© 2008 American Thoracic Society
Is Salmeterol/Fluticasone Propionate Equivalent to Tiotropium Bromide in the Treatment of COPD?To the Editor:I read with interest the article by Dr. Wedzicha and colleagues (1) wherein the authors compared clinical efficacy of a 104-week treatment with salmeterol/fluticasone propionate fixed combination (SFC) with a treatment with tiotropium bromide in chronic obstructive pulmonary disease (COPD). However, a few important aspects regarding the severity of COPD in the recruited patients and the interpretation of the results merit further attention. First, the authors included COPD patients with a post-bronchodilator FEV1 < 50% of the predicted normal value. Thus, the study population represents patients with severe–very severe COPD according to the GOLD guideline classification. The rationale for using an alternative classification, which was based on the use of the term "moderate" as comprising COPD stages II and III in the publication on methodology by Seemungal and colleagues (2), is unclear. If any conclusions can be drawn from the study, they only apply to patients with severe–very severe COPD. Second, it is difficult to fathom the statement that the differential withdrawal rate is in itself an indirect marker of treatment efficacy given that Figure 1 for both groups presents virtually identical numbers of patients withdrawing due to lack of efficacy and adverse events (1). Finally, the authors rightfully make a very careful statement about the reduction in mortality in the SFC group compared with tiotropium bromide, since mortality was not a prespecified efficacy endpoint. Therefore, no measures were taken to confirm primary causes of death by an independent clinical endpoint committee (1). It is, however, encouraging to recognize that both treatment regimens resulted in an all-cause mortality which was considerably lower (3–6% in 2 yr) than that reported across all groups of the TORCH trial (12.6–15.2% in 3 yr) (3). This is particularly interesting, since the patient population in the INSPIRE study had more severe COPD than that in TORCH (1, 3) In summary, the real "unexpected finding" of this study is that SFC and tiotropium were equally efficacious with respect to the primary endpoint of exacerbations. This result is even more interesting in a patient population where guidelines recommend that long-acting bronchodilation should be complemented with an inhaled corticosteroid.
St. George Medical Center FOOTNOTES Conflict of Interest Statement: A.G. has received fees for advisory board activities from GlaxoSmithKline (GSK) ($10,500 in 2005, $8,500 in 2006, $9,100 in 2007) and Boehringer Ingelheim ($3,000 in 2005, $3,000 in 2006, $2,700 in 2007); he has received lecture fees from GSK ($7,500 in 2005, $8,000 in 2006, $9,200 in 2007), Boehringer Ingelheim ($2,000 in 2005, $3,500 in 2006, $330 in 2007), and Pfizer ($500 in 2006, $750 in 2007); he has received industry-sponsored grants from Boehringer Ingelheim ($97,000 in 2006 and 2007). REFERENCES
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