CHEST Guidelines-Roflumilast-in-COPD

Roflumilast-in-COPD_chest

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In a recent correspondence to CHEST journal, Dr. Erin Worndl and colleagues presented findings from a retrospective review conducted at Cork University Hospital regarding the use of roflumilast in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Their study, focusing on the real-world application of the drug, revealed higher rates of side effects and treatment discontinuation than those reported in previous industry-sponsored clinical trials.<br /><br />In the retrospective review, 25 patients were prescribed roflumilast, and an alarming 84% discontinued treatment after an average of just three months. The primary reason for discontinuation was intolerance to side effects, reported by 81% of these patients. The most common side effects included nausea (52%), diarrhea (16%), and vomiting (12%). This contrasts sharply with larger studies that reported discontinuation rates ranging from 14% to 20%.<br /><br />The correspondence highlights a vital discrepancy between controlled clinical trial environments and real-world clinical practice. While acknowledging that roflumilast may still hold potential benefits for a subset of patients (notably the 20% who reported symptom improvement and enhanced quality of life), the authors urge careful consideration of the drug's side effect profile in routine clinical settings.<br /><br />Additional real-world data from other institutions, such as a retrospective analysis from two hospitals in Barcelona, Spain, supported these findings. In this analysis, about half of the patients discontinued roflumilast within a year due to side effects, further underscoring the challenges associated with its use outside clinical trials.<br /><br />These insights serve as critical feedback for clinicians considering roflumilast for COPD treatment and underscore the importance of weighing potential benefits against the high likelihood of side effects that could lead to treatment discontinuation.

Keywords

roflumilast

COPD

side effects

treatment discontinuation

real-world study

clinical trials

Cork University Hospital

nausea

retrospective review

Barcelona hospitals