Earlier is better and Combination is better Park...cerebrovascular disease prevention effect. We...
Transcript of Earlier is better and Combination is better Park...cerebrovascular disease prevention effect. We...
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Earlier is better and Combination is better
Division of Cardiology, Department of Internal Medicine,
Hanyang University College of Medicine
Cardiovascular center, Hanyang University Guri Hospital
Kyungchun-ro 153, Guri city, Republic of Korea
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Disclosure
The author have no financial conflicts of interest to disclose
concerning the presentation
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Dyslipidemia
1. What is Dyslipidemia?
2. Dyslipidemia in Korea
3. Guidelines for Dyslipidemia
01
Limitations of statin monotherapy
1. Low LDL-C Goal Achievement rate
2. Additional need for LDL-C reduction
3. Safety
02
Benefits of adding Ezetimibe
1. LDL-C Lowering Effect
2. Prevention the Risk of CV Events
3. Additional Benefits
03
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Dyslipidemia01
1. What is Dyslipidemia?
2. Dyslipidemia in Korea
3. Guidelines for Dyslipidemia
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1. What is Dyslipidemia?
DyslipidemiaAbnormal amount of lipids in the blood
TG
≥ 150mg/dL
TC
≥ 200mg/dL
LDL-C
≥ 130mg/dL
HDL-C
< 40mg/dL
Cardiovascular risk IncreaseTG = TriglycerideTC = Total CholesterolLDL-C = Low Density Lipoprotein CholesterolHDL-C = High Density Lipoprotein Cholesterol
Ref.> Korean Guidelines for the Management of Dyslipidemia 4th ed. Committee of Clinical Practice Guideline of KSoLA. 2018.
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1. What is Dyslipidemia?
Ref.> Dzau V, et al. Am Heart J. 1991;121(4 Pt 1):1244-1263.
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2. Dyslipidemia in Korea
1495
2283
3272
4165
5553
6780
8258
9914
11558
0
2000
4000
6000
8000
10000
12000
14000
2002 2004 2006 2008 2010 2012 2014 2016 2018
(X1000person)
Number of People Diagnosed with Dyslipidemia
0 20 40 60 80 100
57.6%
48.1%
Awareness 2016-2018
TreatmentRate 2016-2018
X 7.8
1 out of 5 Korean adults had hypercholesterolemia (2018)
20.7%
Prevalence and Management of Hypercholesterolemia
41.3%Control Rate 2016-2018
Ref.> Dyslipidemia fact sheets in Korea. Korean Society of Lipidology and Atherosclerosis (KSoLA). 2020.
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2. Dyslipidemia in Korea
※ Hypertension is defined as systolic/diastolic blood pressure ≥140/90mmHg or taking
Antihypertensive medication
※ Diabetes is defined as fasting plasma glucose ≥126 mg/dl, previously diagnosed, or taking glucose-lowering drugs.
Dyslipidemia in Adults with Hypertension Dyslipidemia in Adults with Diabetes
31.3
56.6
68.3%
0
10
20
30
40
50
60
70
80
36.8
69.2
86.4%
0
20
40
60
80
100
Without hypertensionLDL-C ≥160 mg/dl
With hypertension LDL-C ≥160 mg/dl
With hypertension LDL-C ≥130 mg/dl
(%) (%)
Without diabetesLDL-C ≥160 mg/dl
With diabetesLDL-C ≥160 mg/dl
With diabetesLDL-C ≥100 mg/dl
Ref.> Dyslipidemia fact sheets in Korea. Korean Society of Lipidology and Atherosclerosis (KSoLA). 2020.
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Treated for Hypertension or Diabetes
Patient Treated for Dyslipidemia (7694 person)
74.2%
Treated for Dyslipidemia alone
25.8%
Dyslipidemia+Hypertension
40.6%
Dyslipidemia+Hypertension+Diabetes
20.7%
Dyslipidemia+Diabetes
11.1%
Treatment for Hypertension and Diabetes Among Persons Treated for Dyslipidemia
Ref.> Dyslipidemia fact sheets in Korea. Korean Society of Lipidology and Atherosclerosis (KSoLA). 2020.
2. Dyslipidemia in Korea
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Dual therapy
18.6%
Monotherapy
80.3%
Triple therapy
1.1%
Statin+Ezetimibe
72%
Prescriptions of Lipid-Lowering Drugs
2. Dyslipidemia in Korea
Prescription
Pattern
Ref.> Dyslipidemia fact sheets in Korea. Korean Society of Lipidology and Atherosclerosis (KSoLA). 2020.
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Treatment Algorithm for LDL-C Lowering
Ref.> Mach F, et al. Eur Heart J. 2020;41(1):111-188.
3. Guidelines for Dyslipidemia
2019 ESC· EAS Guideline
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Treatment goals for LDL-C across categories of 10-year risk of fatal CVD (SCORE)
Ref.> Mach F, et al. Eur Heart J. 2020;41(1):111-188.
3. Guidelines for Dyslipidemia
2019 ESC· EAS Guideline
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Secondary Prevention in Patients With Clinical ASCVD
3. Guidelines for Dyslipidemia
2018 AHA/ACC Guideline
Ref.> Grundy SM, et al. Circulation. 2019;139(25):e1082-e1143.
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Primary Prevention
3. Guidelines for Dyslipidemia
2018 AHA/ACC Guideline
Ref.> Grundy SM, et al. Circulation. 2019;139(25):e1082-e1143.
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Treatment goals for LDL-C and non-HDL-C in different risk categories
3. Guidelines for Dyslipidemia
2018 Korea Dyslipidemia Guideline
Ref.> Korean Guidelines for the Management of Dyslipidemia 4th ed. Committee of Clinical Practice Guideline of KSoLA. 2018.
Risk Categories LDL-C (mg/dL)
Very High risk
High risk
Moderate risk
Low risk
Non – HDL-C (mg/dL)
Diabetes 2)
Coronary artery disease
Atherosclerotic Ischemic Stroke
Transient ischemic attack
Peripheral artery disease
Carotid artery disease1)
Abdominal aortic Aneurysm
Major risk factor 3) ≤1
Major risk factor 3) ≥2
1) In case of significant Carotid artery stenosis (which has been shown to be strongly predisposed to clinical events)2) Target goal can be lowered in patients who have target organ damage or major cardiovascular risk factors.
3) Age (Male ≥ 45y, Female ≥ 55y), family history of premature ASCVD, Hypertension, Smoking, Low HDL-C
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Pharmacological Hypercholesterolemia treatment Strategy
Ref.> Korean Guidelines for the Management of Dyslipidemia 4th ed. Committee of Clinical Practice Guideline of KSoLA. 2018.
2018 Korea Dyslipidemia Guideline
3. Guidelines for Dyslipidemia
CV risk evaluation
Very High risk
Statin
Moderate risk
LDL-C Goal Reached?
· CAD· Atherosclerotic Ischemic Stroke or
Transient ischemic attack· Peripheral artery disease
· Carotid artery disease· Abdominal aortic Aneurysm· Diabetes
· Major risk factor ≥2
High risk
YES NO
YES
NO
Maintain current therapy
Adverse event evaluation
Maximum tolerableStatin
Very High risk < 70 mg/dLHigh risk < 100mg/dLModerate risk < 130mg/dL
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Recommendations for the treatment of Dyslipidemias in DM
Ref.> Mach F, et al. Eur Heart J. 2020;41(1):111-188.
3. Guidelines for Dyslipidemia with DM
2019 ESC· EAS Guideline
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2019 Korea Diabetes Guideline Treatment of Dyslipidemia in DM
성공모델 sP 내용 넣기1. Serum lipid profile test (TC, HDL-C, TG, LDL-C) should be done once DM diagnosed, and follow up annually. Evaluate treatment response and adherence by testing before and after 4-12 week. [E, I]
2. In DM patients without Cardiovascular disease, LDL-C goal of ‹100 mg/dL recommended. [A, I]
3. In DM patients with Cardiovascular disease, LDL-C goal of ‹70 mg/dL recommended. [A, I]
4. In DM patients with Risk factors such as Albuminuria, CKD(GFR 60 mL/min/ ‹1.73 m2), Target organ damage, Hypertension, smoking, family
history of premature ASCVD , LDL – C goal of ‹70 mg/dL recommended. [B, IIa]
5. Target goals are TG <50 mg/dL , HDL –C > 40 mg/dL(male), >50 mg/dL(female). Promote active lifestyle modification and strict blood glucose control to reach this goal. [C, I]
6. In patients with Dyslipidemia, promote active lifestyle modification. [A, I]
7. In DM patients with Dyslipidemia, Statin should be 1st line therapy. [A, I]
8. Adding Ezetimibe or PCSK9 inhibitors are recommended in DM patients with Cardiovascular disease if the LDL-C goal is not achieved on
maximal tolerated Statin. However, Ezetimibe is favored considering the cost. [B, IIa]
9. Adding Ezetimibe is recommended in DM patients without Cardiovascular disease if the LDL-C goal is not achieved on maximal tolerated
Statin. [C, IIb]Ref.> Treatment Guideline for Diabetes 6th ed. Korean Diabetes Association. 2019.
3. Guidelines for Dyslipidemia with DM
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2018 Korea Hypertension Guideline
Treatment of Dyslipidemia in Hypertension
Ref.> Treatment Guideline for Hypertension. The Korean Society of Hypertension. 2018.
3. Guidelines for Dyslipidemia _with Hypertension
10.7.2. Lipid lowering agent treatment
Lipid lowering agents for high risk hypertension patients have significant Cardio-
cerebrovascular disease prevention effect. We cannot present exact number due to the
lack of Korean data. However, significant prevention effect of showing more than 50%
reduction using Statin appeared in study with Hypertension patients of LDL-C
≥130mg/dL without Cardio-cerebrovascular disease. In Hypertension patients with
Coronary artery disease, target goal of LDL-C <70mg/dL is recommended. In
Hypertension patients with history of Stroke, average 133mg/dL LDL-C statin therapy
effect is significant, but there is lack of data on lowering <70mg/dL treatment.
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Limitations of statin monotherapy 02
1. Low LDL-C Goal Achievement rate
2. Additional need for LDL-C reduction
3. Safety
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DYSIS
Europe and Canada study1
48.2%
CEPHEUS
Pan-Asian study2
50.9%
1. Low LDL-C Goal Achievement rate
Ref.> 1. Gitt AK. Eur J Prev Cardiol. 2012;19(2):221-30. 2. Park JE. Eur J Prev Cardiol. 2012;19(4):781-94. 3. Akyea RK, et al. Heart. 2019;105(13):975-981.
Number at risk Optimal response 80802 73747 57766 43543 29881 17588 6922 Sub-Optimal response 84609 76145 57326 41509 27426 15584 6295
22%
LDL-C goal Optimal responders
LDL-C goal Sub-optimal responders
(LDL-C reduction < 40%)
Adjusted HR(95% CI)=1.22(1.19-1.25)
Follow-up(years)
CVD risk
1DYSIS Europe and Canada studyDYSIS: the Dyslipidemia International Study∙ Objective: To assess the prevalence and types of persistent lipid
abnormalities in patients receiving statin therapy.∙ Patients: 11 European countries and 22,063 Canada patients treated with statins∙ Methods: multicenter, epidemiologic cross-sectional study
2CEPHEUS Pan-Asian study CEPHEUS Pan-Asian study: the Centralized Pan-European survey on the Under-treatment of hypercholesterolemia∙ Objective: to determine the proportion of patients on lipid-lowering pharmacological treatment attaining LDL-C goals,
as defined by the NCEP ATP III guidelines ∙ Patients: 8 Asian countries (Korea, Taiwan, Thailand, Indonesia, Philippines, Malaysia, Vietnam, Hongkong, China)∙ Methods: prospective, multinational, cross-sectional study
∙ Objective3 : To assess LDL-C response in patients after initiation of statins, and future risk of CVD.∙ Methods3 : Prospective Cohort study. 165411 patients who treated Statin for CVD primary prevention between 1990y~ 2006y. Analyzed relationship between optimal LDL-C response rate and CVD event(ASCVD,TIA, Peripheral vascular
disease, death by CVD). <40% reduction in baseline LDL-C within 24months was classified as a sub-optimal statin response.
LDL-C goal attainment failure rate by Statin monotherapy
Incidence of CVD according to LDL-C goal attainment3
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2. Additional need for LDL-C reduction
Ref.> 1. Rosenson RS. Expert Opin Emerg Drugs. 2004;9(2):269–279. 2. LaRosa JC, et al. N Engl J Med. 2005;352(14):1425–1435. 3. Pedersen TR, et al. JAMA. 2005;294(19):2437-2445. 4. Nakamura H, et al. Lancet. 2006;368(9542):1155-1163. 5. Gragnano F, et al. Atherosclerosis. 2018; 269:219-228.
Relationship between LDL-C reduction and CV incidence reduction1-
4Relationship between LDL-C Reduction and
Plaque regression5
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The earlier is better ?
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The earlier is better ?
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Intracellular actions of statins in β-cells
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The earlier is better ?
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The earlier is better ?
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Asian Race
FemaleGender
Variability Of Metabolizing
Enzymes
Variability of Transporters
Interactions
LactoneForm
Co-morbidites
Increase risk of statin-associated
myotoxicity
HighDose
LipophilicStatin
FattyMeal
AdvancedAge
Gen
etic R
isk Fa
ctors O
fSta
tin M
yop
ath
y
EnvironmentalRisk Factors-Patient Related
En
viro
nm
en
tal
Ris
k F
act
ors
Dru
g R
ela
ted
SAMS(Statin-Associated Muscle Symptoms)
3. Safety
Ref.> Taha DA, et al. Transl Res. 2014;164(2):85-109.
Statin Associated Muscle Symptoms(SAMS): Risk factors
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Creatine kinase elevations > 10times ULN Alanine amino transferase elevations > 3times ULN
3. Safety
Statin related Major adverse effect
Ref.> Brewer HB Jr. Am J Cardiol. 2003;92(4B):23K-29K.
ULN, upper limit of normal[Study design] to examine the benefit-risk profile of rosuvastatin at doses of 10 to 40 mg, Compared LDL-C reduction effect and Safety data between atorvastatin 10-80 mg, simvastatin 10-80 mg, pravastatin 10-40 mg.
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Benefits of adding Ezetimibe03
1. LDL-C lowering effect
2. Prevention the risk of CVD events
3. Additional benefits
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AtheromaBlood
LiverIntestine
Bile Acids
FreeChol
Chol
Acetyl CoA
Remnantreceptors
Hepatic Apo B100
Intestinal Apo B48
Cholesterol Pool
CMRCM
VLDL
lDL
LDL
Peripheral Tissues
Intestine : EZETIMIBE
Liver : STATIN
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1. LDL-C Lowering Effect
Ref.> 1. Shepherd J. Eur Heart J. 2001;3(Suppl E):E2-E5. 2. McTaggart F, et al. Am J Cardiol. 2001;87(5A):28B-32B. 3. Jeu L, et al. Clin Ther. 2003;25(9):2352-2587.
Statin and Ezetimibe: DUAL INHIBITION in cholesterol
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10 20 30 40 50 60
Reduction in LDL-C(%)
0
Statin 10 mg 20mg 40mg 80mg
-6% -6% -6%
-18%
3-step Statin titration
+ Ezetimibe 10mgStatin 10 mg“1-step”Co-administration
1. LDL-C Lowering Effect
Ref.> Bays H, et al. Expert Opin Pharmacother. 2003;4(5):779-790.
Rule of six
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Ref.>. Ouchi Y, et al. Circulation. 2019; 140(12):992-1003.
EWTOPIA 75
2. Prevention the risk of CVD events
16951716
15821617
14181445
12171219
887897
383387
No. at RiskControlEzetimibe
34%
EWTOPIA 75 study ∙ Objective : To evaluate the preventive efficacy of ezetimibe for patients aged ≥ 75years, with elevated LDL-C without history of coronary artery disease∙ Method : prospective, randomnized, open-label, blined end-point evaluation (PROBE design)
3796 Patients aged ≥ 75years, with LDL-C 140mg/dL, without history of CHD were randomly assigned (1:1) to receive ezetimibe(10mg/day) versus usual care with dietary counseling
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N Baseline After treatment % change p value
Fasting Blood Glucose (mg/dL) 116 94.0±23.8 94.3±28.4 0.5±14.7 NS
Fasting Insulin (μIU/mL) 102 12.7±17.5 9.4±8.2 -12.8±9.8 P <0.05
HbA1c (%) 35 6.2±1.0 5.9±1.0 -3.4±8.6 P <0.05
hs-CRP (ng/mL) 76 601.8±461.6 485.1 ±366.9 -10.8±36.8 P <0.01
Adiponectin (㎍/mL) 102 10.8±5.9 11.8±6.8 13.4±47.5 P <0.01
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* hsCRP = High-Sensitive C-Reactive Protein
•Objective : The effects of ezetimibe on clinical benefit of inhibiting intestinal cholesterol absorption, surrogate markers of cholesterol absorption and synthesis, lipid and glucose metabolism, and obesity and inflammation•Subjects : 120 patients with dyslipidemia who had not achieved the LDL-C goal recommended by 2007 JAS(=Japan Atheroscleosis Society) Guideline despite diet/exercise or any statin therapy•Methods : After treated with ezetimibe 10mg/day for 12 weeks, following parameters are monitored
; serum lipid profile(TC, LDL-C, TG, HDL-C), glucose metabolism(fasting blood glucose, fasting insulin, HbA1c) , markers of obesity and inflammation(adiponectin, hsCRP),markers of cholesterol absorption and synthesis, BMI, waist circumference, blood pressure and heart rate
3. Additional benefits
Improvements in levels of glucose metabolism and inflammatory markers
Ref.> Hiramitsu S, et al. J Atheroscler Thromb. 2010;17(1):106-114.
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Take-home Messages
• The prevalence of dyslipidemia in South Korea is rising every year and
dyslipidemia is prevalent among HTN or DM patients.
• Guidelines recommends that the higher patient has the risk of CVD, the more
LDL-C levels should be reduced significantly.
• Statin monotherapy is difficult to achieve LDL-C goals and high-dose statin
can cause major adverse effects.
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Take-home Messages
• Ezetimibe added to statin therapy showed additional LDL-C lowering effect and
prevention the risk of CVD events
![Page 37: Earlier is better and Combination is better Park...cerebrovascular disease prevention effect. We cannot present exact number due to the lack of Korean data. However, significant prevention](https://reader036.fdocuments.in/reader036/viewer/2022071608/6146550f8f9ff8125420329c/html5/thumbnails/37.jpg)
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