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Evidence Roflumilast Reduces Severe Exacerbations?Evidence Roflumilast Reduces Severe Exacerbations? FREE TO VIEW

Timothy Coyle, DO
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From the Department of Pulmonary and Critical Care, University of Connecticut School of Medicine.

Correspondence to: Timothy Coyle, DO, Department of Pulmonary and Critical Care, University of Connecticut School of Medicine, 263 Farmington Ave, MC1321, Farmington, CT 06030; e-mail: Coyle@uchc.edu


Financial/nonfinancial disclosures: The author has 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. 2014;145(2):427-428. doi:10.1378/chest.13-2283
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To the Editor:

In the May 2013 issue of CHEST, Wedzicha et al1 conclude in the abstract section of their article that the reduction in severe exacerbations leading to hospitalization or death associated with roflumilast was similar between subgroups defined as infrequent and frequent exacerbators. This is misleading, as it implies there is a reduction in severe exacerbations associated with roflumilast. The datasets published in this article report the number of patients who experienced infrequent exacerbations (zero or one) or frequent exacerbations (two or more) with roflumilast vs placebo. Although listed as a study end point, there are no data presented illustrating the number of patients experiencing severe exacerbations to support the claim that there is a reduction in severe exacerbations associated with roflumilast. The authors state that in patients defined as frequent exacerbators in the year prior to study, 3.4% in the roflumilast and 6.5% in the placebo group had two or more severe exacerbations after 1 year.1 This approached, but did not reach, statistical difference (P = .0516).1 They do not, however, include severe exacerbation data in the placebo and roflumilast groups at year 0 to support there being a reduction in severe exacerbations at 1 year. From the data presented, all that can be concluded is that there is no difference in the number of frequent exacerbator phenotype patients who experience two or more severe exacerbations while given roflumilast when compared with placebo.

In the pivotal study by Calverley et al2 there was a reduction in the combined end point of moderate/severe exacerbations in roflumilast compared with placebo (1.14 vs 1.37, P < .0003).2 However, a closer look at the data reveals that there was no difference in severe exacerbation rate (0.12 vs 0.15, P = .1334), indicating that the improvement in the combined end point is truly an improvement in the rate of moderate exacerbation alone.2 I believe it is important that the effect of roflumilast on severe exacerbations of COPD be represented accurately by Wedzicha et al,1 as previously published data do not provide evidence that roflumilast prevents severe exacerbations of COPD.

References

Wedzicha JA, Rabe KF, Martinez FJ, et al. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013;143(5):1302-1311. [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

Wedzicha JA, Rabe KF, Martinez FJ, et al. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013;143(5):1302-1311. [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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