Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 250 mcg, 500 mcg) |
Drug Class | 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.
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Summary
- 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 Title | Year | Source |
---|---|---|
Daliresp (roflumilast) Prescribing Information. | 2020 | AstraZeneca Pharmaceuticals LP, Wilmington, DE |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The Dosing Strategy to Improve Adherence to Roflumilast in Treatment for Chronic Obstructive Lung Disease: A Systemic Review and Meta-Analysis | 2024 | International Journal of Chronic Obstructive Pulmonary Disease |
Effectiveness of Roflumilast in Treating Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis | 2022 | Cureus |
Interventions to improve adherence to pharmacological therapy for chronic obstructive pulmonary disease (COPD) | 2021 | The Cochrane Database of Systematic Reviews |
Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease | 2020 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. | 2023 | Global Initiative for Chronic Obstructive Lung Disease |
Pocket guide to COPD Diagnosis, Management, and Prevention. | 2023 | Global Initiative for Chronic Obstructive Lung Disease |
2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients with Stable COPD. | 2023 | Canadian Journal of Respiratory, Critical Care, and Sleep Medicine |
Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary. | 2023 | European Respiratory Journal |
Global strategy for prevention, diagnosis and management of COPD. | 2021 | Global Initiative for Chronic Obstructive Lung Disease |
Global initiative for chronic obstructive lung disease: pocket guide to COPD. | 2020 | Global Initiative for Chronic Obstructive Lung Disease |