Comparative Risk of Neuropsychiatric Adverse Events Associated With Leukotriene-Receptor Antagonists Versus Inhaled Corticosteroids.

BACKGROUND

Leukotriene-receptor antagonists (LTRA) and inhaled corticosteroids (ICS) are common controller medications for asthma, but limited studies examine their comparative risks on neuropsychiatric adverse events (NAEs) in patients with asthma.

OBJECTIVE

To investigate the comparative risks of LTRA versus ICS on 7 distinct categories of NAEs in patients with asthma at a nationwide level.

METHODS

We conducted a nationwide cohort study during 2010-2021. Incident NAEs and their clinical subgroups (eg, psychotic disorders, anxiety disorders, movement disorders, behavioral and emotional disorders, mood disorders, sleep-related disorders, and personality disorders) were assessed. Cox proportional hazards regressions were used to quantify the comparative risks.

RESULTS

There were 1,249,897 patients with asthma aged 6 to 64 years. Incidence rates for NAEs were 25.10 per 1000 person-years among patients treated with LTRA and 23.46 per 1000 person-years among those treated with ICS. The incidence rate difference was 1.64 (95% confidence interval [CI]: 0.30-2.98) per 1000 person-years. Positive associations of NAEs and 3 clinical subgroups were found in patients treated with LTRA compared with ICS (hazard ratios [HR]: 1.06 [95% CI: 1.00-1.12] for NAEs; HR: 1.88 [95% CI: 1.24-2.84] for psychotic disorders; HR: 1.10 [95% CI: 1.01-1.20] for anxiety disorders; and HR: 1.27 [95% CI: 1.02-1.58] for behavioral and emotional disorders), but not for movement disorders, mood disorders, sleep-related disorders, and personality disorders.

CONCLUSIONS

This nationwide cohort study identified heightened risks, ranging from 6% to 88%, of NAEs and 3 clinical subgroups in patients with asthma treated with LTRA compared with ICS. These findings underscore the necessity for clinicians to communicate with patients regarding potential neuropsychiatric harms when prescribing LTRA.