease account for around 70% of the direct medical costs of COPD.[12]
Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. SPARK is one of ten studies investigating QVA149 for the treatment of COPD in the IGNITE Phase III clinical trial program, which involves more than 7,000 patients across 42 countries.
References:
  1. Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of Chronic Obstructive Pulmonary Disease Exacerbations with the Dual Bronchodilator QVA149 Compared with Glycopyrronium and Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study. Lancet Respir Med 2013 http://www.thelancet.com/journals/lanres/onlinefirst Accessed 23 April 2013
  2. Niewoehner DE, Rice K, Cote C, et al. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med 2005; 143: 317-26.
  3. Wedzicha JA, Calverley PM, Seemungal TA, et al, for the INSPIRE Investigators. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med 2008; 177: 19-26.
  4. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011; 364: 1093-103.
  5. Tashkin DP, Celli B, Senn S, et al, for the UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-54.
  6. Simoens S et al. Clinical and economic analysis of antimicrobial therapy of chronic obstructive pulmonary disease exacerbations. Int J Clin Pract. 2007; 61: 200-206.
  7. Hurst J et al. Chronic obstructive pulmonary disease: the clinical management of an acute exacerbation. Postgrad Med J. 2004; 80: 497-505.
  8. Kanner RE, Anthonisen NR, Connett JE; Lung Health Study Research Group. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med 2001; 164:358-64
  9. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002; 57:847-52.
  10. Seemungal TA, Donaldson GC, Paul EA, et al. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1998; 157: 1418-22.
  11. Lung and Asthma Information Agency. Trends in hospital admissions for lung disease. Fact sheet 2001/4. London: St George’s Hospital Medical School.
  12. Sullivan SD, Ramsey SD, Lee TA: The economic burden of COPD. Chest 2000;117(suppl 2):5S-9S.


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