Ciclesonide inhalation aerosol for persistent asthma.

摘要

A recent issue of this Journal published a report of the combined analysis of 2 studies conducted by Aventis Pharmaceuticals to support marketing approval of ciclesonide inhalation aerosol for asthma in the United States. The authors conclude that ciclesonide at once-daily doses of 80mug, 160 |xg, and 320 mug is effective in the treatment of mild-to-moderate persistent asthma. There are 2 major issues with this article worth noting. First, combining 2 studies post hoc as if they were 1 study and presenting data from the combined analyses is not appropriate. Such analyses, with increased sample size, may show statistical significance for small, potentiallyclinically insignificant differences. Second, the article mentions 2 strata of eligibility for enrollment-patients previously not on inhaled corticosteroids (ICSs) and patients previously maintained on low-to-moderate ICS doses-but results from these 2 strata are not presented. It would have been more appropriate for the authors to present results of the 2 studies separately based on the original analysis plan, and also present the 2 strata of patients from each study separately. This would have allowed the readers to get a better sense of efficacy of once-daily ciclesonide from the studies, analyzed as planned.