Abstract
We are curious about whether an analysis stratified according to prestudy medication would have altered the findings of Klaus Rabe and colleagues' trial.1 Fewer patients in the placebo group than in the roflumilast 500 μg group took inhaled corticosteroids (17% vs 22%) and inhaled long-acting β2 agonists (13% vs 17%) before study entry. Since both these medications were discontinued at the start of the run-in phase, a greater improvement in FEV1 might have occurred in the roflumilast group. In addition, Rabe and colleagues do not state whether there were any changes in patients' smoking habits during the study—a factor that would also have great influence on the forced expiratory volume in 1 s (FEV1).
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