Background: Inhaled corticosteroids (ICS) have an essential and established role in the treatment of asthma. Both systemic and local adverse effects may accompany the long-term use of ICS. Systemic adverse drug reactions (ADRs) of ICS are well established. However, there is a paucity of information on local ADRs, especially in the Indian population.
Objectives: This study aimed to determine the prevalence, severity, predictability, and preventability of local ADRs to ICS and their associated risk factors.
Methods: Patients with asthma who need ICS were enrolled. Study patients were interviewed with open-ended questions to assess local ADRs to ICS at baseline and each follow-up visit, once a month for three months. Causality (Naranjo’s algorithm and WHO scale), severity (Hartwig SC scale), predictability (based on the frequency of occurrence of ADR and history of drug exposure), and preventability (Schumock and Thornton criteria) of local ADRs were assessed. Bivariate analysis and subsequently multivariate logistic regression were used to identify the risk factors for local ADRs to ICS.
Results: A total of 243 patients (134 female) were included in the study. A total of 74 local ADRs were observed in 59 patients (a prevalence of 24.3%). The most common local ADRs included the feeling of thirst (14.8%), followed by cough during inhalation (8.6%) and taste disturbance (4.5%). All ADRs were predictable and mild in severity. Preventability assessment found 85.1% of local ADRs as ‘probably preventable’. Two out of five patients who had ADRs reduced or skipped doses because of the discomfort, despite their physician’s recommendation to continue their regular dose of ICS. Age >41 years, use of MDI without spacer, and use of budesonide were identified as the risk factors for developing ADRs to ICS.
Conclusion: Local ADRs to ICS were observed in approximately one in four patients with asthma. Two out of five patients who had ADRs reduced or skipped doses. Strategies to prevent local ADRs to ICS should focus on patients aged >41 years, receiving budesonide, and using MDI without a spacer. We need to establish standards on the best practices for preventing ADRs, such as identifying the most suited device or ICS that is best tolerated by the individual patient and identifying the least ICS dose that maintains ideal asthma control.
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