dyslipidemia in diabetes, applicability of recent ... soebagijo adi - dyslipedemia in diabetes.pdfbp
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Soebagijo Adi S Endocrine & Metabolic Division – Dep. Of Internal Medicine
Faculty of Medicine Airlangga University Dr. Soetomo General Academic Hospital - Surabaya
Dyslipidemia in Diabetes, Applicability of Recent Guidelines to
Achieve Primary and Secondary Target
WS 3.2
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Shamiri M, Ghanaim MMA,..Santoso A,.. et al Int J Gen Med 2018; 11: 313 - 22
Proportion of Dyslipidemia is High in Indonesia Especially High LDL-C (83%)
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Dyslipidemia is very common in Diabetes
DDM = Diagnosed Diabetes Mellitus
UDDM = Undiagnosed diabetes Mellitus
IGT = Impaired Glucose Tolerance
NGT = Normal Glucose Tolerance
NDDM = Newly Diagnosed Diabetes Mellitus
Lipid profile of DM patients in productive aged urban Indonesia1
1. Mihardja L, et al. J Diabetes Invest 2014; 5: 507–512
2. Soebardi S, et al. Acta Med Indonesia 2009; 41: 186-190
2
• In Indonesia, Dyslipidemia in individuals with type 2 diabetes is very common, with a prevalence of 80–90%
• This phenomenon is associated with a significantly increased risk of coronary artery disease relative to
individuals without diabetes
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More Severe Atherosclerosis in Diabetes: Atherosclerotic Diabetic Dyslipidemia (ADD)
Atherosclerotic plaques in the presence of diabetes generally have increased calcification, necrotic cores, receptors for advanced glycosylation endproducts (RAGE), and macrophage and T-cell infiltration. These features can potentially contribute to the more severe atherosclerosis and a higher incidence of acute adverse events.
Faxon DP, et al.Circulation.2004;109(21):2617-25
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UKPDS: LDL-C is a very strong predictor of CHD risk in patients with diabetes
Relation of lipid risk factors* to CHD in 2693 patients with diabetes
Turner RC et al. BMJ. 1998;316:823-8.
0.0
0.5
1.0
1.5
2.0
2.5
<189
189-223
>223
Total cholesterol
P<0.0001
0.0
0.5
1.0
1.5
2.0
2.5
<117
117-150
>150
LDL-C
P<0.0001
0.0
0.5
1.0
1.5
2.0
2.5
<108
108-166
>166
Triglycerides
P<0.0001
0.0
0.5
1.0
1.5
2.0
2.5
<37
37-44
>44
HDL-C
P<0.0001
Ha
za
rd r
ati
o
Lipid tertiles (mg/dL)
*Age- and sex-adjusted.
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Cardiovascular Disease is The Most Common Cause of Death Among Patients With Diabetes
Geiss LS, et al. Mortality in non-insulin-dependent diabetes. In: Diabetes in America. 2nd ed. Bethesda, Md: National Institute
of Diabetes and Digestive and Kidney Diseases, National Institutes of Health; 1995:233-257. NIH Publication No. 95-1468.
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Unadjusted CVD and CHD event rates per 1,000 person-years for subjects with DM, by the number of risk factors at target levels A HbA1c target : 7% B BP target : 130/80 mmHg C LDL-C target : 100 mg/dL
Multifactorial Intervention (A, B, C)
Improves Cardiovascular Outcomes in T2DM
Pooling of ARIC, MESA, and JACKSON Heart Studies
With All 3 Risk Factors Controlled • 62% lower of CVD Events • 60% lower of CHD Events
Wong ND, et al. Diabetes Care. 2016;39:668-676
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Intensive therapy†:
Microalbuminuria with ACEIs, ARBs, or combination
Hypertension
Hyperglycaemia
Dyslipidaemia
Secondary prevention of CVD
Conventional treatment was in accordance with national guidelines
STENO-2 Study Intensive MRF management significantly reduces risk of CV events
Adapted from Gaede P et al. N Eng J Med. 2003;348:383-393.
Pri
mar
y co
mp
osi
te e
nd
po
int*
(%
)
MRF: Multiple risk factor
Multiple risk-factor intervention study comparing conventional vs intensive treatment of risk factors in a high-risk population with type-2 diabetes
Primary composite endpoint: conventional therapy (44%) and intensive therapy (24%). *Death from CV causes, nonfatal MI, CABG, PCI, nonfatal stroke, amputation, or surgery for peripheral atherosclerotic artery disease; †Behavior modification and pharmacologic therapy
0
Months of follow-up
N=160; follow-up = 7.8 years P=0.007
12 24 36 48 72 96 60 84
20% absolute risk reduction
0
10
20
30
40
50
60 Conventional therapy Intensive therapy†
Intensive therapy:
Dyslipidemia
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Lipid-Lowering Therapy Accounted for>70% of CV Risk Reduction in Type 2 Diabetes
Adapted from Gaede P, Pedersen O. Diabetes. 2004;53 (suppl 3):S39–S47.
Multifactorial therapy in type 2 DM , to achieve :
BP <130/80, HbA1c < 6.5%, total cholesterol < 175 mg/dL
Steno 2-Study
The most of the CV benefit was attributable to the use of lipid-lowering therapy
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Which are the primary target in managing dyslipidemia?
↓ Total-cholesterol ?
↓ LDL-cholesterol ?
↑ HDL-cholesterol ?
↓ Triglyceride ?
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3 Requirement Have To Fulfill To Be a Primary Target Dyslipidemia:
1. Patogenesis 2. Epidemiologi 3. Studi Klinis Acak
LDL-C, HDL-C, maupun TG berperan dalam patogenesis
terbentuknya plak aterosklerosis
LDL-C, HDL-C, maupun TG berhubungan dengan
morbiditas dan mortalitas PJK di tingkat populasi
• LDL-C: Penurunan LDL-C Penurunan risiko kardiovaskular
• TG: Hanya menurunkan risiko kardiovaskular bagi pasien dengan LDL-C yang rendah
• HDL-C: Meningkatkan HDL-C tidak menurunkan risiko kardiovaskular
Barter P. Eur Heart J 2004; 69(suppl 6):A19-A22 1. Ballantyne CM. Am J Cardiol. 1998;82:3Q–12Q., 2. The FIELD study investigators. Lancet. 2005;366:1849-61
1. Assman G. Am J Cardiol. 2001;87(suppl):2B-7B 2. Gordon T et al. Am J Med . 1977;62:707-714
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Lipid Modification Clinical Benefit
↓ LDL-C √√
↓ Triglycerides √
↑ HDL-C X
LDL-C is The Primary Target to Focus in Dyslipidemia
Primary target: LDL-C
Secondary target: non-HDL-C (TC – HDL-C)
Not a target: HDL-C
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PERKENI,2015
Alur ACC/AHA
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Lipid Management According To ACC AHA 2018
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Top 10 Take Home Messages To Reduce Risk of ASCVD Through Lipid Management
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Top 10 Take Home Messages To Reduce Risk of ASCVD Through Lipid Management
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Top 10 Take Home Messages To Reduce Risk of ASCVD Through Lipid Management
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Top 10 Take Home Messages To Reduce Risk of ASCVD Through Lipid Management
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ACC/AHA 2018: Primary prevention
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Ten-Year ASCVD Risk
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ADA 2019: Recommendations for Statin and Combination Treatment in Adults With Diabetes
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Lower LDL-C is Better:
AACE 2017 Guideline Highlights More Stringent LDL-C Target
Kheloussi S,et al.US Pharm. 2018;43(7)22-26.
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ESC 2019: New LDL-C target across CV risk categories
1. Mach F, et al. European Heart Journal (2019) 00, 1-78
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ESC 2019 : High intensity statin is recommended as 1st line therapy (Class IA)1
1. Mach F, et al. European Heart Journal (2019) 00, 1-78
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ESC 2019: Recommendations for the treatment of dyslipidemia in diabetes mellitus
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ESC 2019 : Recommendations for the treatment of dyslipidaemias in older people (aged >65 years) 1
1. Mach F, et al. European Heart Journal (2019) 00, 1-78
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ESC 2019: Emphasize on statin safety
1. Mach F, et al. European Heart Journal (2019) 00, 1-78
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Donald M. Lloyd-Jones DM, et al. JACC. 2016;68:92-125
Statin Selection
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Third Generation Statin Highest-Potency Generation of Statins
Kapur Navin K,et al. Vascular Health and Risk Management 2008:4(2) 341–353
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Crestor®: Superior efficacy start from low dose 5 mg
Karlson BW, et al. European Heart Journal – Cardiovascular Pharmacotherapy (2016) 2, 212–217
-41%
-35%
-33%
Crestor 5mg Atorvastatin 10mg Simvastatin 20mg
LDL-
C r
edu
ctio
n f
rom
bas
elin
e (
%)
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Relative efficacy of statin-based therapies in LDL-C reduction2
Crestor is 3rd generation statin, the most potent statin to reduce LDL-C3
2. Adapted from FDA drug safety communication. Available in https://www.fda.gov/Drugs/DrugSafety/ucm256581.htm 3. Kapur Navin K,et al. Vascular Health and Risk Management 2008:4(2) 341–353
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Crestor® showed superior efficacy in improving overall lipid profile as compared to other statin
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Greater Reduction of LDL-C Level with Rosuvastatin vs. Atorvastatin in Patients with Diabetes
*p<0.0001 vs ATV; †p≤0.001 RSV 10 mg vs ATV 10 mg, and RSV 20 mg vs ATV 20 mg; ‡p<0.05 vs ATV; ‡‡p<0.01 vs ATV
Adapted from: 1. Berne C, Siewert-Delle A. Cardiovasc Diabetol 2005; 4: 7
2. Betteridge DJ et al. Diabet Med 2007; 24: 541–549 3. Wolffenbuttel B et al. J Intern Med 2005; 257: 531–539
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ATP III = Adult Treatment Panel III; LDL-C = low density lipoprotein -cholesterol.
Adapted from Ballantyne CM,et al. Am Heart J. 2006;151:975.e1-975.e9
Switching to Rosuvastatin Significantly Helps More Diabetes Patients Achieve LDL-C Goal (MERCURY II STUDY)
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CRESTOR 20 mg monotherapy lowers LDL-C as effectively as atorvastatin 20 mg/10 mg ezetimibe Comparison of percent reduction in LDL-C from baseline from 5 different studies
1. Olsson AG, et al. Cardiovasc Durg Rev. 2001;20(4):303-28 2. Goldberg AC, et al. Mayo Clin Proc. 2004;79:620-629
3. Ballantyne CM, et al. Circulation. 2003;107(19);2409-15 4. Kosoglou T, et al. Curr Med Res Opin 2004;20(8)
5. Ballantyne CM, et al. Am J Cardiol 2007;99:673-680
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JUPITER Primary Trial Endpoint: MI, Stroke, UA/Revascularization, CV Death
Intensive LDL-C Reduction Related to Plaque Stabilization to reduced CV morbidity & Mortality
Placebo
Rosuvastatin (CRESTOR)
HR 0.56, 95% CI 0.46-0.69 P < 0.00001
- 44 %
0 1 2 3 4
0.0
2
0.0
4
0.0
6
0.0
8
Cu
mu
lati
ve In
cid
ence
Follow-up (years)
0.0
0
Ridker et al, N Engl J Med. 2008;359:2195-207 Only in a few months
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Rosuvastatin is a Hydrophilic Statin and Not Metabolized by CYP3A4 Less Prone To Drug Interactions & Rhabdomyolysis
Ramosevac AC, et Al. Acta Pharm 2013
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KDIGO 2013: Adjusment Dose Apply To All Statins, Including Atorvastatin
KDIGO, ISN 2013.
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Intensive LDL-C-Lowering Treatment with Rosuvastatin Does Not Affect the Risk of Developing Renal Insufficiency or Renal Failure in Patients Who Do Not Have Advanced, Pre-existing Renal Disease
Stein EA, et al. Atherosclerosis 2012.
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Summary
• Type 2 diabetes is associated with a marked increase in the risk of atherosclerotic cardiovascular disease.
• Treatment initiation (and initial statin dose) is now driven primarily by risk status rather than LDL cholesterol level
• LDL-C is the primary target of lipid-lowering therapy in patients with diabetes & newest dyslipidemia guideline recommend more aggressive LDL-C target to reduce CV risk
• High intensity statin is recommended as 1st line therapy to be added to lifestyle therapy
• Rosuvastatin is proven as the most potent statin among different patient profile including diabetes with excellent safety