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Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK

Voorham, Jaco; Roche, Nicolas; Benhaddi, Hicham; van der Tol, Marianka; Carter, Victoria; van Boven, Job F.M.; Bjermer, Leif LU ; Miravitlles, Marc and Price, David B. (2018) In BMJ Open 8(10).
Abstract

METHODS: Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β2-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.

OBJECTIVES: Budesonide/formoterol (BF) Spiromax ® is an inhaled... (More)

METHODS: Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β2-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.

OBJECTIVES: Budesonide/formoterol (BF) Spiromax ® is an inhaled corticosteroid/long-acting β2-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.

RESULTS: Comparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95% CI -0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler® reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.

CONCLUSIONS: Among UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
asthma, budesonide/formoterol, chronic obstructive pulmonary disease, comparative effectiveness research, disease control, inhalation devices
in
BMJ Open
volume
8
issue
10
publisher
British Medical Journal Publishing Group
external identifiers
  • scopus:85055659550
ISSN
2044-6055
DOI
10.1136/bmjopen-2018-022051
language
English
LU publication?
yes
id
346c5a7b-6426-42d8-8792-700faabc20e5
date added to LUP
2018-11-15 10:37:47
date last changed
2019-02-20 11:36:04
@article{346c5a7b-6426-42d8-8792-700faabc20e5,
  abstract     = {<p>METHODS: Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β2-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.</p><p>OBJECTIVES: Budesonide/formoterol (BF) Spiromax ® is an inhaled corticosteroid/long-acting β2-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.</p><p>RESULTS: Comparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95% CI -0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler® reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.</p><p>CONCLUSIONS: Among UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.</p>},
  articleno    = {e022051},
  author       = {Voorham, Jaco and Roche, Nicolas and Benhaddi, Hicham and van der Tol, Marianka and Carter, Victoria and van Boven, Job F.M. and Bjermer, Leif and Miravitlles, Marc and Price, David B.},
  issn         = {2044-6055},
  keyword      = {asthma,budesonide/formoterol,chronic obstructive pulmonary disease,comparative effectiveness research,disease control,inhalation devices},
  language     = {eng},
  month        = {10},
  number       = {10},
  publisher    = {British Medical Journal Publishing Group},
  series       = {BMJ Open},
  title        = {Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK},
  url          = {http://dx.doi.org/10.1136/bmjopen-2018-022051},
  volume       = {8},
  year         = {2018},
}