OREANDA-NEWS. September 27, 2011. New data analysis presented at ERS 2011 supports the ability of roflumilast to shift COPD patients from the frequent to the more stable infrequent exacerbator state1  

Data support use of roflumilast to prevent exacerbations, which currently impose a substantial burden on patients and health-care systems worldwide2

Nycomed announced new findings to show that Daxas® (roflumilast) helps to prevent exacerbations in COPD patients of the ‘frequent exacerbator’ phenotype.1 The data, presented at the 2011 European Respiratory Society (ERS) Annual Congress in Amsterdam, 24 – 28 September, have important implications for the management of COPD in this patient population, who are at increased risk of disease progression compared with those who have no or infrequent exacerbations.2 Frequent exacerbations are of concern to a significant group of COPD patients, despite access to available therapy. 3 They are distressing for patients and lead to poorer health status and faster disease progression, imposing a substantial burden on patients.2  Exacerbations also significantly impact the functional ability of COPD patients – patients with frequent exacerbations reduce the time they spend outdoors at a faster rate compared with those with infrequent exacerbations and are more likely to become housebound.4

Lead investigator Professor Jadwiga Wedzicha comments: “The results of our analysis are important because they show that the anti-inflammatory effects of roflumilast can help to reduce exacerbations in the ‘frequent exacerbator’ phenotype and this is clinically significant from both the patients’ and clinicians’ perspective. This ‘frequent exacerbator’ group show worse health status and faster disease progression than those who are ‘infrequent exacerbators’. Thus in this patient population, reducing exacerbations is a key treatment goal. We also need to be better at identifying these patients at risk by proactively asking patients about their exacerbation history, including previous worsening episodes treated with oral steroids and/or antibiotics or requiring admission to hospital.”

The data presented at ERS 2011 are from a post-hoc pooled analysis of two one-year studies of more than 1,500 roflumilast-treated patients with severe COPD, chronic bronchitis and a history of exacerbations.1* Among patients identified as frequent exacerbators, treatment with roflumilast over a year lowered the risk for those remaining in the frequent exacerbator state by 20% as compared to placebo (RR=0.799, p=0.0148).1 Among patients identified as infrequent exacerbators, treatment with roflumilast over a year lowered the risk of becoming a frequent exacerbator by 23% as compared to placebo (RR=0.768, p=0.0018).1 Thus this analysis shows that roflumilast offers COPD patients an improvement in their exacerbations status by shifting patients from the frequent to the more stable infrequent exacerbator state.1

Anders Ullman, Executive Vice President, Research and Development at Nycomed, comments: “These are important data, as they continue to reinforce the therapeutic value of roflumilast to reduce exacerbation frequency. COPD exacerbations are frightening and devastating to experience, and roflumilast provides added value to patients suffering from frequent exacerbations by helping them achieve a more stable disease state.”

Daxas is the first in a new class of treatment, phosphodiesterase 4 (PDE4) inhibitors, and has received approval in several countries, including the European Union, US and Canada for the treatment of severe COPD associated with chronic bronchitis. In the 2010 update of its COPD management guidelines, The Global Initiative for Chronic Obstructive Lung Disease (GOLD) included roflumilast as a new treatment option, acknowledging its principal action to reduce inflammation and the clinical implications in terms of exacerbation reduction in GOLD stage III and IV COPD patients.5

* Notes to editors

Among roflumilast-treated frequent exacerbators (n=413), 32.0% still had frequent exacerbations at year 1 vs. 40.8% of placebo-treated patients (n=417; RR=0.799, p=0.0148).1 Among infrequent exacerbators, 17.5% of roflumilast-treated patients (n=1124) had ?2 exacerbations at year 1 vs. 22.9% of placebo-treated patients (n=1137; RR=0.768, p=0.0018).1