Guidelines on Lowering LDL-C Levels

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2 Scientific Insights Into LDL-C, PCSK9, and CV Risks High circulating LDL-C levels are associated with increased risk for ASCVD 1,2 Statin drugs interfere with cholesterol production, lowering serum LDL-C levels and reducing the rate of CV events 3-5 Many patients do not tolerate or adhere to statin therapy 6 A new class of therapeutic antibodies, the PCSK9 inhibitors, can markedly reduce plasma LDL-C levels 7-9 Alirocumab and evolocumab interfere with PCSK9 binding to LDL receptors This increases recycling of the receptors back to the cell surface to clear circulating LDL 7-9 Guidelines on Lowering LDL-C Levels 1. Stamler J, et al. JAMA. 1986; 256(2): ; 2. Anderson KM, et al. JAMA. 1987;257(16): ; 3. Jacobson TA, et al. J Clin Lipidol. 215;9(2): Gill S, et al. Cell Metab. 211;13(3):26-273; 5. Minhas R. Br J Cardiol. 24;11(6); 6. Cohen JD, et al. J Clin Lipidol. 212;6(3):28-215; 7. Duff CJ, et al. Biochem J. 29;419(3): ; 8. Ni YG, et al. J Biol Chem. 21;285(17): ; 9. Poirier S, Mayer G. Drug Des Devel Ther. 213;7: NLA Recommendations Treatment Goals Stratified by Risk Assessment Risk Category Low Moderate High Very high Criteria -1 major ASCVD risk factors Consider other risks, if known 2 major ASCVD risk factors Consider quantitative risk scoring Consider other risk indicators 3 major ASCVD risk factors Diabetes mellitus (type 1 or 2) a -1 other major ASCVD risk factors No evidence of end-organ damage CKD stage 3B or 4 b LDL-C 19 mg/dl c Risk score reaches high threshold d ASCVD Diabetes mellitus (type 1 or 2) 2 other major ASCVD risk factors OR Evidence of end-organ damage e Treatment Goal Non-HDL-C, mg/dl LDL-C, mg/dl <13 <1 <13 <1 <13 <1 <1 <7 Consider Drug Therapy Non-HDL-C, mg/dl LDL-C, mg/dl a Consider non-hdl-c goal of <1 mg/dl (LDL-C <7 mg/dl) for diabetes + 1 major ASCVD risk; b Calculators may underestimate risk in CKD Stage 3B or 4; c Consider severe phenotype (eg, FH); d High-risk: 1% with Adult Treatment Panel III Framingham Risk Score for hard CHD, 15% with 213 Pooled Cohort Equations for hard ASCVD, or 45% with Framingham long-term CVD risk calculation; e Increased ACR, CKD, or retinopathy. ACR, albumin-to-creatinine ratio; CHD, coronary heart disease; CKD, chronic kidney disease; FH, familial hypercholesterolemia; HDL-C, high-density lipoprotein cholesterol. Jacobson TA, et al. J Clin Lipidol. 215;9(2): No No No Patients With Clinical ASCVD With Comorbidities a On Statins for Secondary Prevention Patient has 5% LDL-C reduction on maximum tolerated statin b 1. Address statin adherence 2. Intensify lifestyle modifications (may consider phytosterols) 3. Increase to high-intensity statin if not already taking 4. Evaluate for statin intolerance if unable to tolerate moderate-intensity statin c 5. Control other risk factors Patient has 5% LDL-C reduction on maximum tolerated statin b CLINICIAN-PATIENT DISCUSSION FACTORS TO CONSIDER 1. May reduce ASCVD risk more with added nonstatin therapy to lower LDL-C 2. Adding nonstatin therapy may cause AEs or drug-drug interactions 3. Patient preferences Consider Nonstatin ezetimibe first d 1 drugs to 2 consider Consider adding or replacing with PCSK9 inhibitor second e Patient has 5% LDL-C reduction on maximum tolerated statin b Yes Decision for no additional medication Monitor drug and lifestyle adherence, and LDL-C response to therapy a Comorbidities: T2DM, acute ASCVD event (within 3 months), ASCVD event on statin therapy, baseline LDL-C 19 mg/dl, poorly controlled major ASCVD risk factors, elevated lipoprotein(a), and CKD; b Consider if LDL-C <7 mg/dl or non-hdl-c <1 mg/dl in patients with diabetes; c Consider specialist referral if statin intolerant; d Consider bile acid sequestrant if ezetimibe-intolerant and triglycerides <3 mg/dl; e Consider only if on maximally tolerated statin. and ezetimibe or bile acid sequestrant with persistent <5% LDL-C reduction or LDL-C 7 mg/dl. AE, adverse event. Lloyd-Jones DM, et al. J Am Coll Cardiol. 216 Mar 28. [Epub ahead of print]. Yes Yes Optimizing Lipid-Lowering Therapy Statin Therapy Reduces LDL-C Levels by 3% to 5% Depending on Treatment Intensity Intensity of Therapy Average Reduction in LDL-C With Daily Dose Examples High Intensity Moderate Intensity Low Intensity 5% 3% to <5% <3% Atorvastatin 4-8 mg Rosuvastatin 2-4 mg Atorvastatin 1-2 mg Fluvastatin 4 mg twice daily Fluvastatin XL 8 mg Lovastatin 4 mg Pitavastatin 2-4 mg Pravastatin 4-8 mg Rosuvastatin 5-1 mg Simvastatin 2-4 mg Fluvastatin 2-4 mg Lovastatin 2 mg Pitavastatin 1 mg Pravastatin 1-2 mg Simvastatin 1 mg Stone NJ, et al. Circulation. 214;129(25 suppl 2):S1-S45; Lloyd-Jones DM, et al. J Am Coll Cardiol. 216 Mar 28. [Epub ahead of print]..

3 Familial Hypercholesterolemia Clues to a Diagnosis Very elevated levels of LDL-C LDL-C 25 mg/dl in patients aged 3 years LDL-C 22 mg/dl in patients aged 2 to 29 years LDL-C 19 mg/dl in patients aged <2 years Physical characteristics Tendon xanthomas at any age (most common in Achilles tendon and finger extensor tendons but can also occur in patellar and triceps tendons) Arcus corneae in patients <45 years of age Tuberous xanthomas or xanthelasma in patients <2 years of age Family history of premature CHD Familial Hypercholesterolemia Goals of Therapy Initial goal 5% reduction in LDL-C from baseline Optimal Goals Criteria NO ASCVD or major CV risk factors ANY ASCVD or major CV risk factors LDL-C <1 mg/dl <7 mg/dl Cascade screening is recommended after an established FH index case is identified. Goldberg AC, et al. J Clin Lipidol. 211;5(suppl 3):S1-S8; Robinson JG. J Manage Care Pharm. 213;19(2): Gidding SS, et al. Circulation. 215;132(22): Statin-Related AEs Can Be Challenging In a large internet study of >1, current and former statin users 1 62% of former users cited side effects as primary reason for discontinuation 6% of former and 25% of current statin users reported muscle-related side effects One third of those who stopped their statin due to muscle side effects did not inform their doctor Statin rechallenge can help confirm whether myopathy is statin-associated 2 Myalgia Muscle ache, weakness, cramps, stiffness No elevation in CK levels Myositis Muscle ache, weakness, cramps, stiffness Elevated CK levels How do you define statin intolerance in your patients? CK, creatine kinase. 1. Cohen JD, et al. J Clin Lipidol. 212;6(3):28-215; 2. Ahmad Z. Am J Cardiol. 214;113(1): Factors Increasing the Risk of Statin Intolerance History of: Muscular symptoms with other lipid-lowering therapies Unexplained muscular symptoms Unexplained creatine kinase elevation Muscular symptoms with other lipid-lowering therapies (family) Strenuous exercise Hypothyroidism Stulc T, et al. Curr Atheroscler Rep. 215;17(12):69. Female sex Advanced age Low body mass index Alcohol abuse Vitamin D deficiency Drug interactions Gemfibrozil Macrolides Azole antifungals Verapamil Amiodarone Protease inhibitors Cyclosporine Managing Statin Intolerance LDL-C lowering with statins remains the primary lipid target for most patients to reduce CHD risk Options for the patient with myalgia and normal CK Trial of discontinuation for a few weeks and rechallenge Try a lower dose Try a different statin (perhaps with different metabolism or hydrophilicity) Trial of alternate day or weekly dosing (off-label) Check and correct hypothyroidism Check and/or supplement vitamin D Trial of Coenzyme Q1 (free ubiquinone)? Consider nonstatin medication (either as monotherapy or combination therapy) Rosenson RS, et al. J Clin Lipidol. 214;8(suppl 3):S58-S71.

4 Suboptimal LDL-C Levels in High-Risk Patients Despite Statin Therapy Patient Cohorts on Statin Therapy Patients Achieving LDL-C <1 mg/dl, % Patients Achieving LDL-C <7 mg/dl, % Overall (N=4,154) 65.1% 18.7% History of CHD 67.7% 19.9% History of stroke/aaa but not CHD 63.5% 18.2% Diabetes without history of CHD or stroke/aaa 62.7% 18.2% FRS >2% without history of CHD, stroke/aaa, or diabetes 48.6% 5.6% Unmet Needs in Patients on Statin Therapy Despite well-documented efficacy of statins, many patients are still at risk for: 1,2 Insufficient response to therapy Statin intolerance Poor treatment adherence Subgroups of patients have not been well studied 1 Older patients Patients <4 years with low estimated 1-yr ASCVD risk, but high lifetime ASCVD risk Patients with comorbid conditions N=11,611 US patients in the REGARDS study cross-sectional analysis were 45 y of age with a history of CHD or risk equivalents. AAA, abdominal aortic aneurysm; FRS, 1-year Framingham CHD risk score. Gamboa CM, et al. Am J Med Sci. 214;348(2): Stone NJ, et al. Circulation. 214;129(25 suppl 2):S1-S45; 2. Cohen JD, et al. J Clin Lipidol. 212;6(3): Achieving Clinically Meaningful Reductions in LDL-C Levels With Nonstatin Therapy Nonstatin Agents With Efficacy in Reducing LDL-C Levels Drug Class Bile acid sequestrants Cholesterol absorption inhibitors Fibric acids Microsomal triglyceride transfer protein inhibitor Nicotinic acid Oligonucleotide inhibitor of apo B-1 synthesis PCSK9 inhibitors Examples of Agents Colestipol Colesevelam Cholestyramine Ezetimibe Fenofibric Acid a Lomitapide b Niacin a Mipomersen b Alirocumab Evolocumab a In April 216, the FDA withdrew approval of fenofibric acid delayed-release capsules and niacin extended-release tablets in combination with statins due to lack of evidence that coadministration further reduced CV risk. Accessed May 2, 216; b FDA-approved as an adjunct to lipid-lowering treatments and diet for people with HoFH. IMPROVE-IT Trial Study Design Adults 5 years of age, stabilized 1 days after ACS LDL-C mg/dl (or 5-1 mg/dl with prior lipid-lowering therapy) (N=18,144) Simvastatin 4 mg QD a (n=9,77) Randomized 1:1 Sim 4 mg QD a + ezetimibe 1 mg QD (n=9,67) 1 Hazard ratio,.936 (95% CI,.89.99) Minimum follow-up, 2.5 y b ; 525 events Years Since Randomization Primary Endpoint: Composite death from CVD, a major coronary event, or nonfatal stroke IMPROVE-IT, IMproved Reduction of Outcomes Vytorin Efficacy International Trial. a Dose increased to simvastatin 8 mg QD if LDL-C >79 mg/dl on 2 consecutive follow-up visits, until FDA guidance issued in June 211 limited new prescriptions of simvastatin 8 mg; b Median follow-up, 6 y. Sim, simvastatin; QD, once daily. Cannon CP, et al. N Engl J Med. 215;372(25): Event Rate, % IMPROVE-IT: Lower LDL-C Levels Reduced the CV Event Rate Clinical Benefit of Ezetimibe Add-on a P=.16. Cannon CP, et al. N Engl J Med. 215;372(25): Simvastatin Monotherapy Simvastatin Ezetimibe Simvastatin- Ezetimibe Group Simvastatin Monotherapy Group Primary endpoint, CV event rate (at 7 y) 32.7% a 34.7% Median LDL-C during study, mg/dl 53.7 mg/dl 69.5 mg/dl

5 How do you monitor patients on lipidlowering therapy? FDA- Approved Indication Approved Dosing Clinical Topics Novel Therapy PCSK9 Inhibitors Alirocumab 1 Evolocumab 2 In people who require additional LDL-C lowering, adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH Clinical ASCVD 75 mg SQ Q2W; dose can be increased to 15 mg SQ Q2W if response is inadequate LDL-C levels should be measured 4-8 weeks after initiating or titrating therapy Current trials assessing effects on CV morbidity and mortality In people who require additional LDL-C lowering, adjunct to diet and Maximally tolerated statin in adults with HeFH or clinical ASCVD Other LDL-C lowering therapies in patients with HoFH Clinical ASCVD or HeFH, 14 mg SQ Q2W or 42 mg SQ QM HoFH, 42 mg QM Current trials assessing effects on CV morbidity and mortality Q2W, every 2 weeks; QM, every month; SQ, subcutaneously Accessed May 31, 216; 2. Accessed May 31, 216. to Week 24, % to week 12, % PCSK9 Inhibitors in Heterozygous Familial Hypercholesterolemia ODYSSEY FH I and II 1,b (HeFH) Alirocumab 75 mg Q2W (n=322) PBO (n=163) Alirocumab 75 mg Q2W (n=166) a a Evolocumab 14 mg Q2W (n=11) FH I PBO (n=81) RUTHERFORD-2 2,c (HeFH) PBO Q2W (n=54) a -2 Evolocumab 42 mg QM (n=11) a FH II PBO QM (n=55) 5.5 From Baseline to Week 12, % PCSK9 Inhibitors in Homozygous Familial Hypercholesterolemia TESLA Part B b Evolocumab 42 mg QM (n=33) PBO (n=16) a c P<.1 vs PBO; b Patients with HeFH (diagnosed clinically or with genetic testing) who had an LDL-C level 1 mg/dl or an LDL-C level 7 mg/dl and a history of CVD despite high-dose statin therapy (alirocumab dose increased to 15 mg Q2W at week 12 if LDL-C level at week 8 was 7 mg/dl). c Patients 18-8 y of age with HeFH diagnosed clinically and on a stable statin dose. PBO, placebo. 1. Kastelein JJP, et al. Euro Heart J. 215;36(43): ; 2. Raal FJ, et al. Lancet. 215;385(9965): a P<.1 vs PBO; b Patients 12 y of age with HoFH (diagnosed clinically or with genetic testing) and an LDL-C level 13 mg/dl after at least 4 weeks of a stable, low-fat diet and baseline lipid-lowering therapies. Raal FJ, et al. Lancet. 215;385(9965): to Week 24, % to Week 12, % PCSK9 Inhibitors vs Ezetimibe as Monotherapy Alirocumab 75 mg Q2W (n=52) Evolocumab 14 mg Q2W + PBO QD (n=153) a -57 a,b ODYSSEY MONO 1,b MENDEL-2 2,c PBO Q2W + Ezetimibe 1 mg PBO Q2W + PBO QD (n=77) QD (n=76).1 Ezetimibe 1 mg QD (n=51) Evolocumab 42 mg QM + PBO QD (n=153) PBO QM + Ezetimibe 1 mg QD (n=77) a,b PBO QM + PBO QD (n=78) -1.3 to Week 24, % Alirocumab in Statin-Intolerant Patients Odyssey Alternative Alirocumab 75 mg Q2W (n=126) Ezetimibe 1 mg QD (n=122) -14.6% -45.% a a P<.1 vs ezetimibe; b P<.1 vs placebo; b Patients with LDL-C levels 1-19 mg/dl and a 1-year risk of fatal CV events 1% and <5% (European Systematic Coronary Risk Estimation); no LLT was used in the 4 weeks prior to screening and alirocumab dose could be titrated up to 15 mg Q2W at week 12 if LDL-C levels were 7 mg/dl at Week 8; b Adults with LDL-C levels of 1-19 mg/dl, TG levels 4 mg/dl, and 1-year Framingham CHD risk scores 1; no LLT was used in the 3 months before study initiation. 1. Roth EM, et al. Intern J Cardiol. 214;176(1):55-61; 2. Koren MJ, et al. J Am Coll Cardiol. 214;63(23): a P<.1. Adults 18 y of age with primary hypercholesterolemia, moderate-high CV risk and an LDL-C 1 mg/dl, or very high risk and an LDL-C 7 mg/dl, who previously discontinued 2 statins due to intolerance. Moriarty PM, et al. J Clin Lipid. 215;9(6):

6 to Week 12, % to week 24, % Evolocumab in Statin-Intolerant Patients Evolocumab 14 mg Q2W (n=13) a a GAUSS-2 1,b Ezetimibe 1 mg QD + PBO Q2W (n=51) GAUSS-3 2,c Evolocumab 42 mg SQ QM (n=145) Evolocumab 42 mg QM + PBO QD (n=12) a Ezetimibe 1 mg QD + PBO QM (n=51) Ezetimibe 1 mg QD (n=73) c P<.1 vs ezetimibe; a Study population included adults 18-8 y of age on no to low-dose statins due to previous intolerance to 2 statins. b Study population included adults with history of intolerance to 2 statins. Phase A used a 24-wk crossover procedure with atorvastatin or placebo to identify patients having symptoms only with atorvastatin, but not placebo. Phase B, after a 2-wk washout patients were randomized to ezetimibe or evolocumab for 24 wk.. 1. Stroes E, et al. Am J Cardiol. 214;63(23): Nissen SE, et al. JAMA. 216;315(15): PCSK9 Inhibitors Are Generally Safe AE a Placebo (n=1276) Alirocumab (n=2476) 1,b Nasopharyngitis 11.1% 11.3% Injection-site reactions c 5.1% 7.2% Influenza 4.6% 5.7% Urinary tract infection 4.6% 4.8% Diarrhea 4.4% 4.7% Bronchitis 3.8% 4.3% Myalgia 3.4% 4.2% AE a Placebo (n=32) Evolocumab (n=599) Nasopharyngitis 9.6% 1.5% Upper respiratory tract infection 6.3% 9.3% Influenza 6.3% 7.5% Back pain 5.6% 6.2% Injection-site reactions d 5.% 5.7% Cough 3.6% 4.5% Urinary tract infection 3.6% 4.5% Sinusitis 3.% 4.2% a AEs occurring in >4% of drug-treated patients and more frequently than placebo arm. b 75 mg Q2W and 15 mg Q2W combined; c Includes erythema/redness, itching, swelling, pain/tenderness; d Includes erythema, pain, bruising Accessed May 31, Accessed May 31, 216. PCSK9 Inhibitors and CV Outcomes Alirocumab: ODYSSEY LONG TERM 1,c CV AEs of Interest, N (%) Alirocumab (n=155) Evolocumab: OSLER 1 and 2 2,e PBO (n=788) Nonfatal MI 14 (.9) a 18 (2.3) Adjudicated major adverse CV events 26 (3.3) in post hoc analysis d 27 (1.7) b HR,.52 (.31-.9) Endpoint, N (%) Evolocumab + SOC (n=2976) All CV events 29 (.95) Post hoc analysis included death, major coronary events, and major cerebrovascular events 28 (.95) SOC (n=1489) 31 (2.18) HR,.47 ( ) 3 (2.11) HR,.47 ( ) a P=.1 vs PBO; b P=.2 vs PBO; c Adults 18 y of age with HeFH, CHD, CHD risk equivalent and LDL-C 7 mg/dl; d Post hoc analysis not specified in the study protocol (composite primary end point from ODYSSEY OUTCOMES: death from CHD, nonfatal MI, fatal or nonfatal ischemic stroke, or UA requiring hospitalization; e Participants were eligible if they completed 1 of 12 phase 2 or 3 trials. SOC, standard of care. 1. Robinson JG, et al. N Engl J Med. 215;372(16): ; 2. Sabatine MS, et al. N Engl J Med. 215;372(16): Effect of PCSK9 Inhibitor Therapy on CV Outcomes Large, Prospective Trials Currently Underway Alirocumab 1,2 Evolocumab 3,4 Bococizumab 5,6 Trial ODYSSEY OUTCOMES FOURIER SPIRE I SPIRE II Sample size 18, 27,564 17, 11, Inclusion criteria 4 to 52 weeks MI, stroke, or symptomatic High risk for post-acs PAD CV event Statin therapy Baseline LDL-C (mg/dl) Pcsk9i dosing Endpoint Atorvastatin 4 mg or 8 mg or rosuvastatin 2 mg or 4 mg daily Atorvastatin 2 mg daily or equivalent PAD, peripheral artery disease; PCSK9i, PCSK9 inhibitor. 1. Schwartz GG, et al. Am Heart J. 214;168(5): Accessed May 31, 216; 3. Sabatine MS, et al. Am Heart J. 216;173: Accessed May 31, Accessed May 31, Accessed May 31, 216. Any lipid-lowering therapy mg SQ Q2W or 15 mg SQ Q2W CHD death, MI, ischemic stroke, or hospitalization for UA 14 mg SQ Q2W or 42 mg SQ Q4W CV death, MI, stroke, hospitalization for UA, or coronary revascularization 15 mg SQ Q2W CV death, MI, stroke, or urgent revascularization Estimated completion 12/217 1/217 4/218 1/218 Importance of Shared Decision Making Communicate ASCVD risk in language patients can understand Explain benefits of lower LDL-C levels When discussing treatment options, communicate Efficacy and safety of statin and nonstatin therapy options Set expectations for percent LDL-C reduction with chosen treatment Potential for adverse events Outline strategies to mitigate risk and address emergence of side effects Engage patients in health care decisions to improve treatment adherence Integrate patient preferences on dosing frequency, mode of administration, cost, and potential for adverse events into treatment decisions 1. Martin SS, et al. J Am Coll Cardiol. 215;65(13): ; 2. Barrett B, et al. BMC Fam Pract. 216;17:41; 3. Turin A, et al. J Cardiovasc Pharmacol. 215;2(5): ; 4. Lloyd-Jones DM, et al. J Am Coll Cardiol. 216 Mar 28. [Epub ahead of print]. 67-year-old man Presents to his PCP for a follow-up visit Experienced an acute MI 3 months prior MI, myocardial infarction; PCP, primary care provider. PAUL Background Medical history Hypertension diagnosed 1 years ago Lisinopril 4 mg daily Atenolol 5 mg daily Hypercholesterolemia diagnosed 5 years ago Atorvastatin 8 mg daily Family history Father and uncle died relatively young from coronary artery disease

7 PAUL Physical Exam and Lab Testing Height, 5 1 Weight, 215 lb BMI, 3.8 kg/m 2 BP, 131/78 mm Hg FPG, 115 mg/dl Prediabetes diagnosed 1 year ago Has smoked regularly since his mid 2 s Lipids TC, 224 mg/dl LDL-C, 14 mg/dl HDL-C, 41 mg/dl TG, 215 mg/dl Despite atorvastatin therapy, PAUL experienced an MI and his LDL-C levels remain elevated. How would you now manage his CV risk? BMI, body mass index; BP, blood pressure; FPG, fasting plasma glucose; HDL-C, high-density lipoprotein cholesterol; TC, total cholesterol, TG, triglycerides. ELIZABETH Background ELIZABETH Physical Exam and Lab Testing 61-year-old woman Presents to her PCP for a follow-up visit Medical history Coronary artery disease Diagnosed 1 year ago after a few episodes of stable angina Treated with rosuvastatin 2 mg once daily Titrated up from 1 mg once daily 3 months ago Height, 5 4 Weight, 156 lb BMI, 26.8 kg/m 2 BP, 13/79 mm Hg FPG, 9 mg/dl CK, 12 U/L ALT, 15 U/L AST, 2 U/L Nonsmoker Lipids TC, 214 mg/dl LDL-C, 129 mg/dl Reduced from 258 mg/dl since rosuvastatin therapy initiated HDL-C, 55 mg/dl TG, 15 mg/dl PCP, primary care provider. BMI, body mass index; BP, blood pressure; FPG, fasting plasma glucose; HDL-C, high-density lipoprotein cholesterol; TC, total cholesterol, TG, triglycerides. ELIZABETH Current Presentation Stopped taking her rosuvastatin last week Experienced frequent muscle stiffness and associated pain Symptoms were particularly problematic when she got up from her chair after sitting for extended periods States that she read online that statins can cause muscle pain Based on ELIZABETH s CV risk factors and reports of muscle stiffness, how would you next address her hypercholesterolemia?

8 34-year-old man Presented to his PCP for first visit in 5 years Strong family history of cardiovascular disease GARY Background MI, myocardial infarction; PCP, primary care provider; UA, unstable angina. Family history Father died after a major stroke at 48 years old Paternal uncle died after acute MI at 49 years old Mother s cholesterol levels are normal with no evidence of ASCVD Brother recently hospitalized at 42 years old for UA that required catheterization and a stent GARY Physical Exam and Lab Results Physical exam Bilateral superior corneal arcus Thickened and irregular left Achilles tendon Lipids TC, 363 mg/dl LDL-C, 289 mg/dl HDL-C, 44 mg/dl TG, 152 mg/dl HDL-C, high-density lipoprotein-cholesterol; TC, total cholesterol, TG, triglycerides. GARY Physical Exam and Lab Results at First Visit GARY Follow-up Visit FPG, 85 mg/dl CK, 1 U/L ALT, 25 U/L AST, 2 U/L BP, 127/82 mm Hg BMI, 25.1 mg/kg 2 Nonsmoker A diagnosis of HeFH was made Counseled on diet and lifestyle changes Prescribed simvastatin 4 mg and ezetimibe 1 mg once daily After 1 year, there is little improvement in his lipid levels Lipids TC, 284 mg/dl LDL-C, 218 mg/dl HDL-C, 42 mg/dl TG,12 mg/dl BP, 13/85 mm Hg BMI, 25.8 kg/m 2 BMI, body mass index; BP, blood pressure; FPG, fasting plasma glucose. With an HeFH diagnosis and elevated LDL-C levels despite therapy, how would you now manage GARY to reduce his risk of a future CV event?

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