- Recent ACS (within the past 12 mo.)
- History of MI (other than recent ACS event listed above)
- History of ischemic stroke
- Symptomatic PAD (history of claudication with ABI <0.85, or previous revascularization or amputation)
∗ For example, in the Treating to New Targets trial, patients with CHD who received 10 mg of atorvastatin daily had a 5-y event rate of 10.9%, and those who received 80 mg of atorvastatin daily had a 5-y event rate of 8.7%. These numbers (and similar rates from other trials) may inform the number-needed-to-treat. Additional consideration of comorbidities and other poorly controlled or well-controlled risk factors will increase or decrease risk accordingly. See Table 1 for criteria for defining patients at very high risk.
† Use the Pooled Cohort Equations to estimate 10-y ASCVD risk. See Table 1 for criteria for defining patients at very high risk.
‡ Such evidence exists for ezetimibe from the IMPROVE-IT study, with a 6% relative/2% absolute risk reduction in a composite ASCVD endpoint over 7 y when added to a moderate-intensity statin. Evidence from FOURIER and ODYSSEY Outcomes demonstrate 2% absolute/15% relative ASCVD risk reduction. Data are lacking for addition of BAS to statins, bempedoic acid, inclisiran, and evinacumab. Niacin preparations have been associated with no benefit and potential for significant harms when added to statin therapy.
§ For example, patients on maximally-tolerated statin therapy with LDL-C ≥130 mg/dL may receive more benefit from the addition of a nonstatin therapy than those with on-statin LDL-C of 80 mg/dL.
‖For example, when added to statins, ezetimibe may lower LDL-C an additional 20%-25% on average; PCSK9 inhibitors may lower LDL-C an additional 60% on average. For each 40-mg/dL reduction in LDL-C using safe and evidence-based therapies, there appears to be an approximate 20% relative risk reduction in ASCVD. This number, combined with the baseline absolute risk, may inform the number-needed-to-treat.
Abbreviations:| ICD-10 Category | Clinical Criteria | With Genetic Testing Performed |
| Heterozygous FH |
|
|
| Homozygous FH |
|
|
| Family history of FH |
|
|
| Persistent Hypertriglyceridemia | Fasting triglycerides > 150 mg/dL following a minimum of 4 to 12 weeks of lifestyle intervention, a stable dose of maximally tolerated statin therapy when indicated, as well as evaluation and management of secondary causes of hypertriglyceridemia. Before beginning triglyceride risk-based nonstatin therapies, a fasting lipid panel should be obtained (2 measurements of fasting lipids, preferably at least 2 weeks apart is recommended). |
| Fasting vs Nonfasting Lipid Measurement | In most patients, the postprandial rise in triglycerides is small, between 12 and 27 mg/dL. The 2018 AHA/ACC/ multisociety cholesterol guideline recommends that for adults aged > 20 years not taking lipid-lowering drug therapy, either a fasting or nonfasting lipid profile may be used to estimate ASCVD risk and document baseline LDL-C. For those with nonfasting triglycerides > 400 mg/dL, a repeat fasting lipid profile is recommended to assess fasting triglycerides and baseline LDL-C. The Martin-Hopkins method provides accurate assessments of LDL-C in individuals with hypertriglyceridemia. Fasting lipid testing is favored under the following circumstances: a) To establish the diagnosis of the metabolic syndrome, as one of the criteria is fasting triglycerides > 150 mg/dL b) To identify lipid disorders in those without ASCVD, but with a family history of premature ASCVD or genetic lipid disorders c) To assess adherence to lifestyle and medical therapy in those being treated with lipid-lowering medication d) To identify those with triglycerides > 500 mg/dL, who are at risk for hypertriglyceridemia-induced pancreatitis, and monitor their response to therapy. |
| Secondary Causes of Hypertriglyceridemia | It is crucial that clinicians investigate and treat secondary causes of hypertriglyceridemia. Diseases, diet/lifestyle, medications, and disorders of metabolism are major causes for elevation of triglycerides that clinicians can use to rule out secondary causes of hypertriglyceridemia. These factors can either cause or contribute to triglyceride elevations in patients. Poor glycemic control may significantly influence plasma lipid levels in patients with diabetes mellitus and significantly exacerbate hypertriglyceridemia. A genetic predisposition to hypertriglyceridemia increases the likelihood and severity of elevated triglycerides in each category. Multifactorial chylomicronemia syndrome is the most common condition that elevates triglyceride levels high enough to cause lipemia retinalis, eruptive xanthomas, abdominal pain, and hyperlipidemic pancreatitis. Clinicians should understand the drugs and conditions which make this disease more likely as pancreatitis associated with hypertriglyceridemia can be fatal. |
| Lifestyle Intervention | Lifestyle modification (ie, adherence to a heart-healthy diet, regular physical activity, avoidance of tobacco products, limited alcohol consumption, and maintenance of a healthy weight) remains a critical component of ASCVD risk reduction, both before and in concert with the use of lipid-lowering medications. Referral to a registered dietitian nutritionist is strongly recommended to improve understanding of heart-healthy dietary principles and individualize nutrition recommendations for patients with hypertriglyceridemia. Given that metabolic risk factors such as hypertriglyceridemia cluster with other metabolic risk factors (abdominal obesity, hypertension, hyperglycemia), adherence to a recommended dietary intervention can markedly benefit the entire metabolic risk profile over the life course. Adherence to lifestyle modification should be regularly assessed at the time of initiation or modification of statin therapy and at each patient visit during monitoring of ongoing therapy. |
| Role of Statin Therapy in Patients with Hypertriglyceridemia | Although commonly recognized for their impact on LDL-C, statins also provide a 10 to 30% dose-dependent triglyceride reduction in patients with elevated triglyceride levels. Trials have demonstrated those with elevated triglyceride levels are at increased risk of ASCVD events and can achieve ASCVD risk reduction with statin therapy. |
| Persistent Hypertriglyceridemia as a Risk-Enhancing Factor in Primary Prevention | Persistently elevated triglycerides (nonfasting triglycerides > 175 mg/dL) are one of the risk-enhancing factors identified by the 2018 AHA/ACC/multisociety cholesterol guideline, according to which the 10-year ASCVD risk derived using the Pooled Cohort Equations (PCE) is a useful tool to predict population risk. However, clinicians should be aware that it has limitations when applied to individuals. The PCE may overestimate risk in individuals from higher socioeconomic status, as well as in those receiving consistent screening and preventive care. One purpose of the discussion is to individualize risk status based on the PCE estimate as well as other factors. These factors may suggest a higher lifetime risk than is denoted by the 10-year risk estimate with the PCE. |
| Role of Omega-3 Fatty Acids in Patients with Hypertriglyceridemia |
|
∗ For example, in the Treating to New Targets trial, patients with CHD who received 10 mg of atorvastatin daily had a 5-y event rate of 10.9%, and those who received 80 mg of atorvastatin daily had a 5-y event rate of 8.7%. These numbers (and similar rates from other trials) may inform the number-needed-to-treat. Additional consideration of comorbidities and other poorly controlled or well-controlled risk factors will increase or decrease risk accordingly. See Table 1 for criteria for defining patients at very high risk.
† Use the Pooled Cohort Equations to estimate 10-y ASCVD risk. See Table 1 for criteria for defining patients at very high risk.
‡ Such evidence exists for ezetimibe from the IMPROVE-IT study, with a 6% relative/2% absolute risk reduction in a composite ASCVD endpoint over 7 y when added to a moderate-intensity statin. Evidence from FOURIER and ODYSSEY Outcomes demonstrate 2% absolute/15% relative ASCVD risk reduction. Data are lacking for addition of BAS to statins, bempedoic acid, inclisiran, and evinacumab. Niacin preparations have been associated with no benefit and potential for significant harms when added to statin therapy.
§ For example, patients on maximally-tolerated statin therapy with LDL-C ≥130 mg/dL may receive more benefit from the addition of a nonstatin therapy than those with on-statin LDL-C of 80 mg/dL.
‖For example, when added to statins, ezetimibe may lower LDL-C an additional 20%-25% on average; PCSK9 inhibitors may lower LDL-C an additional 60% on average. For each 40-mg/dL reduction in LDL-C using safe and evidence-based therapies, there appears to be an approximate 20% relative risk reduction in ASCVD. This number, combined with the baseline absolute risk, may inform the number-needed-to-treat.
Abbreviations:| ICD-10 Category | Clinical Criteria | With Genetic Testing Performed |
| Heterozygous FH |
|
|
| Homozygous FH |
|
|
| Family history of FH |
|
|
*Optimal risk levels for lifetime risk are represented by the simultaneous presence of all of the following: Untreated total cholesterol <180 mg/dL, untreated blood pressure <120/<80 mm Hg, no diabetes history, and not a current smoker
†Nonoptimal risk levels for lifetime risk are represented by 1 or more of the following: Untreated total cholesterol of 180 to 199 mg/dL, untreated systolic blood pressure of 120 to 139 mm Hg or diastolic blood pressure of 80 to 89 mm Hg, and no diabetes history and not a current smoker
‡Elevated risk levels for lifetime risk are represented by 1 or more of the following: Untreated total cholesterol of 200 to 239 mg/dL, untreated systolic blood pressure of 140 to 159 mm Hg or diastolic blood pressure of 90 to 99 mm Hg, and no diabetes history and not a current smoker
§Major risk levels for lifetime risk are represented by any of the following: Total cholesterol ≥240 mg/dL or treated, systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg or treated, or diabetes, or current smoker
Clinical ASCVD includes acute coronary syndromes, history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin.
High-intensity statin therapy should be initiated or continued as first-line therapy in women and men ≤75 years of age who have clinical ASCVD, unless contraindicated.
In individuals with clinical ASCVD in whom high-intensity statin therapy would otherwise be used, when high-intensity statin therapy is contraindicated or when characteristics predisposing to statin-associated adverse effects are present, moderate-intensity statin should be used as the second option if tolerated.
In individuals with clinical ASCVD >75 years of age, it is reasonable to evaluate the potential for ASCVD risk-reduction benefits and for adverse effects, drug-drug interactions and to consider patient preferences, when initiating a moderate- or high-intensity statin. It is reasonable to continue statin therapy in those who are tolerating it. (IIa B)
Individuals with LDL-C ≥190 mg/dL or triglycerides ≥500 mg/dL should be evaluated for secondary causes of hyperlipidemia. (I B)
Adults ≥21 years of age with primary LDL-C ≥190 mg/dL should be treated with high-intensity statin therapy unless contraindicated. For individuals unable to tolerate high-intensity statin therapy, use the maximum tolerated statin intensity. (I B)
For individuals ≥21 years of age with an untreated primary LDL-C ≥190 mg/dL, it is reasonable to intensify statin therapy to achieve at least a 50% LDL-C reduction. (IIa B)
For individuals ≥21 years of age with an untreated primary LDL-C ≥190 mg/dL, after the maximum intensity of statin therapy has been achieved, addition of a nonstatin drug may be considered to further lower LDL-C. Evaluate the potential for ASCVD risk reduction benefits, adverse effects, drug-drug interactions, and consider patient preferences. (IIb C)
Moderate-intensity statin therapy should be initiated or continued for adults 40 to 75 years of age with diabetes mellitus.
High-intensity statin therapy is reasonable for adults 40 to 75 years of age with diabetes mellitus with a ≥7.5% estimated 10-year ASCVD risk unless contraindicated. (IIa B)
In adults with diabetes mellitus, who are <40 or >75 years of age, it is reasonable to evaluate the potential for ASCVD benefits and for adverse effects, for drug-drug interactions, and to consider patient preferences when deciding to initiate, continue, or intensify statin therapy. (IIa C)
The Pooled Cohort Equations should be used to estimate 10-year ASCVD risk for individuals with LDL-C 70 to 189 mg/dL without clinical ASCVD to guide initiation of statin therapy for the primary prevention of ASCVD. (I B)
Before initiating statin therapy for the primary prevention of ASCVD in adults with LDL-C 70 - 189 mg/dL without clinical ASCVD or diabetes it is reasonable for clinicians and patients to engage in a discussion which considers the potential for ASCVD risk reduction benefits and for adverse effects, for drug-drug interactions, and patient preferences for treatment. (IIa C)
Adults 40 to 75 years of age with LDL-C 70 to 189 mg/dL, without clinical ASCVD or diabetes and an estimated 10-year ASCVD risk ≥7.5% should be treated with moderate- to high-intensity statin therapy.
It is reasonable to offer treatment with a moderate-intensity statin to adults 40 to 75 years of age, with LDL-C 70 to 189 mg/dL, without clinical ASCVD or diabetes and an estimated 10-year ASCVD risk of 5% to <7.5%. (IIa B)
In adults with LDL-C <190 mg/dL who are not otherwise identified in a statin benefit group, or for whom after quantitative risk assessment a risk-based treatment decision is uncertain, additional factors may be considered to inform treatment decision making. In these individuals, statin therapy for primary prevention may be considered after evaluating the potential for ASCVD risk reduction benefits, adverse effects, drug-drug interactions, and discussion of patient preferences. (IIb C)
These factors may include:
Statin benefit may be less clear in other groups; additional factors may be considered to inform treatment decision making.
| Primary Prevention Recommendations for Adults 40-75 Years LDL 70-189 mg/dL (1.7 - 4.8 mmol/L) | ||
|---|---|---|
| COR | LOE | Recommendations |
| I | A | 1. In adults at intermediate-risk, statin therapy reduces risk of ASCVD and in the context of a risk discussion, if a decision is made for statin therapy, a moderate- intensity statin should be recommended. |
| I | A | 2. In intermediate risk patients, LDL-C levels should be reduced by ≥ 30%, and for optimal ASCVD risk reduction, especially in high-risk patients, achieve LDL-C reductions of ≥ 50%. |
| I | B-NR | 3. For the primary prevention of clinical ASCVD* in adults 40 to 75 years of age without diabetes and with LDL-C 70 to 189 mg/dL (1.7 to 4.8 mmol/L), the 10-year ASCVD risk of a first "hard" ASCVD event (fatal and non-fatal MI or stroke) should be estimated using the race and sex-specific Pooled Cohort Equations (PCE) and adults should be categorized as low risk (<5%), borderline risk (5 to <7.5%), intermediate-risk (≥7.5 to <20%), and high-risk (≥20%). |
| I | B-NR | 4. Clinicians and patients should engage in a risk discussion that considers risk factors, adherence to healthy lifestyle, the potential for ASCVD risk-reduction benefits and the potential for adverse effects and drug–drug interactions, as well as patient preferences for an individualized treatment decision. |
| IIa | B-R | 5. In intermediate-risk adults, risk-enhancing factors favor initiation or intensification of statin therapy. |
| IIa | B-NR | 6. In intermediate-risk or selected borderline-risk adults, if the decision about statin usage remains uncertain, it is reasonable to use a coronary artery calcium (CAC) score in the decision to withhold, postpone or initiate statin therapy. |
| IIa | B-NR |
7. In intermediate-risk adults or selected
borderline-risk adults in whom a CAC score is
measured for the purpose of making a treatment
decision, AND
|
| IIb | B-R | 8. In intermediate-risk adults who would benefit from more aggressive LDL-C lowering and in whom high-intensity statins are advisable, but not acceptable or tolerated, it may be reasonable to add a non-statin drug (ezetimibe or bile acid sequestrant) to a moderate-intensity statin. |
| IIb | B-R | 9. In patients at borderline risk, in risk discussion, the presence of risk-enhancing factors may justify initiation of moderate-intensity statin therapy. |
| Recommenendations for Older Adults | ||
|---|---|---|
| COR | LOE | Recommendations |
| IIb | B-R | 1. In adults > 75 years of age with LDL-C of 70 to 189 mg/dL (1.7 to 4.8 mmol/L), initiating a moderate- intensity statin may be reasonable. |
| IIb | B-R | 2. In adults > 75 years of age, it may be reasonable to stop statin therapy when functional decline (physical or cognitive), multimorbidity, frailty or reduced life expectancy limit the potential benefits of statin therapy. |
| IIb | B-R | 3. In adults 76-80 years of age with LDL-C of 70 to 189 mg/dL (1.7 to 4.8 mmol/L), it may be reasonable to measure coronary artery calcium (CAC) to reclassify those with CAC = 0 to avoid statin therapy. |
| Recommenendations for Patients with Diabetes Mellitus | ||
|---|---|---|
| COR | LOE | Recommendations |
| I | A | 1. In adults 40 to 75 years of age with diabetes, regardless of estimated 10-year ASCVD risk, moderate-intensity statin therapy is indicated. |
| IIa | A | 2. In adults with diabetes who are 40 to 75 years of age and have LDL-C 70 to 189 mg/dL (1.7 to 4.8 mmol/L), it is reasonable to assess the 10-year risk of a first ASCVD event using the race and sex-specific Pooled Cohort Equations (PCE) to help stratify ASCVD risk. |
| IIa | B-NR | 3. In adults with diabetes who have multiple ASCVD risk factors, it is reasonable to prescribe high-intensity statin therapy with the aim to reduce LDL-C by ≥50%. |
| IIa | B-NR | 4. In adults with diabetes older than 75 years of age who are already on statin therapy, it is reasonable to continue statin therapy. |
| IIb | C-LD | 5. In adults with diabetes and 10-year ASCVD risk ≥20%, it may be reasonable to add ezetimibe to maximum tolerated statin therapy to reduce LDL-C by ≥50%. |
| IIb | C-LD | 6. In adults with diabetes older than 75 years, after a patient discussion of potential benefits and risks, it may be reasonable to initiate statin therapy. |
| IIb | C-LD | 7. In adults 20 to 39 years of age with diabetes either of long duration (≥10 years of Type 2 diabetes, ≥20 years of Type 1), and/or albuminuria (≥30 mcg albumin/mg creatinine), eGFR <60 ml/min/m², retinopathy, neuropathy, it may be reasonable to initiate statin therapy. |
| Recommenendations for Primary Severe Hypercholesterolemia (LDL-C ≥ 190 mg/dL (≥ 4.9 mmol/L)) | ||
|---|---|---|
| COR | LOE | Recommendations |
| I | B-R | 1. In patients 20 to 75 years of age with LDL-C ≥190 mg/dL (≥4.9 mmol/L), maximally-tolerated statin therapy is recommended. |
| IIa | B-R | 2. In patients 20 to 75 years of age with LDL-C ≥ 190 mg/dL (≥4.9 mmol/L), who achieve less than 50% reduction in LDL-C while receiving maximally-tolerated statin therapy, and/or have an LDL-C-≥100 mg/dL (≥2.6 mmol/L), ezetimibe therapy is reasonable. |
| IIb | B-R | 3. In patients 20 to 75 years of age with a baseline LDL-C ≥190 mg/dL (≥4.9 mmol/L), who achieve less than 50% reduction in LDL-C and have fasting triglycerides >300 mg/dL (>3.4 mmol/L) while taking maximally-tolerated statin and ezetimibe therapy, the addition of a bile acid sequestrant may be considered. |
| IIb | B-R | 4. In heterozygous familial hypercholesterolemia patients 30 to 75 years of age with LDL-C ≥100 mg/dL (≥2.6 mmol/L) while taking maximally-tolerated statin and ezetimibe therapy, the addition of a PCSK9 inhibitor may be considered. |
| IIb | C-LD | 5. In patients 40 to 75 years of age with a baseline LDL-C ≥220 mg/dL (≥5.7 mmol/L) who achieve on treatment LDL-C ≥130 mg/dL (≥3.4 mmol/L), while receiving maximally-tolerated statin and ezetimibe therapy, the addition of a PCSK9 inhibitor may be considered. |
| Value Statement: Uncertain Value (B-NR) | 6. Among patients with familial hypercholesterolemia without evidence of clinical ASCVD taking maximally-tolerated statin and ezetimibe therapy, PCSK9 inhibitors provide uncertain value at 2018 US list prices. | |
| Recommenendations for Statin Therapy Use in Patients with ASCVD | ||
|---|---|---|
| COR | LOE | Recommendations |
| I | A | 1. In patients ≤75 years of age with clinical ASCVD*, high-intensity statin therapy should be initiated or continued with the aim of achieving a ≥70% reduction in LDL-C. |
| I | A | 2. In patients with clinical ASCVD in whom high-intensity statin therapy is contraindicated or who experience statin-associated side effects, moderate-intensity statin therapy should be initiated or continued with the aim of achieving a 30-49% reduction in LDL-C. |
| IIa | B-R | 3. In patients with clinical ASCVD who are on maximally tolerated statin therapy and are judged to be at very high-risk, and have LDL-C ≥70 mg/dL (≥1.8 mmol/L), it is reasonable to add ezetimibe therapy. |
| IIa | A SR | 4. In patients with clinical ASCVD, who are judged to be very high-risk and who are on maximally tolerated statin therapy and ezetimibe and have LDL-C ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg/dL (≥2.6 mmol/L), it is reasonable to add a PCSK9 inhibitor following a clinician-patient discussion about the net benefit, safety, and cost. |
| Value Statement: Low Value (LOE: B-NR) | 5. Among patients with clinical ASCVD at high-risk and taking maximally tolerated statin and ezetimibe therapy, PCSK9 inhibitors provide low economic value at 2018 US list prices. | |
| IIa | B-R | 6. In patients with clinical ASCVD older than 75 years, it is reasonable to initiate moderate or high-intensity statin therapy after evaluating the potential for ASCVD risk-reduction, adverse effects, drug-drug interactions, frailty, and patient preferences. |
| IIa | C-LD | 7. In patients with clinical ASCVD older than 75 years of age who are tolerating high-intensity statin therapy, it is reasonable to continue high-intensity statin therapy after evaluating the potential for ASCVD risk-reduction, adverse effects, drug-drug interactions, frailty, and patient preferences. |
| IIb | B-R | 8. In patients with clinical ASCVD who are receiving maximally tolerated statin therapy and LDL-C remains ≥70 mg/dL (≥1.8 mmol/L), it may be reasonable to add ezetimibe. |
| IIb | B-R | 9. In patients with heart failure with reduced ejection fraction due to ischemic heart disease who have a reasonable life expectancy (3-5 years) and are not already on a statin due to ASCVD, clinicians may consider initiation of moderate-intensity statin therapy to reduce the occurrence of ASCVD events. |
This flow diagram is intended to serve as an easy reference guide summarizing recommendations for ASCVD risk assessment and treatment. Assessment of the potential for benefit and risk from statin therapy for ASCVD prevention provides the framework for clinical decision making incorporating patient preferences.
* Percent reduction in LDL–C can be used as an indication of response and adherence to therapy, but is not in itself a treatment goal.
† The Pooled Cohort Equations can be used to estimate 10-year ASCVD risk in individuals with and without diabetes. The estimator within this application should be used to inform decision making in primary prevention patients not on a statin.
‡ Consider moderate-intensity statin as more appropriate in low-risk individuals.
§ For those in whom a risk assessment is uncertain, consider factors such as primary LDL–C ≥160 mg/dL or other evidence of genetic hyperlipidemias, family history of premature ASCVD with onset <55 years of age in a first-degree male relative or <65 years of age in a first-degree female relative, hs-CRP >2 mg/L, CAC score ≥300 Agatston units, or ≥75th percentile for age, sex, and ethnicity (for additional information, see http://www.mesa-nhlbi.org/CACReference.aspx), ABI <0.9, or lifetime risk of ASCVD. Additional factors that may aid in individual risk assessment may be identified in the future.
|| Potential ASCVD risk-reduction benefits. The absolute reduction in ASCVD events from moderate- or high-intensity statin therapy can be approximated by multiplying the estimated 10-year ASCVD risk by the anticipated relative risk reduction from the intensity of statin initiated (~30% for moderate-intensity statin or ~45% for high-intensity statin therapy). The net ASCVD risk reduction benefit is estimated from the number of potential ASCVD events prevented with a statin compared to the number of potential excess adverse events.
¶ Potential adverse effects. The excess risk of diabetes is the main consideration in ~0.1 excess cases per 100 individuals treated with a moderate-intensity statin for 1 year and ~0.3 excess cases per 100 individuals treated with a high-intensity statin for 1 year. In RCTs, both statin-treated and placebo-treated participants experienced the same rate of muscle symptoms. The actual rate of statin-related muscle symptoms in the clinical population is unclear. Muscle symptoms attributed to statin therapy should be evaluated (see Statin Safety Recommendations).
ABI indicates ankle-brachial index; ASCVD, atherosclerotic cardiovascular disease; CAC, coronary artery calcium; hs-CRP, high-sensitivity C-reactive protein; LDL–C, low-density lipoprotein cholesterol; MI, myocardial infarction; RCT, randomized controlled trial.
Daily dose lowers LDL-C, on average by approximately <30%
| dose | |
|---|---|
Daily dose lowers LDL-C, on average by approximately 30% to <50%
| dose | |
|---|---|
Daily dose lowers LDL-C, on average by approximately ≥50%
| dose | |
|---|---|
Statins and doses that are approved by the U.S. FDA but were not tested in the RCTs reviewed are listed in parentheses
* Evidence from 1 RCT (down-titration if unable to tolerate atorvastatin 80 mg)
** Initiation of or titration to simvastatin 80 mg is not recommended by the FDA due to increased risk of myopathy, including rhabdomyolysis
*Fasting lipid panel preferred. In a nonfasting individual, a non–HDL–C ≥ 220 mg/dL may indicate genetic hypercholesterolemia that requires further evaluation or a secondary etiology. If nonfasting triglycerides are ≥ 500 mg/dL, a fasting lipid panel is required.
†In those already on a statin, in whom baseline LDL–C is unknown, an LDL–C <100 mg/dL was observed in most individuals receiving high-intensity statin therapy in RCTs.
‡Refer to Statin Safety Recommendations
To maximize the safety of statins, selection of the appropriate statin and dose in men and nonpregnant/nonnursing women should be based on patient characteristics, level of ASCVD risk, and potential for adverse effects.
Moderate-intensity statin therapy should be used in individuals in whom high-intensity statin therapy would otherwise be recommended when characteristics predisposing them to statin associated adverse effects are present.
Characteristics predisposing individuals to statin adverse effects include, but are not limited to: (I B)
Additional characteristics that may modify the decision to use higher statin intensities may include, but are not limited to:
It is reasonable to evaluate and treat muscle symptoms, including pain, tenderness, stiffness, cramping, weakness, or fatigue, in statin-treated patients according to the following management algorithm: (IIa B)
Individuals receiving statin therapy should be evaluated for new-onset diabetes mellitus according to the current diabetes screening guidelines. Those who develop diabetes mellitus during statin therapy should be encouraged to adhere to a heart healthy dietary pattern, engage in physical activity, achieve and maintain a healthy body weight, cease tobacco use, and continue statin therapy to reduce their risk of ASCVD events. (I B)
For individuals taking any dose of statins, it is reasonable to use caution in individuals >75 years of age, as well as in individuals that are taking concomitant medications that alter drug metabolism, taking multiple drugs, or taking drugs for conditions that require complex medication regimens (e.g., those who have undergone solid organ transplantation or are receiving treatment for HIV). A review of the manufacturer's prescribing information may be useful before initiating any cholesterol-lowering drug. (IIa C)
For individuals presenting with a confusional state or memory impairment while on statin therapy, it may be reasonable to evaluate the patient for nonstatin causes, such as exposure to other drugs, as well as for systemic and neuropsychiatric causes, in addition to the possibility of adverse effects associated with statin drug therapy. (IIb C)
The "2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk" provides clear recommendations for estimating cardiovascular disease risk. Risk assessments are extremely useful when it comes to reducing risk for cardiovascular disease because they help determine whether a patient is at high risk for cardiovascular disease, and if so, what can be done to address any cardiovascular risk factors a patient may have. Here are the highlights of the guideline:
Risk assessments are used to determine the likelihood of a patient developing cardiovascular disease, heart attack or stroke in the future. In general, patients at higher risk for cardiovascular disease require more intensive treatment to help prevent the development of cardiovascular disease.
Risk assessments are calculated using a number of factors including age, gender, race, cholesterol and blood pressure levels, diabetes and smoking status, and the use of blood pressure-lowering medications. Typically, these factors are used to estimate a patient's risk of developing cardiovascular disease in the next 10 years. For example, someone who is young with no risk factors for cardiovascular disease would have a very low 10-year risk for developing cardiovascular disease. However, someone who is older with risk factors like diabetes and high blood pressure will have a much higher risk of developing cardiovascular disease in the next 10 years.
If a preventive treatment plan is unclear based on the calculation of risk outlined above, care providers should take into account other factors such as family history and level of C-reactive protein. Taking this additional information into account should help inform a treatment plan to reduce a patient's 10-year risk of developing cardiovascular disease.
Calculating the 10-year risk for cardiovascular disease using traditional risk factors is recommended every 4-6 years in patients 20-79 years old who are free from cardiovascular disease. However, conducting a more detailed 10-year risk assessment every 4-6 years is reasonable in adults ages 40-79 who are free of cardiovascular disease. Assessing a patient's 30-year risk of developing cardiovascular disease can also be useful for patients 20-59 years of age who are free of cardiovascular disease and are not at high short-term risk for cardiovascular disease.
Risk estimations vary drastically by gender and race. Patients with the same traditional risk factors for cardiovascular disease such as high blood pressure can have a different 10-year risk for cardiovascular disease as a result of their sex and race.
After care providers and patients work together to conduct a risk assessment, it's important that they discuss the implications of their findings. Together, patients and their care providers should weigh the risks and benefits of various treatments and lifestyle changes to help reduce the risk of developing cardiovascular disease.
Source: www.cardiosmart.org
The "2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk" provides recommendations for heart-healthy lifestyle choices based on the latest research and evidence. The guidelines focus on two important lifestyle choices--diet and physical activity--which can have a drastic impact on cardiovascular health. Here's what every patient should know about the latest recommendations for reducing cardiovascular disease risk through diet and exercise.
Source: www.cardiosmart.org
The "2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults" was created to reflect the latest research to outline best practices when it comes to treating obesity--a condition that affects more than one-third of American adults. These guidelines help address questions like "What's the best way to lose weight?" and "When is bariatric surgery appropriate?". Here is what every patient should know about the treatment of overweight and obesity:
Definition of obesity: Obesity is a medical condition in which excess body fat has accumulated to the extent that it can have an adverse effect on one's health. Obesity can be diagnosed using body mass index (BMI), a measurement of height and weight, as well as waist circumference. Obesity is categorized as having a BMI of 30 or greater. Abdominal obesity is defined as having a waist circumference greater than 40 inches for a man or 35 inches for a woman.
Benefits of weight loss: Obesity increases the risk for serious conditions such as cardiovascular disease, diabetes and death, but losing just a little bit of weight can result in significant health benefits. For an adult who is obese, losing just 3-5% of body weight can improve blood pressure and cholesterol levels and reduce the risk for cardiovascular disease and diabetes. Ideally, care providers recommend 5-10% weight loss for obese adults, which can produce even greater health benefits.
Weight loss strategies: There is no single diet or weight loss program that works best for all patients. In general, reduced caloric intake and a comprehensive lifestyle intervention involving physical activity and behavior modification tailored according to a patient's preferences and health status is most successful for sustained weight loss. Further, weight loss interventions should include frequent visits with health care providers and last more than one year for sustained weight loss.
Bariatric Surgery: Bariatric surgery may be a good option for severely obese patients to reduce their risk of health complications and improve overall health. However, bariatric surgery should be reserved for only the highest risk patients until more evidence is available on this issue. Present guidelines advise that weight loss surgery is only recommended for patients with extreme obesity (BMI ≥40) or in patients that have a BMI ≥35 in addition to a chronic health condition.
Source: www.cardiosmart.org
The American College of Cardiology (ACC) and the American Heart Association (AHA) recently developed new standards for treating blood cholesterol. These recommendations are based on a thorough and careful review of the very latest, highest quality clinical trial research. They help care providers deliver the best care possible. This page provides some of the highlights from the new practice guidelines. The ultimate goal of the new cholesterol practice guidelines is to reduce a person's risk of heart attack, stroke and death. For this reason, the focus is not just on measuring and treating cholesterol, but identifying whether someone already has or is at risk for atherosclerotic cardiovascular disease (ASCVD) and could benefit from treatment.
Heart attack and stroke are usually caused by atherosclerotic cardiovascular disease (ASCVD). ASCVD develops because of a build-up of sticky cholesterol-rich plaque. Over time, this plaque can harden and narrow the arteries.
These practice guidelines outline the most effective treatments that lower blood cholesterol in those individuals most likely to benefit. Most importantly, they were selected as the best strategies to lower cholesterol to help reduce future heart attack or stroke risk. Share this information with your health care provider so that you can ask questions and work together to decide what is right for you.
Based on the most up-to-date and complete look at available clinical trial results:
Health care providers should focus on identifying those people who are most likely to have a heart attack or stroke and make sure they are given effective treatment to reduce their risk.
Cholesterol should be considered along with other factors known to make a heart attack or stroke more likely.
Knowing your risk of heart attack and stroke can help you and your health care provider decide whether you may need to take a medication—most likely a statin—to lower that risk.
If a medication is needed, statins are recommended as the first choice to lower heart attack and stroke risk among certain higher-risk patients based on an overwhelming amount of evidence. For those unable to take a statin, there are other cholesterol-lowering drugs; however, there is less research to support their use.
Your health care provider will first want to assess your risk of ASCVD (assuming you don't already have it). This information will help determine if you are at high enough risk of a heart attack or stroke to need treatment.
To do this, your care provider will 1) review your medical history and 2) gauge your overall risk for heart attack or stroke. He/she will likely want to know:
whether you have had a heart attack, stroke or blockages in the arteries of your heart, neck, or legs.
your risk factors. In addition to your total cholesterol, LDL cholesterol, and HDL (so-called "good") cholesterol, your health care provider will consider your age, if you have diabetes, and whether you smoke and/or have high blood pressure.
about your lifestyle habits, other medical conditions, any previous drug treatments, and if anyone in your family has high cholesterol or suffered a heart attack or stroke at an early age.
A lipid or blood cholesterol panel will be needed as part of this evaluation. This blood test measures the amount of fatty substances (called lipids) in your blood. You may have to fast (not eat for a period of time) before having your blood drawn.
If there is any question about your risk of ASCVD, or whether you might benefit from drug therapy, your care provider may make additional assessments or order additional tests. The results of these tests can help you and your health care team decide what might be the best treatment for you. These tests may include:
Lifetime risk estimates —how likely you are to have a heart attack and stroke during your lifetime
Coronary artery calcium (CAC) score —a test that shows the presence of plaque or fatty build-up in the heart artery walls
High-sensitivity C-Reactive Protein (CRP) —a blood test that measures the amount of CRP, a marker of inflammation or irritation in the body; higher levels have been associated with heart attack and stroke
Ankle-brachial index (ABI) —the ratio of the blood pressure in the ankle compared to blood pressure in the arm, which can predict peripheral artery disease (PAD)
If you have very high levels of low-density lipoprotein (LDL or "bad") cholesterol, your care provider may want to find out if you have a genetic or familial form of hypercholesterolemia. This condition can be passed on in families.
Before coming up with a specific treatment plan, your care provider will talk with you about options for lowering your blood cholesterol and reducing your personal risk of atherosclerotic disease. This will likely include a discussion about heart-healthy living and whether you might benefit from a cholesterol-lowering medication.
Adopting a heart-healthy lifestyle continues to be the first and best way to lower your risk of problems. Doing so can also help control or prevent other risk factors (for example: high blood pressure or diabetes). Experts suggest:
Eating a diet rich in vegetables, fruits, and whole grains ; this also includes low-fat dairy products, poultry, fish, legumes, and nuts; it limits intake of sweets, sugar-sweetened beverages and red meats.
Getting regular exercise ; check with your health care provider about how often and how much is right for you.
Maintaining a healthy weight .
Not smoking or getting help quitting .
Staying on top of your health , risk factors and medical appointments. For some people, lifestyle changes alone may not be enough to prevent a heart attack or stroke. In these cases, taking a statin at the right dose will most likely be necessary.
There are two types of cholesterol-lowering medications: statins and non-statins.
There is a large body of evidence that shows the use of a statin provides the greatest benefit and fewest safety issues. In particular, specific groups of patients appear to benefit most from taking moderate or high-intensity statin therapy. Based on this information, your care provider will likely recommend a statin if you have:
ASCVD
Very high LDL cholesterol (190 mg/dL or higher)
Type 2 diabetes and are between 40 and 75 years of age
Above a certain likelihood of having a heart attack or stroke in the next 10 years (7.5% or higher) and are between 40 and 75 years of age
In certain cases, your care provider may still recommend a statin even if you don't fit into one of the groups above. He/she will consider your overall health and other factors to help decide if you are at enough risk to benefit from a statin. Based on the guidelines, these may include:
Family history of premature heart attack or stroke
Your lifetime risk of ASCVD
LDL-cholesterol ≥160 mg/dL
hs-CRP ≥2 mg/L
Results from other special testing (CAC scoring, ABI)
People who have had a heart attack, stroke or other types of ASCVD tend to benefit the most from taking the highest amount (dose) of statin therapy if they tolerate it. This may be more appropriate than taking multiple drugs to lower cholesterol.
A more moderate dose of statin may be appropriate for some people with ASCVD, such as those over 75 years or those that might have problems taking the highest dose of a statin (i.e., those with prior organ transplantation).
Sometimes more than one statin needs to be tried before finding the one that works best.
If you are 75 years or older and have not already had a heart attack, stroke or other types of ASCVD, your care provider will discuss whether a statin is right for you.
Not all patients will be able to take the optimum dose of statin. After attention to lifestyle changes and statin therapy, non-statin drugs may be considered if you have high-risk with known ASCVD, diabetes, or very high LDL cholesterol values (≥190 mg/dL) and:
Have side effects from statins that prevent you from getting to the optimal dose or are not able to take a statin at all.
Are limited from taking an optimal dose due to other drugs that you are taking, including:
Transplant drug regimens to prevent rejection
Multiple drugs to treat HIV
Some antibiotics like erythromycin and clarithromycin or certain oral anti-fungal drugs
As always, it's important to talk with your health care provider about which medication is right for you.
Although keeping LDL-cholesterol lower with an optimal dose of statin is supported strongly by clinical trials, getting to a specific goal level is not.
Take steps to lower your risk factors for heart attack, stroke and other problems —Make healthy choices (eating a healthy diet, getting exercise, maintaining a healthy weight and not smoking). Drug therapy, if needed, can help control risk factors.
Report side effects —Muscle aches are commonly reported and may or may not be due to the statin. If you are having problems, your care provider needs to know to help manage any side effects and possibly switch you to a different statin.
Take your medications as directed .
Get blood cholesterol and other tests that are recommended by your health care team. These can help assess whether statin therapy—and the dose—is working for you.
What are my risk factors for heart attack and stroke? Am I on the best prevention program to minimize this risk?
Is my cholesterol high enough that it might be due to a genetic condition?
What lifestyle changes can I make to stay healthy and prevent problems?
Do I need to be on a statin?
How do I monitor how I am doing?
What should I do if I develop muscle aches or weakness after starting the statin?
What do I do if I have other symptoms after starting the statin?
Source: www.cardiosmart.org
For additional cardiovascular terms visit www.cardiosmart.org
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February 2024
The ACC Lipid Manager app is meant to be used in relation to patients who may need lifestyle intervention or drug therapy to lower their triglycerides and/or LDL-C, particularly with the goal to lower their risk for heart disease and stroke.
The ACC Lipid Manager app contains four tools to help clinicians manage a patient’s CV risk from therapy initiation through treatment calibration with a goal of lowering ASCVD risk:
Each tool within the app is designed to be used on its own or in combination to manage a patient’s therapy throughout their continuum of care. The Lipid Manager App aims to streamline use at point of care by offering access to all of ACC’s Lipid management tools from one place.
Advice from the LDL-C Lowering Therapy tool is derived from the 2022 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk, meant to address current gaps in care for LDL-C lowering by providing firmer and more specific guidance on the adequacy of statin therapy and whether or when to use non-statin therapies if response to statins is deemed inadequate. The app is intended for use with patients who are currently taking or who have attempted to take a statin.
The ACC Statin Intolerance App guides clinicians through the process of managing and treating patients who report muscle symptoms while on statin therapy. The information and recommendations in this app are derived from the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults, and the prescribing information for each statin.
Hypertriglyceridemia is a tool based on the 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia. Consensus recommendations are provided for clinicians and patients regarding unique aspects of lifestyle interventions for management of hypertriglyceridemia and the use of statins and triglyceride risk-based nonstatin therapies for ASCVD risk reduction in the following patient groups with persistent hypertriglyceridemia:
The ASCVD Risk Estimator within this app offers the same functionality as ACC’s pre-existing app of the same name. It is intended as a companion tool to the 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk and the 2018 ACC/AHA Guideline on the Management of Blood Cholesterol. This Risk Estimator enables health care providers and patients to estimate 10-year and lifetime risks for atherosclerotic cardiovascular disease (ASCVD), defined as coronary death or nonfatal myocardial infarction, or fatal or nonfatal stroke, based on the Pooled Cohort Equations and lifetime risk prediction tools. The Risk Estimator is intended for use with patients without ASCVD with a LDL-cholesterol <190 mg/dL.
The information and recommendations in this App and all its component tools are meant to support clinical decision making. They are not meant to represent the only or best course of care, or replace clinical judgment. Therapeutic options should be determined after discussion between the patient and their care provider.
Tools within the app were designed and vetted through collaboration with writing committee members from each of the ACC clinical policy source documents, members of the LDL Think Tank Work Group, and the ACC Best Practices and Quality Improvement Subcommittee. It was further refined via user testing with physicians, nurse practitioners, pharmacists, and other specialties.
This was developed as part of the ACC's Lipid Management Solutions Initiative. Financial support for the Initiative was provided by Amgen Inc and Regeneron. All of the content was independently developed with no sponsor involvement.
Please see the Resources section of this App for links to additional references.
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