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 90. I'm your co‑host, Dr. Kane. I'm Dr. Schuman, and today we have a very special guest with us, as Dr. Patel is still on maternity leave, I'd like to introduce Dr. Srivastava, or Dr. S, to the podcast today. Welcome. Thank you. I'm excited to be here, and one of the reasons that we brought you on Dr. S is to talk about an exciting new guideline update that happened a couple months ago, and that's the 2018 ACC/AHA lipid guidelines. So the title of today's podcast is HelixTalk's top 10 recommendations from the 2018 ACC/AHA lipid guidelines. Speaker 1 01:04 Did you just take that first page and make it the top 10? So we didn't. Dr. Sean Kane 01:08 There is a top 10 list provided by the ACC/AHA, but we've decided to come up with our own because we thought that there were some other key elements in that guideline that are absolutely notable and podcast‑worthy. Speaker 2 01:20 So first, it looks like are we getting to take another trip back into our time machine? Dr. Sean Kane 01:24 I think that maybe no time machine for this episode, okay, but we should note that we did cover the 2013 guidelines all the way back, literally in HelixTalk episode number one, wow. And what were some of the big things that came out from the 2013 guidelines? Speaker 2 01:39 Well, one of the things I believe at that time was really looking at some of the ascvd risk and scoring system, something that now we use very routinely in a clinical practice, but really kind of introducing that as well as the removal of LDL goals. Speaker 1 01:52 And me, being the newbie, I saw that you also did one on PCSK9 inhibitors not too long ago as well, when they first came out. And so it's interesting that years later, we're talking about them again, absolutely. Dr. Sean Kane 02:05 And you know, one of the things to know about these newer guidelines is that they've really added in the role of drugs like ezetimibe and PCSK9 inhibitors, whereas those really weren't covered, because we actually didn't have a lot of clinical outcomes data for those two drug classes at the time. And that's one of the big things in that 2018 Speaker 2 02:23 update, right? And again. And back to that with 2013 Well, one of the things we didn't have the cardiovascular benefit, that's now we're moving more into that era of moving past her and Dr. Kane, you're a big hater on the surrogate endpoints, but really looking at what are the actual benefits beyond just LDL lowering, beyond just blood sugar lowering, what does it do for your cardiovascular risk burden? So that's again, now something we're moving forward and really focusing on. Dr. Sean Kane 02:47 So Dr. S in thinking of the 2018 guidelines, of course, we'll go through our own top 10 list. But what are some things? If you had to come up with one or two of the most notable things that's new or different about these guidelines, what would you say that Speaker 1 02:59 is, I would say that the numbers are back. Dr. Sean Kane 03:01 Whoa, when you say the numbers are back, what do you mean by that, especially a focus Speaker 1 03:06 on LDL, and this might be great for people as they're thinking about it, the LDL less than 100 LDL less than 70. Those numbers are reinforced and re emphasized again in these guidelines. Dr. Sean Kane 03:17 Now it's a throwback to the pre‑2013 guidelines, where we used to have LDL goals and percent LDL reduction, that basically went away in 2013 and now it's kind of back. The other thing I think that is notable is the number of organizations that are involved in these guidelines. So historically, it was basically the ACC/AHA. Now we have something like 10 different organizations that aren't just endorsing it, but are involved in the guideline production, including APhA, which is a really big deal for pharmacy, Unknown Speaker 03:44 and it makes a citation very long. Dr. Sean Kane 03:47 So as we mentioned in the briefing on page seven of the guideline document that is linked in the show notes for episode 90 at HelixTalk.com it's notable that the guideline authors do have a top 10 list in terms of they've come up with, out of the 121 pages of their guideline document, what are the top 10 things? And they have kind of a brief paragraph about each of those. That's great. But as we mentioned, we think that we have our own top 10, some of which are the same, but many of which are different. That provides a little bit more value to the HelixTalk listeners. Speaker 1 04:18 And we should mention that in addition to the 121 pages, there's an entire supplement. Of 200 plus pages as well, which also has really good information. But there's only so much time to get Dr. Sean Kane 04:29 through it all. Yeah. Well, why don't we start with number one? And Dr. S, I know that as we were working through this document, this is one of the things that you were passionate about, right? So we'll start with number one, your most passionate topic, which was also number one in the guideline document as well. Speaker 1 04:45 Yes, it truly, truly excites me how this guideline, as well as some of these other guidelines for chronic conditions, are really focusing on lifestyle. And so I absolutely love that they state that we should be focusing in a heart healthy. Lifestyle throughout the life, and this needs to be emphasized. Back in 2013 it said it should be encouraged, and even that slight change in Word emphasize versus encourage changes things for clinicians and I love that it also says it's throughout the lifetime. We know that many of these lifestyle habits start early on, and so focusing from childhood forward on, eating healthier physical activity, the types of foods we should be eating. I absolutely love that they make this number one, because it just sends a message. Dr. Sean Kane 05:29 And, you know, that makes sense, and I think it's something that clinicians commonly kind of forget about, is it's so easy to calculate that ascvd score and then just give a statin without talking about dietary modifications, physical activity, things like that, that are probably, arguably even more important than the drug therapy. But it's, you know, as pharmacists, we think about the drug therapy, and sometimes it's hard to remember that non pharmacologic therapy as well. Speaker 2 05:52 And a lot of times, too, is sometimes it's, it's easier to just say, I'm going to write this prescription as a provider or as a patient, to say, you know, just give me the pill, versus the idea, you know, again, I it's the same, same analogy with the Psychotherapy is, again, to really get at individual and creating changes and positive messages. It's going to take a lot of time and reinforcement, and you're going to have some some ups, and you're gonna have some downs, but really to encourage the individual to make that overall trends towards a better lifestyle, you're going to have times when, yeah, you're not gonna exercise as much, your diet is gonna be poor, but keep moving towards that better lifestyle. Speaker 1 06:24 And we shouldn't be afraid of talking with our patients about this. A lot of times, we're just thinking, well, they're not gonna do it anyways, or these changes are too big, or we're taking the pleasure of eating these yummy foods, but the patient at least deserves to know how they can impact their Dr. Sean Kane 06:40 cholesterol levels, exactly No. Dr. S, as passionate for number one as you were. I'm equally as passionate for our number two, which I think is pretty emphatic throughout the guidelines, the concept of shared decision making with the patient, particularly as it relates to initiating drug therapy. What that means is basically not just saying, Hey, your ascvd risk is above an arbitrary threshold. You should be on a statin, and I'm going to give you a statin instead. They're emphasizing the fact that some patients may have different value systems or different thoughts in terms of initiating a new drug therapy, and that process, that shared decision making process between the provider, educating the patient, then coming up with a shared decision that's really, really important. So I love the fact that they're now recommending that shared decision making process before starting statin therapy. And again, clinically, what I've seen is someone calculates that ascvd score, it's above seven and a half percent, and it's basically a black and white they should be on a statin, and that's just not correct. And I love that the guidelines have emphasized that that is not the appropriate approach. Speaker 2 07:44 It's an interesting thought because, again, is if you sit down and talk to the patient about, for example, the benefits of the medication and the reason for the risk, you may have become an individual who's willing to work on some of those risk factors. Again, you think about things like smoking status, and again, working with an individual who may say at this point, well, instead of adding a medication, what about potentially making some some modifiable changes that could reduce my my scores, or, again, the diet and lifestyle modifications as well? So you may be able to engage an individual to create some lifestyle changes that, versus if they did get just get on the medication, may have said, well, I don't need to change anything. The medication is going to Speaker 1 08:20 protect me. What's really cool is that shared decision making, while it may not be something that we formally follow, it is something that we've done with our patients for a very long time, but they do provide a supplement checklist on what things we should include when we are talking about shared decision making, and one of those is at the end, doing that whole teach back with our patients, but not just teach back, but assessing what they're hearing. So we're talking about the risks. We're talking about their ascvd score, and part of decision making is asking them what that means to them now that you've given them that information, how are they perceiving it, and what that risk means, and what they're willing to do, and coming to a decision together. So table seven, which is a checklist for clinician, patient shared decision making for initiating therapy in the main document and then in the supplement, it's table s8 which goes more into detail about what to include when talking about risk. And we have Dr. Sean Kane 09:08 links to both of those in our show notes. Again, Episode 90, and just to kind of highlight a couple things, because I think just to give the listeners a concept of what that involves, it involves stuff like talking about what is the actual benefit of drug therapy. So are you less likely to have heart attacks, less likely to die? What is the actual benefit to that particular patient? What are the side effects of drug therapy, which we should be talking about anyway, when we initiate any new drug therapy? Speaker 2 09:31 Yeah, there's always, you know, you think about myalgias is one that even you know, rates of it aside, people hear about it, and people get very scared about it on a clinic, or if they had one with one stat and so, you know, I'm not touching anything else in that class again, or had a blood I had a buddy that had happened to concerns about drug interactions. You know, culture scene is one every now and the patients who have frequent gout attacks and some fear there as far as dosing of the medications, Dr. Sean Kane 09:53 and then, of course, cost and the patient preferences. So what does it mean to them to have another pill that they have to take a day and have. Another copay every month, and things like that, you know, things like that. And again, those checklists cover a lot more, but I love the fact that the guidelines are emphasizing that more. So Dr. Schuman, how about number three? What was another thing that stood out for our team? So number Speaker 2 10:13 three, again, is it gets not just in that black and white of are you above 7% or are you below 7% but now kind of stratifying things a little bit within that classification. So now saying, well, there's a borderline risk somebody who has a 10 year ascvd risk of five to 7.5% with something called Risk enhancers, which I believe we'll get to a little bit later. These individuals, there's a class to be recommendation, so a little bit lower level, but considering a moderate intensity statin in this population, and Dr. Sean Kane 10:39 again, if we go back to the older guidelines, this five to seven and a half percent group would not get a statin, but again, what they've added to this group is the idea of risk enhancers that we'll talk about later, to this particular group to help identify people who, based on ascvd alone, wouldn't normally get a statin, but maybe based on other risk factors that ascvd doesn't Capture, maybe they would be appropriate for stat and again, as part of that shared decision making process, Speaker 1 11:05 absolutely and it classifies the three groups into that borderline intermediate and high risk. High risk being greater than 20% they're still recommending the ascvd risk calculator that's available within the app store or online as well, and to utilize that when making these calculations right? Speaker 2 11:23 So that high risk group greater than 20% high intensity statins reduce the LDL greater than 50% and in between there, though, there's still the intermediate risk group, 7.5 to 20% and there we're now thinking moderate intensity statins, and again, back into that classifications of high moderate intensity, but also looking at the LDL lowering percentages here, so moderate intensity would be about a 30 to 50% LDL lowering. Dr. Sean Kane 11:48 And then they also introduced kind of a new thing as part of a decision making process called the CAC score that we'll talk about later, and that belongs in this intermediate risk group to help make decisions on how aggressive to be with statin therapy. So again, for number three, it's basically the fact that we don't have a yes, no or above or below seven and a half percent, but now we have this borderline risk, intermediate risk and high risk groups, of which we have different decision processes for each of those groups. Speaker 1 12:14 So the next one is that they recognize other factors that aren't present in that ascvd Risk Calculator. So when that calculator so when that calculator came out, we were all using it, but realized that there's definitely maybe some concerns or some missing information. So now these guidelines are recognizing that there are certain factors not included within this calculator, Dr. Sean Kane 12:31 and a great example of that is the family history. Way back before the 2013 guidelines, an early history of cardiovascular disease was a big risk factor, and it wasn't present in the ascvd calculation, probably because when you come up with these scoring algorithms, it's really hard to capture something like family history because it's not well denoted and these big databases that they use to develop these algorithms with. So if you go back to what is, what makes up your ascvd, it's your your sex, your age, your race, your lipid panel, your blood pressure, your diabetes status and your smoking status, and the guidelines now recognize these risk enhancers, which are other risk factors that aren't part of ascvd that may push a clinician to categorize a patient as a higher risk than what the ascvd 10 year risk indicates for that patient. Speaker 1 13:20 So what are these risk enhancing factors? A couple of them, Speaker 2 13:23 first family history of early cardiovascular disease. Dr. Kane, as you already mentioned, metabolic syndrome. So large waist, high blood pressure, high blood glucose, low HDL and high triglycerides. Again, something when I think about our psychiatric population, that's a big concern there, and so that puts you right into a higher risk. CKD, interestingly, to see, I don't think that's one that we've really focused on as much in previous years, chronic inflammatory disorders, rheumatoid arthritis, again, thinking about the idea about holistically and the body and the inflammatory system, and what that does to overall cardiovascular risk. Interestingly, South Asian ancestry as well, and which has been I know an area looking into concepts like normal weight, obesity, or in populations, to where you there may actually be a higher risk than what's simply seen based upon a BMI, for example. So it's very interesting to see that focus on on different demographics Speaker 1 14:12 there absolutely so in the ADA guidelines, they define for South Asians, a BMI greater than 23 — they should be screened for diabetes versus a BMI greater than 25 in the general population, right? Speaker 2 14:22 So again, trying to keep in line with that. Is it groups that may may have been missed previously, if you looked simply on a black and white numbers Dr. Sean Kane 14:29 based and again, if you go back to ascvd, when we talk about race, the race categorization in ascvd is, are you black or non black? They don't recognize other races. Beyond this dichotomy of yes, no, black, and we do have plenty of data indicating that certain races are going to be at a higher risk than others. It's not as simple as a dichotomous yes, no. So again, the whole point of these risk enhancers is to capture other things that ascvd isn't capturing that you know are risk factors for cardiovascular disease, and of course, we haven't even mentioned all of them. These are kind of the main ones that Speaker 2 15:01 stood out to us. So when would we apply these risk advancing factors, though? Speaker 1 15:05 So mainly we should be thinking about it when they're in that borderline risk of five to 7.5% to help decide if we need to start a statin or not. Dr. Sean Kane 15:13 So what you're saying, Dr. S, is basically these are people normally you wouldn't give a statin to, but if they have these risk enhancers based on your clinical judgment and that shared decision making process, you may elect to give them a statin, even though they're less than that arbitrary but magical cutoff of seven and a half percent for their ASCVD 10‑year risk. Absolutely. All right, so I Speaker 2 15:32 think then we're ready for number five of our top 10. So number five, very high risk, is recognized as a specific patient population, not a nebulous term, and this is going to be defined by things like multiple major ASCVD events, or one major event and multiple high‑risk conditions as well — just a few of the definitions. So when they say major ASCVD event, we're talking about an MI/acute coronary syndrome, stroke, or symptomatic/more severe peripheral artery disease (PAD). Dr. Sean Kane 16:01 And basically what they're saying here is, you know, classically, we just said, Did you have an ascvd event or not? And if you did, we treated you in the secondary prevention arm for lipid therapy, meaning that you've already had your heart attack. Now everyone who's had a heart attack, we're going to give x therapy to. What they're now saying is, within that group of the secondary prevention where you've had an ascvd event, they're recognizing that there are some people that have had a heart attack 10 years ago, and we treat them differently than someone who's had their fourth heart attack. And that makes sense, right? And we're going to call these people very high risk people. And again, to Dr. Schumann's point, people who have had multiple events, or had one major event and then a bunch of high risk conditions, maybe we should treat them differently. Speaker 1 16:44 So taking that patient and saying, okay, they've had an MI, but they're also older, greater than 65 they have diabetes, hypertension, chronic kidney disease, currently smoking. So we're really considering all of those risk factors and determining, do they belong in that very Dr. Sean Kane 16:57 high risk and one thing that I thought was really interesting that, to my knowledge, hasn't really been delineated out historically, is chronic kidney disease is a risk factor, but the guidelines now recognize that end stage renal disease so people who are on dialysis. There's been two RCTs that have actually shown that statin therapy does not improve outcomes in that particular patient population. We can talk a lot about why that could be but they actually say that CKD without dialysis is a risk factor, but CKD with dialysis does not constitute that risk factor. So be Speaker 2 17:28 interesting to see, then, if, if further data comes out to kind of confirm that or possibly refuted in the future, I can imagine that'll be an area for future research. Dr. Sean Kane 17:36 Yeah, my best guess is that patients who receive dialysis typically don't have as long of a lifespan as someone who is a non dialysis but CKD patient. So it could be that they just don't live long enough to derive the benefit of five years to be able to have that statin benefit. So again, why does this matter? So it's great that we have a new patient group that we're going to call very high risk these people with multiple acvd events, or a major acvd event, plus a bunch of risk factors. What do we do about that? Speaker 1 18:02 So we have additional medications that we should consider for these patients — ezetimibe and PCSK9 inhibitors play a great role. We know that they lower LDL substantially. And so while we don't typically use the statin combination with these two medications in other patient populations, for very‑high‑risk patients we will definitely be considering this, Dr. Sean Kane 18:25 and throughout the guidelines, they do make mention of ezetimibe and PCSK9 inhibitors for a variety of patient groups; this is one of the targeted groups for those drug classes, and actually our key point number six piggybacks on that — what is the role of ezetimibe and PCSK9 inhibitors for secondary prevention? Speaker 2 18:45 Again, point number six, they're generally recommended for individuals who have a history of ascvd events and who have not achieved an LDL goal less than 70. And so again, emphasizing LDL goals are back, baby. So prior to 2013 we had the classification LDL goal, less than 70 was your highest risk, less than 100 was your moderate risk. And we targeted that, really, with with anything, any lipid therapy, statins, non statins, whatever. And then 2013 guidelines got rid of the LDL goals altogether. And we had the moderate, moderate, high and high intensity statin groups, and said, Alright, these are the statins you use. These the doses you use. And pretty much left the other the other medications got a little bit more nebulous. Dr. Sean Kane 19:22 More nebulous. So Dr. Schuman, what you're saying is that our primary targets — Zetia and PCSK9 inhibitors — based on the 2018 guidelines, are going to be those very‑high‑risk patients or patients who don't achieve LDL < 70 despite statin therapy (secondary prevention/ASCVD event). Speaker 2 19:36 Yep. And so as one general approach for secondary prevention following that initial ASCVD event, we're looking at reducing LDL by greater than 50% using a high‑intensity statin to try to get an LDL goal less than 70. If it's still greater than 70, it is considered reasonable to add ezetimibe. Dr. Sean Kane 19:56 And of course, the brand name of ezetimibe is Zetia. Speaker 2 20:00 So then, if the LDL is still greater than 70, it's a reasonable option to add a PCSK9 inhibitor following patient discussion about net benefit, safety and cost; the guideline notes these agents are not currently cost‑effective (QALY > $150k). Is actually for another article I was reading too. So that's used across the board many different disease states. So since it's greater than that, again, it's kind of up in the air. And so you really have that patient dialog. Dr. Sean Kane 20:33 I thought this was actually really interesting, because typically, we don't see a lot of guidelines even addressing cost, let alone going into quality adjusted life years and using that as part of that decision point. And I think that, in all fairness to the guidelines, they kind of recognize that in 2018 currently not cost effective, but presumably the cost will drop over time, potentially before the next guideline release occurs, and at some point it may become more cost effective. And that's kind of one of the reasons I believe that they decided to add this, is that, you know, this is a hotter topic in terms of, is it cost effective for all patients, or for this group or for a specific group? So I think that's great that they added that in there absolutely. Speaker 1 21:10 And we'll see over time as well, with this guidelines and these guidelines being implemented in our patients, what that looks like in terms of outcomes for our patients. Yeah. Speaker 2 21:19 And so just something else to note is, as far as monthly cost is, we're talking about $1,000 a month, so 12 grand a year for this treatment. So it certainly is not a small cost that the patient will be bearing. And if somebody does want to hear a little bit more about these medications, we actually talked about these in episode number 33 — Repatha and Praluent are a couple of those options. Dr. Sean Kane 21:40 So let's move on to number seven. Our key point number seven was statin therapy still is a cornerstone of lipid management, and we still have the low, moderate, high intensity statins, but again, now one of the new things that they've really added is the concept of LDL reduction. So we haven't really changed anything, but they've now added the fact that, you know, the high intensity statins should reduce your LDL by a greater than 50% the moderate should be about 30 to 50% and the low intensity should be less than 30% LDL reduction. Speaker 1 22:10 And the statins within these categories still remain the same as well. So for example, your high‑intensity statins are atorvastatin (preferably 80 mg) or rosuvastatin 20–40 mg. Speaker 2 22:19 So good, at least we don't have to memorize a whole new cut off point — it's a little bit easier. You can use atorvastatin 40 mg (less preferred), but those are options. Dr. Sean Kane 22:28 And then for moderate intensity, the list is a little bit longer for the students that don't want to memorize every single item, what are some of the statins that you guys commonly see in clinical practice that would constitute a moderate intensity statin? Speaker 2 22:39 I think in my clinic, a lot of times simvastatin and pravastatin are probably the other two that get used less commonly, but still get used. So simvastatin 20 to 40 milligrams would be considered moderate intensity. Pravastatin 40 to 80 milligrams would also be considered moderate intensity. Speaker 1 22:54 And then we still have some of those other options of pravastatin 40, lovastatin 40 as well, within that group — and for low intensity, the one I see most is simvastatin 10 milligrams. Dr. Sean Kane 23:06 That's kind of a nod to the fact that you need to be on a statin. But maybe you have statin intolerance, or you've had other issues in the past that make it hard for you to get to that moderate or high intensity level. Speaker 2 23:16 And similarly, pravastatin 10 to 20 milligrams would probably also fall into that lot. Speaker 1 23:21 And Dr. Kane, that's a really good point. And within the guidelines as well, they discuss where maybe in certain other medications of patients intolerant to it, the medication may not be as necessary, and we're willing to take it off, but knowing the benefits that Statins have, they talk about all the ways to maybe manage patients. So maybe they need a higher intensity, but we work with them on a lower intensity one because of tolerance issues, or we do a different sort of dosing schedule for a patient. And so there is a lot of guidance available on what we should do if we're able to use a statin in a patient it's not absolutely contraindicated. Dr. Sean Kane 23:56 I believe that was page 60 to 61 in the guidelines that are also linked Correct. Speaker 2 24:00 Yes. So now we're ready for point eight of our top 10 primary prevention in people with diabetes. Most individuals with diabetes who are 40 to 75 years of age should probably receive at least a moderate intensity statin, Dr. Sean Kane 24:14 and basically, if they have a higher risk, so if they have multiple ascvd risk factors, again, this is more of a clinical judgment, it's not a specific cutoff, then you should consider a high intensity to achieve an LDL lowering of more than 50% otherwise, just go with the moderate intensity statin for patients with diabetes. So Dr. S, what do you think about that, in terms of basically, all patients with diabetes who are above 40 but less than 75 basically should be on a statin, either a moderate or high intensity statin Absolutely. Speaker 1 24:41 And you know, with patients with diabetes, I think oftentimes we have it synonymous with, okay, if you have diabetes, we're going to start you on certain other medications as well for lowering that risk of cardiovascular disease. And now we know, and this is for a different topic, aspirin may or may not play a role. It doesn't mean if you have diabetes, synonymous. Honestly, you have to be on aspirin. And the same with diabetes and statins. Just because you have diabetes, you don't need to be on a high intensity statin. We really are looking at the risk and a lot of our patients with diabetes, you're being diagnosed with diabetes much earlier because of some of the other lifestyle related, especially type two diabetes, lifestyle related factors. And so we really have to break that connection and evaluate that patient to see if they truly need a statin, and do they need a moderate or high intensity? Speaker 2 25:26 Yeah, we're only getting out of the idea that these are check boxes that if you have diabetes, check box, high intensity statin, check box, aspirin, 81 milligrams. So kind of getting back into the idea about being person centered in a lot of what we do. Dr. Sean Kane 25:38 So number nine, again, thinking about primary prevention in patients who do not have diabetes. So this is your patient without diabetes who is 40 to 75 years of age that doesn't have some of the familial hypercholesterolemia, so their LDL is not sky high like above 190 so your typical patient that's never had an ascvd event. What do we do for those patients? And again, we go back to ascvd, just like we did in the 2013 guidelines. So if you're that borderline risk, seven and a half to 20% ascvd risk, they suggest using a statin to reduce your LDL by 30 to 50% which would be a moderate intensity statin. And then if your ascvd is above 20% that's that high risk category, then that's where you would go with that high intensity statin to reduce the LDL by more than 50% Speaker 1 26:24 and that's great for those patients where we know exactly what to do and what to start, we still want to talk with the patient and go through that shared decision making process to make sure the patient's on board as well. But it's especially in those patients with that borderline risk, 7.5 to 20% when we're not sure that a statin should be added, we're going to think about those risk enhancers. Yeah, that's Speaker 2 26:45 what I really like, again, is the idea, because a lot of times in clinical practice, you see, well, you know, this, this person's on the border here, what should we, you know, what should do? I I'd see what, you know, pay, or patients a little bit hesitant about medication. I think they need it, but I'm not really sure what should I do. And so fortunate we have this, this, whatever the heck it is, a CAC score. So, Dr. Kane, I've been wondering the whole time I'm going through this, what is a CAC score? Dr. Sean Kane 27:06 Yeah, so CAC score is CT scan, also called a coronary artery calcium score, or a heart scan. Basically what it does is it uses a CT scan to evaluate how much calcification you have in the arteries of your heart and more calcification typically means that you have more plaque buildup in the arteries, which typically means that your risk of an ascvd event is going to be higher the more of this calcification that you have. So this CAC score gives you a number between zero and 400 the higher the score, the higher the risk or the more calcification. And again, I think it's important to note that we're only using this in that intermediate risk intermediate risk category, this ascvd risk of seven and a half to 20% either to initiate statin therapy or to be more aggressive in our statin therapy. And this is part of that kind of clinical decision making process where it's not a one size fits all. But this is another thing, another data point to help you have that conversation with a patient. Speaker 1 28:01 So when we look at that CAC score, it's anywhere from zero to 400 and the higher the score, the higher the risk. So if a patient has a score of zero, we're not going to give that patient a statin unless there's other significant risk factors. Score of one to 99 a statin is probably necessary, especially if our patient's greater than 55 but once again, we're going to look at the whole picture when we're considering it, and then those patients with the score of 100 or above, it is very reasonable to start a statin, unless there's a strong reason not to. If the patient refuses, we talk with them and they're just not ready to. But a statin would be recommended in that Speaker 2 28:40 and again, when we say stat, we're referring to moderate intensity statin here, because again, if they were in that 20% or higher group, they would automatically be looking at, or likely looking at, a high intensity stat here. Dr. Sean Kane 28:51 And one interesting thing about this that Dr. S you brought up earlier, before we started recording, was the thought that a pharmacist potentially could be recommending that a patient who's in this intermediate risk category might actually go and consult with a cardiologist to see if it's appropriate to do a CAC scan to help risk stratify them. And again, I think that this, fortunately, is a fairly like limited patient group that this is going to be for. If someone has an ascvd risk of 19.9% they're technically not in the high risk category, but again, ascvd is an estimate, right? And if the patient can tolerate a high intensity statin clinically, I'd probably just give them the high intensity statin, skip the CAC test, save some money, save some radiation from the CT scan. But if you have that patient that is really borderline to initiate statin therapy or can't really tolerate the higher intensity. This is, again, another data point for this one specific patient group, Speaker 1 29:47 and I'm imagining many of the patients that will fall into this category are the ones that may be younger, but have family history or other risk factors, but obviously have not had an event or have many risk factors. See. Dr. Sean Kane 30:01 So we did come up with the top 10 list, but we couldn't help ourselves, and we had just one or two small honorable mentions that we wanted to point out before we conclude the podcast. So Dr. S, what was one of your kind of honorable mentions that you wanted to Speaker 1 30:13 bring up? So one of those honorable mentions is that, especially us, being pharmacists, we want to talk with our patients about the statins, and we talked about how statin therapy sometimes comes alongside with biases from the patients already or preconceived notions that it's going to cause certain side effects that they're already worried about. And so these guidelines do a really good job about all of these potential side effects and how we should address them with the patients before even even initiating, including talking about the MSK issues and strategies for evaluating and managing these side effects, which doesn't always include stopping the medication completely, but it may include adjusting the dose or the statin that they're using. Dr. Sean Kane 30:54 And number two, one thing that I believe was present already in the guidelines, but it's great that they re emphasized, it was lab monitoring, basically what to monitor and how often. You know, historically, when I was in pharmacy school, it wasn't uncommon to get routine lft liver function test monitoring, or to get routine creatine phosphokinase or CK levels. But the guidelines basically say you don't have to do that routinely. If a patient is having kind of the musculoskeletal pain, you probably should check a CK level if they have any signs or symptoms of hepatotoxicity. You should do that liver function testing. But if they don't have any symptoms or signs of those problems, you should not routinely check those things. Dr. S, what did they mention about LDL monitoring? Speaker 1 31:37 So LDL monitoring should occur four to 12 weeks after statin initiation, or if there's any dose changes, being that these guidelines are emphasizing that LDL reduction, we're monitoring those levels, not just for adherence, but to make sure that the statin is effective in lowering that patient's risk. And then they recommend measuring every three to 12 months, depending if the patient needs it, to assess adherence safety. And I think Dr. Sean Kane 32:06 that's actually a really important point, because historically, personally, I didn't see a lot of role of re measuring LDL levels after you initiate a high intensity statin. Now that we have these LDL goals in this high risk patient population, it makes sense that you would want to see is your LDL less than 70, if not, and they meet some of those higher risk categories. That's when you're starting to think about even non statin therapies to add on to achieve your LDL goal. Speaker 2 32:29 And so number three, and again, in our kind of participation trophy area of this so one that I've always been really intrigued by, at least in our population, is targeting low HDL or high triglycerides. I know I see a lot with some of the psychiatric medication, particularly some of the antipsychotics, isolated hyper triglyceridemia, where everything else with the parameter is pretty good. But what about the triglycerides — moderate hypertriglyceridemia (150–499 mg/dL): treat the underlying cause (lifestyle, or if another medication is contributing). So again, think about the psychotropic that may be contributing and weigh risks/benefits; these patients are often associated with multiple ASCVD risk factors. So you may want to go ahead and use a statin in this population anyway. And then the third piece: if the hypertriglyceridemia is ≥ 500 mg/dL, the risk of pancreatitis becomes a major concern. Address and eliminate underlying factors, implement a very‑low‑fat diet, and then consider fibrates or omega‑3 fatty acids. The guideline notes that if adding a fibrate to a statin, fenofibrate is generally preferred over gemfibrozil. Dr. Sean Kane 33:54 To wrap up our top 10, plus a couple honorable mentions, our number one was, we love the fact that they had lifestyle modifications as one of the key elements of a heart healthy lifestyle. Speaker 1 34:08 Number two was integrating shared decision making before starting a statin with our patients. Speaker 2 34:14 Number three is, we're no longer looking at that binary greater than or less than 7.5% we got borderline intermediate and high risk categorizations there. Dr. Sean Kane 34:21 Number four was the fact that they came up with this risk enhancing factors, which are other factors not captured by ascvd that may help a clinician decide to initiate or escalate therapy for lipid management. Speaker 1 34:33 Number five is that there is a new specific patient population called the very high risk patients, which are patients that have had multiple major ascvd events, or have had a ascvd event plus multiple high risk conditions. Speaker 2 34:49 Number six: LDL goals are back — if you have somebody for secondary prevention who needs to achieve an LDL < 70, ezetimibe and PCSK9 inhibitors are recommended. Dr. Sean Kane 35:00 Seven is statins are still the cornerstone of management, and historically, we had the low, moderate and high intensity statin they've added to that the anticipated LDL reduction for each of those categories. High intensity is greater than 50% LDL reduction. Moderate it's 30 to 50% LDL reduction. And then the low intensity is a less than 30% LDL reduction. Speaker 1 35:21 Number eight was about primary prevention and people with diabetes. Most people with diabetes between the ages of 40 to 75 will need a moderate intensity statin. Speaker 2 35:34 Number Nine for primary prevention in persons without diabetes, you're now considering the ASCVD 10‑year risk and other factors. Dr. Sean Kane 35:42 Number 10 was that the new concept of the coronary artery calcium score as a thing that you add as a data point to your decision making process, only for that intermediate risk category, which was the ascvd risk, 10 year risk, between seven and a half and 20% to help make a decision on initiating statin therapy or escalating statin therapy. So with that, if you want to see our show notes that has links to a variety of different resources related to the 2018 guidelines, we're at HelixTalk.com episode 90. We're also on Twitter, where we kind of release a couple snippets and key concepts from past episodes at HelixTalk. And with that, I'm Dr. Kane, Speaker 2 36:19 I'm Dr. Schuman, I'm Dr. Srivastava, and as always, on behalf of Dr. Patel, study hard. Narrator - Dr. Abel 36:25 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 - ? 36:36 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.