Real-world evidence for neuropsychiatric safety of leukotriene-receptor antagonists
Published online October 3, 2024
Asthma affects more than 330 million people worldwide, causing substantial global impact. Leukotriene-receptor antagonists (LTRA) have been recommended as an alternative or add-on controller to inhaled corticosteroids (ICS) for treating patients with persistent asthma in the Global Initiative for Asthma guidelines. However, a number of pharmacovigilance studies have sparked concerns related to the potential effects of LTRA use on neuropsychiatric adverse events (NAEs). As such, the US Food and Drug Administration (USFDA) has issued a black box warning in 2020, particularly for montelukast, regarding the risk of serious mental health adverse effects. Current evidence on the comparative safety between LTRA and ICS in real-world settings is limited and inconclusive. Given a rising number of asthma patients worldwide, it is critical to discern the risk of NAEs in relation to LTRA compared to ICS.
In a nationwide cohort study recently published in The Journal of Allergy and Clinical Immunology: In Practice, Yao et al. leveraged the entire medical claims data from the National Health Insurance Research Database of Taiwan to investigate the comparative risk of LTRA versus ICS on seven distinct categories of NAEs among 1,249,897 patients with asthma in a real-world setting.
This study provided real-world evidence that, compared to those receiving ICS, asthma patients receiving LTRA had an increased risk – ranging from 6% to 88% – of NAEs, including psychotic disorders, anxiety disorders, and behavioral and emotional disorders, but not of movement disorders, mood disorders, sleep-related disorders, and personality disorders. These findings highlight the necessity for practicing clinicians to communicate with asthma patients about the potential neuropsychiatric risks associated with LTRA and underscore the importance of vigilantly monitoring neuropsychiatric symptoms during LTRA treatment to ensure patient safety.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.
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