Roflumilast

(Daliresp®)

Daliresp®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 250 mcg, 500 mcg)
Drug ClassPhosphodiesterase 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.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Roflumilast improved quality of life and reduced inflammation in chronic obstructive pulmonary disease (COPD) patients, with modest improvements in lung function observed, including increases in forced expiratory volume in 1 second (FEV₁) (mean difference (MD) 49.33 mL) and peak expiratory flow (PEF) (MD 6.54 L/min).
  • Dose-adjusted regimens, including dose-escalation and low-dose strategies, led to reduced discontinuation rates compared to standard dosing (relative risk (RR) 0.81 and 0.62, respectively) and showed improved adherence, although other pharmacotherapy changes showed minimal impact on adherence.
  • The likelihood of COPD exacerbation was slightly reduced (odds ratio (OR) 0.78), with no significant impact on hospitalization or exacerbations from changes in pharmacotherapy.
  • The low-dose roflumilast group showed a significantly reduced rate of diarrhea compared to the standard dose group (RR 0.58), and both dose-escalation and low-dose groups had lower discontinuation rates due to adverse reactions.
  • The likelihood of experiencing adverse events was higher in roflumilast users compared to control (OR 1.30), with notable increases in gastrointestinal symptoms such as diarrhea (OR 3.20) and psychiatric adverse events with roflumilast 500 µg (OR 2.13). No significant effect on mortality was observed (OR 0.98).
  • There is no population types or subgroups information available in the reviewed studies.

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