What is Aflumilast (Zyflo)?

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Last updated: April 7, 2025View editorial policy

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From the Guidelines

Aflumalast is not a recommended treatment for any condition, as it is still an investigational medication and not yet approved by regulatory agencies like the FDA for medical use. The most recent and highest quality study available is from 2023, which discusses the use of roflumilast, a phosphodiesterase-4 inhibitor, in patients with stable COPD 1. According to this study, roflumilast may be considered as an add-on therapy in patients with COPD who have a chronic bronchitic phenotype, are at high risk of exacerbations, and have a moderate to high symptom burden and/or health status impairment despite being on LAMA/LABA/ICS triple combination therapy.

Key Points

  • Aflumalast is an investigational oral medication being developed as a potential treatment for inflammatory conditions.
  • It belongs to the class of phosphodiesterase-4 (PDE4) inhibitors, which work by blocking an enzyme that breaks down cyclic adenosine monophosphate (cAMP), thereby reducing inflammation.
  • The mechanism of action involves increasing intracellular cAMP levels in inflammatory cells, which suppresses the release of pro-inflammatory mediators and cytokines.
  • Until clinical trials are completed and regulatory approval is obtained, healthcare providers cannot prescribe aflumalast for any condition.

Recommendations

  • Patients interested in this medication would need to participate in clinical trials where dosing, safety, and efficacy are being evaluated.
  • Roflumilast, a similar phosphodiesterase-4 inhibitor, may be considered as an add-on therapy in patients with COPD who meet specific criteria, as outlined in the 2023 Canadian Thoracic Society guideline 1.
  • Healthcare providers should follow established treatment guidelines and use approved medications for the management of COPD and other respiratory conditions.

From the Research

Aflumalast

  • There are no research papers to assist in answering this question about Aflumalast, as the provided studies do not mention Aflumalast.
  • The studies provided discuss the effectiveness of combination therapies such as salmeterol/fluticasone and tiotropium in the treatment of chronic obstructive pulmonary disease (COPD) 2, 3, 4, 5.
  • These studies suggest that combination therapies can lead to improved lung function, reduced symptoms, and improved health status in patients with COPD 2, 3, 4, 5.
  • Additionally, one study investigated the anti-inflammatory effects of salmeterol/fluticasone, tiotropium/fluticasone, and tiotropium alone in COPD patients, finding that salmeterol/fluticasone caused a significant reduction in interleukin-8 and matrix metalloprotease-9 in induced sputum 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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