Press release
Sep 5, 2016

New findings confirm Ultibro® Breezhaler® is consistently more effective than Seretide® in reducing COPD flare-ups across different patient groups


  • Ultibro® Breezhaler® reduced the rate of all COPD exacerbations across different patient sub-groups vs Seretide in new results from the FLAME study 
  • Ultibro Breezhaler also lowered patients’ need for rescue medication and had an improved benefit-risk profile compared to Seretide, with less evidence of systemic effects 
  • Sub-group analyses of FLAME and a large-scale study showing inhaled corticosteroid use and pneumonia risk interrelationship to be shared at ERS 2016


Tokyo, Japan – 5 September 2016: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the announcement by Novartis that new analyses from the head-to-head FLAME study confirmed that Ultibro® Breezhaler® is a more effective option for patients at risk of chronic obstructive pulmonary disease (COPD) flare-ups (exacerbations) than Seretide®, across different patient sub-groups1-10. These findings will be presented to the scientific community at the 2016 European Respiratory Society (ERS) International Congress, September 3-7, 2016 in London, UK.

In the new analyses, once-daily Ultibro Breezhaler (indacaterol/glycopyrronium bromide) 110/50 mcg demonstrated consistent reductions in the rate of all exacerbations (mild, moderate and severe)1, regardless of age, smoking status, exacerbation history, disease severity2 and previous inhaled corticosteroid (ICS) use3,4, versus twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg. Specifically, among patients with the severest forms of COPD*, Ultibro Breezhaler significantly reduced the rate of exacerbations and improved their health status versus the commonly used inhaled corticosteroid (ICS)/LABA† 5. Furthermore, patients using Ultibro Breezhaler needed less rescue medication during the day6.

Data to be presented at ERS 2016 also showed that, compared to Seretide, Ultibro Breezhaler was associated with fewer systemic effects, namely impairment of adrenal function8, which regulates the natural production of hormones. Ultibro Breezhaler use has previously shown to be associated with significantly fewer cases of pneumonia than the ICS/LABA combination11.

Adding weight to the need to reduce inappropriate use of ICS therapy, results of a large observational study involving >87,000 participants (with and without COPD) from Sweden will also be shared at ERS 201612. The ARCTIC study found that COPD patients were at higher risk of pneumonia than those without the disease, but that this risk was more acute for those taking an ICS (whether at a low or high dose)12. In fact, even people without COPD that took an ICS increased their risk of pneumonia, further demonstrating their interrelationship12

Novartis is presenting over 35 abstracts from across its broad respiratory portfolio at ERS 2016. The company is committed to continual clinical and patient-led research to address the evolving unmet needs of people living with respiratory diseases.

* GOLD Group D

†a long-acting beta2-adrenergic agonist

 

References

1. Wedzicha J, Vogelmeier CF, Ayers T et al. Once-daily indacaterol/glycopyrronium (IND/GLY) reduces all exacerbations compared with twice-daily salmeterol/fluticasone (SFC) in COPD patients with ≥1 exacerbation in the previous year: the FLAME study. [ERS 2016 abstract 852871; Session 183; Date: September 4, 2016 Time: 12:50-14:40].

2. Wedzicha J, Chapman KR, FowlerTaylor A et al. Indacaterol/glycopyrronium (IND/GLY) reduces exacerbations compared with salmeterol/fluticasone (SFC) in various subgroups from the FLAME study. [ERS 2016 abstract 852899; Session 183; Date: September 4, 2016 Time: 12:50-14:40].

3. Chapman KR, Vogelmeier CF, FowlerTaylor A et al. Effect of indacaterol/glycopyrronium (IND/GLY) vs salmeterol/fluticasone (SFC) on moderate or severe COPD exacerbations and lung function based on baseline blood eosinophil counts: Results from the FLAME study. [ERS 2016 abstract 853471; Session 123; Date: September 4, 2016 Time: 08:30-10:30].

4. Patalano F, Wedzicha J, Vestbo J et al. Indacaterol/glycopyrronium (IND/GLY) reduces exacerbation and improves lung function versus salmeterol/fluticasone (SFC) in patients with and without prior ICS use: the FLAME study. [ERS 2016 abstract 852689; Session 183; Date: September 4, 2016 Time: 12:50-14:40].

5. Wedzicha J, Mezzi K, Timothy RA et al. Indacaterol/glycopyrronium (IND/GLY) reduces the risk of exacerbations versus salmeterol/fluticasone (SFC) in moderate-to-very severe COPD patients irrespective of prior ICS/LABA/LAMA therapy: the FLAME study. [ERS 2016 abstract; Session 695; Date: September 7, 2016 Time: 09:30].

6. Larbig M, Vogelmeier CF, Roche N et al. Efficacy of indacaterol/glycopyrronium (IND/GLY) versus salmeterol/fluticasone (SFC) on exacerbations and health status in GOLD Group D COPD patients: the FLAME study. [ERS 2016 abstract 852867; Session 183; Date: September 4, 2016 Time: 12:50-14:40].

7. Fogel R, Chapman KR, Vogelmeier CF, et al. Once-daily indacaterol/glycopyrronium (IND/GLY) reduces use of rescue medication versus twice-daily salmeterol/fluticasone (SFC) in patients with moderate-tovery severe COPD: results from the FLAME study. [ERS 2016 abstract 852907; Session 183; Date: September 4, 2016 Time: 12:50-14:40].

8. Olsson P, Vogelmeier CF, Chapman KR et al. Effect of indacaterol/glycopyrronium versus salmeterol/fluticasone on hypothalamic pituitary-adrenal axis function in moderate-to very severe COPD patients: results from the FLAME study. [ERS 2016 abstract 853124; Session 183; Date: September 4, 2016 Time: 12:50-14:40].

9. Olsson P, Roche N, Vestbo J, et al. Cardiovascular (CV) safety of indacaterol/glycopyrronium (IND/GLY) compared with salmeterol/fluticasone combination (SFC) in moderate-to-very severe COPD patients with prior exacerbations: The FLAME study. [ERS 2016 abstract 853013; Session 123; Date: September 4, 2016 Time: 08:30-10:30].

10. Chapman KR, Roche N, Ayers T et al. Indacaterol/glycopyrronium (IND/GLY) is superior to salmeterol/fluticasone (SFC) in improving health status of patients with moderate-to-very severe COPD: Results from the FLAME study. [ERS 2016 abstract 852898; Session 183; Date: September 4, 2016 Time: 12:50-14:40].

11. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol/Glycopyrronium Versus Salmeterol/Fluticasone for COPD Exacerbations. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 29 July 2016].

12. Janson C, Johansson G, Ställberge B, et al. ICS and risk of pneumonia in Swedish COPD patients: The ARCTIC study. [ERS 2016 abstract; Session 593; Date: September 6, 2016 Time: 12:50-14:40]

13. Ultibro Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002679/WC500151255.pdf [Accessed 29 July 2016]. 

 

 

 


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