Endocrine Practice 31 (2025) 236e262
Endocrine
Practice TM
www.endocrinepractice.org
AACE Clinical Guidance
American Association of Clinical Endocrinology Clinical Practice
Guideline on Pharmacologic Management of Adults
With Dyslipidemia
Shailendra B. Patel, BM, ChB, DPhil 1, Kathleen L. Wyne, MD, PhD, FACE, FNLA 2,
Samina Afreen, MD 3, L. Maria Belalcazar, MD 4, Melanie D. Bird, PhD, MSAM 5,
Sarah Coles, MD, FAAFP 6, Joel C. Marrs, PharmD, MPH 7, Carol Chiung-Hui Peng, MD 8,
Vishnu Priya Pulipati, MD 9, Shahnaz Sultan, MD, MHSc, AGAF 10,
Mihail Zilbermint, MD, MBA, FACE 11, 12
1
University of Cincinnati, Cincinnati, and Cincinnati Veterans Affairs Medical Center, Ohio
2
The Ohio State University Wexner Medical Center, Columbus, Ohio
3
University of Virginia, Charlottesville, Virginia
4
University of Texas Medical Branch, Galveston, Texas
5
American Association of Clinical Endocrinology, Jacksonville, Florida
6
North Country HealthCare, Flagstaff, Arizona
7
University of Tennessee Health Sciences Center, Nashville, Tennessee
8
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan
9
Warren Clinic Endocrinology, St. Francis Health System, Tulsa, Oklahoma
10
University of Minnesota, Minneapolis, Minnesota
11
Johns Hopkins University School of Medicine, Baltimore, Maryland
12
Johns Hopkins Community Physicians, Baltimore, Maryland
a r t i c l e i n f o a b s t r a c t
Article history: Objective: To review the evidence and provide updated and new recommendations for the phar-
Received 21 August 2024 macologic management of adults with dyslipidemia to prevent adverse cardiovascular outcomes.
Received in revised form These recommendations are intended for use by clinicians, health care team members, patients,
19 September 2024 caregivers, and other stakeholders.
Accepted 23 September 2024 Methods: This guideline was developed by a multidisciplinary task force of content experts and
guideline methodologists based on systematic reviews of randomized controlled trials or cohort
studies from database inception to November 7, 2023. An updated literature search was completed
for any additional articles published by May 31, 2024. Clinical questions addressing nonstatin
Abbreviations: AACE, American Association of Clinical Endocrinology; ApoB, apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; BA, bempedoic acid; CAC,
coronary artery calcium; CI, confidence interval; COI, conflict of interest; CPG, clinical practice guidelines; CV, cardiovascular; CVD, cardiovascular disease; DHA, docosa-
hexaenoic acid; DM, diabetes mellitus; EPA, eicosapentaenoic acid; FDA, U.S. Food and Drug Administration; FRS, Framingham Risk Score; GRADE, Grading of Recom-
mendations Assessment, Development, and Evaluation; HDL-C, high-density lipoprotein cholesterol; HeFH, heterozygous familial hypercholesterolemia; HoFH, homozygous
familial hypercholesterolemia; IPE, icosapent ethyl; LDL-C, low-density lipoprotein cholesterol; LDLR, low-density lipoprotein receptor; Lp(a), lipoprotein a; mAb, monoclonal
antibody; MACE, major adverse cardiovascular event; MI, myocardial infarction; MID, minimally important difference; NRI, net reclassification index; OTC, over-the-counter;
PCE, Pooled Cohort Equations; PCSK9, proprotein convertase subtilisin/kexin type 9; PICO, population, intervention, comparator, outcome(s); PVD, peripheral vascular
disease; RCT, randomized controlled trial; RR, risk ratio; TG, triglyceride; T1D, type 1 diabetes mellitus; T2D, type 2 diabetes mellitus.
Address correspondence to American Association of Clinical Endocrinology, 7643 Gate Pkwy, Ste 104-328, Jacksonville, FL 32256.
Email address:
Disclaimer: American Association of Clinical Endocrinology clinical practice guidelines include systematically developed recommendations to assist health care professionals
in medical decision-making for specific clinical conditions. Most of the content herein is based on scientific evidence. In areas of uncertainty, or when clarification is required,
expert opinion and professional judgment were applied. This guideline is a working document that reflects the state of the field at the time of publication. Since rapid
changes in this area are expected, periodic revisions are inevitable. We encourage health care professionals to use this information in conjunction with their best clinical
judgment. The presented recommendations may not be appropriate in all situations. Any decision(s) by health care professionals to apply the recommendations provided in
this guideline, including prescribing of any medications, must be made in consideration of the recommendations presented, the most recently published prescribing in-
formation for medications, local resources, and individual patient circumstances.
https://doi.org/10.1016/j.eprac.2024.09.016
1530-891X/© 2024 AACE. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
,S.B. Patel, K.L. Wyne, S. Afreen et al. Endocrine Practice 31 (2025) 236e262
medications and patient-important outcomes were prioritized. The task force assessed the certainty
Key Words:
of the evidence and developed recommendations using the Grading of Recommendations Assess-
atherosclerotic cardiovascular disease
ment, Development, and Evaluation framework. All recommendations were based on the consid-
cardiovascular risk
eration of the certainty of the evidence across patient-important outcomes, in addition to issues of
cholesterol
feasibility, acceptability, equity, and patient preferences and values.
dyslipidemia
Results: This guideline update includes 13 evidence-based recommendations for the pharmacologic
guideline
management of adults with dyslipidemia focused on patient-important outcomes of atherosclerotic
hypertriglyceridemia
cardiovascular disease (ASCVD) risk reduction. The task force issued a good practice statement to
pharmacotherapy
assess the risk of ASCVD events for primary prevention in adults with dyslipidemia. The task force
suggested the use of alirocumab, evolocumab, or bempedoic acid for adults who have ASCVD or who
are at increased risk for ASCVD in addition to standard care. The task force suggested against the use
of these medications in adults without ASCVD. There was insufficient evidence to recommend for or
against the addition of inclisiran. For adults with hypertriglyceridemia and ASCVD or increased risk
of ASCVD, the task force suggested the use of eicosapentaenoic acid but not eicosapentaenoic acid
plus docosahexaenoic acid and strongly recommended against the use of niacin. There was insuf-
ficient evidence for recommendations regarding pharmacologic management in adults with severe
hypertriglyceridemia (500 mg/dL). The task force suggested a low-density lipoprotein cholesterol
treatment goal of <70 mg/dL in adults with dyslipidemia and ASCVD or at increased risk of ASCVD.
Conclusions: Pharmacotherapy is recommended in adults with dyslipidemia to reduce the risk of
ASCVD events. There are several effective and safe treatment options for adults with dyslipidemia
who have ASCVD or at increased risk of ASCVD who need additional lipid-lowering medications.
Shared decision-making discussions are essential to determine the best option for each individual.
© 2024 AACE. Published by Elsevier Inc. All rights are reserved, including those for text and data mining,
AI training, and similar technologies.
Scope and Purpose highest prevalence of CVD.7 Inequities in health care access
contribute to variations in use of dyslipidemia medications because
Given the high prevalence of dyslipidemia in the global popu- statin prescriptions vary by race, ethnicity, sex, area poverty level,
lation and the introduction of newer treatment options, the pur- income level, and insurance coverage.8,9 While cardiovascular (CV)
pose of this clinical practice guideline is to provide practical events are higher in men than women, women experience higher
evidence-based recommendations for nonstatin pharmacother- rates of CV-related mortality.7
apies for the management of dyslipidemia. This guideline focuses Multiple endocrine disorders are associated with dyslipidemia,
on critical aspects of risk assessment and the benefits and harms with diabetes mellitus (DM) presenting the largest challenge. For
of newer pharmacologic treatment options for adults with persons with DM, CVD is the leading cause of death, contributing to
dyslipidemia and their impact on individual patient-important >66% of deaths with as many as 95% of patients with type 2 DM
atherosclerotic cardiovascular disease (ASCVD)erelated outcomes. (T2D) having 1 abnormal lipid level, for which clinicians need to
Clinical topics such as screening, lipid panels, nutrition, physical be able to assess and make treatment recommendations.10,11
activity, and statin use are not addressed, but relevant guidance Management of hypertriglyceridemia, particularly severe hyper-
from AACE and others may be referenced to facilitate imple- triglyceridemia, continues to be an important area to address with
mentation. The target audience for this guideline are all clinicians evidence-based guidance. While lifestyle changes and statin ther-
and health care team members who care for adults with dyslipi- apy remain the foundations of management for adults with dysli-
demia. The target population is adults with dyslipidemia. Differing pidemia,12-14 there are newer data available from an increasing
treatment options for specific subgroups of individuals were dis- number of CV outcomes trials using agents such as the proprotein
cussed if evidence was available. convertase subtilisin/kexin type 9 (PCSK9) inhibitors, icosapent
ethyl (IPE), and bempedoic acid (BA).
Introduction This 2025 clinical practice guideline serves as a focused update
of the 2017 AACE Guidelines for Management of Dyslipidemia and
The global burden of ASCVD remains high, with more than half a Prevention of Cardiovascular Disease13 and provides evidence-
billion people around the world affected, resulting in 20.5 million based recommendations for the pharmacologic management of
deaths in 2021.1 More than 800,000 people in the United States die adults with dyslipidemia by clinicians and their care teams. While
of cardiovascular disease (CVD) each year, accounting for 1 in every this guideline is primarily focused on pharmacotherapy, the task
3 deaths.2 Despite recent substantial decreases in the rates of force emphasized the importance of ASCVD risk assessment,
premature CVD mortality in adults 25 to 64 years of age, heart including regular screening for dyslipidemia, and non-
disease causes 1 in 5 deaths in this age group.3 CVD mortality in pharmacologic interventions. Healthy dietary and lifestyle patterns
younger adults also substantially impacts health care burden, costs, are critical for improvement of patient-important outcomes and
and the economy. The cost of heart disease including health care successful management of dyslipidemia. The task force supports
services, medicines, and lost productivity was >$252 billion in continual patient-centered discussions on lifestyle patterns and
2020.4 At least 25% of these deaths are directly attributed to offering or referring adults who are at increased risk for ASCVD to
elevated low-density lipoprotein cholesterol (LDL-C) as the primary intensive counseling interventions to promote healthy diet and
but not the only marker of dyslipidemia.5 LDL-C levels have physical activity (Figure).12 The target populations for the recom-
decreased in recent years, but >76% of adults with ASCVD in the U.S. mendations include adults with dyslipidemia (see Box A for more
have LDL-C levels >70 mg/dL and over a quarter of adults without details).
ASCVD had LDL-C levels >130 mg/dL.6 The recommendations are supported by a rigorous evaluation of
The prevalence of CVD is impacted by social determinants of the current evidence, which includes consideration of study limi-
health and varies by race/ethnicity with Black adults having the tations as well as benefits and harms of different treatment options
237
, S.B. Patel, K.L. Wyne, S. Afreen et al. Endocrine Practice 31 (2025) 236e262
Fig. Summary of Recommendations: Pharmacotherapy for Adults with Dyslipidemia to Prevent ASCVD Events.
238
Endocrine
Practice TM
www.endocrinepractice.org
AACE Clinical Guidance
American Association of Clinical Endocrinology Clinical Practice
Guideline on Pharmacologic Management of Adults
With Dyslipidemia
Shailendra B. Patel, BM, ChB, DPhil 1, Kathleen L. Wyne, MD, PhD, FACE, FNLA 2,
Samina Afreen, MD 3, L. Maria Belalcazar, MD 4, Melanie D. Bird, PhD, MSAM 5,
Sarah Coles, MD, FAAFP 6, Joel C. Marrs, PharmD, MPH 7, Carol Chiung-Hui Peng, MD 8,
Vishnu Priya Pulipati, MD 9, Shahnaz Sultan, MD, MHSc, AGAF 10,
Mihail Zilbermint, MD, MBA, FACE 11, 12
1
University of Cincinnati, Cincinnati, and Cincinnati Veterans Affairs Medical Center, Ohio
2
The Ohio State University Wexner Medical Center, Columbus, Ohio
3
University of Virginia, Charlottesville, Virginia
4
University of Texas Medical Branch, Galveston, Texas
5
American Association of Clinical Endocrinology, Jacksonville, Florida
6
North Country HealthCare, Flagstaff, Arizona
7
University of Tennessee Health Sciences Center, Nashville, Tennessee
8
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan
9
Warren Clinic Endocrinology, St. Francis Health System, Tulsa, Oklahoma
10
University of Minnesota, Minneapolis, Minnesota
11
Johns Hopkins University School of Medicine, Baltimore, Maryland
12
Johns Hopkins Community Physicians, Baltimore, Maryland
a r t i c l e i n f o a b s t r a c t
Article history: Objective: To review the evidence and provide updated and new recommendations for the phar-
Received 21 August 2024 macologic management of adults with dyslipidemia to prevent adverse cardiovascular outcomes.
Received in revised form These recommendations are intended for use by clinicians, health care team members, patients,
19 September 2024 caregivers, and other stakeholders.
Accepted 23 September 2024 Methods: This guideline was developed by a multidisciplinary task force of content experts and
guideline methodologists based on systematic reviews of randomized controlled trials or cohort
studies from database inception to November 7, 2023. An updated literature search was completed
for any additional articles published by May 31, 2024. Clinical questions addressing nonstatin
Abbreviations: AACE, American Association of Clinical Endocrinology; ApoB, apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; BA, bempedoic acid; CAC,
coronary artery calcium; CI, confidence interval; COI, conflict of interest; CPG, clinical practice guidelines; CV, cardiovascular; CVD, cardiovascular disease; DHA, docosa-
hexaenoic acid; DM, diabetes mellitus; EPA, eicosapentaenoic acid; FDA, U.S. Food and Drug Administration; FRS, Framingham Risk Score; GRADE, Grading of Recom-
mendations Assessment, Development, and Evaluation; HDL-C, high-density lipoprotein cholesterol; HeFH, heterozygous familial hypercholesterolemia; HoFH, homozygous
familial hypercholesterolemia; IPE, icosapent ethyl; LDL-C, low-density lipoprotein cholesterol; LDLR, low-density lipoprotein receptor; Lp(a), lipoprotein a; mAb, monoclonal
antibody; MACE, major adverse cardiovascular event; MI, myocardial infarction; MID, minimally important difference; NRI, net reclassification index; OTC, over-the-counter;
PCE, Pooled Cohort Equations; PCSK9, proprotein convertase subtilisin/kexin type 9; PICO, population, intervention, comparator, outcome(s); PVD, peripheral vascular
disease; RCT, randomized controlled trial; RR, risk ratio; TG, triglyceride; T1D, type 1 diabetes mellitus; T2D, type 2 diabetes mellitus.
Address correspondence to American Association of Clinical Endocrinology, 7643 Gate Pkwy, Ste 104-328, Jacksonville, FL 32256.
Email address:
Disclaimer: American Association of Clinical Endocrinology clinical practice guidelines include systematically developed recommendations to assist health care professionals
in medical decision-making for specific clinical conditions. Most of the content herein is based on scientific evidence. In areas of uncertainty, or when clarification is required,
expert opinion and professional judgment were applied. This guideline is a working document that reflects the state of the field at the time of publication. Since rapid
changes in this area are expected, periodic revisions are inevitable. We encourage health care professionals to use this information in conjunction with their best clinical
judgment. The presented recommendations may not be appropriate in all situations. Any decision(s) by health care professionals to apply the recommendations provided in
this guideline, including prescribing of any medications, must be made in consideration of the recommendations presented, the most recently published prescribing in-
formation for medications, local resources, and individual patient circumstances.
https://doi.org/10.1016/j.eprac.2024.09.016
1530-891X/© 2024 AACE. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
,S.B. Patel, K.L. Wyne, S. Afreen et al. Endocrine Practice 31 (2025) 236e262
medications and patient-important outcomes were prioritized. The task force assessed the certainty
Key Words:
of the evidence and developed recommendations using the Grading of Recommendations Assess-
atherosclerotic cardiovascular disease
ment, Development, and Evaluation framework. All recommendations were based on the consid-
cardiovascular risk
eration of the certainty of the evidence across patient-important outcomes, in addition to issues of
cholesterol
feasibility, acceptability, equity, and patient preferences and values.
dyslipidemia
Results: This guideline update includes 13 evidence-based recommendations for the pharmacologic
guideline
management of adults with dyslipidemia focused on patient-important outcomes of atherosclerotic
hypertriglyceridemia
cardiovascular disease (ASCVD) risk reduction. The task force issued a good practice statement to
pharmacotherapy
assess the risk of ASCVD events for primary prevention in adults with dyslipidemia. The task force
suggested the use of alirocumab, evolocumab, or bempedoic acid for adults who have ASCVD or who
are at increased risk for ASCVD in addition to standard care. The task force suggested against the use
of these medications in adults without ASCVD. There was insufficient evidence to recommend for or
against the addition of inclisiran. For adults with hypertriglyceridemia and ASCVD or increased risk
of ASCVD, the task force suggested the use of eicosapentaenoic acid but not eicosapentaenoic acid
plus docosahexaenoic acid and strongly recommended against the use of niacin. There was insuf-
ficient evidence for recommendations regarding pharmacologic management in adults with severe
hypertriglyceridemia (500 mg/dL). The task force suggested a low-density lipoprotein cholesterol
treatment goal of <70 mg/dL in adults with dyslipidemia and ASCVD or at increased risk of ASCVD.
Conclusions: Pharmacotherapy is recommended in adults with dyslipidemia to reduce the risk of
ASCVD events. There are several effective and safe treatment options for adults with dyslipidemia
who have ASCVD or at increased risk of ASCVD who need additional lipid-lowering medications.
Shared decision-making discussions are essential to determine the best option for each individual.
© 2024 AACE. Published by Elsevier Inc. All rights are reserved, including those for text and data mining,
AI training, and similar technologies.
Scope and Purpose highest prevalence of CVD.7 Inequities in health care access
contribute to variations in use of dyslipidemia medications because
Given the high prevalence of dyslipidemia in the global popu- statin prescriptions vary by race, ethnicity, sex, area poverty level,
lation and the introduction of newer treatment options, the pur- income level, and insurance coverage.8,9 While cardiovascular (CV)
pose of this clinical practice guideline is to provide practical events are higher in men than women, women experience higher
evidence-based recommendations for nonstatin pharmacother- rates of CV-related mortality.7
apies for the management of dyslipidemia. This guideline focuses Multiple endocrine disorders are associated with dyslipidemia,
on critical aspects of risk assessment and the benefits and harms with diabetes mellitus (DM) presenting the largest challenge. For
of newer pharmacologic treatment options for adults with persons with DM, CVD is the leading cause of death, contributing to
dyslipidemia and their impact on individual patient-important >66% of deaths with as many as 95% of patients with type 2 DM
atherosclerotic cardiovascular disease (ASCVD)erelated outcomes. (T2D) having 1 abnormal lipid level, for which clinicians need to
Clinical topics such as screening, lipid panels, nutrition, physical be able to assess and make treatment recommendations.10,11
activity, and statin use are not addressed, but relevant guidance Management of hypertriglyceridemia, particularly severe hyper-
from AACE and others may be referenced to facilitate imple- triglyceridemia, continues to be an important area to address with
mentation. The target audience for this guideline are all clinicians evidence-based guidance. While lifestyle changes and statin ther-
and health care team members who care for adults with dyslipi- apy remain the foundations of management for adults with dysli-
demia. The target population is adults with dyslipidemia. Differing pidemia,12-14 there are newer data available from an increasing
treatment options for specific subgroups of individuals were dis- number of CV outcomes trials using agents such as the proprotein
cussed if evidence was available. convertase subtilisin/kexin type 9 (PCSK9) inhibitors, icosapent
ethyl (IPE), and bempedoic acid (BA).
Introduction This 2025 clinical practice guideline serves as a focused update
of the 2017 AACE Guidelines for Management of Dyslipidemia and
The global burden of ASCVD remains high, with more than half a Prevention of Cardiovascular Disease13 and provides evidence-
billion people around the world affected, resulting in 20.5 million based recommendations for the pharmacologic management of
deaths in 2021.1 More than 800,000 people in the United States die adults with dyslipidemia by clinicians and their care teams. While
of cardiovascular disease (CVD) each year, accounting for 1 in every this guideline is primarily focused on pharmacotherapy, the task
3 deaths.2 Despite recent substantial decreases in the rates of force emphasized the importance of ASCVD risk assessment,
premature CVD mortality in adults 25 to 64 years of age, heart including regular screening for dyslipidemia, and non-
disease causes 1 in 5 deaths in this age group.3 CVD mortality in pharmacologic interventions. Healthy dietary and lifestyle patterns
younger adults also substantially impacts health care burden, costs, are critical for improvement of patient-important outcomes and
and the economy. The cost of heart disease including health care successful management of dyslipidemia. The task force supports
services, medicines, and lost productivity was >$252 billion in continual patient-centered discussions on lifestyle patterns and
2020.4 At least 25% of these deaths are directly attributed to offering or referring adults who are at increased risk for ASCVD to
elevated low-density lipoprotein cholesterol (LDL-C) as the primary intensive counseling interventions to promote healthy diet and
but not the only marker of dyslipidemia.5 LDL-C levels have physical activity (Figure).12 The target populations for the recom-
decreased in recent years, but >76% of adults with ASCVD in the U.S. mendations include adults with dyslipidemia (see Box A for more
have LDL-C levels >70 mg/dL and over a quarter of adults without details).
ASCVD had LDL-C levels >130 mg/dL.6 The recommendations are supported by a rigorous evaluation of
The prevalence of CVD is impacted by social determinants of the current evidence, which includes consideration of study limi-
health and varies by race/ethnicity with Black adults having the tations as well as benefits and harms of different treatment options
237
, S.B. Patel, K.L. Wyne, S. Afreen et al. Endocrine Practice 31 (2025) 236e262
Fig. Summary of Recommendations: Pharmacotherapy for Adults with Dyslipidemia to Prevent ASCVD Events.
238
