Leukotriene Modifiers

To the Editor—

I read with interest the review article on leukotriene (LT) modifiers in pediatric asthma.¹ There are several inconsistencies that deserve attention. On page 387, 2 discordant statements appear: “There are no pediatric studies addressing asthma control in children with mild persistent asthma,” yet the author concludes (p. 387), “LT modifiers can be used as first-line treatment of young wheezy preschool children with mild recurrent symptoms.” In the author’s review of the Knorr study² of moderate to severe asthmatics, Bisgaard states that the “β-agonist was significantly reduced by 0.6 dose per day compared with a 0.2 dose per day in the placebo group.” In Table 2 of the Knorr study, the P value is .08. Further, Bisgaard fails to discuss lack of clinical significance of Knorr’s primary endpoint, forced expiratory volume in 1 second (FEV₁). Knorr established the FEV₁ as the primary endpoint with a planned sample size of 240 children to detect a 7.1% difference in FEV₁ between treatment groups. FEV₁ in the montelukast group was significantly different from placebo, but the difference from placebo achieved was only 4%, not the planned 7.1%. The clinical relevance of a 4% change in FEV₁ in children with a mean baseline FEV₁ of …