© 2007 American Thoracic Society
Hospitalizations with Severe COPDFrom the Authors:We appreciate Dr. Oba's comments on our recent article (1), and we agree that hospitalizations are likely to be the most important single factor with regard to costs related to chronic obstructive pulmonary disease (COPD). In Germany, hospitalizations are responsible for as much as 26% of the total costs of COPD (2). To our knowledge, there are only observational database cohort studies evaluating the effects of inhaled corticosteroids (ICS) on rehospitalization rates in patients that had been hospitalized with an exacerbation. These studies were either negative (3–5) or induced controversial discussions (6). Unfortunately, the effect of combination treatment on hospitalizations was not a predefined outcome in the present study. Nevertheless, the number of hospitalizations was 48 in 487 patients and 34 in 507 patients in the salmeterol and combination therapy group, respectively, showing a nonsignificant trend (p = 0.08) in favor of the combination group. As Dr. Oba points out, this is the first study demonstrating a significantly higher number of suspected cases of pneumonia in patients under ICS treatment (23 versus 7 cases). Since the investigators at the time of the study were not aware of this potential risk of ICS therapy in COPD, it is not surprising that the pneumonias were not suspected to be related to the study drug. This result was replicated in the much larger TORCH study (7). Only 18 out of the 30 pneumonias were considered to be a serious adverse event, 4 in the salmeterol and 14 in the combination group, respectively (p = 0.03). It is worth mentioning that one patient in each group died from pneumonia, and that in both groups 40% of patients with pneumonia and severe COPD had not been assessed as having a serious adverse event. As the adverse event "pneumonia" could be defined by the investigators with a radiograph, it is likely that a considerable number of these events do not represent a classical pneumonia with consolidations on the radiograph, but a distinct form of exacerbations (e.g., with fever and focal rales). Clearly, more research is urgently needed to definitely answer this question.
Maingau Hospital, Frankfurt am Main, Germany
Frankfurt am Main, Germany
Hannover, Germany
Philipps University, Marburg, Germany FOOTNOTES
* M.W. and T.G. were employees of GlaxoSmithKline Germany at the time of the study. Conflict of Interest Statement: P.K. has been reimbursed by Altana, AstraZeneca (AZ), Cefalon, GlaxoSmithKline (GSK), Novartis, and Viatris for attending several conferences; he has participated as a speaker in scientific meetings and courses organized and financed by various pharmaceutical companies (Altana, AZ, Berlin-Chemic, Boehringer Ingelheim [BI], Cefalon, GSK, Novartis, Pfizer). He has served on advisory boards for the following companies: AZ, BI, GSK, Novartis, Pfizer, and has received aggregated honoraria of $12,000 in 2005 from GSK and $11,000 from Novartis. His group has received $14,000, $18,000, and $15,000 in 2003, 2004, and 2005, respectively, from Altana, AZ, GSK, and Novartis as research grants for participating in several multicenter clinical trials. M.W. was an employee of GlaxoSmithKline Germany at the time of the study. T.G. was an employee of GlaxoSmithKline Germany at the time of the study. C.V. has given presentations in the last three years at industry symposia sponsored by Altana, AstraZeneca (AZ), Bayer, Boehringer Ingelheim, GSK, Merck Darmstadt, Novartis, Pfizer, Sanofi Aventis, and Talecris; he also served on advisory boards for Altana, AZ, Bayer, Boehringer Ingelheim, GSK, Pfizer, and Sanofi Aventis; in addition, his institution took part in clinical studies sponsored by AZ, GSK, and Intermune; in 2005, aggregated honoraria and industry sponsored grants comprised $22,000 from Altana, $50,000 from AZ, and $30,000 from GSK. REFERENCES
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