Large trials, new knowledge: the changing face of COPD management

Soyza, Anthony De; Calverley, Peter M.A.

doi:10.1183/09031936.00179714

Cited by 24 publications

(18 citation statements)

References 106 publications

(125 reference statements)

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“…In the last decade, a series of large clinical trials have provided the evidence base for current drug treatment of COPD,3–5 and these findings have been incorporated into treatment guidelines 6. These studies resolved many questions about the effect of drugs on individual outcomes.…”

Section: Introductionmentioning

confidence: 99%

Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD

Calverley¹,

Eriksson²,

Jenkins³

et al. 2016

COPD

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Background and objectiveLarge clinical trials have confirmed the long-term efficacy of inhaled corticosteroid/long-acting β2-agonist combinations in patients with chronic obstructive pulmonary disease (COPD). It was hypothesized that significant treatment effects would already be present within 3 months after the initiation of treatment across a range of clinical outcomes, irrespective of COPD severity.MethodsPost hoc analysis of 3-month post-randomization outcomes, including exacerbation rates, dropouts, symptoms, reliever use, and lung function, from three studies with similar inclusion criteria of moderate-to-very-severe COPD. Patients (n=1,571) were treated with budesonide/formoterol (B/F) 320/9 μg or placebo, twice daily; in one study, tiotropium 18 μg once daily was also given.ResultsOver the first 3 months of treatment, fewer patients randomized to B/F experienced exacerbations versus the placebo group (111 and 196 patients with ≥1 exacerbation, respectively). This was true in each COPD severity group. Compared with placebo, B/F treatment led to significantly lower 3-month exacerbation rates in the moderate and severe COPD severity groups (46% and 57% reduction, respectively), with a nonsignificant reduction (29%) in very severe COPD. Fewer dropouts occurred among patients treated with B/F versus placebo, this effect being greater with increasing COPD severity. B/F was associated with improved forced expiratory volume in 1 s, morning peak expiratory flow rate, total reliever use, and total symptom score versus placebo.ConclusionTreatment with B/F decreased exacerbations in patients with moderate-to-very-severe COPD within 3 months of commencing treatment. This effect was paralleled by improved lung function, less reliever medication use, and fewer symptoms, irrespective of disease severity.

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Section: Introductionmentioning

confidence: 99%

Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD

Calverley¹,

Eriksson²,

Jenkins³

et al. 2016

COPD

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“…Efforts should be made to interpret and summarise findings originating from different research approaches, i.e. randomised controlled trials and observational studies, to guide decision-making from both clinical and drug-regulatory perspectives [28,29]. COPD patients with concomitant CVD diseases represent a big everyday challenge for clinicians.…”

Section: Discussionmentioning

confidence: 99%

COPD and bronchodilators: should the heart pay the bill for the lung?

Agabiti¹,

Corbo

2017

Eur Respir J

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@ERSpublications Treatment with bronchodilators in COPD patients should take into account cardiovascular comorbidities http://ow.ly/gMIG30aAwTKCite this article as: Agabiti N, Corbo GM. COPD and bronchodilators: should the heart pay the bill for the lung? Eur Respir J 2017; 49: 1700370 [https://doi.org/10.1183/13993003.00370-2017. The questionThe pharmacological treatment of patients with coexisting cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) is challenging, because some drugs for COPD patients should be used with caution in patients with CVD, and vice versa. The crucial question on cardiovascular safety of long-acting bronchodilators, i.e. long-acting β 2 -agonists (LABAs) and long-acting anti-muscarinic agents (LAMAs, principally tiotropium), has no definitive answer. Because of different mechanisms of action, the combination of these drugs is expected to be more effective than the individual components in the maintenance treatment of COPD [1]. Evidence available from randomised controlled trails and observational studies on increased risk of cardiovascular adverse events is large but difficult to summarise because of complex methodology, different comparison groups and potential bias in each study [2][3][4][5]. Results are controversial and inconclusive. The risks of combining LABAs and tiotropium for the treatment of COPD are still unclear. Whether COPD patients treated with long-acting bronchodilators have increased risk of heart failure, or patients with both COPD and heart failure have higher risk of adverse events, remain open questions. What the study addsIn this issue of the European Respiratory Journal, the study presented by SUISSA et al.[6] interestingly contributes to the ongoing debate. The focus is on the concurrent use of long-acting bronchodilators. A large COPD patient cohort was selected from the UK Clinical Practice Research Datalink for 2002-2012 and followed up over 1 year. Compared with monotherapy, adding a second long-acting bronchodilator (either a LABA or tiotropium) did not increase the risk of myocardial infarction, stroke or arrhythmia. However, a statistically significant 16% increase in the risk of heart failure was found with the addition of a second long-acting bronchodilator rather than monotherapy; the increase was higher (23%) when patients with previous diagnosis of heart failure (about 3% of the whole study population) were excluded. Large numbers from real-world settings, sophisticated analytical approaches and sensitivity analyses led to robust results, considering the known limits of observational studies on the comparative effectiveness and safety of drugs. The fact that the use of two long-acting bronchodilators was found to be safe, in terms of major cardiovascular events, is reassuring and supports the guidelines/recommendations regarding the use of fixed-dose combination bronchodilators. However, the effect on heart failure is relevant and deserves some additional consideration.

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“…After that comes the choice of medical treatment which almost invariably involves the selection of an inhaled bronchodilator. This is a rational thing to do, as impairment in lung mechanics is the basis of much of the symptomatology reported by COPD patients and it can be improved by regular treatment, particularly with bronchodilators . For decades, physicians used regular short‐acting inhaled beta‐agonists and inhaled anti‐muscarinic agents such as ipratropium singly or in combination to try and reduce the symptom burden of COPD and these agents are still recommended as first‐line therapy for patients with minimal or intermittent symptoms .…”

mentioning

confidence: 99%