Tokyo, Japan –22 November 2016: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the announcement by Novartis welcoming the publication of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 report. For the first time, GOLD has recommended the first-line use of dual bronchodilators, such as Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg, in the treatment of the majority of symptomatic chronic obstructive pulmonary disease (COPD) patients, regardless of their exacerbation risk1.
The GOLD 2017 report is a tool to help health care professionals worldwide implement effective COPD management programs. Significantly, the use of inhaled steroid-containing combination therapies is now only recommended in a minority of patients (those with a history of two or more exacerbations in the previous year, or one hospitalization), following dual bronchodilator (LABA/LAMA*) treatment1.
Today’s new recommendations may translate to health care professionals moving away from the historical reliance on inhaled corticosteroid (ICS)/LABA combinations as first line therapy for the prevention of exacerbations1. The GOLD 2017 report clearly identifies the elevated risk of adverse effects (including pneumonia) when using these treatments and references evidence showing no significant harm from withdrawing this medication in many patients when used as part of a triple regimen1.
Ultibro Breezhaler is currently the only steroid-free treatment to offer prescribers clinically proven superiority over the most prescribed ICS/LABA combination** in preventing COPD exacerbations2. The head-to-head FLAME study2 was considered significant enough to be included as a reference for the first-line use of dual bronchodilators in symptomatic patients with high exacerbation risk.
* Long-acting beta2-adrenergic agonist/Long-acting muscarinic antagonist
** Seretide® Accuhaler® (salmeterol/fluticasone) 50 microgram /500 microgram /dose inhalation powder. Seretide and Accuhaler are registered trademarks of the GlaxoSmithKline group of companies
1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed 16 November 2016].
2. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 16 November 2016].
3. GOLD. About Us. Available at: http://goldcopd.org/about-us/ [Accessed 16 November 2016].
4. 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 16 November 2016].