Montelukast prescription prevalence and impact on clinical outcomes among patients with asthma: a cross-sectional study in Saudi Arabia
File(s)
Accepted version
Supporting information
Author(s)
Type
Journal Article
Abstract
Background: Although montelukast is widely prescribed as an add-on therapy for asthma management, the current rate of montelukast prescription and its association with clinical outcomes among asthmatic patients in Saudi Arabia are unknown. In addition, the U.S. Food and Drug Administration has recently issued a warning regarding potential serious neuropsychiatric adverse effects associated with montelukast use. Therefore, this study aimed to evaluate the prevalence of montelukast prescription and its impact on clinical outcomes among asthmatic patients in Saudi Arabia.
Methods: A cross-sectional study was conducted among asthmatic patients attending a pulmonary clinic. Clinical and demographic data were obtained from medical records, while anxiety, depression, inhaler adherence, asthma control, and quality of life were assessed using validated questionnaires. Group differences were analyzed using independent t-tests and chi-square tests. Logistic regression analyses were performed to identify factors associated with montelukast use.
Results: A total of 213 patients with asthma were included in the study; 103 were using montelukast, and 110 were not. The prevalence of montelukast prescription was 48%. Anxiety symptoms were higher among montelukast users compared with non-users (44.6% vs 15.5%), as were depressive symptoms (33.0% vs 11.0%). Montelukast use was significantly associated with increased odds of anxiety symptoms (aOR 4.1, 95% CI 2.01–8.45; P < 0.0001) and depressive symptoms (aOR 4.3, 95% CI 1.92–9.86; P < 0.0001). However, adherence to inhalers, asthma control, and quality of life were not significantly associated with montelukast use.
Conclusion: Montelukast prescription was common among asthmatic patients in Saudi Arabia and was associated with higher levels of anxiety and depressive symptoms. Clinicians should consider monitoring psychological symptoms in patients receiving montelukast, and prospective longitudinal studies are needed to further evaluate its psychiatric safety profile.
Methods: A cross-sectional study was conducted among asthmatic patients attending a pulmonary clinic. Clinical and demographic data were obtained from medical records, while anxiety, depression, inhaler adherence, asthma control, and quality of life were assessed using validated questionnaires. Group differences were analyzed using independent t-tests and chi-square tests. Logistic regression analyses were performed to identify factors associated with montelukast use.
Results: A total of 213 patients with asthma were included in the study; 103 were using montelukast, and 110 were not. The prevalence of montelukast prescription was 48%. Anxiety symptoms were higher among montelukast users compared with non-users (44.6% vs 15.5%), as were depressive symptoms (33.0% vs 11.0%). Montelukast use was significantly associated with increased odds of anxiety symptoms (aOR 4.1, 95% CI 2.01–8.45; P < 0.0001) and depressive symptoms (aOR 4.3, 95% CI 1.92–9.86; P < 0.0001). However, adherence to inhalers, asthma control, and quality of life were not significantly associated with montelukast use.
Conclusion: Montelukast prescription was common among asthmatic patients in Saudi Arabia and was associated with higher levels of anxiety and depressive symptoms. Clinicians should consider monitoring psychological symptoms in patients receiving montelukast, and prospective longitudinal studies are needed to further evaluate its psychiatric safety profile.
Date Acceptance
2026-06-08
Citation
Journal of Asthma and Allergy
ISSN
1178-6965
Publisher
Dove Medical Press
Journal / Book Title
Journal of Asthma and Allergy
Copyright Statement
Copyright This paper is embargoed until publication. Once published the Version of Record (VoR) will be available on immediate open access.
License URL
Publication Status
Accepted