Abstract
Co-prescription of Aerochamber® spacer with non-extrafine beclometasone diproprionate (non-EF BDP) is common but unlicensed. We report a comparison of inhaled corticosteroid (ICS)-related adverse events between patients co-prescribed Aerochamber compared to the licensed Volumatic® spacer. We utilised two historical cohorts: questionnaire-based and electronic medical record (EMR)-based, to assess patient-reported and EMR-recorded adverse events in patients with asthma prescribed non-EF BDP. Marginal effect estimate (MEE) was calculated to determine non-inferiority of Aerochamber compared to Volumatic in terms of patient-reported oral thrush and hoarseness with margin of 0.13. Other patient-reported adverse events (sore throat, bruising, weight gain, and coughing), and EMR-recorded adverse events were also assessed. Rate of patient-reported oral adverse events were non-inferior in 385 patients prescribed Aerochamber compared to 155 patients prescribed Volumatic (27.7 vs 29.9%; MEE, −0.043; 95% CI, −0.133 to 0.047). Total patient-reported adverse events did not differ significantly between Aerochamber and Volumatic (53.3 vs 49.7% with ≥1 adverse event). The EMR-based study of 1471 matched pairs of subjects did not show significantly different number of EMR-recorded adverse events between Aerochamber and Volumatic (12.5 vs 12.8% with ≥1 adverse events). Co-prescribing Aerochamber with non-EF BDP does not increase the risk for patient-reported and EMR-recorded ICS-related adverse events compared to co-prescribing Volumatic.
Highlights
Asthma is a heterogeneous disease characterised by chronic airway inflammation that has a substantial impact on quality of life and healthcare resources
Oropharyngeal adverse events associated with inhaled corticosteroids (ICS) use include oral candidiasis, hoarseness, dysphonia, pharyngitis, and cough reflex.[11–13]
This relationship between risk of oral thrush and the type, dose, and delivery device of ICS has been observed in chronic obstructive pulmonary disorder (COPD) patients.[6]
Summary
Asthma is a heterogeneous disease characterised by chronic airway inflammation that has a substantial impact on quality of life and healthcare resources. ICS treatment has proven to be efficient at improving lung function, decreasing airway hyperresponsiveness, reducing symptoms, frequency, and severity of exacerbations, and improving patient quality of life.[3–5]. Despite their proven efficacy, ICS can cause both oropharyngeal and systemic adverse events.[6–10]. Multiple factors have been reported to contribute to the incidence of oral thrush in patients with asthma, including the type and dose of ICS prescribed, the delivery device used, and patient adherence to medication instructions.[22–24]. Multiple factors have been reported to contribute to the incidence of oral thrush in patients with asthma, including the type and dose of ICS prescribed, the delivery device used, and patient adherence to medication instructions.[22–24] This relationship between risk of oral thrush and the type, dose, and delivery device of ICS has been observed in chronic obstructive pulmonary disorder (COPD) patients.[6]
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