Narrator - Dr. Abel 00:00 Welcome to HelixTalk, an educational podcast for healthcare students and providers, covering real life clinical pearls, professional pharmacy topics and drug therapy discussions. This podcast is Narrator - ? 00:12 provided by pharmacists and faculty members at Rosalind Franklin University, College of Pharmacy. Narrator - Dr. Abel 00:17 This podcast contains general information for educational purposes only. This is not professional advice and should not be used in lieu of obtaining advice from a qualified health care provider. Narrator - ? 00:27 And now on to the show. Dr. Sean Kane 00:31 Welcome to HelixTalk, Episode 159 I'm your host, Dr. Kane, and unfortunately, Dr. Patel is not feeling well. She has lost her voice, so she is not with us today, but we do have a very special guest with us who I will introduce in a second. But the title of today's episode is a breath of fresh air, big changes to the 2023 GOLD guidelines for COPD and I mentioned our special guest here, so I am excited to introduce the audience to Dr. Rachel Neu who is a faculty member here at Rosalind Franklin University College of Pharmacy. Dr. Neu, could you just kind of introduce yourself and tell the audience about who you are? Speaker 1 01:07 Sure thing. My name is Dr. Rachel Neu. I am a clinical assistant professor here at the college. I have a split position, so about 70% of the time I'm actually practicing as an internal medicine pharmacy specialist at Advocate Lutheran General Hospital in Park Ridge, and 30% of the time I am teaching here at the college, primarily in the pharmacotherapy classes and some classes in the pharmacogenomics as well. Dr. Sean Kane 01:32 And of course, we've tapped you for today because you are the lecturer who teaches COPD to our students. So it seems pretty logical that we'll pull you in as a content expert on the topic. Thank you for having me here. Well, Dr. Neu, why don't we get started with a patient case to kind of introduce a typical scenario that a clinician might see, even if they're not a COPD expert, and this would be someone like a 64 year old former smoker who comes to the hospital with their very first severe COPD exacerbation, and we'll say that skipping kind of the acute management, but once that acute management of the exacerbation has been managed, thinking about, how can we get this patient who is either on an as needed inhaler or no inhalers? How can we optimize their COPD regimen so that they are less likely to have a future COPD exacerbation, especially having one that requires hospitalization. So Dr. Neu, why don't we think about that case as we kind of go through a little bit of background on COPD the new guidelines and the update? Could you kind of give us a an overview of what are the COPD guidelines, and how often are they updated? Speaker 1 02:37 Yeah, for sure. So when it comes to COPD management, we have the GOLD guidelines, which stands for Global Initiative for Chronic Obstructive Lung Disease. The keyword here is global, meaning that this is used internationally. It's not specifically designated for just United States use. So you might see some inhaler strengths that we don't commonly see in the United States. The GOLD guideline is updated annually. So just like GINA for asthma and ADA for diabetes, these organizations update guidance yearly, which is why we often consult the GOLD report when managing patients with COPD. Dr. Sean Kane 03:20 I think obviously there's a huge undertaking into updating a guideline every year, but ADA can do it with diabetes. GINA for asthma and GOLD for COPD — I do think that some of the other guidelines out there could maybe take a tip from these organizations that are able to do timely updates when appropriate. And I totally agree. So then the 2023 GOLD guidelines, they came out in November, 2022 so it's kind of like a new car where, like, the year is really in the future. But we call these the 2023 guidelines. And globally, Dr. Neu what is the biggest thing that you think the audience needs to know about these new guideline updates? Speaker 1 03:59 So the guideline itself is very long. It has about 205 pages. Obviously, that's a lot. But I think the main thing that has been updated is we're simplifying how we categorize COPD staging. That's one of the big changes. And there's more emphasis on combination therapy with LABA+LAMA versus regimens that include ICS. Dr. Sean Kane 04:25 And of course, you know, we don't have time in our fairly short podcast episode to go through all of the updates, so we will have a link in our show notes. And actually, right now, the University website is paused for the holiday season, so we won't be able to post it yet, but once it's unpaused in early January, we'll have show notes and things like that with a link to the 205-page guideline document. Listeners are welcome to read every single page in all its glory if they really want to. So Dr. Neu, historically — and this is probably more than a decade ago — the way that we classified COPD, which is still used in some clinical trials, was based on post-bronchodilator FEV1. Could you maybe just explain what that is and why we moved away from that categorization many years ago? Speaker 1 05:12 So like you said, Dr. Kane, FEV1 is the forced expiratory volume in one second — how much you can breathe out in one second. In obstructive disease like COPD, it's like blowing through a straw — you can't move as much air in one second as someone without obstruction. In the past, we used the grade system 1–4 based on FEV1. For instance, an FEV1 of 40% was considered severe. Many trials still use FEV1 for inclusion criteria, but several years ago GOLD moved away from using FEV1 alone because it doesn't capture symptoms, exercise limitation, quality of life, or risk of exacerbation. Dr. Sean Kane 06:15 So then some years ago they moved from the grade 1–4 system to an ABCD classification to capture symptoms, quality of life, and exacerbation risk. Is that correct? Speaker 1 06:45 Correct. It's a combined assessment using symptoms and exacerbation history. Dr. Sean Kane 06:56 How could you go from chatting with a patient about activities of daily living to actually quantifying that for guideline use? Speaker 1 07:10 There are validated questionnaires. One common tool is the COPD Assessment Test (CAT). It's an eight-item questionnaire scored 0–40; a score of 10 or more indicates more significant symptoms. It's more comprehensive than the mMRC because it also captures cough, activity limitations, energy, etc. Dr. Sean Kane 08:02 And Dr. Neu, in clinical trials a longer instrument like the St George's Respiratory Questionnaire is often used, but that's more for research. The CAT is quick and practical in clinic. Speaker 1 08:32 Exactly. It's quick and useful at the bedside. Dr. Sean Kane 08:37 Our patient case is someone who had their first COPD exacerbation and was hospitalized. We want to reduce future exacerbation risk. How many exacerbations is considered high risk? Speaker 1 09:05 Generally, patients are considered high risk if they have had two or more exacerbations in the past year, or any exacerbation requiring hospitalization. A history of exacerbations is the best predictor of future exacerbations. Dr. Sean Kane 09:41 Historically GOLD used groups A–D. Can you walk through how A versus B versus C versus D were defined in the older system? Speaker 1 10:06 Groups A and B were low exacerbation risk: A had fewer symptoms, B had more symptoms. C and D were high exacerbation risk: C had fewer symptoms, D had more symptoms. In 2023 the system was simplified to A, B, and E — the E group (exacerbation) combines former C and D. Dr. Sean Kane 11:14 So A and B remain (low exacerbation risk; A fewer symptoms, B more symptoms). E is high exacerbation risk regardless of symptoms. That categorization drives initial therapy choice. Speaker 1 11:56 Exactly — the categories determine recommended initial therapy, especially for patients naive to maintenance treatment. Dr. Sean Kane 12:53 Before we discuss therapies, let's review the common inhaled bronchodilator drug classes: SABA, SAMA, LABA, LAMA, and ICS — the alphabet soup. Speaker 1 13:24 SABA is short-acting beta agonist (usually albuterol). SAMA is short-acting muscarinic antagonist (usually ipratropium). These are not preferred for maintenance but are used for intermittent symptoms. LABAs are long-acting beta agonists that activate beta-2 receptors to relax bronchial smooth muscle — common examples include salmeterol, formoterol, indacaterol, olodaterol, and arformoterol. Dr. Sean Kane 14:21 And LAMAs are long-acting muscarinic antagonists that block the M3 receptor, also causing bronchodilation. Speaker 1 14:52 The common LAMA agents include tiotropium, umeclidinium, aclidinium, glycopyrrolate, and revefenacin. You'll often see the suffix "-ium" on LAMAs. Dr. Sean Kane 15:10 Inhaled corticosteroids (ICS) are anti-inflammatory; they commonly end in "-asone" or "-onide" (for example, fluticasone or budesonide). ICS are widely used in asthma but are only indicated in select COPD patients because of risks like pneumonia. Speaker 1 15:59 Right. In COPD, ICS is not used as monotherapy and is reserved for patients likely to benefit, such as those with higher blood eosinophil counts. Dr. Sean Kane 16:29 What are the preferred initial therapies by GOLD A/B/E groups in the 2023 update? Speaker 1 16:29 Group A (low exacerbation risk, fewer symptoms): a bronchodilator (short- or long-acting) — long-acting preferred if available and affordable. Group B (low exacerbation risk, more symptoms): LABA+LAMA combination; if only one agent, LAMA may be preferred. Group E (high exacerbation risk — 2+ exacerbations or 1 hospitalization): LABA+LAMA is preferred; consider LABA+LAMA+ICS (triple therapy) if blood eosinophils are elevated (e.g., ≥300 cells/µL), or in selected patients. Dr. Sean Kane 17:40 So LABA+LAMA is the mainstay for most patients except Group A; triple therapy is for selected Group E patients with higher eosinophils or frequent exacerbations. Speaker 1 18:18 Yes — LABA+LAMA for most, triple therapy for selected high-risk patients with elevated eosinophils. Dr. Sean Kane 19:00 Why is ICS use more limited in COPD compared with asthma? Speaker 1 19:37 ICS reduces exacerbations but increases pneumonia risk in COPD. So it's reserved for patients in whom the benefit outweighs the risk — higher eosinophil counts (≥300) identify patients more likely to benefit; 100–300 is a gray zone; avoid ICS if eosinophils are very low or if there is recurrent pneumonia history. Dr. Sean Kane 21:05 Historically products like Advair (fluticasone/salmeterol) and Symbicort (budesonide/formoterol) were used, but GOLD now recommends avoiding ICS+LABA combinations without a LAMA — patients who need ICS should be on triple therapy instead. Speaker 1 21:38 Correct. LAMA is superior to LABA for exacerbation prevention, and LABA+LAMA is better than monotherapy for symptoms, so patients who would previously have been on ICS+LABA are generally better served with triple therapy when ICS is indicated. Dr. Sean Kane 22:31 Why the enthusiasm for triple therapy? Speaker 1 23:08 Two large randomized trials, IMPACT and ETHOS, studied triple therapy (ICS+LABA+LAMA) versus dual therapies. In appropriate patient populations (frequent exacerbators) triple therapy reduced moderate-to-severe exacerbations by ~15–25% and was associated with reduced all-cause mortality (estimates around 40–50% in certain analyses), although it also increased pneumonia risk. Speaker 1 24:32 ETHOS also compared higher versus lower ICS doses as part of triple therapy; the higher ICS dose arm showed a mortality reduction versus LABA+LAMA, while the lower ICS dose did not demonstrate a statistically significant mortality benefit. Dr. Sean Kane 26:10 What triple-inhaler products are available? Speaker 1 26:28 Two single-inhaler triple therapies are available: Trelegy Ellipta (fluticasone + umeclidinium + vilanterol), which was used in the IMPACT study, and Breztri Aerosphere (budesonide + glycopyrrolate + formoterol), which was used in the ETHOS study. Both can be expensive without insurance. Dr. Sean Kane 27:44 Are there common LABA+LAMA combination inhalers clinicians will see? Speaker 1 30:07 Yes — examples include Anoro Ellipta (vilanterol + umeclidinium), Stiolto Respimat (olodaterol + tiotropium), Bevespi Aerosphere (formoterol + glycopyrrolate), and Duaklir Pressair (formoterol + aclidinium). Dr. Sean Kane 30:37 That's a lot of brand names and devices; pharmacists play a key role in identifying what's on formulary and what's affordable for patients, and in providing inhaler technique education. Speaker 1 33:23 Right — poor inhaler technique can look like treatment failure and lead to unnecessary escalation of therapy. Training and choosing a device the patient can use reliably is critical. Dr. Sean Kane 34:18 Back to our patient case: a 64-year-old hospitalized for a COPD exacerbation — a Group E patient. What's a typical initial regimen? Speaker 1 34:41 At minimum start LABA+LAMA (ideally as a combo inhaler if available for adherence and cost). Obtain blood eosinophils; if elevated, consider triple therapy (LABA+LAMA+ICS) based on the trials and guideline recommendations. Dr. Sean Kane 35:28 So in summary: A, B, and E groups; LABA+LAMA for most patients (except A), and consider triple therapy for Group E patients with elevated eosinophils or frequent exacerbations. Speaker 1 36:06 Exactly. Pharmacists are essential to implement the guideline recommendations, ensure affordability, and teach proper inhaler technique. Dr. Sean Kane 37:36 Well, Dr. Neu, I really appreciate your time. For listeners, once our website is unpaused we'll have show notes with links to the GOLD guidelines and the IMPACT and ETHOS studies. We love five-star reviews in iTunes and we have a mailing list and Twitter feed @HelixTalk for clinical pearls. Thanks again for joining us. Speaker 1 37:36 Thank you for having me here. It's been a pleasure. Narrator - Dr. Abel 38:20 If you enjoyed the show, please help us climb the iTunes rankings for medical podcasts by giving us a five-star review in the iTunes Store. Search for HelixTalk and place your review there. Narrator - ? 38:31 To suggest an episode or contact us, we're online at HelixTalk.com. Thank you for listening to this episode of HelixTalk. This is an educational production copyright Rosalind Franklin University of Medicine and Science.