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Correspondence |

Roflumilast in COPDRoflumilast in COPD FREE TO VIEW

Erin Worndl, MB; Eoin B. Hunt, MD; Marcus P. Kennedy, MB, FCCP; Michael T. Henry, MB; Barry J. Plant, MB; Desmond M. Murphy, MB, PhD, FCCP
Author and Funding Information

From the Department of Respiratory Medicine, Cork University Hospital.

CORRESPONDENCE TO: Desmond M. Murphy, MB, PhD, FCCP, Department of Respiratory Medicine, Cork University Hospital, Cork, Ireland; e-mail: desmond.murphy@hse.ie


FINANCIAL/NONFINANCIAL DISCLOSURES: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;148(1):e31. doi:10.1378/chest.15-0664
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To the Editor:

We read with interest the Point and Counterpoint editorials in CHEST (May 2014) by Suissa and Rabe1 and Rho et al2 about the appropriateness of industry-sponsored roflumilast trials. In the editorials, reference was made to the level of patient withdrawal as well as to the level of side effects experienced by patients receiving this drug during clinical trials.2 In our real-world clinical experience, we have found both the reported side effect and drug discontinuation rates to be at far higher than reported levels.

Following the initial introduction of roflumilast to the Irish market, we carried out a retrospective review of all patients who received the drug as part of therapy at our institution to document efficacy with particular reference to the adverse events experienced, the discontinuation rate, and the perceived clinical benefit to treatment. Twenty-five patients with moderate to severe COPD were prescribed roflumilast, with 84% discontinuing treatment after a mean of just 3½ months. The most cited reason for stopping treatment was intolerance to side effects (81%), followed by a lack of clinical benefit (19%). Side effects were experienced by 72% of all patients, with nausea (52%), diarrhea (16%), and vomiting (12%) the most common. Our numbers, albeit small, are in stark contrast to the side effect profile reported in larger roflumilast studies in which discontinuation rates of 14% to 20% were reported as opposed to 84% of patients discontinuing treatment in our patient group.3,4

Our findings suggest that roflumilast has a high side effect burden leading to discontinuation of therapy among a majority of patients. Although we recognize that there may be a role for roflumilast in the treatment of COPD (20% of the patients did find an improvement in symptoms and in their quality of life), the decision to treat has to be tempered carefully against the side effect profile associated with it, at least in our real-world findings.

References

Suissa S, Rabe KF. Point: were industry-sponsored roflumilast trials appropriate? Yes. Chest. 2014;145(5):937-939. [CrossRef] [PubMed]
 
Rho J, Ho N, Prasad V. Counterpoint: were industry-sponsored roflumilast trials appropriate? No. Chest. 2014;145(5):939-942. [CrossRef] [PubMed]
 
Rabe KF, Bateman ED, O’Donnell D, Witte S, Bredenbröker D, Bethke TD. Roflumilast—an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2005;366(9485):563-571. [CrossRef] [PubMed]
 
Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009;374(9691):685-694. [CrossRef] [PubMed]
 

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References

Suissa S, Rabe KF. Point: were industry-sponsored roflumilast trials appropriate? Yes. Chest. 2014;145(5):937-939. [CrossRef] [PubMed]
 
Rho J, Ho N, Prasad V. Counterpoint: were industry-sponsored roflumilast trials appropriate? No. Chest. 2014;145(5):939-942. [CrossRef] [PubMed]
 
Rabe KF, Bateman ED, O’Donnell D, Witte S, Bredenbröker D, Bethke TD. Roflumilast—an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2005;366(9485):563-571. [CrossRef] [PubMed]
 
Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009;374(9691):685-694. [CrossRef] [PubMed]
 
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