CHEST Guidelines-Roflumilast-in-COPD--Response

Roflumilast-in-COPD--Response_chest (1)

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This correspondence in CHEST discusses the real-world experiences with roflumilast, a medication for chronic obstructive pulmonary disease (COPD), comparing them with findings from industry-sponsored trials. Dr. Erin Worndl and colleagues from Cork University Hospital conducted a retrospective study and discovered higher rates of side effects and treatment discontinuation than reported in the trials. Among 25 patients with moderate to severe COPD, 84% discontinued roflumilast after an average of three months, primarily due to side effects like nausea, diarrhea, and vomiting. This contrasts significantly with the 14-20% discontinuation rates reported in larger studies.<br /><br />In response, Dr. Jason Rho and colleagues highlight similar findings from other independent studies, emphasizing discrepancies in side-effect reporting between real-world data and published trials. For example, unpublished FDA data revealed cases of severe diarrhea requiring hospitalization, and unreported increases in psychiatric disturbances such as suicidality. Despite recognizing roflumilast's potential benefits for 20% of patients in improving symptoms and quality of life, these studies suggest a need for further investigation into its tolerability and side effects.<br /><br />The correspondence underlines the difference between the controlled settings of clinical trials and real-world applications, where broader patient populations might experience higher adverse effects. It urges that more independent, larger-scale studies are required for a comprehensive understanding of roflumilast's safety profile, reflecting that independent research may shed light on the true impact of medications, supplementing industry data for balanced healthcare decisions. Both correspondences include disclosures of no conflicts of interest from the authors.

Keywords

roflumilast

COPD

side effects

treatment discontinuation

real-world data

clinical trials

safety profile

independent studies

patient population

healthcare decisions