Neuropsychiatric Events Related to Montelukast and Pranlukast in Adults With Asthma and Rhinitis: A 10-Year Nationwide Population-Based Study.

BACKGROUND

Epidemiological studies of neuropsychiatric events (NPEs) associated with leukotriene receptor antagonists (LTRAs) have yielded inconsistent results. Recent studies have demonstrated strong temporal relationships between LTRA prescription and NPE occurrence, indicating a need for further investigation.

OBJECTIVE

To investigate potential LTRA-related NPEs and associated risk factors.

METHODS

Adults with asthma or rhinitis were enrolled from the Korean claims database. The temporal relationship between the first NPE diagnosis and the last LTRA prescription before NPE was evaluated. Nested case-control studies for NPEs and suicide were conducted. Cases (those with NPEs) were matched to controls for age and sex to compare the frequency of LTRA prescription in the lag time before NPE diagnosis. The risk factors for LTRA-related NPEs (developed within 6 months of LTRA prescription) were assessed in people on LTRAs by comparing those with LTRA-related NPEs to those on LTRAs who did not have NPEs.

RESULTS

Montelukast and pranlukast were more frequently prescribed within 6 months before NPEs (odds ratio, 1.31, 95% CI, 1.21-1.41, and odds ratio, 1.25, 95% CI, 1.15-1.35). Older adults, low income, high comorbidity burden, and asthma exhibited stronger associations with LTRA-related NPEs than with general NPEs. Sleep disturbances appeared more prevalent in LTRA-related NPEs than in other NPEs. An LTRA prescription within 6 months was associated with suicide in univariate but not in multivariate analysis.

CONCLUSIONS

Increased neuropsychiatric risk was observed within 6 months after LTRA prescription. LTRA may lower the threshold for NPEs in those at risk for NPEs, irrespective of sex.