Added protection against exacerbations
Daxas® is the first oral COPD-specific anti-inflammatory therapy for severe COPD patients on maintenance treatment with inhaled drugs who have:
• Symptoms of chronic cough and sputum
• A history of frequent exacerbations
Patients with COPD and symptoms of chronic cough and sputum have a higher risk of exacerbations compared with patients without these symptoms (Figure 1).1,2 Exacerbations are distressing for patients and their loved ones and can be life-threatening. During an exacerbation, patients report fearing that they may die, feeling as though they are suffocating, and often becoming depressed after the event at the prospect of further events occurring.3,4 In addition, frequent exacerbations are associated with faster decline in lung function,5 more rapid disease progression,6,7 and increased mortality.7,8 The GOLD strategy document recommends preventing exacerbations as a major goal of COPD management programmes.9
Figure 1. Increased risk of exacerbations in patients with COPD and symptoms of chronic cough and sputum.
Adapted from Burgel, et al 2009.1
Exacerbations may be classified as moderate if they necessitate treatment with oral/parenteral corticosteroids, and severe if they lead to hospitalization or death.10,11 Clinical studies have shown that Daxas® significantly reduced the risk of moderate and severe exacerbations in the Daxas® target population (patients with severe COPD with symptoms of chronic cough and sputum and who have a history of frequent exacerbations).10-12 When added on top of LABAs, Daxas® reduced exacerbation rate by 21% compared with placebo (Figure 2).12 Daxas® therefore provides added benefits to these patients, over and above that achieved with long-acting bronchodilators alone.11,12
Reduction of exacerbations
Figure 2. Daxas® significantly reduced the rate of moderate/severe exacerbations when added on top of LABAs.
By reducing exacerbations, Daxas® offers an effective additional treatment option for patients who are already using inhaled drugs as first-line maintenance treatment.
- Burgel PR, Nesme-Meyer P, Chanez P, et al. Cough and sputum production are associated with frequent exacerbations and hospitalizations in COPD subjects. Chest 2009;135:975-982.
- Kim V, Han MK, Vance GB, et al. The chronic bronchitic phenotype of COPD. Chest 2011;140:626-633.
- Kessler R, Ståhl E, Vogelmeier C, et al. Patient understanding, detection, and experience of COPD exacerbations. Chest 2006;130:133-142.
- Breathing fear: The COPD effect. Report comissioned by Allen & Hanbury's and the British Lung Foundation, 2003.
- Donaldson GC, Seemungal TAR, Bhowmik A, et al. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002;57:847-852.
- Seemungal TA, Donaldson GC, Bhowmilk A, et al. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2000;161:1608-1613.
- Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005;60:925-931.
- Groenewegen KH, Schols AMWJ, Wouters EFM. Mortality and mortality-related factors after hospitalization for acute exacerbation of COPD. Chest 2003;124:459-467.
- Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of COPD. 2010. www.goldcopd.org
- Calverley PMA, Rabe KF, Goehring UM, et al. Roflumilast in symptomatic chronic obstructive disease: two randomised clinical trials. Lancet 2009;374:685-694.
- Fabbri LM, Calverley PMA, Izquierdo-Alonso JL, et al. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet 2009;374:695-703.
- Bateman ED, Rabe KF, Calverley PMA, et al. Roflumilast with long-acting ß2-agonists for COPD: influence of exacerbation history. Eur Respir J 2011;38:553-560.
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