In this interview, Fernando Martinez, MD, MS, chief of the Pulmonary and Critical Care Medicine Division, Weill Cornell Medicine, New York, discusses the 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (COPD).
In November 2022, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) published their 2023 global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (COPD).
In this interview, Fernando Martinez, MD, MS, chief of the Pulmonary and Critical Care Medicine Division, Weill Cornell Medicine, New York Presbyterian, New York, discusses some of the key changes in this edition of the guidelines, which include a new definition of COPD, a new section on tele-rehabilitation, information about adherence and inhaler choice, drug therapy and reductions in mortality, a change in the assessment tool used for grading exacerbations, and more.
What were the most notable updates in the 2023 COPD GOLD report, from your perspective?
This was a significant change in the GOLD therapeutic strategy. There were a series of changes that were really quite significant in this particular version. And so, those included a clarification in the definition, in that during this particular cycle, we altered the definition to include much more explicitly the heterogeneity of the disease, the symptoms that are the most common symptoms, and then trying to emphasize the fact that there are both airway and alveolar peripheral lung disease, peripheral lung manifestations of the disorders, even in the definition, there were changes. There was an additional series of concepts that have gotten a fair amount of traction in the literature right now in the last year, which are proposed nomenclatures for categorization of COPD into multiple different categories—genetically determined, abnormal lung development, and so on. There have been 2 publications, one in the [American Journal of Respiratory and Critical Care Medicine] blue journal and one in The Lancet, that tried to make this argument. So, even with regards to the definition, there were a series of changes that took place. There was the introduction of a concept that many of us have been advocating, which is the concept of pre-COPD, sort of at-risk for COPD, and how that's defined. And so, that's now incorporated into the GOLD documents.
Even in the first chapter of the GOLD document, the therapeutic strategy document, the definition had a significant change. The second major change came in the second chapter, which was the assessment tool that we brought out probably a decade ago, 10 years ago, which was the idea that you categorize patients. You diagnose based on airflow obstruction, but you categorize the patient into grades, into categories I should say, by an assessment of symptoms, symptomatic burden, and risk for exacerbation. And that was the old ABCD quadrant schema that we had generated.
The major change that was made with regards to the assessment is the removal of Category C, which was alow symptom, high risk of exacerbation group. And the merging of groups C and D into a group E, standing for exacerbation prone. And that was done to highlight the importance of exacerbations, the fact that group C didn't seem to be very common in any of the datasets, we thought was probably not appropriate to have that. So, instead of having an A, B, C, D scheme, it became an A, B, E schema. That was a second major change that that took place.
Where does triple therapy fit in the chronic management of COPD?
We made some changes in the pharmacotherapy recommendations, and that’s where this whole issue of triple therapy comes in. There have been 2 large studies, I’ve had the good fortune of being involved in both of them, one supported by GlaxoSmithKline, one supported with AstraZeneca, that compared triple inhaled therapy versus the dual combinations, inhaled corticosteroids (ICS)/ long-acting beta-agonists (LABA), dual bronchodilators in 8 to 10,000 patients, high-risk patients for exacerbation, so these were really very high-risk exacerbation prone individuals.
In both of these studies, the inhaled combination of triple LABA/ LAMA/ICS clearly beat the dual with regards to exacerbation rate, lung function symptoms, and all-cause mortality. And as a result of the fact that we now had evidence that triple-inhaled therapy really did seem to win out in multiple endpoints, the recommendation for steroid-based therapy was to incorporate it in a triple-inhaled format, versus an ICS/LABA. ICS/LABA remained only for those patients in whom there was a significant concern regarding asthma, since that's an early treatment paradigm in the asthma field. So, that was a major change, this issue of removing ICS/LABA from any of the boxes, any of the longitudinal schema, and making a strong recommendation that any steroid-based therapy for a COPD patient should be considered within the construct of a triple regimen.
That's a big change.
There were some other relatively minor changes. So, we emphasize the potential of telerehabilitation since that really became very relevant during the pandemic, because a lot, if not all, the big pulmonary rehab programs closed and tried to transition to remote-based approaches. And so, that was now incorporated with the understanding that the evidence base is still evolving and the best practices are not yet completely characterized, but that there was an important component that related to the potential of using them.
We also made a recommendation that was more emphatic for the use of dual bronchodilators. Before we used to say start with a single and go up to a dual and I think now based on several studies, but clearly most importantly, the EMAX study that compared head-to-head dual bronchodilator with the individual LAMA and LABA and dual clearly won on all of the endpoints. We thought that for a person that is symptomatic, at least Group B, dual bronchodilation was the best first-line agent. I've already made to you the comment regarding the triple versus the ICS/LABA, and we also further strengthened the recommendations regarding the use of eosinophils (EO) to help guide the potential need for inhaled corticosteroid therapy, emphasizing that an EO count greater than 300 clearly does seem to be the clearest separation in most of the endpoints between a steroid and a non-steroid containing regimen.
And so, in the GOLD document, there is a clear recommendation that if your EO is greater than 300, you should consider a steroid-based therapy.
The exacerbation section was changed mostly in introducing the potential of what's called the Rome proposal, which is a proposal that was published in the blue journal by my mentor, another person from Boston, [Bartolome] Celli, who has recommended an alteration in how exacerbations are defined, and that to include a multi-factorial approach, including potential vital signs and biomarkers. That's not been widely accepted yet, but GOLD introduced the potential that something like this would potentially be seen as relevant in the future. So, those really were the major changes that took place.
Where does triple therapy fit in the chronic management of COPD, and who would be a candidate for triple therapy?
For triple therapy, the current recommendation is for a group E person, so an exacerbation-prone individual, particularly if their eosinophil count is greater than 300.
How would that differ for, or who would be a candidate, for dual therapy for an ICS/LABA?
Right now, ICS/LABA is not emphasized anywhere in that GOLD document. And we have a little asterisk that says that ICS/LABA can still be considered in an individual where the principal diagnosis is felt to be asthma. And so, I think we still felt that if you think a person has asthma and you're unsure, and you're sort of following the asthma paradigm you know ICS/LABA can be used in that setting. That's the party line of GOLD.