Major study published in NEJM confirms LABA/LAMAdual bronchodilator superiority over ICS/LABA in preventing COPD exacerbations

· FLAME study showed consistent superiority of LABA-LAMA (long-acting beta₂-adrenergic agonist and Long-acting muscarinic antagonistInhaler [indacaterol/glycopyrronium bromide]) Dual Bronchodilator over ICS-LABA (Inhaled Cortico-Steroids and long-acting beta₂-adrenergic agonist)across exacerbation outcomes, lung function and health-related quality of life in COPD patients

· LABA/LAMA dual brochodilatoralso significantly reduced the rate and prolonged the time to the first moderate or severe exacerbation, compared to ICS-LABA

· Results published in the New England Journal of Medicine are anticipated to have important implications for the care of people living with COPD in India

Mumbai, November 08, 2016: A study published by the New England Journal of Medicine of the head-to-head FLAME study[1], compared the efficacy of once-daily LABA-LAMA (indacaterol/glycopyrronium bromide) 110/50 mcg to twice-daily ICS-LABA(salmeterol/fluticasone [SFC]) 50/500 mcg in reducing chronic obstructive pulmonary disease (COPD) exacerbations. In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of LABA-LAMA Dual Bronchodilator over the widely used ICS-LABA combination on exacerbation outcomes¹. The published FLAME results are anticipated to impact the future management and treatment of COPD patients.

Preventing exacerbations is one of the primary goals of long-term care for COPD patients. These episodes have a detrimental effect on quality of life and disease progression², contributing to further lung function decline^3,4 and, in severe cases, hospitalization⁵ and even death².

Speaking on the study Dr. Ashok Mahasur, Senior Pulmonologist said, “Reducing exacerbations in COPD patients is paramount to improve patient outcomes and quality of life. The superiority of once daily LABA/LAMA dual bronchodilator combination to the currently used inhaled corticosteroid has been proved and is also more effective in reducing COPD exacerbations. This is expected to change all available standard of care which is of great news for COPD patients in India.”

The results of FLAME confirmed that LABA-LAMAdual bronchodilatoris superior to ICS-LABA in reducing exacerbation outcomes regardless of a patient’s disease severity and eosinophil levels (a type of white blood cell)¹. Significantly, compared to ICS-LABA, LABA-LAMA dual bronchodilator both reduced the rate of moderate or severe exacerbations with a 17% risk reduction (rate ratio, 0.83), and prolonged the time to the first of these episodes with a 22% risk reduction (hazard ratio, 0.78)¹. The safety profiles of the two treatments were consistent with their known profiles. The incidence of pneumonia was higher with ICS-LABA than LABA-LAMA dual bronchodilator(4.8% vs 3.2%: a statistically significant difference)¹.

These data were also presented to the scientific community at the 2016 Annual Meeting of American Thoracic Society (ATS) in San Francisco, USA.

Corporate Comm India(CCI Newswire)