CHEST Guidelines-Roflumilast-in-COPD

Roflumilast-in-COPD_chest (1)

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A correspondence published in the CHEST journal discusses the real-world effectiveness and side effects of roflumilast, a treatment for Chronic Obstructive Pulmonary Disease (COPD). Following its introduction to the Irish market, the authors, from Cork University Hospital, conducted a retrospective review of roflumilast's efficacy, side effects, and discontinuation rates among patients. They found that 84% of the 25 patients with moderate to severe COPD who started roflumilast discontinued it after an average of just 3 months. The primary reasons for discontinuation were intolerable side effects (81%) and lack of perceived clinical benefit (19%).<br /><br />These real-world findings contrast sharply with those reported in industry-sponsored trials, where discontinuation rates were significantly lower, between 14% and 20%. Commonly reported side effects among Irish patients included nausea (52%), diarrhea (16%), and vomiting (12%), affecting 72% of participants. The letter highlights a significant disparity between real-world data and figures from controlled trials, suggesting a higher burden of side effects and discontinuations in practice.<br /><br />In a response, the journal acknowledges the letter from Dr. Worndl and colleagues, affirming that these real-world observations are crucial for understanding the actual impact of roflumilast compared to what randomized clinical trials suggest. Similar discrepancies in treatment continuation have been observed in other regions, such as a study from two hospitals in Barcelona, Spain.<br /><br />The correspondence emphasizes the necessity for healthcare providers to carefully weigh the benefits and side effects of roflumilast in treating COPD, considering these substantial real-world findings. Both the observations from Ireland and other independent studies underline the importance of evaluating the clinical management of COPD beyond the scope of controlled environments.

Keywords

roflumilast

Chronic Obstructive Pulmonary Disease

COPD

real-world effectiveness

side effects

discontinuation rates

Cork University Hospital

clinical trials

Ireland

treatment management