Maura Jones, PharmD, BCPS, on Lipid Management for Patients With Diabetes
In this podcast, Maura J. Jones, PharmD, BCPS, discusses clinical practice guidelines and various medication regimens for managing cardiovascular disease risks in patients with diabetes. This was a topic she recently presented on at ADCES21.
Raney EC, Jones MJ. Reducing cardiovascular risk in diabetes through lipid management. Talk presented at: Association of Diabetes Care & Education Specialists Conference; August 12-15, 2021; Virtual.
Maura Jones, PharmD, BCPS, is an assistant professor at Midwestern University's College of Pharmacy in Glendale, Arizona.
Leigh Precopio: Hello everyone, and welcome to another installment of Podcasts360, your go‑to resource for medical news and clinical updates. I'm your moderator, Leigh Precopio, with Consultant360.
Cardiovascular risk management is just one of the many aspects health care practitioners must consider when treating patients with diabetes. Lipid management through the use of statin medications is common among these patients, but is not the only pharmacotherapy option available for reducing cardiovascular disease risk.
Today, we are joined by Maura Jones, PharmD, BCPS, who recently presented on this topic at the Association of Diabetes Care and Education Specialists (ADCES) 2021 Conference. Dr Jones is an assistant professor at Midwestern University's College of Pharmacy in Glendale, Arizona.
Thank you for taking the time to speak with me today about your presentation. Could you give us a brief overview of your session?
Maura Jones: Sure. We know that individuals with diabetes are at an increased risk for atherosclerotic cardiovascular events or ASCVD. Dyslipidemia itself contributes to that risk and historically statin medications have been recommended for primary and secondary prevention of ASCVD.
In this session my colleague Aaron Rainey and I reviewed guideline‑recommended lipid management for patients specifically with diabetes, and then discussed the pharmacotherapy options, a few of them, beyond statin medications.
Leigh Precopio: Could you briefly discuss the latest updates to the clinical practice guidelines for managing hyperlipidemia in patients with diabetes?
Maura Jones: Of course. When we consider clinical practice guidelines, again for specifically patients with diabetes and their dyslipidemia management, there are quite a few guidelines that are available.
Three that I'll mention now and that we discussed during the session are, 1, the ACCAHA multisociety guidelines that were published in 2019. Just published last year in October, the AACE and ACE management of dyslipidemia and prevention of cardiovascular diseases. Then 3, the American Diabetes Association standards of medical care, which are published every year, most recently in January of this year.
Each of these guidelines vary slightly in the cardiovascular risk assessment that they recommend for patients. However, all of them do use that 10‑year ASCVD risk score. As far as pharmacotherapy recommendations overall for patients with diabetes, which is a risk factor again for ASCVD itself, each of the guidelines do recommend at least a moderate to high‑intensity statin for these patients.
Then, just as a reminder, that intensity reflects the percent LDL lowering. For those high‑intensity statins we would anticipate at least a 50% LDL lowering. Each guideline slightly differs again in their lipid goals. Primarily, that goal that they're looking for is an LDL of less than 70, or at least targeting that max tolerated statin dose.
Overall, like I mentioned, most of the guidelines that do specifically discuss patients with diabetes and dyslipidemia management, those statin medications are going to be the first line recommended for pharmacotherapy.
Leigh Precopio: What are some patient‑specific factors, such as age or other health conditions, that would impact whether you initiate statins or other pharmacotherapy options in patients with diabetes?
Maura Jones: Yeah, that's a great question, and it kind of goes hand‑in‑hand with the clinical practice guideline discussion. As mentioned, each guideline does slightly vary in their patient‑specific considerations when looking at cardiovascular risk assessment. All of them do use that 10‑year ASCVD risk score, which includes patient's age, and their history of diabetes, hypertension, those sort of risk factors.
The ACC/AHA guidelines more specifically discussed diabetes‑specific risk enhancers. Those risk factors include how long patients have had diabetes. For patients with type 2 diabetes, that risk increased when it's been over 10 years, whereas it's over 20 years for type 1 diabetes.
Additionally, those diabetes‑specific risk enhancers include microvascular complications, such as an albuminuria, neuropathy, nephropathy, retinopathy, or a GFR of less than 60. Finally, the last one that ACC/AHA guidelines consider is an ABI, or ankle brachial index, of less than 0.9.
Other risk factors, like I mentioned, do include age. Generally patients over the age of 50 are at a higher risk as well as other ASCVD risk factors in general.
Leigh Precopio: Are there any potential drug interactions that may occur between statins or non‑statin regimens and insulin therapy?
Maura Jones: The short answer to that question of statins or non‑statin regimens and drug interactions with insulin, the short answer is no. There's not a direct interaction with insulin therapy itself. I did briefly want to mention though that there has been some literature published on statins and the increased risk of elevating hemoglobin A1C. Potentially, statins could increase blood glucose causing hyperglycemia. However, it has been found that the benefits of statin from an ASCVD risk reduction and dyslipidemia management far outweighs that risk of hyperglycemia.
On the flip side, there's also been some literature published on the risk of hypoglycemia, specifically in patients who are critically ill and using high‑intensity statins. Theoretically that risk could be increased with the addition of insulin therapy.
But again, these have been seen in a minor subset of patients and so in general it would be safe for patients to use insulin therapy in addition to statin or non‑statin regimens to help manage not only their diabetes but also that ASCVD risk reduction.
Leigh Precopio: What is the role of non‑statin medications for patients with diabetes?
Maura Jones: For patients with diabetes and the use of non‑statin medication, again, this comes into play a little differently between the different guidelines. As all guidelines recommend statins are first line therapy for dyslipidemia management in patients with diabetes.
However, there may be certain scenarios in which patients either, 1, do not qualify for statin due to potentially intolerance, or maybe they have a history of an allergy. Or patients may need additional lipid lowering therapy in addition to that statin so these non‑statin medications may be used in combination.
Going back to the guidelines for patients at very high risk or extreme ASCVD risk, or for patients who've already had an ASCVD event and we want to provide that secondary prevention. These patients may have an LDL goal of less than 70 or even less than 55, and they may require the addition of a non‑statin medication to help achieve those LDL lowering goals.
For example, the PCSK9 inhibitors are going to be one of the agents that we have with the highest additional LDL lowering in addition to a statin. Some of our historical agents that have been used, ezetimibe and colesevalam, the bile acid resins can be also used. However, they do come with more side effects, including GI upset and drug‑drug interactions. Bempedoic acid is one of the newest approved medications that will also provide additional LDL lowering in addition to statins and works by inhibiting that cholesterol synthesis in the liver.
Briefly going back to the question on drug interactions, there are not necessarily interactions with these non‑statin medications with insulin. However bempedoic acid has been shown to increase statin levels specifically for simvastatin at a dose of greater than 20 milligrams a day, and pravastatin at a dose of greater than 40 milligrams a day. Just something to keep in mind of additional drug interactions when selecting those non‑statin medications.
Leigh Precopio: What management strategies are recommended for patients who report statin intolerance?
Maura Jones: For statin intolerance in evaluation and management we don't want to label patients as statin intolerance with 1 incidence of potentially muscle pain or weakness. There are some guidance as to how to specifically evaluate these patients, and one consideration is the use of the SAMS‑CI score, which is the statin‑associated muscle symptoms clinical index score.
When considering this score we want to take into account, are there other causes that can affect the musculoskeletal system that these patients are experiencing? Are there any drug interactions that might be worsening the risk for the statin side effects that we can mitigate?
Consider screening patients for hypothyroidism or vitamin D deficiency, which can contribute to muscle pain outside of statin therapy. If at this point, and we've ruled other causes out, we can discontinue the statin and if patients experience resolution of these muscle symptoms, we may be able to find that correlation. If those symptoms do resolve, it's recommended to restart the statin at a lower dose, have an alternative regimen, or even try an alternative statin. We don't want to call it one and done. If patients are still experiencing those muscle side effects and intolerance, at this point, we could classify them as statin intolerant, and then consider a non‑statin lipid therapy.
However, just to re‑emphasize that we don't want to rule these patients out initially from that first muscle weakness complaint. Especially because we know the benefits that patients can receive from statin therapies.
Leigh Precopio: What are the key takeaway messages from your session? How can these takeaways be implemented in clinical practice?
Maura Jones: I think, overall, the 3 takeaways from this session would be that, 1, again statins are and remain the primary pharmacotherapy recommendation for lipid management in patients with diabetes, especially at a high risk of ASCVD events.
Two, we also want to consider that before classifying a patient as statin intolerance, there could be other causes that are creating this muscle pain or weakness. Should we try other statins first? We really want to work through that checklist before labeling patients as statin intolerant because we do know the exceptional benefits that patients may receive from taking these statin therapies.
Three, there are additional options as alternatives or in addition to statin therapy for further LDL lowering and ASCVD risk reduction with even more medications in the pipeline. With the new medications, especially the PCSK9 inhibitors that are injectable, we want to keep in mind different patient factors and considerations whenever we are implementing this into practice.
I believe that for this implementation, whether it's the statin therapy alone, in combination with non‑statin medications, or just non‑statin medications by themselves, we definitely want to take that patient‑centered approach, provide patient education, and ensure, overall, that patients are able to obtain and access these medications, and that they understand the benefits that they will receive out of them.
Leigh Precopio: Great. Thank you so much for answering all of my questions today.
Maura Jones: Thank you for the opportunity. I really appreciate it.