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Published on: August 7, 2017
Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a
Mir M Ali1, Catherine E O'Brien, Mario A Cleves
1Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Insights
This study found no consistent significant link between montelukast and neuropsychiatric events (NE) in children with asthma. Further research is needed to fully understand the montelukast-NE association in pediatric asthma patients.
Area of Science:
- Pediatric Pulmonology
- Child Psychiatry
- Pharmacovigilance
Background:
- Conflicting evidence exists regarding montelukast's association with neuropsychiatric events (NE).
- Understanding this relationship is crucial for managing pediatric asthma.
- Asthma management in children often involves medications like montelukast.
Purpose of the Study:
- To investigate the association between montelukast use and neuropsychiatric events (NE) in children diagnosed with asthma.
- To clarify the safety profile of montelukast concerning neuropsychiatric adverse effects in pediatric populations.
Main Methods:
- A matched nested case-control study utilized a 10% sample of health plan claims data (1998-2009).
- Children under 18 with asthma were identified, and NE cases were defined using psychiatric diagnoses and psychotropic medication use.
- Conditional logistic regression analyzed the association between montelukast exposure (any, recency, duration, dose) and NE, controlling for confounders.
Main Results:
- No consistent significant positive association was detected between montelukast exposure and NE using the broadest case definition (adjusted OR=1.01).
- A moderate chronic cumulative dose of montelukast showed a higher odds of neuropsychiatric disturbances (OR=1.27), while high doses showed a lower odds (OR=0.64).
- A clear dose-response relationship was not observed.
Conclusions:
- The study did not find a consistent significant positive association between montelukast and neuropsychiatric events in children with asthma.
- While some dose-related effects were observed, overall evidence did not support a strong link.
- Further investigation may be warranted to fully elucidate potential risks.
Purpose:
There is conflicting evidence regarding the association between montelukast and neuropsychiatric events (NE). We sought to examine this association among children with asthma.
Methods:
Using a 10% sample of the LifeLink Health Plan Claims data, subjects less than 18 years of age with a primary diagnosis of asthma between 1 January 1998 and 31 December 2009 were identified. A range of case definitions for NE was formulated based on diagnoses of psychiatric disorders and use of psychotropic medications. Using a matched nested case-control design, three controls were matched to each case on age, gender and geographic region, and assigned a matching index date. Exposure to montelukast was measured as any exposure during the year, recency of exposure, cumulative duration of exposure, and cumulative dose. Conditional logistic regression was used to estimate unadjusted and adjusted odds ratio (OR) controlling for potential confounders.
Results:
Using the broadest case definition, 1920 cases were identified. Subjects exposed to montelukast during the prior year had an unadjusted OR of 1.09 (95%CI [0.96, 1.22]) and adjusted OR of 1.01 (95%CI [0.88, 1.14]) for experiencing NE measured using the broadest definition. A clear dose-response relationship was not observed. Exposure to a moderate chronic cumulative dose of montelukast (481 mg-1050 mg) had a higher odds of being diagnosed with neuropsychiatric disturbances (OR = 1.27; 95%CI [1.03, 1.57]) while exposure to high cumulative doses (>1050 mg) had a lower odds (OR = 0.64; 95%CI [0.50, 0.82]).
Conclusions:
These data did not detect a consistent significant positive association between montelukast and NE in children with asthma.
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