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- W2068683807 abstract "To the Editor .—In their recent Pediatrics article, Garcia Garcia et al1 conclude that montelukast is not inferior to fluticasone in treating mild persistent asthma by using asthma rescue-free days (RFDs) as their primary objective in a 1-year study that involved 6- to 14-year-old patients despite the fact that patients on montelukast had significantly more asthma attacks and required more rescue systemic and/or inhaled corticosteroids. Also, other secondary end points were significantly more improved in the fluticasone group (such as percentage of predicted forced expiratory volume in 1 second [FEV1], days with β-receptor agonist use, and quality of life). The conclusion based on the primary end point (RFDs) is also doubtful. Although the authors calculated the noninferiority interval on the basis of prior studies and before recruitment, the results presented in their Table 2 for asthma RFDs clearly show that there is a statistically significant difference in the favor of fluticasone; the 95% confidence interval of mean difference between groups does not cross 0 (see also their results for FEV1 as percent predicted for comparison).Other problems concerning the study protocol and conclusions that the authors draw from the results are also apparent. There is ample …" @default.
- W2068683807 created "2016-06-24" @default.
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- W2068683807 date "2006-02-01" @default.
- W2068683807 modified "2023-09-25" @default.
- W2068683807 title "Inferiority Complex for a Reason" @default.
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- W2068683807 doi "https://doi.org/10.1542/peds.2005-2495" @default.
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