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. Narrator - ? 00:11 This podcast is 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 94 I'm your co host. Dr. Kane, Unknown Speaker 00:34 I'm Dr. Schuman and welcoming Unknown Speaker 00:36 back. Dr. Patel, glad to be back. Dr. Sean Kane 00:38 Glad to have you back. Yeah, looking forward to it. Thank you. Speaker 1 00:41 Excitingly coming back, we're going to talk about the updates in the 2019 Standards of Diabetes Care. And we're going to call this a sweet, sweet taste of annually updated guidelines. And we're going to discuss the 2019 Standards of Care updates, as well as the October 2018 ADA–EASD consensus statement, which the 2019 Standards of Care has woven into its recommendations. Dr. Sean Kane 01:05 And I will say part of this title comes as a slight dig to some of those other guidelines out there that aren't as frequently updated. I'm looking at you stress ulcer prophylaxis, 1999 guidelines. But it's great again that the diabetes guidelines, in addition to COPD and the GINA asthma guidelines, get annual updates. It's a really big deal, and these organizations should be really commended for their hard work. Speaker 1 01:27 Yes, sweet and gold. We can't get better than that. Dr. Sean Kane 01:30 So what are some of the areas that you want to start with? Dr. Patel in terms of what is new with the 2019 update? Speaker 1 01:38 You know, there are a lot of updates provided in this particular guideline, but with the time frame in mind for this recording, we're going to focus on some of the important ones, and kind of getting started quickly. You know, when you're having a patient with diabetes, or you're suspecting that they have diabetes, you know, bring on the diagnosis, right? How do we do that? The bigger emphasis now is placed on proper A1c monitoring. We know there were other tests such as fasting blood glucose or two‑hour postprandial glucose or even CBG, but certain patients (pregnancy/postpartum, hemoglobinopathies, G6PD deficiency) can have altered A1c results. You know people who are on hemodialysis, erythropoietin therapy and all that these patients even sees, have something called variant so the results are not as accurate. So the recommendation is: if fasting blood glucose and A1c results don't match, use an A1c assay certified by the National Glycohemoglobin Standardization Program (NGSP) and standardized to the DCCT assay. Dr. Sean Kane 02:56 Now, just a little bit of background on this. So if I'm in a clinic that does A1c testing, am I already doing an NGSP‑certified A1c assay, or is that a special send‑out? Speaker 1 03:07 I can give you my clinic's example: we run a regular A1c test, but if a clinician suspects that the A1c is inaccurate (because of an underlying condition that biases A1c), we send a specialized assay to determine the exact A1c. Dr. Sean Kane 03:26 is that a unique order in your electronic health record Unknown Speaker 03:29 correct? Yes, it is. So I think another Speaker 2 03:31 thing that's that's interesting about this is the idea about the diagnosis of diabetes being made from two different abnormal test results for the same blood sample. Dr. Todd thought that was really interesting reading. But also tell me a little bit about where that comes from. Speaker 1 03:42 Yeah. Up until last year, they said, you know, you can, you only can diagnose diabetes by confirming two different tests on two different day, and that basically means you need another sample from the patient. I think the providers realize that, and the medical community realize that sometimes there is a lot of gap between that second test patients are lost to follow up. And so now they're saying that you can do two tests from the same sample. And so, for example, you can run two different tests from the same sample — one result 7.0%, the other 6.9% — and call it diabetes. Or if the same sample gives an FBG of ~130 mg/dL and an A1c of 7.0%, that also meets diagnostic criteria. This can be done on different day. If you know the patient is compliant, they're going to follow up and do the test as required, or come to the office visit. But there is no longer that mandate of it needs to be a different sample anymore, Dr. Sean Kane 04:41 and just for clarity, what would be the cut‑offs for an A1c and a fasting blood glucose to meet diagnostic criteria for diabetes? Speaker 1 04:49 So the diagnostic criteria remain the same: an A1c ≥ 6.5% or fasting blood glucose ≥ 126 mg/dL (or a 2‑hour OGTT ≥ 200 mg/dL). But if you are running the two hour oral glucose tolerance test, we're looking for that blood glucose to be either equal to or higher than 200 Dr. Sean Kane 05:13 so I understand that one of the big updates in the 2019 guidelines is a re emphasis of, you know, cardiovascular risk reduction, so prevention of cardiovascular risk. What are some of the things that play a role with that? With the new update Speaker 1 05:27 diabetes guidelines always talked about looking at risk factors for heart disease, and you know, such as having hypertension, family history, etc, they want to now just align themselves with the American Heart Association and American College of Cardiology guidelines that were published. So the big word they're using and utilizing is the ascvd risk score. So now they're recommending that while you're assessing patients for risk of diabetes, you should also throw in the assessment for cardiovascular risk by calculating their ascvd. And if you calculate that, then you can use that answer in also determining the therapy that you should put patient on if they do happen to have diabetes. Dr. Sean Kane 06:10 And I believe this is the first time also these guidelines were also endorsed by the ACC is that correct? Correct? Speaker 1 06:16 The section on the cardiovascular comorbidity, particularly is now endorsed by the American College of Cardiology. Dr. Sean Kane 06:22 It's kind of nice to see different guidelines playing well with each other, right? Speaker 2 06:26 Yeah, I thought it was also interesting too. Is the idea about really delineating some of the risk factors for hypoglycemia, and so they mentioned specifically, some of the medications we think about are sulfonylureas and meglitinides. Meglitinides are less commonly used — examples include repaglinide (Prandin) and nateglinide (Starlix) — and they can cause treatment‑induced hypoglycemia. But they also talked about the duration of the diabetes symptoms, fragility and older age. We think about that fragile or brittle diabetes patient or patient with diabetes, and then also being aware of things that come up a lot in my clinic, is cognitive impairment as that progressive that influences something we talk about in lecture. Dr. Patel is diabetes and cognitive impairment, diabetes and depression of those individuals as time goes on, if there's forgetting doses and then doubling up on it, as well as the polypharmacy, again, potentially leading to that confusion and additive hypoglycemic risk, Speaker 1 07:18 absolutely, you know, think about beta blockers masking the risk symptoms of hypoglycemia and stuff. And I think it was, it was interesting to specifically call out these risk factors, and then it helps clinicians choose better treatment therapy. And as we will look at the treatment decisions too, they have that sort of, quote, unquote second line recommendation for those who are deemed at higher risk of hypoglycemia. Dr. Sean Kane 07:43 Nutrition was another area that also changed with the guideline update, and I understand this deals with both sodium intake as well as sweetened beverage intake, right? Dr. Patel, Speaker 1 07:51 absolutely, you know, first thought was that cut out the sweetened beverages. Obviously, you can cut out the sugars and the calories, you know, help with the late weight loss too. And they said, Yeah, you can go ahead with the artificially sweetened beverages, and that's fine. They're shying away from those as well. This, during these guidelines, you know, there are a lot of meta analysis that have given a clear cut Okay, to the artificial sweeteners, and saying, you know, yes, it helps you preserve some calories, you know, preserve some carbohydrates that are coming in, so go ahead and use it. But then there are other guidelines are actually indicating that artificial sweetener and beverages, or artificial sweeteners themselves, are causing weight gain. So with this new finding, they're saying, You know what, why don't we just go with plain old Dr. Sean Kane 08:38 water, and then also with the sodium restriction. This is something we've talked about with hypertension, with heart failure. And basically, a, any sodium restriction is really hard for patients to be compliant with. And B, there's really a lack of data supporting a specific cut off. So, you know, historically, the sodium restriction was 1500 milligrams per day if you had hypertension and diabetes, it sounds like now they've relaxed that a little bit, right? Speaker 1 09:04 Yeah, they had reverted back to the normal restriction that's recommended for somebody who even doesn't have diabetes, which is back to less than 2300 milligrams per day. Again, not that these people do it, but basically there is no more stringent recommendation on sodium intake and Dr. Patel. Speaker 2 09:20 Another thing I thought was interesting is, you know, we've had definitions like pseudo hypoglycemia, individuals that have a blood sugar above 70, but have symptoms, and then you have hypoglycemia that less than 70. But my understanding that they've kind of delineated again into what hypoglycemia is staging to kind of again mirror other conditions like hypertension. So tell me about that. Speaker 1 09:38 Yeah, I think those guidelines are focusing a lot more on hypoglycemia, and they not only identify the risk factors, treatment associated risk factors, as we discussed earlier, but define hypoglycemia a little bit better. And I think this is kind of in alignment with some of the clinical trials. They're using different levels of hypoglycemia. So we have our run of the mill, level one hypoglycemia. We call it blood sugar of less than 70 but now there is a bottom cut off that is a blood sugar of between 70 and 54 is basically considered level one. Level two is considered a blood glucose of less than 54 and level three is almost like your severe type of hypoglycemia, where you know, extreme events can happen requiring assistance due to altered mental status or altered physical status, and which can even result to, you know, ER visit or hospitalization as well. Dr. Sean Kane 10:35 One hotter topic in diabetes management is some of the technology involved. So I'd assume that every year for probably the next many years, we're going to see updates regarding the use of this technology, its safety and efficacy and things like that. So where do these 2019, guidelines lie with some of this new, newer technology? Speaker 1 10:52 You know, this is really exciting as many as gadgets and devices and apps that are approved by FDA to do clinical health monitoring. This section was long of eight, and we were aware of lot of different devices that I just mentioned, but they created a specific section along with recommendations. Call it diabetes technology, and this includes recommendations and discussion about various medication delivery devices. Blood Glucose Monitors, continuous blood glucose monitors, but some of them are like the real time, some of them are like the flash technology type, and then insulin pumps as well. And one of the new continuous blood glucose monitor that is using the flash technology, and that's actually been promoted very well in the market too, is the Libre system from Abbott, and that was a big deal. I've had so many patients in the clinic asking me, you know, hey, I'm a patient of type two diabetes. Do you think my insurance will cover it? Well, it depends, you know, if you're on rigorous monitoring, because you're you have type two or you're on intensive insulin therapy, your insurance may cover it, but these experts have assigned a level C recommendation for the use of flash glucose monitor, needing frequent glucose monitoring for those patients. Dr. Sean Kane 12:10 So Dr. Patel, we're going to have to help this poor inpatient pharmacist over here. So flash continuous blood glucose monitoring. What is flash versus not flash glucose Speaker 1 12:20 monitoring, a great question. So the real time continuous glucose monitors, you don't have to, per se, tap the machine and say, Hey, monitor my sugar. It just monitors it every five seconds. And it measures interstitial glucose. The flash monitors are slightly different. The sensor is worn just like the real time continuous glucose monitor, but to read it, a reader (or phone) is brought close to the sensor on the arm so you can check glucose many times a day without finger‑sticks. But I have to kind of flash the meter next to the sensor in order to register the blood glucose. So kind of going along the lines with, you know, monitoring the blood glucose, something we call the self monitoring of blood glucose, SMBG monitoring has some updates as well. It used to be part of the A1c goals or the blood‑glucose goals section. Now, with technology section being developed, the diabetes technology being a new section, they kind of move the monitoring, blood glucose monitoring under that section itself. But besides the physical movement of the content and the guidelines, I think the important recommendation that came out was patients who are not on intensive insulin regimen, the benefits of self monitored blood glucose is less clear, Dr. Sean Kane 13:53 meaning that if I'm on a sulfonylurea isn't as clear what the benefit is in frequent assessment of my glucose Speaker 1 14:00 Correct, as opposed to somebody who's on a basal bolus insulin therapy, Speaker 2 14:04 and I'm guessing, again, going back to that certain medications where the risk of hypoglycemia with tightly controlled regimens is higher, compared with someone on metformin, you know, if they test them, so the number needed to treat to avoid a hypoglycemic episode is probably Much, much higher. Speaker 1 14:21 There absolutely are — most orals and injectables like GLP‑1 receptor agonists provide a predictable decrease in A1c, so patients on these agents generally do not require intensive SMBG. Now it's a different story. If you're putting a patient on, let's just say, a basal insulin regimen to get started, because that's their path of you know, treatment progression, you can still utilize the home blood glucose monitoring to titrate that dose. But somebody who's just on metformin, or, say, a DPP‑4 inhibitor, subjecting them to three times‑daily BG checks provides no additional benefit. We kind of laid out the land for diagnosis and blood‑glucose monitoring; the important piece now is the updated treatment recommendations for patients in general, Dr. Sean Kane 15:21 one specific thing about diabetes management first line therapy was Metformin, right? It still is awesome. Okay, so we've got that covered if you're a candidate for it. And then, at least historically, it was a lot of sulfonylureas and stuff like that. And I know that that's been a changing practice over the last several years, right, correct? Speaker 1 15:39 And you know this as an instructor who teaches diabetes pharmacotherapy, it was really hard for me to kind of step wise, lay out the land and say, you know, if first line Metformin, that was clear, but then second line, I don't know, you have list of, you know, a bucket list of different agents that you can pick from, and what these guidelines did, following that consensus statement that came out in October 2018 is kind of assign co morbidities or compelling indication. Quote, unquote, if I can steal it from the AHA guidelines, you know. So Metformin therapy, if you know there is no contraindication and patient tolerates it, definitely put them on it's still the gold gold standard, aka first line therapy, but the second line now depends on lot of different factors. Those being Dr. Sean Kane 16:30 so ascvd risk, for example. So if you're a higher risk of cardiovascular disease, perhaps we should pick a diabetic regimen that targets, you know, a cardiovascular risk reduction, right? Speaker 2 16:41 Yeah, and that's something, again, going back to previous podcasts we've done, we looked at a lot of the newer agents have really been going for those CV as CVD risk benefits, and showing we don't just lower your A, 1c but we actually prevent these things. And so I think a lot to me is, is now we have that data is, is using that. And so it looks like things like liraglutide (Victoza) as a representative of the GLP‑1 agonists would be a top choice, and then semaglutide (Ozempic) and exenatide ER (Bydureon) follow in that class; SGLT2 inhibitors — empagliflozin (Jardiance) and canagliflozin (Invokana) — are preferred for other indications. Speaker 1 17:24 absolutely and other factors to look at while picking the second agent is, you know, whether they have presence of CKD or heart failure, they are recognizing heart failure as one of the important comorbidities of diabetes. So this recommendation has been moving in if you investigate individual trials for cardiovascular outcomes of diabetes agents, some of these findings on benefits to heart failure were more in the subgroup analysis, but obviously the expert have kind of picked up that particular finding as well. So now we can see if they have CKD or heart failure, recommendation is to select an sglt Two inhibitor that has proven benefit. Here the benefit is shown with empagliflozin and canagliflozin (Jardiance and Invokana). Dr. Sean Kane 18:16 And then for those patients that are at a higher risk of hypoglycemia, perhaps we should avoid some of those agents that cause hypoglycemia. So, for example, avoiding sulfonylureas and meglitinides, and instead favoring DPP‑4 inhibitors, GLP‑1 receptor agonists, SGLT2 inhibitors, or thiazolidinediones (TZDs). and thinking about that, we're also thinking about, you know, yes, they have a hypoglycemic risk, but if they also have a cardiovascular risk, then we should be kind of picking, you know, the common agents between those two categories, Speaker 1 18:50 absolutely, you know, weight gain is such an issue in patient with diabetes, you know, we should try and select therapies that either don't put them at risk of weight gain or keep them at neutral and so agents like GLP one receptor antagonists and sglt two inhibitors can help in over here, versus agents like sulfonylureas or insulin or tcds are more prone to cause weight gain. Dr. Sean Kane 19:15 I've always thought it's ironic that we tell these type two diabetic patients to lose weight and then we prescribe them medications to make them gain weight, right? So for sure, this is a change in practice that has it's not like this happened between December 2018 and January 2019 this has been something happening over a long period of time. It's really good to see this continuing to evolve, right? Speaker 1 19:36 And this area is particularly really gray. And what I tell my patient students, actually, when they're rotating in the clinic is, you know, don't shy away from an from adding an agent if it's clinically justified, just because they cause weight gain. And a great example will be insulin. You know, they've had diabetes for 15 years and their A1c is not budging below 9%, and they need insulin — you shouldn't avoid it when clinically indicated. Use your clinical judgment. Speaker 2 20:09 So one thing, yeah, we've talked about is, you know, we we've essentially taught or not talked about a sulfonylureas as much as they don't meet a lot of these boxes. So what would be a place in which we would consider them Speaker 1 20:19 cost is more likely. They increase hypoglycemia and weight gain risk, but they have a good A1c‑reduction benefit (about 1.5–2%). and they have been out in the market for so long that, you know, all three agents are generic. And so if you select a good patient who has good hypoglycemia awareness, is not overtly obese and have issues paying, you know, with their insurance, sulfonylureas are still an option. And if I'm not wrong, you know, doing my residency at the VA, I mean metformin and sulfonylureas were like the primary oral agents, and I remember, by the time Januvia came out, it still required prior authorization. Yeah, they've Speaker 2 21:09 got some preferred ones now, but yeah, it's still a lot of times that's what we're using. We are moving on to things like a fair amount of semaglutide coming out and utilized too, as well. So it's good to see that one represented. Dr. Sean Kane 21:18 So you know, we've covered these typical agents, and we haven't really talked a lot about insulin, and where does insulin fit into our algorithm here? So where does that fit in? Speaker 1 21:27 Yeah, that's a really good point you make. You know, previous guidelines have delineated how to do the monotherapy, their dual therapy, their triple therapy, and then, you know, how do you progress to the insulin? It's still the same layout, but what changed here is they're now recommending GLP, one agonist if you must choose an injectable agent for better efficacy over adding a basal insulin. That's pretty Speaker 2 21:56 surprising, but I mean, again, I've seen it in practice, kind of moving towards that with the newer data coming out with them, but it's very interesting to see it written down. Speaker 1 22:03 You're right. You know, the AACE guideline (American Association of Clinical Endocrinology) had favored GLP‑1 agents after metformin for the past couple of years. And it took ADA a little longer time to kind of say, You know what? We're probably going to go that route as well. Dr. Sean Kane 22:21 And of course, this is going to have pretty big cost implications. You know, insulin is not cheap on its own, but neither are the GLP one agonists, right, correct? Speaker 1 22:31 Yeah, we are worried about the cost. They none of the GLP one receptor agonists are generic in the market. If you listen to our previous podcasts, we know we have one basal insulin that is quote, unquote generic or follow on. So there is some cost benefit there. But if you look at the median acquisition cost for GLP, one for 30 day prescription is 800 upper $800 per month cost versus for basal insulin therapy, it's somewhere mid 300 Dr. Sean Kane 23:01 so again, patient specific preferences, values and just financial ability may play a role in your selection here, right, Speaker 1 23:08 correct, and, you know, looking at cost. Yes, I feel like sometimes in my clinic, insurances do drive the therapy decisions, you know. But if you were to talk about some of the benefits that GLP ones give over insulin. It may help justify the cost. Those benefits include less weight gain (often weight loss), less hypoglycemia, reduced need for stringent BG monitoring, and cardiovascular benefits seen with liraglutide, semaglutide and exenatide. Dr. Sean Kane 23:41 Er, so I know that one thing about the ADA guidelines is that it's not just about blood glucose for the recommendations that they have, but they cover things like blood pressure goals and lipid therapy and things like that. So was there anything new with the 2019 update with respect to any of these cardiovascular treatments that are not specific to diabetes, but cardiovascular treatment in patients with diabetes, absolutely. Speaker 1 24:08 You know, we kind of talked about how this section is now endorsed by the American College of Cardiology, and they are now recognizing heart failure as one of the important comorbidities of diabetes, which should be taken in consideration if you're putting patient on certain treatment agents again to align themselves with other organizations. Guidelines you know, their their blood pressure targets have been better defined while taking the acvd risk consideration. So what I mean by that this is nothing different than the previous guidelines. They just kind of I would say it's trending by giving a CVD percentages. So if you have a patient with diabetes and has a CVD risk, 10 year acvd risk of greater than 15% they're saying to keep the goal of blood pressure less than 130 over 80. But if that 10 year risk is. Below 15% then you can do a little bit of relaxed blood pressure control, which is less than 140 over 90. I think Speaker 2 25:06 it's interesting to note. It looks like that the 140/90 goal cut‑off for an ASCVD risk <15% is Level A evidence, whereas the tighter goal for ASCVD risk >15% is Level C evidence. So that's a little bit interesting, maybe a little bit of a inconsistent there, as far as how enforced it's going Speaker 1 25:24 to be, you know, because they want to play friendly with their aha. ACC colleagues, they kind of redefine this. But there is a nice table within this guidelines too that talk about trials for blood pressure, that consider large amount of patient with diabetes. A relevant example is the ACCORD blood‑pressure trial, which showed patients with diabetes did well with a BP goal <140/90 in many settings. But now then you start adding into cardiovascular morbidity, such as a higher ascvd risk, and therefore looking at other trials, and even though patients with diabetes may not have been included in those, we want to minimize those risks, and therefore astringent blood pressure code at Level C is still endorsed. Dr. Sean Kane 26:15 And the elephant in the room that you're talking about Dr. Patel is largely the SPRINT trial, right? So the SPRINT trial did exclude those diabetics because, likely they felt like they were going to muddy the waters. Because there were, there was at least one, if not two, trials prior to sprint specific in diabetics that did not show benefit with this tighter blood pressure goal so great that we're playing well with our colleagues between different guidelines. But this is a massively complicated problem, right in terms of what is the optimal blood pressure goal in this patient population? It's extremely controversial, yeah. Speaker 1 26:47 And again, just because this section is endorsed by ACC, they felt the need to delineate the blood pressure management recommendation. So there is a very nice figure 10.1 in Section 10 that kind of lays out all the treatment recommendation for the blood pressure as well. Speaker 2 27:04 And so I think one other thing to note, as we've kind of already mentioned, is the importance is reinforced about calculating that ascvd risk and then really using that to help guide therapy, not just for the diabetic agents, but also, again, thinking in a broader scope, about playing well with these other organizations, but looking at their lipid management too. Speaker 1 27:22 And again, the recommendations for adding statins are unchanged — calculate the ASCVD risk so you can better select therapy. Dr. Sean Kane 27:34 And then, you know, chronic kidney disease is one comorbidity that we worry about in diabetics. That's one of our microvascular complications, that you get this nephropathy caused by your poorly controlled diabetes. What was new with that one Speaker 1 27:46 so recommendation on annual albuminuria micro albuminuria assessment was already there, but now that we have to select treatment accordingly in patients who have signs of diabetic kidney disease, they're saying that once a year, we should make the assessment and kind of stage the patients of their CKD, if they have diabetes, or if they have diabetes plus hypertension. Speaker 2 28:10 One thing I'm looking forward to is, I'm hoping that finally, once and for all, we've really decided how many of our patients with diabetes should get aspirin. So tell me we've got something good here. Speaker 1 28:20 I don't have a good news for you either on that one. Oh yeah, it's more complicated than it seems on the surface, and it became even more complicated, or I should say, even grayer, for this guidelines to recommend aspirin for primary prevention in itself. And there's quite a few studies that the subsection enlist, including one of the meta analysis, and the results are all over the place. You know, obviously what the end all and be all recommendation from the ADA is that if you are going to put patient on aspirin for primary prevention, make sure you assess the bleeding risk while assessing the benefits of avoiding some of these cardiovascular events. So the first meta‑analysis they discuss is from the Antithrombotic Trialists' Collaboration, which pooled six large trials of low‑dose aspirin for primary prevention (≈95,000 patients; ~4,000 with diabetes). They found aspirin reduced vascular events by ~12%, with the largest reduction in nonfatal MI; there was little effect on stroke or total CV death. Dr. Sean Kane 29:46 and then other trials came out — ASCEND, ASPREE and ARRIVE. ASCEND (~15,000 patients with diabetes) showed a ~12% reduction in the primary CV endpoint, but that benefit was offset by an increased risk of major bleeding (~1% absolute increase). Unknown Speaker 30:20 Yeah, and those finding was statistically significant, Speaker 2 30:23 and then the ASPREE and ARRIVE studies — done in non‑diabetic and elderly populations for primary prevention — showed no CV benefit. And again, the thing to point out is that increased risk of bleeding that was statistically significant in those taking aspirin. So I think it looks like, I guess, to summarize, it's back to gray. And the important thing still is, to me, recognize that just giving somebody even a baby aspirin dose a day is not itself without without concerns. And we, I think we have to respect that, as it's not just one of these meds that throw it out. Worst case scenario doesn't work, but they can Speaker 1 30:54 actually have some concerns. Yeah, and this recommendation doesn't really mean that you know those patients with diabetes who are young and healthy, has no higher risk for bleeding, are tolerating aspirin, low dose aspirin regimen. Just okay that you need to take them off, just because this recommendation says so, but you need to kind of just have the discussion, you know, you may have patients. Hey, I heard it on the morning news today, or, you know, I saw this on the newspaper on my daily morning vlog, and you just have to address these concerns and reevaluate the therapy at that point. Or when they become of an older age, or have a major bleeding to can say, you know, okay, we're going to take you off of the aspirin, or we're going to continue. So we kind of, you know, again, banging the same door here for diabetes, diabetic kidney disease. We talked about the staging for the diabetes kidney disease as we talked about treatment recommendation, kind of highlights the presence of CKD and selection of appropriate agent. And that's what's recommended to do, pick better agents that have proven benefits for renal outcomes, as we discussed earlier. Those are going to be your SGLT2s. For patients who can't tolerate an SGLT2, a GLP‑1 with cardiovascular benefit (for example liraglutide) is recommended — liraglutide showed renal benefits in the LEADER trial. Speaker 2 32:19 And one other thing I appreciate again, is the idea about, you know, going outside of just what we think about with diabetes, but the complications. So once again, focusing in on the neuropathy piece. And so already existing for years, has been the recommendation to use medications like duoxetine and pregabalin, which have their indications. And definitely a lot of data about diabetic neuropathy. But now adding gabapentin to the list (largely because of cost and efficacy) is notable — gabapentin is inexpensive and widely used for neuropathic pain, though pharmacokinetic/dynamic differences exist versus pregabalin. But again, if you're looking from a cost standpoint, I think you really need to consider Gabapentin. Dr. Sean Kane 33:06 And I think it's actually kind of interesting that the guidelines just added this, because this is something that has been done in practice forever with gabapentin, so I guess it's good that they've kind of updated that to reflect the evidence in current clinical practice, too. Speaker 1 33:20 Gabapentin remains off‑label for diabetic neuropathy, but it's notable that the ADA now includes it as an option. Speaker 2 33:31 And also, foot evaluations every three months can be done for high‑risk patients; a comprehensive annual foot exam should be performed for all patients. Dr. Sean Kane 33:49 So Dr. Patel, you know, this is a larger document, and it's great that they update it every year, which means that there's a lot of meat to these new guideline updates. We've only covered some of the high points. What are some other areas that really stood out to you that the audience could potentially look into more if they're interested in? Speaker 1 34:05 Yeah, absolutely. You know, there is more than what it meets the eye. If you look at the the intensity of the documents and evidence they have to rigorously analyze. But what's added, in addition to what we discussed, is things like smoking cessation, for the prevention, you know, using telemedicine, using interdisciplinary team, pharmacists are part of this interdisciplinary team to improve outcomes for these patients. Examples of exercises and leisure time activities are added, if that's what floats your patients, both in getting them active. So be it there are more delineated in the nutrition section, they're saying, you know, use of E cigarettes is not any better than using your usual standard of care modality for smoking cessation. Obesity management has more evidence on better tracking, again, going back to the diabetes technology section. You know, use, use those FDA approved apps to track the weight and the intake of dietary products. Other recommendations are patients in special population, like adolescence, the gestational diabetes as well as older adults. Sort of nothing new in gestational diabetes arena, they're just emphasizing the use of insulin as the first line therapy over the oral agents for adults and patients, the recommendations are better delineated, including screening diagnosis, you know, assessing for comorbidities and the treatment. What's interesting, and I'd like to dive a little bit detail into, is management for the older adults, they now include pathways a flow diagram for de escalation or de prescribing of the agent. So they're saying we knew that we don't have cookie‑cutter goals for A1c for all patients with diabetes — older patients are at higher risk of hypoglycemia, polypharmacy, cognitive impairment and falls — so we frequently avoid a stringent A1c target and should consider deprescribing when appropriate. And this is kind of like that, no, no zone that most physicians don't want to do. Well, if that's not, you know, they're not hurting and they're tolerating you. Okay? Their insurance is covering it. We're just going to leave them to be on this guideline is saying, no, no. Re look at them and then see if you can de escalate some of these agents, especially insulin. Speaker 2 36:26 Yeah. Again, it reminds me what, what has been done with benzodiazepines? The idea that, well, you don't wait till the bad thing happens before saying, Oh yeah, now we should. Is the idea that the retroactive we say, you know, we have a number of patients on these medications that may increase risk of falls before they fall. Go ahead and make that decision so they don't fall, instead of waiting afterwards, saying, Oh yeah, now's the time to do it. Because again, what are you preventing now you're dealing with the fallout of it, so keep that thing from Dr. Sean Kane 36:49 happening in the first place. So if you're interested in delving deeper into these guidelines, we'll have a link at our website, at HelixTalk.com episode 94 we also have a couple of our key points listed there. So key concepts, if you want the Cliff Notes version of our cliff notes version of the guidelines, we're on Twitter at HelixTalk, where we're kind of releasing these simple clinical pearls that if you kind of want to get those in your Twitter feed related to older episodes, you're welcome to do that. So with that, I'm Dr. Kane, I'm Speaker 1 37:18 Dr. Schuman, and I'm Dr. Patel. And is refreshing to say it again. Study hard. Narrator - Dr. Abel 37:24 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 - ? 37:35 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.