AMA CME Accreditation Information
Credit Designation Statement: The American Medical Association designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships.
If applicable, all relevant financial relationships have been mitigated.
Video 1 Transcript
Kate Kirley: [00:02] Hello, my name is Kate Kirley. I am a family physician and health services researcher and I'm the director of chronic disease prevention at the American Medical Association. This presentation is about statin management in high-risk groups. Specifically we'll recap some of the key highlights from the 2018 ACC and AHA guideline on the management of blood cholesterol. As I already indicated, the purpose of this talk will be to touch on those highlights from the 2018 ACC and AHA guideline about blood cholesterol, and really I'll focus on reviewing statin management in the three high risk patient groups.
So first, I wanted to discuss the overall statin management approach outlined in the ACC/AHA 2018 guideline. The first step is to determine which statin management group your patient falls into. After you've determined which statin management group your patient is in, you're going to want to do two things. First, you want to institute lifestyle therapies, and simultaneously you want to initiate the appropriate intensity statin therapy. It's important to note that this is not a sequential process. The reason for this is that lifestyle therapy alone will typically not reduce LDL to the degree that we want to see in high risk patient groups. So for example, diet will typically reduce LDL by less than 10 milligrams per deciliter. And exercise really the same thing--LDL is reduced by about five milligrams per deciliter. With high risk patient groups, we want to see an LDL reduction of 30%, sometimes more than 50%. And so that's why we want to initiate both lifestyle therapies and statin therapy at the same time. Lifestyle therapy is very important, but it's not the focus of this presentation today.
After we initiate therapy, we want to monitor the patient's response to therapy, and then for certain people who are not experiencing an LDL reduction that we would like to see, we may consider adding non statin therapy as well. That is also not included in this presentation; I'm going to focus primarily on determining risk groups, appropriate intensity statin treatment, and monitoring patients responses.
So first, let's review the four statin management groups. Those with stars on them are three high risk groups that this project is focused on. The first group is patients with clinical ASCVD. This includes patients who have a history of acute coronary syndromes, patients with a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, and people with peripheral arterial disease that's presumed to be of atherosclerotic origin. The second group are adults aged 20 to 75, who have a very high LDL, which is an LDL greater than or equal to 190 milligrams per deciliter. Most of these individuals have familial hypercholesterolemia. The third group are people who have diabetes, but do not fall into the previous two groups. So this would mean people with diabetes who do not have ASCVD or do not have a very high LDL and instead have an LDL that falls between 70 and 189. The fourth group that is not the focus of this project, are people who do not have diabetes or a very elevated LDL, or ASCVD, but needs statins for primary prevention.
Now, I want to point out that the three high risk groups with the stars do not need to have their 10-year ASCVD risk calculated before statin therapy is initiated. Calculating a 10-year ASCVD risk is only required for people who fall into that primary prevention group.
Before I review appropriate intensity statin therapy in the three high risk groups, I want to first talk about how the benefits and risks play out for these three high risk groups. So this table here is recapping an analysis of enhanced data, and the way to think about this table is that this first row is focused on people who have clinical ASCVD. What they did in this study was they looked at the sample in N Haynes that has ASCVD which represents a sample in the US of 5 730 000 patients. And what we see if we give these people statins, we would expect to see 62 600 fewer ASCVD events per year. The number needed to treat for this population is 9 people, meaning that we would need to treat 9 people who have ASCVD with a statin for 10 years to prevent one incidence of ASCVD or one ASCVD event. This is actually a very, very good number needed to treat indicating that statins are highly effective for patients with ASCVD. Same thing for the next rows. So for people who have a very elevated LDL, the number needed to treat for 10 years is 19 people. Again, this indicates a highly effective number needed to treat.
The last rows here look at people with diabetes. They're broken down by their ASCVD risk, which is not something that you need to do in practice, but you do need to know that most of your patients with diabetes are going to fall into that row for people who have an ASCVD risk of greater than or equal to 7.5%. And so for this group, the number needed to treat is 15 for 10 years. So again, statins are highly effective for all of these high risk groups. And if we compare this to the numbers needed to harm, we see that we would need to treat about 167 people for five years with statins in order to cause one significant adverse event. For high intensity statins, the number needed to harm is 63. So in the end, the benefit risk trade off indicates that for people in this high risk group or these three high risk groups, statin therapy, the benefits clearly outweigh the risks.
So now let's talk about high intensity and moderate intensity statin therapy. High intensity statin therapy means using a statin that is dosed to reduce the LDL by at least 50%. There are two options in the United States: atorvastatin dosed 40 to 80 milligrams per day, and rosuvastatin dosed 20 to 40 milligrams per day. Moderate intensity statin means reducing the LDL by 30 to 49%. And you have several options there for moderate intensity statin therapy, including atorvastatin, rosuvastatin, and pravastatin at the doses indicated. I want to point out that the statins that have an asterisk next to them have a longer half-life. And what that means is that you can actually administer them at any time of day. So for patients who are struggling to take their statin at night, it may be easier for them to take it in the morning with the rest of their medications. So those with the asterisk can be administered in the morning.
Now let's review appropriate intensity statin therapy for our three high risk groups. Starting with our patients who have clinical ASCVD. This group is actually fairly straightforward. So for people age 75 and younger, it is clearly recommended and there's strong evidence that these people should be treated with a high intensity statin. For people over the age of 75, you can consider it a moderate or high intensity statin and you want to think through their risk factors and their functional status and have a conversation with your patients before you decide which intensity to pursue. We all have many patients in this age group who actually have a pretty significant life expectancy, and may be expected to live more than 10 years, and for those people, it's definitely worth considering a high intensity statin. On the other hand, if you have a patient who is frail, or could potentially struggle with multiple drug-drug interactions, in those folks perhaps a moderate intensity statin may be more appropriate.
One thing that is new about the 2018 guideline is that it addresses heart failure patients. So for patients who have clinical ASCVD, and they have heart failure due to ischemic ASCVD, and they also have a life expectancy of three or more years, consider using a moderate intensity statin. The takeaway really is that for most of our patients with clinical ASCVD, they should be on a high intensity statin. Now moving on to patients who have a very elevated LDL-C of greater than or equal to 190 milligrams per deciliter. This is also a very straightforward group. For all of these people, they should be on a high intensity statin or if they're unable to tolerate it, they should be on their maximally tolerated statin. I do have a couple notes here about additional treatments in the case where you're not seeing the expected LDL reduction. So this is a group of people in which you may consider using ezetimibe, or you may consider using a PCSK9 inhibitor if they're not experiencing the expected LDL reduction. But the focus of this project is really on appropriate statin use, and for all of these people who are able to tolerate it, you want to be using a high intensity statin.
Our third high risk group are people who have diabetes and do not fall into those previous two groups. So this is primary prevention in people who have diabetes and an LDL-C of 70 to 189 milligrams per deciliter. For adults ages 40 to 75 you want to start a moderate intensity statin regardless of their ten-year ASCVD risk. However, if they do have multiple ASCVD risk factors, you can consider using a high intensity statin in those people. For people who are over the age of 75, and who are already on a statin, it's reasonable to continue that statin. And for those who are over 75, but not already on a statin, you can consider starting one after having that risk-benefit discussion with your patient. And again, I just want to remind people that many of our patients over the age of 75 still have a significant life expectancy, and for those people, I would strongly encourage considering statin use.
The guideline also talks about adults who are under the age of 40. So adults ages 20 to 39, who have diabetes, for those people, you may consider starting a statin if they have a long duration of their diabetes, so 10 years or more, or if they already have evidence of microvascular disease.
I did want to put in a quick note about interactions. Most of the interactions that you may encounter with statins can result in increasing statin exposure. This could theoretically increase a person's chances of experiencing adverse effects. But for the most part, it's fine to use statins, and in some cases, you can choose a statin that is less likely to have an interaction. I do want to point out that atorvastatin can increase digoxin levels, and that several stands can increase an INR for people on warfarin. But that doesn't mean that you should avoid statins and people on warfarin. In fact, they're almost certainly indicated, but you do want to make sure that you monitor that patient's INR.
After you've initiated statin therapy, you need to follow up with your patients and check their lipid panel. For patients who have just started a statin you want to check a lipid panel 4 to 12 weeks later. And then after that you're checking every 3 to 12 months as indicated. Statins produce a pretty predictable response in LDL. So the main reason to check an LDL level after a patient has started a statin is to check for medication adherence. So if you don't see the expected reduction in LDL after initiating a statin, the first conversation that you want to have is about medication adherence before you think about adjusting that statin dose. One important piece in the guideline is that you don't need to routinely monitor transaminases. In fact, you don't even need to check baseline transaminases before initiating statins. I actually say the new baseline that you should be checking is having a conversation with your patient about muscle symptoms and documenting any muscle symptoms before you start statins because you may need that later on if your patient comes back experiencing potential side effects.
So I just covered a lot in a few minutes, and I'm sure you're all thinking how do I remember all of this. I recommend you take advantage of the American College of Cardiology's LDLC Manager Tools. The link is included on this slide. You can use these tools to determine the initial management group of your patient and how to initiate treatment. You can also use these tools to determine if your patient's responding appropriately to a statin as well as a tool on how to deal with statin associated side effects. Also, the Journal of the American College of Cardiology has a great guideline summary that's an excellent quick reference tool. And those are the key highlights from the 2018 ACC AHA cholesterol management guideline. Now you're ready to initiate appropriate intensity statin therapy for the three high risk groups as well as monitor responses to treatment.