Summary

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• Daliresp (roflumilast) is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
• This summary is based on the review of six systematic review(s)/meta-analysis(es). ^[1-5]
• FEV1 Improvement: Roflumilast combined with ICS/LABA significantly increased Forced Expiratory Volume in One Second (FEV1) both before (MD = 46.62, 95% CI [30.69, 62.55]) and after (MD = 45.62, 95% CI [34.95, 56.28]) bronchodilator use in severe COPD patients.
• COPD Exacerbation Rate Reduction: Roflumilast combined with ICS/LABA reduced the COPD exacerbation rate (RR = 0.90, 95% CI [0.87, 0.94], p = 0.001).
• Quality of Life and Mental Health: Limited evidence supports roflumilast's improvement of long-term quality of life in COPD patients, with insufficient evidence to confirm its impact on long-term depression and anxiety.
• Adverse Events: Roflumilast compared to placebo is associated with a higher incidence of adverse events, including diarrhea, headache, nausea, weight loss, back pain, loss of appetite, and insomnia. Mild to moderate adverse effects were common, but no significant severe adverse events were reported.
• PDE4 Inhibitor-Related Reactions: There is an increased incidence of adverse reactions related to PDE4 inhibitors in the roflumilast group, necessitating careful monitoring.
• There is no population type or subgroup information available in the reviewed studies.