CHEST Guidelines-Roflumilast-in-COPD--Response

Roflumilast-in-COPD--Response_chest

Pdf Summary

The document discusses the real-world efficacy and side effect profile of the drug roflumilast, used for treating chronic obstructive pulmonary disease (COPD). It contains correspondence between researchers sharing their findings and responses by other experts in the field. The primary letter, authored by medical professionals from Cork University Hospital in Ireland, raises concerns about the discrepancies between industry-sponsored trial results and actual clinical experiences. In their retrospective review of 25 COPD patients treated with roflumilast, they found an 84% discontinuation rate largely due to intolerable side effects like nausea, diarrhea, and vomiting, a stark contrast to the 14-20% discontinuation rate reported in larger, controlled studies. They argue that while some patients may benefit from roflumilast, the high side effect burden necessitates caution in its prescription.<br /><br />The response, contributed by Dr. Jason Rho, Dr. Nancy Ho, and Dr. Vinay Prasad, acknowledges the findings from the Cork University team, highlighting similar real-world challenges in different settings, including a study from Barcelona where significant side effects led to high discontinuation rates. They point out that discrepancies exist between trial reports and real-world data, emphasizing that severe side effects and psychiatric issues were downplayed or omitted in industry-sponsored studies. They advocate for nonindustry-sponsored studies to provide more transparent and realistic assessments of roflumilast's safety profile. Both correspondences stress the need for careful consideration of roflumilast's side effects against its potential therapeutic benefits, emphasizing the importance of conducting further independent studies to better understand its real-world impact on patients with COPD.

Keywords

roflumilast

COPD

side effects

clinical trials

discontinuation rate

real-world data

Cork University Hospital

nonindustry-sponsored studies

safety profile

therapeutic benefits