Roflumilast

(Daliresp®)

Roflumilast

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Drug updated on 4/10/2024

Dosage FormTablet (oral; 250 mcg, 500 mcg)
Drug ClassSelective phosphodiesterase 4 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.

Summary
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  • Roflumilast (Daliresp) 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. It has been found to enhance lung function significantly when combined with ICS/LABA therapy, although it is associated with a higher incidence of PDE4 inhibitor-related adverse effects such as diarrhea, headache, nausea, weight loss, back pain, loss of appetite, and insomnia.
  • The information was derived from six studies that provided comprehensive analysis on the safety and effectiveness of Roflumilast compared to other treatments for COPD.
  • There is moderate evidence supporting the positive effect of cognitive behavioral therapy on long-term depression in COPD patients; however, limited evidence exists regarding Roflumilast’s effectiveness in improving long-term quality of life or reducing depression/anxiety symptoms among these patients.
  • Despite mild-to-moderate adverse effects, severe adverse events were reportedly rare, suggesting the benefits outweigh its risks. This also highlighted significant improvements in quality-of-life measures along with a reduction in the inflammatory process due to Roflumilast use among COPD patients.
  • Interventions aimed at improving adherence to pharmacological treatments may have low certainty over slight improvements in patient’s quality of life. Changes like different doses or using a single inhaler instead of two had little impact on hospitalizations/exacerbation rates, indicating a need for more effective strategies to improve medication compliance among COPD patients.
  • Oral PDE₄ inhibitors, including Roflumilast, showed a small benefit in enhancing lung function and reducing the likelihood of exacerbations versus placebo, but increased incidences of gastrointestinal side effects, weight loss, and psychiatric symptoms were noted without any impact on mortality rate, making them suitable only as add-on therapies for a persistent symptomatic subgroup despite standard management practices being followed.

Product Monograph / Prescribing Information

Document TitleYearSource
Daliresp (roflumilast) Prescribing Information. 2020AstraZeneca Pharmaceuticals LP, Wilmington, DE

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease.2023Global Initiative for Chronic Obstructive Lung Disease
Pocket guide to COPD Diagnosis, Management, and Prevention.2023Global Initiative for Chronic Obstructive Lung Disease
2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients with Stable COPD.2023Canadian Journal of Respiratory, Critical Care, and Sleep Medicine
Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary.2023European Respiratory Journal
Global strategy for prevention, diagnosis and management of COPD. 2021Global Initiative for Chronic Obstructive Lung Disease
Global initiative for chronic obstructive lung disease: pocket guide to COPD.2020Global Initiative for Chronic Obstructive Lung Disease
Canadian Thoracic Society clinical practice guideline on pharmacotherapy in patients with COPD – 2019 update of evidence.2019Canadian Journal of Respiratory, Critical Care, and Sleep Medicine