High cholesterol, also known as hyperlipidemia, affects millions of individuals in the United States (US). This condition can lead to serious health issues, such as an increased risk of heart disease and stroke. Globally, approximately one-third of cases of ischaemic heart disease are linked to high cholesterol levels. Elevated total cholesterol is a significant contributor to the disease burden in both developed and developing countries, as it is a key risk factor for heart disease and stroke.

According to the Centers for Disease Control (CDC), between 2017 and 2020, 10% of adults aged 20 or older had total cholesterol levels exceeding 240 mg/dL, while around 17% had low levels of high-density lipoprotein (HDL) cholesterol below 40 mg/dL. Despite the prevalence of high cholesterol, only slightly more than half of US adults who could benefit from cholesterol-lowering medication are currently taking it, totaling 47 million individuals.

An alarming 86 million adults in the US aged 20 or older have total cholesterol levels above 200 mg/dL, with nearly 25 million individuals having levels exceeding 240 mg/dL. These statistics underscore the urgent need for increased awareness and management of high cholesterol to prevent the associated health risks.

Due to this urgent need this article will explore new advancements that have been made in in in the management of hyperlipidemia since the publication of the most recent guidelines and speculate on potential evolutions in future Hyperlipidemia or Cholesterol Clinical Practice Guidelines in light of new FDA-approved medications and emerging updates.

Part 1 – Current Hyperlipidemia Guidelines

To start, here is a listing of some of the most recent hyperlipidemia treatment and management guidelines published in the US:

Part 2 – FDA Approvals Since the Most Recent Guidelines

The medications/therapies that have been approved by the FDA since the last Hyperlipidemia Clinical Guideline published: in 2020

  • LEQVIO® (inclisiran) injection
    • Novartis
    • FDA approved:  December 2021
    • Leqvio (inclisiran) is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA used to reduce low-density lipoprotein cholesterol (LDL-C). It is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C).

  • NEXLETOL® (bempedoic acid)
    • Esperion
    • FDA approved: February 2020
    • NEXLETOL is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

  • NEXLIZET® (bempedoic acid and ezetimibe) 
    • Esperion
    • FDA approved: February 2020
    • NEXLIZET, a combination of bempedoic acid, an adenosine triphosphate citrate lyase (ACL) inhibitor, and ezetimibe, a dietary cholesterol absorption inhibitor, is indicated as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). 

Part 3 – Predictions

Now that we’ve covered the current available hyperlipidemia guidelines, the “what’s changed” and new FDA approvals since the most recent 2020 publication, we can jump into the predictions. As a reminder, this is a list of predictions focused specifically on treatment of hyperlipidemia, including pharmacological treatments. These predictions are not based on specific guidelines or a specific organization, but instead provide broad, high-level predictions covering potential next guideline(s) on the topic of hyperlipidemia, regardless of which organization produces them.

  • Prediction 1
    • Medication Approvals and Combination Therapies: It is anticipated that additional medications, such as those previously mentioned, will be included in future guidelines. These approvals offer new avenues for managing high cholesterol, particularly for individuals with genetic predispositions. Furthermore, the combination of traditional statins with newer agents like PCSK9 inhibitors and ezetimibe has shown additional benefits in reducing cholesterol levels and minimizing associated risks. This innovative approach to treatment showcases promising results in the realm of cholesterol management.
  • Prediction 2
    • Targeted Therapies: The medical community is increasingly emphasizing the use of targeted therapies, such as small interfering RNA (siRNA), which enable less frequent dosing. These therapies have the potential to significantly reduce cholesterol levels with fewer side effects. As advancements continue to be made in this field, the effectiveness and safety of targeted therapies are expected to improve, offering patients a more efficient and manageable treatment option for managing cholesterol levels.
  • Prediction 3
    • Lifestyle Interventions: Lifestyle interventions play a crucial role in managing hyperlipidemia, with a strong emphasis on heart-healthy habits such as diet and exercise. It is expected that future guidelines will further integrate these lifestyle interventions with medical treatments to optimize patient outcomes.

There you have it – an overview of the current hyperlipidemia guidelines, updates on recent major changes and FDA approvals have happened since publication, and our informal, but evidence-based, predictions for what the next guidelines may include. Once the next hyperlipidemia guideline update is released, we will compare our predictions to the actual changes to assess our accuracy.

In the interim, we welcome suggestions for other topics you would like to see covered in future guideline prediction series articles. Please feel free to contact us with your ideas.

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