&amp;ldquo;Real-life&amp;rdquo; inhaled corticosteroid withdrawal in COPD: a subgroup analysis of DACCORD

Vogelmeier, Claus; Worth, H.; Buhl, Roland; Criée, Carl-Peter; Lossi, Nadine S.; Mailänder, Claudia; Kardos, Péter

doi:10.2147/copd.s125616

Cited by 49 publications

(56 citation statements)

References 17 publications

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“…12 Due to safety concerns, in particular the risk of developing pneumonia, several trials have investigated discontinuation of ICS, [13][14][15] including trials with a more "real-life" setting. 16,17 Even with this evidence, while modern guidelines have shifted towards advocating ICS use only in those with a higher exacerbation risk, there still remains little clarity as to who, or how, patients should be stepped down from triple therapy, or switched from LABA-ICS, to LABA-LAMA. In the UK, ICS withdrawal is ostensibly a growing clinical practice that is encouraged in primary care.…”

Section: Introductionmentioning

confidence: 99%

<p>Inhaled Corticosteroid Treatment Regimens and Health Outcomes in a UK COPD Population Study</p>

Bloom¹,

Douglas²,

Usmani³

et al. 2020

COPD

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Background: Inhaled corticosteroids (ICS) are a prevailing treatment option for COPD patients but recent guidelines have relegated their use predominantly to patients with frequent exacerbations. Yet large numbers of patients worldwide are currently treated with ICS-containing regimens. We wished to determine in routine clinical practice how common ICS withdrawal is and the differences in health outcomes between patients managed on ICScontaining and non-ICS containing regimens. Patients and Methods: COPD patients were identified from the UK primary care electronic healthcare records, between 2014 and 2018. Patients were grouped into three treatment regimens: long-acting beta-agonist (LABA) and inhaled corticosteroids (ICS), LABA and long-acting muscarinic antagonist (LAMA), and triple therapy (LABA, LAMA and ICS). Annual incidence of ICS withdrawal was measured. Multivariable logistic regression was used to identify patient factors associated with withdrawal. Multivariable Poisson regression was used to assess the association of exacerbations and hospitalised pneumonia between the ICS-containing regimens (LABA-ICS and triple therapy) and patients prescribed LABA-LAMA. Results: Of 117,046 patients, around three-quarters were prescribed ICS-containing inhalers but ICS withdrawal occurred annually in only approximately 2-3% of patients. Exacerbations in the past year, but not a past history of pneumonia, were associated with ICS withdrawal. A total of 31,034 patients using three treatment regimens (LABA-ICS, LABA-LAMA or triple therapy) were assessed for their relative risk of exacerbations and pneumonia; the exacerbation risk was slightly lower in LABA-ICS users but the same in triple therapy users, as compared to LABA-LAMA users (LABA-ICS adjusted IRR=0.82 (95% CI 0.73-0.93), triple adjusted IRR=0.99 (95% CI 0.88-1.11)). There was no difference in the pneumonia risk (LABA-ICS adjusted IRR=0.96 (95% CI 0.71-1.31), triple adjusted IRR=1.16 (95% CI 0.87-1.57)). Conclusion: Use of ICS-containing inhaled medication is prevalent across the UK while ICS withdrawal from established treatment was relatively uncommon. Exacerbations and pneumonia risk was similar between the ICS-containing and non-ICS containing treatment regimens.

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Section: Introductionmentioning

confidence: 99%

<p>Inhaled Corticosteroid Treatment Regimens and Health Outcomes in a UK COPD Population Study</p>

Bloom¹,

Douglas²,

Usmani³

et al. 2020

COPD

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“…These findings are consistent with the results of the interventional FLAME study, in which patients randomised to receive a LABA/LAMA FDC experienced fewer exacerbations and an improvement in health status compared with those receiving a LABA plus an ICS e although the differences between the groups in mean SGRQ-C total score in FLAME were below the MCID, with fewer than 50% of patients reporting a clinically relevant improvement [16]. The group switching from triple therapy to LABA/LAMA FDC add to the body of evidence on the withdrawal of ICS in the management of COPD, including interventional studies [17,18], observational studies [19], and data from the first cohort of DACCORD [4]. In particular, when comparing the 6 months prior to entry with the 1-year follow-up data there was no increase in the percentage of patients exacerbating.…”

Section: Discussionmentioning

confidence: 99%

“…We have previously reported data from the first cohort of patients, who entered DACCORD following COPD maintenance treatment change or initiation, approximately two thirds of whom started or switched to a treatment regimen including glycopyrronium prior to entry [3e6]. In one of the publications, we described 2-year follow-up data from a subgroup of patients from whom ICS was withdrawn prior to entry [4]. In the current manuscript, we describe data from the second cohort of patients, approximately two thirds of whom either started or switched to a regimen containing a LABA/LAMA fixed-dose combination (FDC) prior to entry.…”

Section: Introductionmentioning

confidence: 99%

GOLD 2017 treatment pathways in ‘real life’: An analysis of the DACCORD observational study

Worth

Buhl²,

Criée

et al. 2017

Respiratory Medicine

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Overall, the results support the GOLD recommendations in suggesting that a switch from a mono-bronchodilator or LABA plus ICS to LABA/LAMA FDC is a valid treatment option for patients with COPD. The results also validate the use of a LABA/LAMA FDC as initial maintenance treatment for COPD, and provide first 'real world' evidence to support the newly added 'step down' recommendation (from triple to LABA/LAMA FDC).

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“…In our study the use of dual bronchodilation with IND/GLY resulted in significant reduction in the use of ICS, indicating the possibility of treatment regimen simplification and reduction of risks associated with ICS use (e.g., pneumonia and fractures). Experience from a real-life study conducted in Germany showed that ICS withdrawal is possible with no increased risk of exacerbations in patients with COPD managed in primary and secondary care [22]. In addition, use of IND and/ or GLY also reduced the need for use of short-acting medicines in every studied group.…”

Section: Discussionmentioning

confidence: 99%

Quality of life of patients with chronic obstructive pulmonary disease treated with indacaterol and/or glycopyrronium: a real-world Polish observational study

Płusa¹

2018

Arch Med Sci Civil Dis

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The aim of this study was to evaluate the impact of routinely administered treatment with indacaterol and/or glycopyrronium on quality of life and level of dyspnoea of patients with chronic obstructive pulmonary disease (COPD) in a real-life setting. Material and methods: It was an observational, non-interventional study in patients with stable, symptomatic chronic obstructive pulmonary disease initiating treatment with indacaterol and/or glycopyrronium as part of routine care. The primary outcomes included a change in quality of life measured using the Clinical COPD Questionnaire (CCQ) and level of dyspnoea evaluated using the modified Medical Research Council scale (mMRC). Patients were followed up for 6 months after initiation of treatment. Results: Analysis included baseline data from 586 patients. At 6 months 82.5% (n = 483) of patients were continuing initiated treatment. Improvement of mMRC and CCQ scores was observed in all treatment arms. The mean total CCQ score ± SD changed after 6 months from 2.2 ±0.9 to 1.2 ±0.9 in the indacaterol group (p < 0.001), from 2.1 ±1.0 to 1.0 ±0.9 (p < 0.001) in the glycopyrronium group and 2.6 ±1.1 at baseline to 1.3 ±1.0 (p < 0.001) in the indacaterol/glycopyrronium group. The mean mMRC ± SD decreased from 2.1 ±0.9 to 1.4 ±0.9 (p < 0.001) in the indacaterol group, from 2.1 ±0.9 to 1.2 ±1.0 (p < 0.001) in the glycopyrronium group, and from 2.3 ±0.8 to 1.4 ±0.9 (p < 0.001) in the indacaterol/glycopyrronium group. Conclusions: Use of indacaterol and/or glycopyrronium improved quality of life and breathlessness in patients with stable COPD, efficiently reducing the symptoms burden.

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“Real-life” inhaled corticosteroid withdrawal in COPD: a subgroup analysis of DACCORD

Cited by 49 publications

References 17 publications

<p>Inhaled Corticosteroid Treatment Regimens and Health Outcomes in a UK COPD Population Study</p>

<p>Inhaled Corticosteroid Treatment Regimens and Health Outcomes in a UK COPD Population Study</p>

GOLD 2017 treatment pathways in ‘real life’: An analysis of the DACCORD observational study

Quality of life of patients with chronic obstructive pulmonary disease treated with indacaterol and/or glycopyrronium: a real-world Polish observational study

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