From the Guidelines
Roflumilast (Daxas) is effective in reducing the frequency of moderate to severe COPD exacerbations in patients with chronic bronchitis and a history of exacerbations, as evidenced by a decrease in the rate of exacerbations per patient-year (rate ratio 0.85,95% CI 0.78–0.91) 1. The medication works by inhibiting phosphodiesterase-4 (PDE4), reducing inflammation in the airways.
- Key benefits of roflumilast include:
- Decreased rate of moderate or severe exacerbations per patient-year
- Increased time to next exacerbation (hazard ratio 0.88,95% CI 0.81–0.96)
- Improved lung function, as measured by post-bronchodilator FEV1 and FVC
- However, roflumilast is also associated with an increased risk of adverse events (67.4% versus 60.9%; risk ratio 1.11,95% CI 1.06–1.15) 1. The European Respiratory Society/American Thoracic Society guideline recommends roflumilast for patients with COPD associated with chronic bronchitis and exacerbations to prevent subsequent exacerbations 1. In the context of cold weather, there is no specific evidence to suggest that roflumilast is less effective, and its mechanism of action targets the underlying inflammation rather than just treating symptoms, which helps maintain effectiveness across different weather conditions.
- Patients with COPD should continue to take roflumilast as directed, even during cold seasons, to minimize the negative impact of exacerbations and prevent subsequent events 1.
From the FDA Drug Label
The effect of roflumilast tablets 500 mcg once daily on COPD exacerbations was evaluated in five 1-year trials (Trials 3,4,5,6 and 9) Two of the trials (Trials 3 and 4) conducted initially enrolled a population of patients with severe COPD (FEV1 ≤50% of predicted) inclusive of those with chronic bronchitis and/or emphysema who had a history of smoking of at least 10 pack years The rate of moderate or severe COPD exacerbations was a co-primary endpoint in both trials
The efficacy of roflumilast (Daxas) in treating COPD exacerbations is supported by five 1-year trials, with a focus on patients with severe COPD. However, there is no specific information on the efficacy of roflumilast in treating COPD exacerbations associated with cold. 2
From the Research
Efficacy of Roflumilast in Treating COPD Exacerbations
- Roflumilast is a selective phosphodiesterase 4 (PDE4) inhibitor that decreases systemic and pulmonary inflammation and improves disease symptoms in patients with severe chronic obstructive pulmonary disease (COPD) 3.
- It is an effective treatment in patients with moderate to severe COPD, improving lung function and reducing the risk of exacerbation, particularly in patients with more severe disease and/or chronic bronchitis, cough, and sputum 3.
- Roflumilast has been shown to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations 4.
Clinical Benefits of Roflumilast
- Early treatment with roflumilast after hospital or emergency department discharge for a COPD exacerbation can reduce the risk of subsequent exacerbations and rehospitalizations, as well as lower healthcare costs 5.
- Roflumilast can improve forced expiratory volume (1 sec) and reduce COPD-related and all-cause rehospitalizations, outpatient visits, and procedures or therapies 4, 5.
- Combination therapy of roflumilast with long-acting beta agonists can result in reduced COPD exacerbations in patients with severe COPD 4.
Safety and Tolerability of Roflumilast
- Roflumilast is generally well tolerated, with common adverse events including diarrhea, nausea, and psychiatric disturbances 3, 4.
- It may be associated with significant drug-drug interactions with CYP3A4 inducers (strong) and immunosuppressants 4.
- Roflumilast is not associated with an increased risk of respiratory disease and infection, and may decrease the risk of cardiovascular adverse events 3.