# Cholesterol numbers and medicines explained Guide · id `cardio:guide-cholesterol-numbers-and-medicines` · Cardiovascular Atlas · release `f4600233112e1c27` (public) > General information only. This guide shows what the sources it cites say. It is not medical advice, it cannot tell you what is right for you, and no clinician has reviewed it. Talk to a qualified health professional about your own care. In an emergency, call your local emergency number. > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. What LDL and Lp(a) are, the levels that MedlinePlus and the abstract of a 2018 guideline that a 2026 guideline replaces name, and where statins and other cholesterol medicines fit. It does not read anyone's own result. ## What LDL and Lp(a) are - LDL and HDL are two types of lipoproteins, which combine fat and protein so the fat can move through the blood. [1] - LDL is sometimes called bad cholesterol because a high LDL level leads to a buildup of cholesterol in the arteries. [1] - According to MedlinePlus, extra LDL forms plaque in the arteries, and plaque buildup in the arteries of the heart is coronary artery disease. [2] - MedlinePlus describes lipoprotein (a), written Lp(a), as a type of LDL. [3] - It says Lp(a) particles are stickier than other LDL particles, so they may be more likely to cause blockages and blood clots in the arteries. [3] - Genes control how much Lp(a) a person makes, and NHLBI says the level is unlikely to shift much over a lifetime. [4, 5] - MedlinePlus also says diet and exercise may not change Lp(a) levels. [4] - MedlinePlus says a routine cholesterol test can show a healthy-looking LDL level. [3] - It says the risk could still be high if Lp(a) carries a large share of the LDL. [3] ## The numbers on a cholesterol test - A cholesterol test, also known as a lipid panel, is a blood test that measures cholesterol and triglycerides, a type of fat. [6] - Cholesterol is usually measured in milligrams of cholesterol per deciliter of blood, written mg/dL. [7] - The LDL on a report may be calculated, an estimate from total cholesterol, HDL and triglycerides, or measured directly from the blood sample. [7] - For adults aged 20 or older, MedlinePlus lists an LDL of less than 100 mg/dL as a healthy level. [7] - MedlinePlus says a healthy level may depend on age, family history, lifestyle and other risk factors. [7] - It says a provider can explain what is right for the person. [7] ## Levels named for starting medicines - MedlinePlus lists four situations in which a health care provider may prescribe cholesterol medicines. [8] - One is a past heart attack, a past stroke, or peripheral arterial disease. [8] - Another is an LDL cholesterol level of 190 mg/dL or higher. [8] - Another is the combination of an age of 40 to 75, diabetes, and an LDL level of 70 mg/dL or higher. [8] - The last is the combination of an age of 40 to 75, a high risk of heart disease or stroke, and an LDL level of 70 mg/dL or higher. [8] ## Levels in the 2018 AHA/ACC guideline (since replaced) - The 2026 ACC/AHA guideline on dyslipidemia retires and replaces the 2018 AHA/ACC guideline on managing blood cholesterol. [9] - The abstract of the 2026 guideline names none of the levels below, so they come from the 2018 abstract. [10, 11] - PubMed lists two corrections to the 2018 guideline, from 2019 and 2023, with no text that shows whether they change these levels. [12] - The 2018 abstract named adults who are 40 to 75 years old, have no diabetes, and whose estimated 10-year risk of atherosclerotic cardiovascular disease (ASCVD) is 7.5% to 19.9%, which it called intermediate risk. [11] - For them, it said risk-enhancing factors favor starting a statin. [11] - It listed a persistently elevated LDL of 160 mg/dL or higher as one of those factors. [11] - It also listed a lipoprotein (a) level of at least 125 nmol/L or 50 mg/dL, if measured in selected people, especially at higher values. [11] - For people with atherosclerotic cardiovascular disease at very high risk, it set 70 mg/dL of LDL as the level to consider adding a nonstatin medicine to a statin. [13] - It defined very high risk as a history of several major events, or one major event plus several high-risk conditions. [13] - In that group it called adding ezetimibe reasonable when LDL stayed at 70 mg/dL or higher on the most statin a person could take. [13] - If LDL still stayed at 70 mg/dL or higher on that statin plus ezetimibe, it called adding a PCSK9 inhibitor reasonable. [13] - It noted that long-term safety beyond 3 years was uncertain and that, at the list prices of mid-2018, cost-effectiveness was low. [13] ## Testing for Lp(a) - MedlinePlus says a test for Lp(a) is not a routine screening test. [14] - It says the test is usually ordered if a provider thinks a person might be at high risk of heart problems, or if high Lp(a) runs in the family. [14] - MedlinePlus adds that researchers are still studying how Lp(a) levels affect health and when the test should be used. [14] - MedlinePlus lists situations, such as those in the checklist below, in which a provider may order a test for Lp(a). [15] - In 2022, the European Atherosclerosis Society published a consensus statement that recommended adults have Lp(a) measured at least once. [16] - Without therapies that specifically lower Lp(a), the panel recommended early, intensive management of risk factors. [16] - The panel said this management is targeted by overall cardiovascular risk and the Lp(a) level. [16] - NHLBI says that for a person with a high Lp(a) level, a provider may prescribe statins to help lower heart disease risk, even when the other cholesterol numbers are healthy. [5] - On 4 September 2026, Novartis reported that a phase 3 trial of pelacarsen, a medicine that lowers Lp(a), missed its main goal. [17] - The trial compared pelacarsen with placebo in adults with elevated Lp(a) and established cardiovascular disease. [17] - The press release gave no numbers and said full results would be shown at a future scientific meeting, so the result may be refined. [17] ## Where statins and other medicines fit - MedlinePlus calls statins the most commonly used medicines for high cholesterol. [18] - MedlinePlus says statins slow how much cholesterol the liver makes. [19] - It says they also increase the liver's ability to remove LDL already in the blood. [19] - MedlinePlus says a provider may prescribe a statin when lifestyle changes fail to lower high cholesterol enough. [18] - MedlinePlus says studies show statins reduce the chance of a heart attack or a stroke for people whose LDL cholesterol is high. [19] - MedlinePlus says statins usually cause no side effects but may increase type 2 diabetes risk, mostly for people who are already at high risk for it. [20] - It adds that statins may cause abnormal liver enzyme test results, but that actual liver damage is very rare. [20] - It calls muscle damage an uncommon side effect that can, in rare cases, lead to muscle pain and kidney damage. [20] - MedlinePlus says cholesterol absorption inhibitors are used when statins cannot be taken or do not lower cholesterol enough on their own. [21] - NHLBI says a provider may use ezetimibe when statins produce side effects or when a statin and lifestyle changes fail to bring LDL down enough. [22] - PCSK9 inhibitors block a protein called PCSK9, and MedlinePlus says this helps the liver remove LDL from the blood. [21] - MedlinePlus says a provider may prescribe both a statin and a PCSK9 inhibitor for people who have familial hypercholesterolemia. [21] - It names people with a high risk of complications such as heart attack or stroke as another group. [21] ## Who two medicines are labeled for, as of October 2026 - The label for Repatha (evolocumab) lists use to lower the risk of major adverse cardiovascular events in adults at increased risk of them. [23, 24] - The Repatha label also lists use, as an adjunct to diet and exercise, to reduce LDL cholesterol in adults with hypercholesterolemia. [23] - It lists that use in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia. [23] - It also lists that use in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. [23] - The label for Leqvio (inclisiran) lists use, as an adjunct to diet and exercise, to reduce LDL cholesterol in adults with hypercholesterolemia. [25, 26] - The Leqvio label also lists that use in adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia. [25] - It lists that use in pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia. [25] ## Situations MedlinePlus lists for an Lp(a) test - [ ] A father or brother with early heart or blood vessel disease (before age 55), or a mother or sister (before age 65). [15] - [ ] High LDL cholesterol even though the person takes medicine to lower it. [15] - [ ] Heart or blood vessel disease, especially when cholesterol and triglyceride levels are normal without medicine to lower them. [15] - [ ] Signs of familial hypercholesterolemia, an inherited condition that causes high cholesterol levels. [15] - [ ] More than one heart attack, or more than one angioplasty, a procedure to open narrow or blocked arteries in the heart. [15] ## Questions to ask 1. Which LDL levels in these sources, if any, apply to my age and health history? 2. Which levels does my clinician use now, since the 2026 guideline replaced the 2018 one? 3. Was my LDL calculated or measured directly, and does that matter for me? 4. What do my cholesterol numbers mean, given my age, family history and other risk factors? 5. Has my Lp(a) ever been measured, and would a test make sense given my family history? 6. If my Lp(a) is high, what can be done to lower my overall risk? 7. If my LDL stays high on a statin, which other medicines could help, and what are their benefits and side effects? 8. What side effects of a statin are possible, and how would they be checked? 9. Is a medicine I am offered labeled for someone of my age and with my condition? ## Sources 1. LDL: The Bad Cholesterol (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, What are LDL and HDL?. Retrieved 2026-10-14. 2. Claim `cardio:claim-high-ldl-raises-cad-risk`: MedlinePlus says that a high LDL level means too much LDL cholesterol in the blood, that this extra LDL forms plaque in the arteries, and that coronary artery disease is that plaque buildup in the arteries of the heart. NHLBI adds that plaque built up from high LDL cholesterol raises the risk of heart attack, stroke and other conditions. - Applies to: Adults in general. The pages are written for the public and give no study population, age range or risk group for these statements.; General health information for the public; no care setting is stated; United States (pages of US government agencies; some figures on them are US statistics); Adults. The NHLBI coronary page gives a prevalence for adults aged 20 and older.. Follow-up: Not applicable (descriptive statement) - Limitations: Patient-education pages. They explain how the process works and give no study, no size of risk and no LDL threshold. They say high LDL raises the risk of coronary artery disease, not by how much. - Supports: LDL: The Bad Cholesterol (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, How can a high LDL level raise my risk: "This extra LDL, along with other substances, forms plaque.". Retrieved 2026-10-14. - Supports: LDL: The Bad Cholesterol (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, How can a high LDL level raise my risk: "Coronary artery disease happens when the plaque buildup is in the arteries of your heart.". Retrieved 2026-10-14. - Supports: Blood Cholesterol: What Is Blood Cholesterol? (NHLBI) (Webpage, National Heart, Lung, and Blood Institute (NIH)) . Locator: Page body, What is blood cholesterol. Retrieved 2026-10-14. 3. Lipoprotein (a) Blood Test (MedlinePlus medical test) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: What is a lipoprotein (a) blood test?. Retrieved 2026-10-15. 4. Lipoprotein (a) Blood Test (MedlinePlus medical test) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Is there anything else I need to know about a lipoprotein (a) test?. Retrieved 2026-10-15. 5. Blood Cholesterol: Diagnosis (NHLBI) (Webpage, National Heart, Lung, and Blood Institute (NIH)) . Locator: Lipoprotein-a. Retrieved 2026-10-15. 6. Cholesterol Levels (MedlinePlus medical test) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: What is a cholesterol test?. Retrieved 2026-10-15. 7. Cholesterol Levels (MedlinePlus medical test) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: What do the results mean?. Retrieved 2026-10-15. 8. Cholesterol Medicines (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Who needs cholesterol medicines?. Retrieved 2026-10-15. 9. Claim `cardio:claim-acc-aha-2026-dyslipidemia-replaces-2018`: The abstract of the 2026 ACC/AHA multisociety dyslipidemia guideline says it retires and replaces the 2018 guideline on managing blood cholesterol. It says the guideline addresses evaluation, management and monitoring of people with high blood cholesterol, high triglycerides and elevated lipoprotein(a). - Applies to: Individuals with dyslipidemias, which the abstract lists as high blood cholesterol, high triglycerides and elevated lipoprotein(a). The abstract gives no age limits and no inclusion or exclusion criteria.; Not stated in the abstract. The abstract says the guideline covers evaluation, management and monitoring.; Not stated in the abstract (issued by American societies; jurisdiction not verified); Not stated in the abstract. Follow-up: Not applicable (guideline context) - Limitations: Only the abstract and the bibliographic record were read, so no threshold, target, medicine or class of recommendation from the guideline is recorded. PubMed lists two corrections to the guideline (2026-06-23 and 2026-09-08); their text was not read, so it is not known whether they change anything the abstract says. This claim states the replacement. It does not link to a record of the 2018 guideline. - Supports: 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, Circulation) . Locator: Abstract, AIM. Retrieved 2026-10-15. Source state: Corrected. - Supports: 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, Circulation) . Locator: Abstract, STRUCTURE, sentence 1. Retrieved 2026-10-15. Source state: Corrected. - Background: 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, Circulation) . Locator: CommentsCorrectionsList, two ErratumIn entries. Retrieved 2026-10-15. Source state: Corrected. 10. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (Guideline, Circulation) . Locator: Abstract, STRUCTURE. Retrieved 2026-10-15. Source state: Corrected. 11. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines (Guideline, Circulation) . Locator: Abstract, recommendation 8. Retrieved 2026-10-15. Source state: Corrected. 12. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines (Guideline, Circulation) . Locator: CommentsCorrectionsList, two ErratumIn entries. Retrieved 2026-10-15. Source state: Corrected. 13. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines (Guideline, Circulation) . Locator: Abstract, recommendation 3. Retrieved 2026-10-15. Source state: Corrected. 14. Lipoprotein (a) Blood Test (MedlinePlus medical test) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: What is it used for?. Retrieved 2026-10-15. 15. Lipoprotein (a) Blood Test (MedlinePlus medical test) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Why do I need a lipoprotein (a) test?. Retrieved 2026-10-15. 16. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement (Publication, European Heart Journal) . Locator: Abstract. Retrieved 2026-10-15. 17. Claim `cardio:claim-lpa-horizon-pelacarsen-topline-null`: Novartis reported topline results on 4 September 2026 for Lp(a)HORIZON, a phase 3 outcomes trial of pelacarsen in adults with elevated Lp(a) and established cardiovascular disease: pelacarsen, compared with placebo, missed the trial primary endpoint, a four-part composite of cardiovascular death, heart attack, stroke and urgent coronary revascularization with hospital admission. Lp(a) fell on pelacarsen, but across all participants this was not shown to cut cardiovascular risk. The release gives no numbers and says full results will be shown at a future scientific meeting. The registry lists 8323 participants and completion on 2026-07-16. - Applies to: Patients with elevated Lp(a) and established cardiovascular disease. Novartis describes two analysis populations for the primary endpoint: everyone with Lp(a) of 70 mg/dL or more, and a subgroup with 90 mg/dL or more. The registry gives ages 18 to 80 years and enrollment of 8323.; Global multicentre trial per the sponsor; site list not read; Global (sponsor wording); countries not read; Adult, 18 to 80 years (registry). Follow-up: Not stated in the sources read. The registry gives completion on 2026-07-16. - Limitations: This is a sponsor topline press release, not a peer-reviewed paper, and it gives no counts, hazard ratios or intervals. A PubMed title search on 2026-10-14 found commentary but no results paper (fetch log rows cg-status-pubmed-lpahorizon.json and cg-status-pubmed-summary.json). The release reports no separate result for the subgroup with Lp(a) of 90 mg/dL or more, although the primary endpoint was defined in both the overall population and that subgroup. The result may be refined when the full data are presented. The finding is for pelacarsen, one Lp(a)-lowering medicine, in people with established disease, and does not by itself settle whether other Lp(a)-lowering approaches would work. - Supports: Novartis announces Lp(a)HORIZON Phase III topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD) (Webpage, Novartis AG (company press release)) . Locator: Press release, paragraph 1, sentence 1 (endpoint statement, first part). Retrieved 2026-10-14. - Supports: Novartis announces Lp(a)HORIZON Phase III topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD) (Webpage, Novartis AG (company press release)) . Locator: Press release, paragraph 1, sentence 1 (endpoint statement, second part). Retrieved 2026-10-14. - Supports: Novartis announces Lp(a)HORIZON Phase III topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD) (Webpage, Novartis AG (company press release)) . Locator: Press release, paragraph 1, sentence 2. Retrieved 2026-10-14. - Supports: Novartis announces Lp(a)HORIZON Phase III topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD) (Webpage, Novartis AG (company press release)) . Locator: Press release, paragraph 2, statement of the Chief Medical Officer. Retrieved 2026-10-14. - Supports: Novartis announces Lp(a)HORIZON Phase III topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD) (Webpage, Novartis AG (company press release)) . Locator: Press release, paragraph 3. Retrieved 2026-10-14. - Supports: Novartis announces Lp(a)HORIZON Phase III topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD) (Webpage, Novartis AG (company press release)) . Locator: Press release, dateline. Retrieved 2026-10-14. - Background: Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (Registry, U.S. National Library of Medicine (ClinicalTrials.gov)) . Locator: protocolSection.identificationModule.officialTitle: "A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230)". Retrieved 2026-10-14. - Background: Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (Registry, U.S. National Library of Medicine (ClinicalTrials.gov)) . Locator: protocolSection.identificationModule.officialTitle: "on Major Cardiovascular Events in Patients With Established Cardiovascular Disease". Retrieved 2026-10-14. - Supports: Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (Registry, U.S. National Library of Medicine (ClinicalTrials.gov)) . Locator: protocolSection.designModule.enrollmentInfo.count: "8323". Retrieved 2026-10-14. - Supports: Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (Registry, U.S. National Library of Medicine (ClinicalTrials.gov)) . Locator: protocolSection.statusModule.completionDateStruct.date: "2026-07-16". Retrieved 2026-10-14. 18. Statins (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, What are statins?. Retrieved 2026-10-14. 19. Statins (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, How do statins lower cholesterol?. Retrieved 2026-10-14. 20. Statins (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: Summary, What are the risks of taking statins?. Retrieved 2026-10-14. 21. Cholesterol Medicines (MedlinePlus health topic) (Webpage, U.S. National Library of Medicine (MedlinePlus)) . Locator: What are the different types of cholesterol medicines?. Retrieved 2026-10-15. 22. Blood Cholesterol: Treatment (NHLBI) (Webpage, National Heart, Lung, and Blood Institute (NIH)) . Locator: Medicines. Retrieved 2026-10-15. 23. REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e) (Label, U.S. Food and Drug Administration (openFDA drug label endpoint)) . Locator: results\[0\].indications\_and\_usage\[0\]. Retrieved 2026-10-14. 24. Claim `cardio:claim-fda-repatha-bla125522-approval`: The US Food and Drug Administration approved REPATHA (evolocumab) under biologics license application BLA125522. The Drugs@FDA record lists an original submission (number 1, class Type 1 - New Molecular Entity) with approval status AP dated 27 August 2015, and AMGEN INC as the applicant. The current label states that REPATHA is indicated to reduce the risk of major adverse cardiovascular events in adults at increased risk for these events, and as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia and in heterozygous familial hypercholesterolemia from age 10, with further indications listed. - Applies to: Set by the product label. The Drugs@FDA application record names the product and applicant and gives no population; the current label states the indications.; Prescription medicine, given by injection (Drugs@FDA route field); United States (decision by the US Food and Drug Administration); See the label indications; not stated in the application record. Follow-up: Not applicable (regulatory decision) - Limitations: openFDA says its data is unvalidated and not for medical decisions. The approval date is the status date of the original submission in the Drugs@FDA record, written as 20150827 there. The indications are those of the current label (version 32, effective 2026-08-19), which the FDA has changed since 2015 through many supplements, so they are not the 2015 indications. This record states the decision and the label wording and is not a finding about how well the medicine works. - Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].application\_number: "BLA125522". Retrieved 2026-10-14. - Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].products\[0\].brand\_name: "REPATHA". Retrieved 2026-10-14. - Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].sponsor\_name: "AMGEN INC". Retrieved 2026-10-14. - Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].submissions\[21\].submission\_type: "ORIG". Retrieved 2026-10-14. - Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].submissions\[21\].submission\_status: "AP". Retrieved 2026-10-14. - Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].submissions\[21\].submission\_status\_date: "20150827". Retrieved 2026-10-14. - Supports: Drugs@FDA overview page for BLA125522 (Regulator, U.S. Food and Drug Administration (Drugs@FDA)) . Locator: Original Approvals or Tentative Approvals table, row ORIG-1. Retrieved 2026-10-14. - Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].submissions\[21\].submission\_class\_code\_description: "Type 1 - New Molecular Entity". Retrieved 2026-10-14. - Supports: REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e) (Label, U.S. Food and Drug Administration (openFDA drug label endpoint)) . Locator: results\[0\].indications\_and\_usage\[0\]: "1 INDICATIONS AND USAGE REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke,". Retrieved 2026-10-14. - Supports: REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e) (Label, U.S. Food and Drug Administration (openFDA drug label endpoint)) . Locator: results\[0\].indications\_and\_usage\[0\]: "unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce". Retrieved 2026-10-14. - Supports: REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e) (Label, U.S. Food and Drug Administration (openFDA drug label endpoint)) . Locator: results\[0\].indications\_and\_usage\[0\]: "low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). adults and". Retrieved 2026-10-14. 25. LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44) (Label, U.S. Food and Drug Administration (openFDA drug label endpoint)) . Locator: results\[0\].indications\_and\_usage\[0\]. Retrieved 2026-10-14. 26. Claim `cardio:claim-fda-leqvio-nda214012-approval`: The US Food and Drug Administration approved LEQVIO (inclisiran) under new drug application NDA214012. The Drugs@FDA record lists an original submission (number 1, class Type 1 - New Molecular Entity) with approval status AP dated 22 December 2021, and NOVARTIS as the applicant. The current label states that LEQVIO is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, in heterozygous familial hypercholesterolemia from age 12, and in children aged 12 and older with homozygous familial hypercholesterolemia. - Applies to: Set by the product label. The Drugs@FDA application record names the product and applicant and gives no population; the current label states the indications.; Prescription medicine, given by injection (Drugs@FDA route field); United States (decision by the US Food and Drug Administration); See the label indications; not stated in the application record. Follow-up: Not applicable (regulatory decision) - Limitations: openFDA says its data is unvalidated and not for medical decisions. The approval date is the status date of the original submission in the Drugs@FDA record, written as 20211222 there. The indications are those of the current label (version 13, effective 2026-08-19), which have changed since 2021 through supplements, so they are not the 2021 indications. The label also says cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events in adults at increased risk treated with statins or monoclonal antibody PCSK9 inhibitors; it does not say that LEQVIO itself has shown this, and this record does not claim it (the ORION-4 trial, which tests inclisiran, had not reported when this record was written). This record states the decision and the label wording only. - Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].application\_number: "NDA214012". Retrieved 2026-10-14. - Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].products\[0\].brand\_name: "LEQVIO". Retrieved 2026-10-14. - Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].sponsor\_name: "NOVARTIS". Retrieved 2026-10-14. - Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].submissions\[0\].submission\_type: "ORIG". Retrieved 2026-10-14. - Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].submissions\[0\].submission\_status: "AP". Retrieved 2026-10-14. - Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].submissions\[0\].submission\_status\_date: "20211222". Retrieved 2026-10-14. - Supports: Drugs@FDA overview page for NDA214012 (Regulator, U.S. Food and Drug Administration (Drugs@FDA)) . Locator: Original Approvals or Tentative Approvals table, row ORIG-1. Retrieved 2026-10-14. - Supports: Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record) (Regulator, U.S. Food and Drug Administration (openFDA drugsfda endpoint)) . Locator: results\[0\].submissions\[0\].submission\_class\_code\_description: "Type 1 - New Molecular Entity". Retrieved 2026-10-14. - Supports: LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44) (Label, U.S. Food and Drug Administration (openFDA drug label endpoint)) . Locator: results\[0\].indications\_and\_usage\[0\]: "1 INDICATIONS AND USAGE LEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:". Retrieved 2026-10-14. - Supports: LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44) (Label, U.S. Food and Drug Administration (openFDA drug label endpoint)) . Locator: results\[0\].indications\_and\_usage\[0\]: "adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older". Retrieved 2026-10-14. - Supports: LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44) (Label, U.S. Food and Drug Administration (openFDA drug label endpoint)) . Locator: results\[0\].indications\_and\_usage\[0\]: "with homozygous familial hypercholesterolemia (HoFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE)". Retrieved 2026-10-14. ## About this guide - Written for: Adults who want to understand cholesterol numbers and medicines, and the people with them - What it covers: Written from US government health pages, the PubMed abstracts of two guidelines and one consensus statement, a company press release and two drug labels. For the 2026 guideline it read only the abstract, which gives none of the levels in this guide. PubMed lists two corrections to the 2018 guideline, and it did not read them. It describes what these sources say. It gives no advice for one person. - Pages it explains: LDL cholesterol blood test (`cardio:ldl-cholesterol`); High LDL cholesterol (`cardio:high-ldl-cholesterol`); Lipoprotein(a) (`cardio:lipoprotein-a`); Statins (`cardio:statins`); Ezetimibe (`cardio:ezetimibe`); PCSK9 (gene and protein) (`cardio:pcsk9`); Evolocumab (Repatha) (`cardio:repatha`); Evolocumab (`cardio:evolocumab`); Inclisiran (Leqvio) (`cardio:leqvio`); Inclisiran (`cardio:inclisiran`) - Sources checked: 2026-10-15 - Next check due: 2027-04-15 - Estimated reading grade: 9.9 (target 10) Every sentence cites a source. Words in quotation marks are the source's own; the rest is the atlas's summary. ## Provenance Content hash: 328ca6027a1ece6bbc5ba45b0419da4301148d4d0471c51ccc1fc16c3178af06 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15