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Published on: August 7, 2017
Neuropsychiatric diagnoses after montelukast initiation in paediatric patients with asthma
Tapio Paljarvi1, Julian T Forton2,3, Courtney Thompson4
1Niuvanniemi Hospital, Kuopio, Finland tapio.paljarvi@niuva.fi.
Insights
Montelukast as an add-on asthma treatment in children and young persons (CYP) was linked to increased neuropsychiatric diagnoses. This includes sleep, anxiety, and mood disorders, highlighting potential risks for this age group.
Area of Science:
- Pediatric Pulmonology
- Child and Adolescent Psychiatry
- Pharmacovigilance
Background:
- Evidence on montelukast's adverse effects in children and young persons (CYP) with asthma is inconclusive.
- Montelukast is often used as an adjunct therapy to inhaled corticosteroids (ICSs).
Purpose of the Study:
- To investigate the 1-year incidence of neuropsychiatric diagnoses following montelukast initiation in CYP with asthma.
- To assess the association between montelukast use and neuropsychiatric outcomes in pediatric asthma patients.
Main Methods:
- A propensity score-matched cohort study using US electronic health records (2015-2019).
- Identified neuropsychiatric diagnoses using ICD-10-CM codes.
- Calculated risk ratios (RRs), absolute risk increase (ARI), and number needed to harm (NNH).
Main Results:
- Montelukast use was associated with a higher incidence of any neuropsychiatric outcome (RR 1.32).
- Excess risk was highest for sleep disorders (RR 1.63), followed by anxiety and mood disorders (RR 1.16 each).
- The 1-year number needed to harm (NNH) for any neuropsychiatric outcome was 58 patients.
Conclusions:
- Adjunct montelukast treatment in CYP with asthma on ICSs was linked to increased neuropsychiatric outcomes.
- Findings suggest a potential association between montelukast and adverse neuropsychiatric events in pediatric asthma patients.
Background:
The evidence base on montelukast-associated adverse outcomes is inconclusive in children and young persons (CYP) with asthma. We aimed to investigate 1-year incidence of neuropsychiatric diagnoses after initiation of montelukast as an adjunct therapy to inhaled corticosteroids (ICSs) in CYP aged 3-17 years with asthma.
Methods:
This propensity score matched cohort study was conducted using electronic health records between 2015 and 2019 in the TriNetX Analytics Network patient repository in the USA. Neuropsychiatric diagnoses were identified using the International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. We estimated risk ratios (RRs), absolute risk increase (ARI) and number needed to harm (NNH) with 95% CIs.
Findings:
The mean age (SD) at index prescription in the 107 384 CYP with asthma was 8.7 (4.0) years (93 461 (87%) mild to moderate asthma; 62 301 (58%) male; 53 485 (50%) white; 33 107 (31%) black/African American). Montelukast was associated with excess incidence of any neuropsychiatric outcome (71 per 1000 persons with montelukast and 54 per 1000 persons with no montelukast; RR 1.32 (95% CI 1.25 to 1.39); ARI per 100 persons, 1.71 (95% CI 1.44 to 1.98); 1-year NNH, 58 patients (95% CI 51 to 69)). The highest excess risk in the montelukast group was for sleep disorders (RR 1.63 (95% CI 1.50 to 1.77); ARI per 100 persons 1.17 (95% CI 1.00 to 1.33); NNH, 85 patients (95% CI 75 to 100)). Montelukast use was also associated with excess incidence of anxiety disorders (RR 1.16 (95% CI 1.08 to 1.24)) and mood disorders (RR 1.16 (95% CI 1.05 to 1.29)).
Conclusions:
In CYP with asthma who were treated with ICSs, adjunct treatment with montelukast was associated with a higher incidence of neuropsychiatric outcomes compared with those who were not exposed to montelukast.
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