Comparison of adverse events associated with different spacers used with non-extrafine beclometasone dipropionate for asthma

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.

Clinical appearance of oral lesions in bronchial asthma patients using inhalation drug

“…22 The use of Inhaled Corticosteroids (ICS) increases the risk of oral candidiasis due to the local immunosuppressant and lack of cleansing function by saliva that provides substances for fungal growth. 23 The use of Dry Powder Inhaler that contains sugar also increases the growth of Candida. 14,22 Candida forms accumulation of desquamated epithelium, candida hyphae, fibrin, and necrotic tissue which provides a clinical appearance as raised white-yellowish plaque.…”

Oral Candidiasis as a Local Adverse Effect of Inhaled Corticosteroids: What the Dental Practitioner Should Know

“…Long-term use of ICs at high doses raises concerns about local and systemic adverse effects (Table 1). Potential adverse effects associated with IC therapy may be systemic as a result of entrance of the drug into the circulation across the lungs and the gastrointestinal tract, or local due to the deposition of the drug which is actively inhaled during administration in the oral cavity and oropharynx (Toogood et al, 1980;Maxwell, 1990;Selroos et al, 1994;Hanania et al, 1995;Roland et al, 2004;Buhl, 2006;Dahl, 2006;Derendorf et al, 2006;Irwin and Richardson, 2006;Rachelefsky et al, 2007;Godara et al, 2011;van Boven et al, 2013;Hejazi et al, 2016;Patil et al, 2016;Ullah et al, 2016;Erdoğan et al, 2019;Ming et al, 2019).…”

“…Table 1. Possible local and systemic adverse effects of inhaled corticosteroids (Data taken and modified from Toogood et al, 1980;Maxwell, 1990;Selroos et al, 1994;Hanania et al, 1995;Roland et al, 2004;Buhl, 2006;Dahl, 2006;Derendorf et al, 2006;Irwin and Richardson, 2006;Rachelefsky et al, 2007;Godara et al, 2011;van Boven et al, 2013;Hejazi et al, 2016;Ullah et al, 2016;Erdoğan et al, 2019;Ming et al, 2019 When inhaled, a substantial part of the dose accumulates in the mouth and pharynx, where it has a high potential for local adverse effects. This deposited dose may be swallowed and afterwards absorbed through the gastrointestinal tract, if not rinsed off the mouth.…”

“…The type and dose of IC used, the frequency of intake, the pharmacokinetic and pharmacodynamic properties, the type of inhaler device, and the compliance of the patient with the instructions for administration are regarded as the factors that determine the frequency of commonly observed local adverse effects of ICs (Toogood et al, 1980;Hanania et al, 1995;Derendorf, 1997;Kennedy et al, 2000;Fukushima et al, 2003;Komiyama et al, 2004;Roland et al, 2004;Buhl et al, 2006;Derendorf et al, 2006;Rachelefsky et al, 2007;van Boven et al, 2013;Dekhuijzen et al, 2016;Hejazi et al, 2016;Erdoğan et al, 2019;Ming et al, 2019).…”

“…Corticosteroids are the most effective and decent agents among anti-inflammatory drugs and play a crucial role in the effective management of asthma since they are able to interfere with several pathways implicated in the process of inflammation (Derendorf et al, 2006;Rachelefsky et al, 2007;Ullah et al, 2016;Ming et al, 2019). This fact causes use of inhaled corticosteroids (ICs) at high doses and for long time periods to a great extent (Maxwell, 1990;Hanania et al, 1995;Lipworth, 1995;Roland et al, 2004;Irwin and Richardson, 2006).…”