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PEDIATRICS Vol. 109 No. 1 January 2002, pp. 170-171

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 "ß-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 72% appears to be insignificant, as it . . . [Full Text of this Article]


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