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Comparative effectiveness of budesonide/formoterol combination and tiotropium bromide among COPD patients new to these controller treatments.

Trudo F, Kern DM, Davis JR, Tunceli O, Zhou S, Graham EL, Strange C, Williams SA - Int J Chron Obstruct Pulmon Dis (2015)

Bottom Line: The Cox proportional hazards model for time to first exacerbation yielded a hazard ratio (HR) of 0.78 (95% CI =[0.70, 0.87], P<0.001), indicating a 22% reduction in risk of COPD exacerbation associated with initiation of BFC versus tiotropium.A post hoc sensitivity analysis found similar effects in those who had a prior asthma diagnosis (HR =0.72 [0.61, 0.86]) and those who did not (HR =0.83 [0.72, 0.96]).BFC initiation was associated with lower COPD-related health care resource utilization and costs ($4,084 per patient-year compared with $5,656 for tiotropium patients, P<0.001).

View Article: PubMed Central - PubMed

Affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA.

ABSTRACT

Background: Inhaled corticosteroid/long-acting β2-agonist combinations and/or long-acting muscarinic antagonists are recommended first-line therapies for preventing chronic obstructive pulmonary disease (COPD) exacerbation. Comparative effectiveness of budesonide/formoterol combination (BFC, an inhaled corticosteroid/long-acting β2-agonist combination) vs tiotropium (long-acting muscarinic antagonist) in the US has not yet been studied.

Methods: Using US claims data from the HealthCore Integrated Research Environment, COPD patients (with or without comorbid asthma) ≥40 years old initiating BFC or tiotropium between March 1, 2009 and February 28, 2012 and at risk for exacerbation were identified and followed for 12 months. Patients were propensity score matched on demographics and COPD disease severity indicators. The primary outcome was time to first COPD exacerbation. Secondary outcomes included COPD exacerbation rate, health care resource utilization, and costs.

Results: The Cox proportional hazards model for time to first exacerbation yielded a hazard ratio (HR) of 0.78 (95% CI =[0.70, 0.87], P<0.001), indicating a 22% reduction in risk of COPD exacerbation associated with initiation of BFC versus tiotropium. A post hoc sensitivity analysis found similar effects in those who had a prior asthma diagnosis (HR =0.72 [0.61, 0.86]) and those who did not (HR =0.83 [0.72, 0.96]). BFC initiation was associated with lower COPD-related health care resource utilization and costs ($4,084 per patient-year compared with $5,656 for tiotropium patients, P<0.001).

Conclusion: In COPD patients new to controller therapies, initiating treatment with BFC was associated with improvements in health and economic outcomes compared with tiotropium.

No MeSH data available.


Related in: MedlinePlus

Exacerbation rates, counting all exacerbations during the post-index period.Notes: Exacerbation rates allowing for multiple exacerbations during the 1-year follow-up period, overall and by exacerbation type.Abbreviations: COPD, chronic obstructive pulmonary disease; ED, emergency department; OCS, oral corticosteroid; BFC, budesonide/formoterol combination; CI, confidence interval.
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f3-copd-10-2055: Exacerbation rates, counting all exacerbations during the post-index period.Notes: Exacerbation rates allowing for multiple exacerbations during the 1-year follow-up period, overall and by exacerbation type.Abbreviations: COPD, chronic obstructive pulmonary disease; ED, emergency department; OCS, oral corticosteroid; BFC, budesonide/formoterol combination; CI, confidence interval.

Mentions: Initiation of BFC compared with tiotropium was also associated with reduced exacerbation rates (BFC =1.23 per patient-year, tiotropium =1.50 per patient-year, rate ratio (RR) =0.82 [0.73, 0.91]). Evaluation of exacerbation rates by type of exacerbation event showed fewer exacerbations for BFC: COPD-related ER visits (RR =0.76 [0.60, 0.95]), COPD-related outpatient visits plus antibiotic and/or OCS (RR =0.83 [0.73, 0.94]), and COPD-related inpatient hospitalizations (RR =0.80 [0.59, 1.09]) (Figure 3). In the sensitivity analysis, the interaction between a prior asthma diagnosis and index medication on the primary outcome was not found to be statistically significant (P=0.176), and the direction of results by asthma status was consistent with the primary analysis result. The rate of exacerbation was reduced in individuals initiating BFC compared with tiotropium for those with asthma (RR =0.75 [0.63, 0.89]) and without (RR =0.88 [0.76, 1.02]), although the effect was no longer statistically significant in the latter group.


Comparative effectiveness of budesonide/formoterol combination and tiotropium bromide among COPD patients new to these controller treatments.

Trudo F, Kern DM, Davis JR, Tunceli O, Zhou S, Graham EL, Strange C, Williams SA - Int J Chron Obstruct Pulmon Dis (2015)

Exacerbation rates, counting all exacerbations during the post-index period.Notes: Exacerbation rates allowing for multiple exacerbations during the 1-year follow-up period, overall and by exacerbation type.Abbreviations: COPD, chronic obstructive pulmonary disease; ED, emergency department; OCS, oral corticosteroid; BFC, budesonide/formoterol combination; CI, confidence interval.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4592033&req=5

f3-copd-10-2055: Exacerbation rates, counting all exacerbations during the post-index period.Notes: Exacerbation rates allowing for multiple exacerbations during the 1-year follow-up period, overall and by exacerbation type.Abbreviations: COPD, chronic obstructive pulmonary disease; ED, emergency department; OCS, oral corticosteroid; BFC, budesonide/formoterol combination; CI, confidence interval.
Mentions: Initiation of BFC compared with tiotropium was also associated with reduced exacerbation rates (BFC =1.23 per patient-year, tiotropium =1.50 per patient-year, rate ratio (RR) =0.82 [0.73, 0.91]). Evaluation of exacerbation rates by type of exacerbation event showed fewer exacerbations for BFC: COPD-related ER visits (RR =0.76 [0.60, 0.95]), COPD-related outpatient visits plus antibiotic and/or OCS (RR =0.83 [0.73, 0.94]), and COPD-related inpatient hospitalizations (RR =0.80 [0.59, 1.09]) (Figure 3). In the sensitivity analysis, the interaction between a prior asthma diagnosis and index medication on the primary outcome was not found to be statistically significant (P=0.176), and the direction of results by asthma status was consistent with the primary analysis result. The rate of exacerbation was reduced in individuals initiating BFC compared with tiotropium for those with asthma (RR =0.75 [0.63, 0.89]) and without (RR =0.88 [0.76, 1.02]), although the effect was no longer statistically significant in the latter group.

Bottom Line: The Cox proportional hazards model for time to first exacerbation yielded a hazard ratio (HR) of 0.78 (95% CI =[0.70, 0.87], P<0.001), indicating a 22% reduction in risk of COPD exacerbation associated with initiation of BFC versus tiotropium.A post hoc sensitivity analysis found similar effects in those who had a prior asthma diagnosis (HR =0.72 [0.61, 0.86]) and those who did not (HR =0.83 [0.72, 0.96]).BFC initiation was associated with lower COPD-related health care resource utilization and costs ($4,084 per patient-year compared with $5,656 for tiotropium patients, P<0.001).

View Article: PubMed Central - PubMed

Affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA.

ABSTRACT

Background: Inhaled corticosteroid/long-acting β2-agonist combinations and/or long-acting muscarinic antagonists are recommended first-line therapies for preventing chronic obstructive pulmonary disease (COPD) exacerbation. Comparative effectiveness of budesonide/formoterol combination (BFC, an inhaled corticosteroid/long-acting β2-agonist combination) vs tiotropium (long-acting muscarinic antagonist) in the US has not yet been studied.

Methods: Using US claims data from the HealthCore Integrated Research Environment, COPD patients (with or without comorbid asthma) ≥40 years old initiating BFC or tiotropium between March 1, 2009 and February 28, 2012 and at risk for exacerbation were identified and followed for 12 months. Patients were propensity score matched on demographics and COPD disease severity indicators. The primary outcome was time to first COPD exacerbation. Secondary outcomes included COPD exacerbation rate, health care resource utilization, and costs.

Results: The Cox proportional hazards model for time to first exacerbation yielded a hazard ratio (HR) of 0.78 (95% CI =[0.70, 0.87], P<0.001), indicating a 22% reduction in risk of COPD exacerbation associated with initiation of BFC versus tiotropium. A post hoc sensitivity analysis found similar effects in those who had a prior asthma diagnosis (HR =0.72 [0.61, 0.86]) and those who did not (HR =0.83 [0.72, 0.96]). BFC initiation was associated with lower COPD-related health care resource utilization and costs ($4,084 per patient-year compared with $5,656 for tiotropium patients, P<0.001).

Conclusion: In COPD patients new to controller therapies, initiating treatment with BFC was associated with improvements in health and economic outcomes compared with tiotropium.

No MeSH data available.


Related in: MedlinePlus