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

Simon Wan Yau Ming, John Haughney, Dermot Ryan, Shishir Patel, Matthias Ochel, Martina Stagno d’Alcontres, Susannah Thornhill, Janwillem W.H. Kocks, David Price*

*Corresponding author for this work

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Article number3
Number of pages8
Journalnpj Primary Care Respiratory Medicine
Volume29
DOIs
Publication statusPublished - 8 Feb 2019

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Beclomethasone
Asthma
Electronic Health Records
Adrenal Cortex Hormones
Oral Candidiasis
Hoarseness
Pharyngitis
Weight Gain
Prescriptions

Keywords

  • METERED-DOSE INHALER
  • CORTICOSTEROID TREATMENT
  • FLUTICASONE PROPIONATE
  • COST-EFFECTIVENESS
  • ORAL CANDIDIASIS
  • REAL-LIFE
  • BECLOMETHASONE
  • EFFICACY
  • SAFETY
  • PRESCRIPTION

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Pulmonary and Respiratory Medicine

Cite this

Comparison of adverse events associated with different spacers used with non-extrafine beclometasone dipropionate for asthma. / Ming, Simon Wan Yau; Haughney, John; Ryan, Dermot; Patel, Shishir; Ochel, Matthias; d’Alcontres, Martina Stagno; Thornhill, Susannah; Kocks, Janwillem W.H.; Price, David.

In: npj Primary Care Respiratory Medicine, Vol. 29, 3, 08.02.2019.

Research output: Contribution to journalArticle

Ming, Simon Wan Yau ; Haughney, John ; Ryan, Dermot ; Patel, Shishir ; Ochel, Matthias ; d’Alcontres, Martina Stagno ; Thornhill, Susannah ; Kocks, Janwillem W.H. ; Price, David. / Comparison of adverse events associated with different spacers used with non-extrafine beclometasone dipropionate for asthma. In: npj Primary Care Respiratory Medicine. 2019 ; Vol. 29.
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abstract = "Co-prescription of Aerochamber {\circledR} 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 {\circledR} 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.",
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AU - Patel, Shishir

AU - Ochel, Matthias

AU - d’Alcontres, Martina Stagno

AU - Thornhill, Susannah

AU - Kocks, Janwillem W.H.

AU - Price, David

N1 - The authors would like to extend their acknowledgement to Dr. Antony Hardjojo for proof-reading this manuscript. This study is funded by Chiesi Limited. All relevant data are within the paper and the supporting information files. The dataset supporting the conclusions of this article was derived from the UK Optimum Patient Care Research Database (www.opcrd.co.uk). We do not have permission to give public access to these databases; however, researchers may request access for their own purposes. Request for access to OCPRD can be made via the OCPRD website (https://opcrd.co.uk/our-database/data-requests/) or via the enquiries email info@opcrd.co.uk.

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N2 - 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.

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KW - ORAL CANDIDIASIS

KW - REAL-LIFE

KW - BECLOMETHASONE

KW - EFFICACY

KW - SAFETY

KW - PRESCRIPTION

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