From the Guidelines
Daliresp (roflumilast) is recommended for patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations to reduce the risk of future exacerbations, as suggested by the European Respiratory Society/American Thoracic Society guideline 1. The standard dose of Daliresp is 500 mcg taken once daily with or without food. Daliresp works as a phosphodiesterase-4 (PDE4) inhibitor, reducing inflammation in the lungs by preventing the breakdown of cyclic AMP, which helps relax airway muscles and reduce inflammation.
Key Points to Consider
- Daliresp is not a rescue medication for acute bronchospasm and should be used as part of a comprehensive COPD management plan that may include bronchodilators.
- Common side effects include diarrhea, weight loss, nausea, headache, back pain, and decreased appetite.
- Patients should be monitored for psychiatric adverse reactions including insomnia, anxiety, and depression, as well as weight loss.
- Daliresp is contraindicated in patients with moderate to severe liver impairment and should be used with caution in patients with a history of depression or suicidal thoughts.
Evidence Supporting the Recommendation
The European Respiratory Society/American Thoracic Society guideline suggests treatment with roflumilast to prevent future exacerbations in patients with COPD with severe or very severe airflow obstruction, symptoms of chronic bronchitis, and exacerbations despite optimal inhaled therapy 1.
Clinical Considerations
- The meta-analysis of three trials demonstrated that roflumilast therapy decreased the number of moderate or severe exacerbations per patient-year and increased time to next exacerbation 1.
- Roflumilast also increased the post-bronchodilator FEV1 and FVC, but was associated with an increased risk of adverse events 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Daliresp Overview
- Daliresp, also known as roflumilast, is a phosphodiesterase 4 inhibitor used for the treatment of chronic obstructive pulmonary disease (COPD) 2, 3, 4, 5, 6.
- It is an oral tablet taken once daily, offering an alternative to inhaler therapy 2.
Efficacy and Safety
- Roflumilast has been shown to improve lung function and reduce exacerbations in patients with severe COPD, especially those with chronic bronchitis and a history of frequent exacerbations 2, 3, 4, 5, 6.
- The most common adverse effects associated with roflumilast are gastrointestinal upset, headache, and weight loss 2, 3, 4, 5, 6.
- Roflumilast has been found to be effective when used concomitantly with bronchodilators and inhaled corticosteroids 5.
Patient Selection
- Roflumilast is approved for the treatment of severe COPD associated with chronic bronchitis and a history of exacerbations 2, 3, 4, 5, 6.
- It is recommended for patients who have not responded adequately to other treatments, such as long-acting bronchodilators and inhaled corticosteroids 4.
Clinical Trials
- Several large, international, multicenter, randomized, placebo-controlled trials have demonstrated the efficacy and safety of roflumilast in patients with COPD 2, 3, 4, 5, 6.
- These trials have shown that roflumilast improves lung function and reduces exacerbations in patients with severe COPD, with the greatest benefits observed in patients with chronic bronchitis and a history of frequent exacerbations 2, 3, 4, 5, 6.