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

摘要

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. Asthma: checking up on spacer safety A study of spacer devices for use with asthma inhalers shows no significant difference in the incidence of side-effects between licensed and unlicensed spacers. Spacers offer a way of improving the dose inhaled, particularly in children and those adults who struggle to use asthma inhalers correctly. However, non-extrafine beclomethasone dipropionate (like Clenil Modulite) inhalers are frequently co-prescribed with unlicensed Aerochamber spacers rather than the Volumatic spacer which is licensed for this drug. David Price at the University of Aberdeen, UK, and co-workers analysed data from two historical studies to verify whether Aerochamber use enhanced the risk of unpleasant side effects for patients, such as oral thrush or hoarseness. They found no significant difference between licensed and unlicensed spacers and the chances of adverse events, suggesting both are suitable for use with non-extrafine beclomethasone dipropionate inhalers.