Increased Dose of Inhaled Corticosteroid vs. Add-On Long-Acting Beta-Agonist for Step-Up Therapy in Asthma

Elliot Israel, Nicolas Roche, Richard J Martin, Gene Colice, Paul M Dorinsky, Dirkje S Postma, Theresa W Guilbert, Willem Mc van Aalderen, Jonathan Grigg, Elizabeth V Hillyer, Anne Burden, Julie von Ziegenweidt, Victoria Thomas, David B Price

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

RATIONALE: Guidelines advocate adding long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) as the preferred step-up therapy to increasing inhaled corticosteroid dose for patients with uncontrolled asthma on inhaled corticosteroid monotherapy. However, <5% of patients with asthma qualify for the randomized controlled trials on which guidelines are based. Thus, real-world data are needed to complement results of randomized trials with narrow entry criteria.

OBJECTIVES: To compare the effectiveness of stepping up asthma therapy with an increased dose of different types of inhaled corticosteroid as compared with add-on LABA.

METHODS: We performed a historical matched cohort study utilizing large primary care databases to compare asthma step-up therapy with small- and standard size-particle inhaled corticosteroid vs. added LABA for patients 12-80 years old. As outcomes, we examined a composite of asthma control and rates of severe exacerbations.

MEASUREMENTS AND MAIN RESULTS: The odds of asthma control and rates of severe exacerbations over 1 outcome year were comparable with increased inhaled corticosteroid dose vs. added LABA. The adjusted odds ratios (95% CI) for achieving asthma control with increased inhaled corticosteroid dose vs inhaled corticosteroid/LABA were 0.99 (0.88-1.12) for small-particle inhaled corticosteroid (n=3036 per cohort) and 0.85 (0.67-1.07) for standard size-particle inhaled corticosteroid (n=809 per cohort). The adjusted rate ratios (95% CI) for severe exacerbations, compared with inhaled corticosteroid/LABA combination inhaler, were 1.04 (0.91-1.20) and 1.18 (0.92-1.54), respectively. The results were not affected by smoking status.

CONCLUSIONS: When applied to a broad primary care population, anti-inflammatory therapy utilizing increased doses of small- or standard size-particle inhaled corticosteroid is as effective as adding LABA, as measured by outcomes important to both patients and providers. Real-world populations and outcomes need to be taken into consideration when formulating treatment recommendations.

Original languageEnglish
Pages (from-to)798-806
Number of pages9
JournalAnnals of the American Thoracic Society
Volume12
Issue number6
Early online date10 Mar 2015
DOIs
Publication statusPublished - 1 Jun 2015

Fingerprint

Adrenal Cortex Hormones
Asthma
Therapeutics
Particle Size
Primary Health Care
Guidelines
Nebulizers and Vaporizers
Population
Cohort Studies
Anti-Inflammatory Agents
Randomized Controlled Trials
Smoking
Odds Ratio
Databases

Keywords

  • adrenergic β2-agonists
  • antiasthmatic agents
  • bronchodilator agents
  • disease exacerbation
  • glucocorticoids

Cite this

Increased Dose of Inhaled Corticosteroid vs. Add-On Long-Acting Beta-Agonist for Step-Up Therapy in Asthma. / Israel, Elliot; Roche, Nicolas; Martin, Richard J; Colice, Gene; Dorinsky, Paul M; Postma, Dirkje S; Guilbert, Theresa W; van Aalderen, Willem Mc; Grigg, Jonathan; Hillyer, Elizabeth V; Burden, Anne; von Ziegenweidt, Julie; Thomas, Victoria; Price, David B.

In: Annals of the American Thoracic Society, Vol. 12, No. 6, 01.06.2015, p. 798-806.

Research output: Contribution to journalArticle

Israel, E, Roche, N, Martin, RJ, Colice, G, Dorinsky, PM, Postma, DS, Guilbert, TW, van Aalderen, WM, Grigg, J, Hillyer, EV, Burden, A, von Ziegenweidt, J, Thomas, V & Price, DB 2015, 'Increased Dose of Inhaled Corticosteroid vs. Add-On Long-Acting Beta-Agonist for Step-Up Therapy in Asthma', Annals of the American Thoracic Society, vol. 12, no. 6, pp. 798-806. https://doi.org/10.1513/AnnalsATS.201412-580OC
Israel, Elliot ; Roche, Nicolas ; Martin, Richard J ; Colice, Gene ; Dorinsky, Paul M ; Postma, Dirkje S ; Guilbert, Theresa W ; van Aalderen, Willem Mc ; Grigg, Jonathan ; Hillyer, Elizabeth V ; Burden, Anne ; von Ziegenweidt, Julie ; Thomas, Victoria ; Price, David B. / Increased Dose of Inhaled Corticosteroid vs. Add-On Long-Acting Beta-Agonist for Step-Up Therapy in Asthma. In: Annals of the American Thoracic Society. 2015 ; Vol. 12, No. 6. pp. 798-806.
@article{fad539e668714dbda6cc181a65d9088c,
title = "Increased Dose of Inhaled Corticosteroid vs. Add-On Long-Acting Beta-Agonist for Step-Up Therapy in Asthma",
abstract = "RATIONALE: Guidelines advocate adding long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) as the preferred step-up therapy to increasing inhaled corticosteroid dose for patients with uncontrolled asthma on inhaled corticosteroid monotherapy. However, <5{\%} of patients with asthma qualify for the randomized controlled trials on which guidelines are based. Thus, real-world data are needed to complement results of randomized trials with narrow entry criteria.OBJECTIVES: To compare the effectiveness of stepping up asthma therapy with an increased dose of different types of inhaled corticosteroid as compared with add-on LABA.METHODS: We performed a historical matched cohort study utilizing large primary care databases to compare asthma step-up therapy with small- and standard size-particle inhaled corticosteroid vs. added LABA for patients 12-80 years old. As outcomes, we examined a composite of asthma control and rates of severe exacerbations.MEASUREMENTS AND MAIN RESULTS: The odds of asthma control and rates of severe exacerbations over 1 outcome year were comparable with increased inhaled corticosteroid dose vs. added LABA. The adjusted odds ratios (95{\%} CI) for achieving asthma control with increased inhaled corticosteroid dose vs inhaled corticosteroid/LABA were 0.99 (0.88-1.12) for small-particle inhaled corticosteroid (n=3036 per cohort) and 0.85 (0.67-1.07) for standard size-particle inhaled corticosteroid (n=809 per cohort). The adjusted rate ratios (95{\%} CI) for severe exacerbations, compared with inhaled corticosteroid/LABA combination inhaler, were 1.04 (0.91-1.20) and 1.18 (0.92-1.54), respectively. The results were not affected by smoking status.CONCLUSIONS: When applied to a broad primary care population, anti-inflammatory therapy utilizing increased doses of small- or standard size-particle inhaled corticosteroid is as effective as adding LABA, as measured by outcomes important to both patients and providers. Real-world populations and outcomes need to be taken into consideration when formulating treatment recommendations.",
keywords = "adrenergic β2-agonists, antiasthmatic agents, bronchodilator agents, disease exacerbation, glucocorticoids",
author = "Elliot Israel and Nicolas Roche and Martin, {Richard J} and Gene Colice and Dorinsky, {Paul M} and Postma, {Dirkje S} and Guilbert, {Theresa W} and {van Aalderen}, {Willem Mc} and Jonathan Grigg and Hillyer, {Elizabeth V} and Anne Burden and {von Ziegenweidt}, Julie and Victoria Thomas and Price, {David B}",
note = "Copyright {\circledC} 2015 by the American Thoracic Society Supported by an unrestricted grant from Teva Pharmaceuticals Limited (Petach Tikva, Israel) (data acquisition and analyses). Access to data from the Optimum Patient Care Research Database was co-funded by Research in Real-Life Ltd (RiRL). Data were collected and analyzed by the authors in the research team at RiRL, and the first draft of the manuscript was written by one of the authors. Teva played no role in study conduct or analysis and did not modify or approve the manuscript.",
year = "2015",
month = "6",
day = "1",
doi = "10.1513/AnnalsATS.201412-580OC",
language = "English",
volume = "12",
pages = "798--806",
journal = "Annals of the American Thoracic Society",
issn = "2325-6621",
publisher = "American Thoracic Society",
number = "6",

}

TY - JOUR

T1 - Increased Dose of Inhaled Corticosteroid vs. Add-On Long-Acting Beta-Agonist for Step-Up Therapy in Asthma

AU - Israel, Elliot

AU - Roche, Nicolas

AU - Martin, Richard J

AU - Colice, Gene

AU - Dorinsky, Paul M

AU - Postma, Dirkje S

AU - Guilbert, Theresa W

AU - van Aalderen, Willem Mc

AU - Grigg, Jonathan

AU - Hillyer, Elizabeth V

AU - Burden, Anne

AU - von Ziegenweidt, Julie

AU - Thomas, Victoria

AU - Price, David B

N1 - Copyright © 2015 by the American Thoracic Society Supported by an unrestricted grant from Teva Pharmaceuticals Limited (Petach Tikva, Israel) (data acquisition and analyses). Access to data from the Optimum Patient Care Research Database was co-funded by Research in Real-Life Ltd (RiRL). Data were collected and analyzed by the authors in the research team at RiRL, and the first draft of the manuscript was written by one of the authors. Teva played no role in study conduct or analysis and did not modify or approve the manuscript.

PY - 2015/6/1

Y1 - 2015/6/1

N2 - RATIONALE: Guidelines advocate adding long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) as the preferred step-up therapy to increasing inhaled corticosteroid dose for patients with uncontrolled asthma on inhaled corticosteroid monotherapy. However, <5% of patients with asthma qualify for the randomized controlled trials on which guidelines are based. Thus, real-world data are needed to complement results of randomized trials with narrow entry criteria.OBJECTIVES: To compare the effectiveness of stepping up asthma therapy with an increased dose of different types of inhaled corticosteroid as compared with add-on LABA.METHODS: We performed a historical matched cohort study utilizing large primary care databases to compare asthma step-up therapy with small- and standard size-particle inhaled corticosteroid vs. added LABA for patients 12-80 years old. As outcomes, we examined a composite of asthma control and rates of severe exacerbations.MEASUREMENTS AND MAIN RESULTS: The odds of asthma control and rates of severe exacerbations over 1 outcome year were comparable with increased inhaled corticosteroid dose vs. added LABA. The adjusted odds ratios (95% CI) for achieving asthma control with increased inhaled corticosteroid dose vs inhaled corticosteroid/LABA were 0.99 (0.88-1.12) for small-particle inhaled corticosteroid (n=3036 per cohort) and 0.85 (0.67-1.07) for standard size-particle inhaled corticosteroid (n=809 per cohort). The adjusted rate ratios (95% CI) for severe exacerbations, compared with inhaled corticosteroid/LABA combination inhaler, were 1.04 (0.91-1.20) and 1.18 (0.92-1.54), respectively. The results were not affected by smoking status.CONCLUSIONS: When applied to a broad primary care population, anti-inflammatory therapy utilizing increased doses of small- or standard size-particle inhaled corticosteroid is as effective as adding LABA, as measured by outcomes important to both patients and providers. Real-world populations and outcomes need to be taken into consideration when formulating treatment recommendations.

AB - RATIONALE: Guidelines advocate adding long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) as the preferred step-up therapy to increasing inhaled corticosteroid dose for patients with uncontrolled asthma on inhaled corticosteroid monotherapy. However, <5% of patients with asthma qualify for the randomized controlled trials on which guidelines are based. Thus, real-world data are needed to complement results of randomized trials with narrow entry criteria.OBJECTIVES: To compare the effectiveness of stepping up asthma therapy with an increased dose of different types of inhaled corticosteroid as compared with add-on LABA.METHODS: We performed a historical matched cohort study utilizing large primary care databases to compare asthma step-up therapy with small- and standard size-particle inhaled corticosteroid vs. added LABA for patients 12-80 years old. As outcomes, we examined a composite of asthma control and rates of severe exacerbations.MEASUREMENTS AND MAIN RESULTS: The odds of asthma control and rates of severe exacerbations over 1 outcome year were comparable with increased inhaled corticosteroid dose vs. added LABA. The adjusted odds ratios (95% CI) for achieving asthma control with increased inhaled corticosteroid dose vs inhaled corticosteroid/LABA were 0.99 (0.88-1.12) for small-particle inhaled corticosteroid (n=3036 per cohort) and 0.85 (0.67-1.07) for standard size-particle inhaled corticosteroid (n=809 per cohort). The adjusted rate ratios (95% CI) for severe exacerbations, compared with inhaled corticosteroid/LABA combination inhaler, were 1.04 (0.91-1.20) and 1.18 (0.92-1.54), respectively. The results were not affected by smoking status.CONCLUSIONS: When applied to a broad primary care population, anti-inflammatory therapy utilizing increased doses of small- or standard size-particle inhaled corticosteroid is as effective as adding LABA, as measured by outcomes important to both patients and providers. Real-world populations and outcomes need to be taken into consideration when formulating treatment recommendations.

KW - adrenergic β2-agonists

KW - antiasthmatic agents

KW - bronchodilator agents

KW - disease exacerbation

KW - glucocorticoids

U2 - 10.1513/AnnalsATS.201412-580OC

DO - 10.1513/AnnalsATS.201412-580OC

M3 - Article

C2 - 25756308

VL - 12

SP - 798

EP - 806

JO - Annals of the American Thoracic Society

JF - Annals of the American Thoracic Society

SN - 2325-6621

IS - 6

ER -