Updates in the Management of COPD: Best Practices and Emerging Therapeutic Options

Course Director

Antonio R. Anzueto, MD

Antonio R. Anzueto, MD
Professor of Medicine
University of Texas
Health Science Center at San Antonio
San Antonio, Texas


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Part 1 of a 2-part series

Dr. Anzueto provides expert feedback to the questions submitted by your peers during a recent survey on this topic.

Overview

Current evidence-based, best-practice recommendations for the management of chronic obstructive pulmonary disease (COPD) are intended to be a core resource for physicians involved in the care of patients with this disorder. The latest update to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) document addresses the growing complexity of managing patients with COPD, and reflects the need for individualization of care. In applying these recommendations to patient care, clinicians will have greater flexibility in establishing treatment goals as well as selection of therapy, which may now include multiple agents.


Disclosures

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Novartis Pharmaceuticals Corporation.
Additional support provided by Penn State College of Medicine and Answers in CME.

Course Director
Antonio R. Anzueto, MD, has a financial interest/relationship or affiliation in the form of:
Consultant for Boehringer Ingelheim Pharmaceuticals, Inc.; Forest Laboratories, Inc.; GlaxoSmithKline; and Novartis Corporation.
Grant/Research Support from GlaxoSmithKline.
Medical Director
Kadrin Wilfong, MD
Answers in CME, Inc.
Kadrin Wilfong, MD currently has no financial interests/relationships or affiliations in relation to this activity.

Answers in CME staff who may potentially review content for this activity have disclosed no relevant financial relationships.

Penn State College of Medicine staff and faculty involved in the development and review of this activity have disclosed no relevant financial relationships.

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Could you please explain the new staging system that is currently recommended for patients with COPD by the revised GOLD classification?

Dr. Anzueto: Certainly; the new GOLD recommendations for COPD have clearly changed in the way we evaluate these patients. And I would recommend to take into consideration not only disease severity assessed by lung function, but also patient symptoms and history of exacerbations.

The initial GOLD document published almost 10 years ago was using lung function (FEV1) to stage the severity of the disease, but this approach only captures one component of COPD severity. A significant percentage of patients have preserved lung function—they are in the moderate range, FEV1s around 60%—[but] they also are symptomatic. If we only assess COPD by spirometry, we will miss this large number of patients. The current spirometric criteria for airflow limitation remain the post-bronchodilator FEV1 and the fixed ratio of FEV1/FVC <70%. And we should emphasize the need to do a spirometry to diagnose this condition. Other aspects of the disease, like severity of symptoms, risk of hospitalizations, and presence of comorbid conditions are very important and are taken into consideration in the new staging system.1

We are now viewing the COPD in a more global way. The fact that we take symptoms that may have impact [on] the patient's quality of life into consideration, and also future events like exacerbations, is going to change the approach to our patients; and the objective is to improve the quality of life and their overall performance. This implies that in our practice, we have to change the way to assess our patients.

First, symptoms cannot be assessed just [by] asking the patients; so it's recommended to use objective tools like the CAT—or the COPD assessment test—the dyspnea scale, the Medical Research Council [MRC] Questionnaire, [or] any tools that you want to use as a healthcare provider to get an objective assessment of how the patient's symptoms are limiting his or her function. 2-5

And then we need to ask our patients about exacerbations and hospitalizations in order to understand that the exacerbations they may have are not day-to-day variations in their symptoms. We now know that having frequent exacerbations, especially the history of previous events, are predictors of future events, so it's very important to identify the patients who are having exacerbations that put them at risk to require hospitalizations.1

So in the new GOLD system, patients are going to be divided—taking into consideration all these factors—in[to] four categories:

  • Category A. Those are low-risk patients, less symptomatic. We used to name them the GOLD 1 or [GOLD] 2 (mild to moderate airflow limitation). They have 0 to 1 exacerbation per year, and their [m]MRC score is 0 to 1 or their CAT score is <10.
  • But patients in Category B, although have the same low risk and fall in the same category on spirometry, these patients have higher scores in the mMRC, >2, or the CAT score is >10.
  • Category C [patients] are high-risk patients that have less symptoms. These are going to be the GOLD 3 and [GOLD] 4, [with] severe and very severe airflow limitation. They're having >2 exacerbations a year or >1 hospitalization, but their [m]MRC grade [is] still low, 0-1 or the CAT score is <10.
  • While [patients] in the Category D, they are going to be high risk. They're having frequent exacerbations and hospitalizations, but they are also more symptomatic.

So you can appreciate if we put all these elements together, we will [be] able to identify a group of patients that have more or less severe disease and to customize the therapy based on their needs.

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Can you please walk through the current guideline recommendations for how to approach the treatment selection for the different subcategories of patients identified through the recommended assessment process? What therapeutic implications do the have—how could we try to incorporate them in making some type of a treatment decision?

Dr. Anzueto: As outlined in the response in the prior question, the combined assessment of patient's symptoms, severity of lung function, of exacerbations, will identify these A, B, C, and D groups. Now the GOLD recommendations [are that] first we need to reduce patients' overall risk, so we must remember that smoking cessation, vaccination, and regular exercise are pivotal interventions in COPD patients.

For patients in Category A, the use of [a] short-acting bronchodilator as needed is indicated. On the other hand, if the patient remains symptomatic or more frequently symptomatic, we should start using long-acting bronchodilators, either LABAs or LAMAs.

Now if despite this combination patients become more symptomatic, they fall in Category B, so we will combine both bronchodilators. And in patients in Group B and C, they are already symptomatic and/or having frequent exacerbations. The combination of LABAs, plus ICS and LAMAs are going to be necessary, first to reduce risk of exacerbations and second to improve the patient's symptoms. If these patients continue to have frequent exacerbations and they are in Category B, we should consider, in the subgroup of individuals who have chronic bronchitis, the use of roflumilast or phosphodiesterase [PDE-4] inhibitor.1

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What is the status of development and latest clinical trial data on the efficacy and safety of the combined dual LABA/LAMA inhalers in COPD?

Dr. Anzueto: I want to remind you that the pivotal abnormality in COPD is airway obstruction. So our therapeutic interventions need to provide sustained bronchodilatation, and clinical studies have shown that if we can provide clinical sustained bronchodilatation, this translates into decreased hyperinflation and improved exercise capacity.

So the combination of bronchodilators, LABAs or LAMAs, which work through different pathways, are providing significant enhancement as each of the mono components. The rationale for this is, because they work through different pathways, [they] are going to be more effective in improving lung function, as well as symptoms.6,7 Many years ago, we had the experience of fixed combinations with short-acting bronchodilators, that this was shown before this improvement over the mono component,8 but the problem that we have, these medications only work for 4 to 6 hours. So in the last year or so, there have been significant advances in the development of fixed combinations of long-acting beta2 agonists and long-acting anticholinergics as a fix in a single inhaler.

There is one medication that was approved by the FDA late last year. This is a combination of umeclidinium with vilanterol for once-daily long-term maintenance treatment of airflow obstruction in patients with COPD. And there are several other medications under development. So our patients on a single inhaler device will be able to take both medications, and the extent of the clinical trials clearly demonstrates that there is enhanced efficacy as either medication given alone.

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References

  1. From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. Available from: http://www.goldcopd.org/.
  2. Jones PW et al. BMC Pulm Med. 2011;11:42.
  3. Kelly JL et al. Respiration. 2012; 84:193-199.
  4. van der Molen T et al. Health Qual Life Outcomes. 2003; 1:13.
  5. COPD Assessment Test (CAT). http://www.catestonline.org.
  6. Feldman GJ, Edin A. Ther Adv Respir Dis. 2013;7:311-319.
  7. Tashkin DP, Ferguson GT. Respir Res. 2013;14:49.
  8. Campbell S. Arch Intern Med. 1999;159:156-160.

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This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Novartis Pharmaceuticals Corporation.
Additional support provided by Penn State College of Medicine and Answers in CME.

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Q&A: How to Apply the Latest Evidence and Recommendations to Practice to Improve the Treatment of Patients With COPD

  1. Answers to Common Challenges in the Management of Patients With COPD