a roussin vascular protection - diabetes - 2006 è evidence è guidelines cda 2003 cda 2003 ada 2006...

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VASCULAR PROTECTION - DIABETES - 2006VASCULAR PROTECTION - DIABETES - 2006

Evidence Evidence GuidelinesGuidelines

CDA 2003CDA 2003 ADA 2006ADA 2006 CHEP 2006CHEP 2006

Evidence Evidence GuidelinesGuidelines

CDA 2003CDA 2003 ADA 2006ADA 2006 CHEP 2006CHEP 2006

André Roussin MD, FRCPAndré Roussin MD, FRCPVascular laboratoryVascular laboratory

Notre-Dame Hospital (CHUM)Notre-Dame Hospital (CHUM)Associate professorAssociate professor

University of MontrealUniversity of Montreal

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Speaker and/or Advisory board memberSpeaker and/or Advisory board member

AstraZenecaAstraZeneca

Bristol-Myers SquibbBristol-Myers Squibb

Merck Frost ScheringMerck Frost Schering

Pfizer Canada Inc.Pfizer Canada Inc.

sanofi aventissanofi aventis

DisclosuresDisclosures André Roussin MDAndré Roussin MD

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Vascular ProtectionVascular ProtectionAttendee ObjectivesAttendee Objectives

TO BE ABLE TO:TO BE ABLE TO:

Define vascular protection and interventionsDefine vascular protection and interventions

Understand the evidenceUnderstand the evidence

Apply CDA, ADA, CHEP and Lipid guidelinesApply CDA, ADA, CHEP and Lipid guidelines

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Vascular ProtectionVascular ProtectionDefinitionDefinition

Prevent the “triple end-point”Prevent the “triple end-point” Stroke (mainly ischemic)Stroke (mainly ischemic) MIMI Vascular deathVascular death

Prevent the broader vascular end-pointPrevent the broader vascular end-point Same as above + hospitalisation for ischemic eventsSame as above + hospitalisation for ischemic events

AlsoAlso All CAD, PAD, ASO renal diseaseAll CAD, PAD, ASO renal disease

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Vascular ProtectionVascular ProtectionMainMain Intervention targetsIntervention targets

For For almost almost all: all: ACE inhibitors and antiplatelet therapyACE inhibitors and antiplatelet therapy Blood pressure controlBlood pressure control Glycemic controlGlycemic control Lipid controlLipid control

LDL and CT/HDLLDL and CT/HDL HDL, TG, ApoA/ApoB, Lp(a)HDL, TG, ApoA/ApoB, Lp(a)

Smoking cessationSmoking cessation Lifestyle modificationLifestyle modification

Weight reductionWeight reduction Sedentarity-activitySedentarity-activity

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Type II Diabetes & Coronary Heart DiseaseType II Diabetes & Coronary Heart Disease7 Year Incidence of Fatal/Nonfatal MI from the East West Study7 Year Incidence of Fatal/Nonfatal MI from the East West Study

3.5%

18.8% 20.2%

45.0%

0

5

10

15

20

25

30

35

40

45

No DM, No MI No DM, MI DM, No MI DM, MI

p<0.001p<0.001

P<0.001P<0.001

Non-diabetic n=1373Non-diabetic n=1373 Diabetic n=1059Diabetic n=1059

Haffner, et al. Haffner, et al. N Engl J Med N Engl J Med 1998;339:229-2341998;339:229-234

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DM- diabetes mellitusDM- diabetes mellitusMI- myocardial infarctionMI- myocardial infarction

Vascular ProtectionVascular ProtectionCHD andCHD and Risk factors in perspective: 1999Risk factors in perspective: 1999

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Vascular ProtectionVascular ProtectionCHD andCHD and Risk factors in perspective: 2006Risk factors in perspective: 2006

Howard BV et al. Diabetes Care 2006, 29:391Howard BV et al. Diabetes Care 2006, 29:391--339797

10 10 yryr

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Prévention primairePrévention primaire Avantages et risques de AAS selon le risque coronarien à 5 ansAvantages et risques de AAS selon le risque coronarien à 5 ans

Hayden M et al. U.S. Preventive ServicesTask Force. Ann Intern Med. 2002;136:161-172Hayden M et al. U.S. Preventive ServicesTask Force. Ann Intern Med. 2002;136:161-172

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Diabète en “prévention primaire”Diabète en “prévention primaire”AntiplaquettairesAntiplaquettaires

La proportion de patients diabétiques est La proportion de patients diabétiques est petite dans la plupart des études en petite dans la plupart des études en

prévention primaireprévention primaire

- PPP: PPP: 17%17%- HOT: HOT: 8%8%- PHS: PHS: 2%2%- BMD: BMD: 2%2%- TPT: TPT: 2%2%


< 20 %< 20 %

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Diabète en “prévention primaire” : AntiplaquettairesDiabète en “prévention primaire” : AntiplaquettairesPhysicians Health StudyPhysicians Health Study

In PHS, patients with diabetes derived In PHS, patients with diabetes derived greater benefit from aspirin than those greater benefit from aspirin than those

without diabetes without diabetes 11

Relative risk: 0.39 vs. 0.60Relative risk: 0.39 vs. 0.60

Risk of MI over 5 years of follow-upRisk of MI over 5 years of follow-up22::Reduced by ASA from 10 % to 4%Reduced by ASA from 10 % to 4%

1. Hayden M et al. U.S. Preventive ServicesTask Force. Ann Intern Med. 2002;136:161-1721. Hayden M et al. U.S. Preventive ServicesTask Force. Ann Intern Med. 2002;136:161-172

2. PHS. N Engl J Med 1989; 321:129-35.2. PHS. N Engl J Med 1989; 321:129-35.

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Diabète en “prévention primaire” : AntiplaquettairesDiabète en “prévention primaire” : AntiplaquettairesAntithromboticAntithromboticTrialists'Trialists'Collaboration 2002Collaboration 2002

BMJ 2002, vol 24: 71-86BMJ 2002, vol 24: 71-86

Much of the new information comes from the early treatment diabetic retinopathy Much of the new information comes from the early treatment diabetic retinopathy

study, in which 3711 people with diabetes (and, generally, no history of myocardial study, in which 3711 people with diabetes (and, generally, no history of myocardial

infarction or stroke) were allocated to receive 650 mg aspirin dailyor placebo.infarction or stroke) were allocated to receive 650 mg aspirin dailyor placebo.

% odds % odds reductionreduction

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Diabète en “prévention secondaire”Diabète en “prévention secondaire”AntiplaquettairesAntiplaquettaires

Pooled data from aspirin trials in secondary Pooled data from aspirin trials in secondary prevention settingsprevention settings11

and a single trial in diabetic patients with and and a single trial in diabetic patients with and without coronary heart diseasewithout coronary heart disease22

suggest that diabetic patients benefit as much suggest that diabetic patients benefit as much or more from aspirin as non diabetic patients.or more from aspirin as non diabetic patients.


1. Antiplatelet Trialists1. Antiplatelet Trialists Collaboration. BMJ. 1994; 308:81-106Collaboration. BMJ. 1994; 308:81-106

2. ETDRS Investigators. JAMA. 1992; 268:1292-3002. ETDRS Investigators. JAMA. 1992; 268:1292-300

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Diabète type I en prévention PRIMAIREDiabète type I en prévention PRIMAIREADA 2006ADA 2006

Utiliser AAS (75Utiliser AAS (75--1162 mg/jr) comme stratégie de 62 mg/jr) comme stratégie de prévention primaire chez les diabétiques type 1:prévention primaire chez les diabétiques type 1: Avec risque cardio-vasculaire augmentéAvec risque cardio-vasculaire augmenté Incluant ceux de plus de 40 ans Incluant ceux de plus de 40 ans Ou ceux avec des facteurs de risque additionnels: Ou ceux avec des facteurs de risque additionnels:

Antécédents familiaux de maladie CVAntécédents familiaux de maladie CV HypertensionHypertension TabagismeTabagisme DyslipidémieDyslipidémie AlbuminurieAlbuminurie

Niveau d’évidence : CNiveau d’évidence : C

AAS non étudiée < 30 ansAAS non étudiée < 30 ansAAS à éviter < 21 ans (S. Reye)AAS à éviter < 21 ans (S. Reye)

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Diabète type II en prévention PRIMAIREDiabète type II en prévention PRIMAIREADA 2006ADA 2006

Utiliser AAS (75Utiliser AAS (75--1162 mg/jr) comme stratégie de 62 mg/jr) comme stratégie de prévention primaire chez les diabétiques type 2:prévention primaire chez les diabétiques type 2: Avec risque cardio-vasculaire augmentéAvec risque cardio-vasculaire augmenté Incluant ceux de plus de 40 ans Incluant ceux de plus de 40 ans Ou ceux avec des facteurs de risque Ou ceux avec des facteurs de risque

additionnels: additionnels: Antécédents familiaux de maladie CVAntécédents familiaux de maladie CV HypertensionHypertension TabagismeTabagisme DyslipidémieDyslipidémie AlbuminurieAlbuminurie

Niveau d’évidence : ANiveau d’évidence : A

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Diabète en prévention SECONDAIREDiabète en prévention SECONDAIREADA 2006ADA 2006

Utiliser AAS (75Utiliser AAS (75--1162 mg/jr) comme stratégie de 62 mg/jr) comme stratégie de prévention secondaire chez les diabétiques prévention secondaire chez les diabétiques avec:avec: Infarctus du myocardeInfarctus du myocardeProcédure de revascularisationProcédure de revascularisationAVC ou ICTAVC ou ICTMaladie artérielle périphériqueMaladie artérielle périphériqueClaudicationClaudicationAngineAngine

Niveau d’évidence: ANiveau d’évidence: A

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Diabète et alternatives antiplaquettairesDiabète et alternatives antiplaquettairesADA 2006ADA 2006

People with: People with: Aspirin allergyAspirin allergy Bleeding tendencyBleeding tendency Receiving anticoagulant therapyReceiving anticoagulant therapy Recent gastrointestinal bleedingRecent gastrointestinal bleeding Clinically active hepatic diseaseClinically active hepatic disease

Are not candidates for aspirin therapy. Are not candidates for aspirin therapy. Other anti-platelet agents may be a reasonable Other anti-platelet agents may be a reasonable

alternative for patients with high risk. alternative for patients with high risk.

Level of evidence : ELevel of evidence : E

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Clopidogrel: amplified benefit over ASA Clopidogrel: amplified benefit over ASA In CAPRIE patients with a history of diabetesIn CAPRIE patients with a history of diabetes

Events : MI, IS, VD, hospitalization for ischemic event / bleeding.Events : MI, IS, VD, hospitalization for ischemic event / bleeding.

Events prevented / 1000 pts/yrEvents prevented / 1000 pts/yrover aspirinover aspirin

non-diabeticnon-diabetic All diabeticsAll diabetics With insulinWith insulin00

55

1010

1515

2020

2525

An

nu

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ven

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te (

%)

An

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te (

%)

ASAASA ClopidogrelClopidogrel

12,7 %12,7 %11,8 %11,8 %

17,7 %17,7 %

15,6 %15,6 %

21,5 %21,5 %

17,7 %17,7 %

2121

99

3838

p = 0.032p = 0.032

Bhatt Bhatt et al.et al. AJC 2002 Sep 15;90(6):625-8 AJC 2002 Sep 15;90(6):625-8

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Multiple vascular bed disease: the CAPRIE experienceMultiple vascular bed disease: the CAPRIE experienceClopidogrel over ASA to prevent IS, MI, VD Clopidogrel over ASA to prevent IS, MI, VD and Hosp for IE or bleeding / yearand Hosp for IE or bleeding / year

High-risk PopulationHigh-risk PopulationASAASA ClopidogrelClopidogrel

Event rate %Event rate % RRR (%)RRR (%) ARR (%)ARR (%) NNTNNT

Total CAPRIE populationTotal CAPRIE population 13.6713.67 8.18.1 1.11.1 9090Patients with PADPatients with PAD NANA NANA NANA NANAPatients with mutivascular Patients with mutivascular territory involvmentterritory involvment NANA NANA NANA NANA

Patients with a history of more Patients with a history of more than one ischemic eventthan one ischemic event 36.5 / 36.5 / 3yr3yr 10.710.7 3.93.9 2626

Patients with diabetesPatients with diabetes 17.717.7 11.811.8 2.12.1 4848Patients with previous CABGPatients with previous CABG 22.322.3 28.728.7 6.46.4 1616Patients taking lipid-lowering Patients taking lipid-lowering agentsagents 14.614.6 18.518.5 2.72.7 3737

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Diabète et combinaison antiplaquettaires Diabète et combinaison antiplaquettaires ADA 2006ADA 2006

Combination therapyCombination therapy

using other antiplatelet agents using other antiplatelet agents

such as clopidrogel in addition to such as clopidrogel in addition to

aspirinaspirin

should be used in patients with severe should be used in patients with severe

and progressive CVDand progressive CVD

Level of evidence : CLevel of evidence : C

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Primary efficacy end point in perspectivePrimary efficacy end point in perspectiveCHARISMA vs CAPRIECHARISMA vs CAPRIE

PrimaryPrimary

end point:end point:MIMI

StrokeStrokeCV deathCV death

28 28 monthsmonths

ASAASA

28 28 monthsmonths

ASA + ASA + Clop.Clop.

RRRRRR P P valuevalue

12 12 monthsmonths

ASAASA

12 12 monthsmonths


ARRARR

Per Per yearyear

Events Events saved/saved/

1000pts/1000pts/yryr


NNTNNT

Per yrPer yr

If p < If p < 0.050.05

CH: ALLCH: ALL 7.3%7.3% 6.8%6.8% 7%7% 0.220.22 3.12%3.12% 2.91%2.91% 0.21%0.21% 2.12.1 476476

ATAT 7.9%7.9% 6.9%6.9% 13%13% 0.0460.046 3.39%3.39% 2.96%2.96% 0.43%0.43% 4.34.3 233233

RFRF 5.5%5.5% 6.6%6.6% -20%-20% 0.20.2 2.36%2.36% 2.83%2.83% -0.88%-0.88% -4.8-4.8

CP: ALLCP: ALL 5.83%5.83% 200200

StrokeStroke 7.7%7.7%

MI/PADMI/PAD 4.8%4.8%

All prev MIAll prev MI 6.25%6.25%

PAD/Str.PAD/Str.

Prev. MIPrev. MI10.7%10.7% 4242

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Lignes directrices de l’ACD 2003Lignes directrices de l’ACD 2003 Protection rénale et vasculaireProtection rénale et vasculaire

Chez tous les patients Chez tous les patients diabétiques:diabétiques: Antiplaquettaire (AAS Antiplaquettaire (AAS

à faible dose)à faible dose) Inhibiteur de l’ECAInhibiteur de l’ECA Contrôle de la TAContrôle de la TA Contrôle de la glycémieContrôle de la glycémie Contrôle des lipidesContrôle des lipides Modification du mode Modification du mode

de viede vie Arrêt du tabagismeArrêt du tabagisme

Chez tous les patients Chez tous les patients diabétiques:diabétiques: Antiplaquettaire (AAS Antiplaquettaire (AAS

à faible dose)à faible dose) Inhibiteur de l’ECAInhibiteur de l’ECA Contrôle de la TAContrôle de la TA Contrôle de la glycémieContrôle de la glycémie Contrôle des lipidesContrôle des lipides Modification du mode Modification du mode

de viede vie Arrêt du tabagismeArrêt du tabagisme

3. TRAITEMENT DE LA NÉPHROPATHIE3. TRAITEMENT DE LA NÉPHROPATHIE

2. MAÎTRISE DE LA TA2. MAÎTRISE DE LA TA

1. PROTECTION VASCULAIRE1. PROTECTION VASCULAIRE

Can J Diabetes 2003; 27:S58-S65Can J Diabetes 2003; 27:S58-S65

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HOPEHOPEObjectif et méthodologie de l’étudeObjectif et méthodologie de l’étude

Critères d’évaluation principaux: Critères d’évaluation principaux: Mortalité CV + IM + AVCMortalité CV + IM + AVC

RamiprilRamipril 10 mg HS 10 mg HS vs placebo vs placeboSuivi de 4,5 ansSuivi de 4,5 ans

n=9 297n=9 297≥ ≥ 55 ans, antécédents de maladie cardiovasculaire55 ans, antécédents de maladie cardiovasculaire

•MCASMCAS•AVC/ICTAVC/ICT

•MAPMAP

•Diabète + 1 autre facteur de risqueDiabète + 1 autre facteur de risque

HOPE Investigators. HOPE Investigators. N Engl J MedN Engl J Med; 2000.; 2000.

38% des pts

• HypertensionHypertension

• Chol élevéChol élevé

• HDL-Chol basHDL-Chol bas

• TabagismeTabagisme

• Micro-Micro-albuminuriealbuminurie

• HypertensionHypertension

• Chol élevéChol élevé

• HDL-Chol basHDL-Chol bas

• TabagismeTabagisme

• Micro-Micro-albuminuriealbuminurie

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HOPE : Ramipril à 10 mg vs placeboHOPE : Ramipril à 10 mg vs placebo Bienfaits CV du ramipril chez les patients atteints de maladie Bienfaits CV du ramipril chez les patients atteints de maladie

CVCVÂge moyen: Âge moyen: 66 ± 7 ans66 ± 7 ans

5

AVC

(p = 0,0003)

Mortalité totale

(p = 0,0053)

Nouveaux casde diabète

(p = 0,0001)

lM, AVC, décèsd’origine CV

(p = 0,000002)

-22,0

Décèsd’origine CV

(p = 0,0002)

-26,0

Infarctus dumyocarde

(p = 0,0005)

-20,0

-16,0

-32,0

-10

-5

-30

RRR (%)

-25

-15

0

-20

-35 -34,0

-23,0

IC

(p < 0,001)

HOPE Investigators. HOPE Investigators. N Engl J MedN Engl J Med; 2000.; 2000.

A RoussinA RoussinHope Study Investigators. Hope Study Investigators. LancetLancet 2000, 355:253-259. 2000, 355:253-259.

Réd

uct

ion

du

ris

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e (%

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édu

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isq

ue

(%)

-40-40

-30-30

-20-20

-10-10

00IMIM AVCAVC

Décès Décès CVCV

NéphropathieNéphropathiesous-jacentesous-jacente

22 %22 %

33 %33 %

37 %37 %

24 %24 %

p p = 0,027= 0,027

p p = 0,0001= 0,0001

p p = 0,007= 0,007

p p = 0,01= 0,01

HOPE : Ramipril à 10 mg vs placeboHOPE : Ramipril à 10 mg vs placebo Bienfaits CV du ramipril chez les patients DIABETIQUESBienfaits CV du ramipril chez les patients DIABETIQUES

Rami.Rami. Plac.Plac. EpidemioEpidemio

TA TA systsyst ↓ ↓ 1.91.9 ↑↑.55.55 ↓↓1010

TA TA diastdiast ↓↓3.33.3 ↓↓2.32.3 ↓↓55

3577 patients

Pour ↓38% AVC↓38% AVC

et ↓16%et ↓16%

MCASMCAS

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HOPE-TOO : Effets à long terme du ramiprilHOPE-TOO : Effets à long terme du ramipril Mortalité CV, IM et AVCMortalité CV, IM et AVC

Proportion de patients

(paramètres d’évaluation

combinés)

Temps (années)

Étude HOPE

Fin de l’étude HOPE

p = 0,0002

Nbre sous placebo 4652 4432 4204 3981 3647 2719 1923 1550 Nbre sous ramipril 4645 4456 4256 4079 3789 2819 2075 1731

0,0

0,05

0,10

0,15

0,20

0,25

0,30

1 2 3 4 5 6 7

Ramipril

Placebo

HOPE/HOPE-TOO Study Investigators. HOPE/HOPE-TOO Study Investigators. CirculationCirculation. 2005; 112:1339-46.. 2005; 112:1339-46.

70%70%sur IECAsur IECA

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MI and microvascular endpointsMI and microvascular endpointsIncidenceIncidence by mean systolic BPby mean systolic BP

Adler et al. Adler et al. BMJBMJ. 2000, 321: 412-419. 2000, 321: 412-419

MIMIMicrovascular end pointsMicrovascular end points

Updated mean systolic Updated mean systolic BP (mm Hg)BP (mm Hg)

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1000

per

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%)

1000

per

son

-y (

%)

5050

4040

3030

2020

1010

00110110 120120 130130 140140 150150 160160 170170

UKPDS 36UKPDS 36

MI

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Blood pressure controlBlood pressure controlADA 2006ADA 2006

Measure BP every visitMeasure BP every visit Confirm any pressure ≥ 130/80 with 2Confirm any pressure ≥ 130/80 with 2ndnd visit visit If between 130-139 or 80-89If between 130-139 or 80-89

Try non-pharm. Tx for max 3 monthsTry non-pharm. Tx for max 3 months If not controlled, add RxIf not controlled, add Rx

If ≥ 140/90 If ≥ 140/90 ⇒⇒ non-pharm. Tx AND Rx non-pharm. Tx AND Rx Initial Rx to include ACEI or ARBInitial Rx to include ACEI or ARB Add CCB, DIURETIC or BBAdd CCB, DIURETIC or BB TARGET: BP < 130/80TARGET: BP < 130/80

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CHEP 2006CHEP 2006Treatment of Systolic-Diastolic Hypertension for DiabetesTreatment of Systolic-Diastolic Hypertension for Diabetes

WITHOUTWITHOUT Diabetic Nephropathy Diabetic Nephropathy

1. ACE-Inhibitor or ARB or

2. Thiazide diuretic or Dihydropyridine CCB

IF ACE-I and ARB and DHP-CCB or Thiazide are contraindicated or not tolerated, SUBSTITUTE• Cardioselective BB* or• Long-acting NON DHP-CCB

More than 3 drugs may be needed to reach target values for diabetic patientsMore than 3 drugs may be needed to reach target values for diabetic patients

Urinary albumin excretion rate less than 30 mg/dayUrinary albumin excretion rate less than 30 mg/day

* Cardioselective BB: Acebutolol, Atenolol, Bisoprolol , Metoprolol* Cardioselective BB: Acebutolol, Atenolol, Bisoprolol , Metoprolol

Threshold equal or over 130/80 mmHg and Threshold equal or over 130/80 mmHg and TARGET below 130/80 mmHgTARGET below 130/80 mmHg

Combination of first line agents

Addition of one or more of:Cardioselective BB orLong-acting CCB

DiabetesDiabeteswithoutwithout

NephropathyNephropathy

DHP: dihydropyridineDHP: dihydropyridine

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WITHWITH Diabetic Nephropathy Diabetic Nephropathy

Urinary albumin excretion rate over 30 mg/dayUrinary albumin excretion rate over 30 mg/day

THRESHOLD equal or over 130/80 mmHg and THRESHOLD equal or over 130/80 mmHg and TARGET below 130/80 mmHgTARGET below 130/80 mmHg

If Creatinine over 150 µmol/L or creatinine clearance below 30 ml/min ( 0.5 If Creatinine over 150 µmol/L or creatinine clearance below 30 ml/min ( 0.5 ml/sec), a loop diuretic should be substituted for a thiazide diuretic if ml/sec), a loop diuretic should be substituted for a thiazide diuretic if control of volume is desiredcontrol of volume is desired

DIABETESDIABETESwithwith

NephropathyNephropathy

ACE Inhibitoror ARB

IF ACE-I and ARB are contraindicated or not tolerated, SUBSTITUTE• Long-acting CCB or• Thiazide diuretic

Addition of one or more ofThiazide diuretic orLong-acting CCB

3 - 4 drugs combination may be needed

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SUMMARYSUMMARY

More than 3 drugs may be needed to reach target values for diabetic patientsMore than 3 drugs may be needed to reach target values for diabetic patients

If Creatinine over 150 µmol/L or creatinine clearance below 30 ml/min ( 0.5 If Creatinine over 150 µmol/L or creatinine clearance below 30 ml/min ( 0.5 ml/sec), a loop diuretic should be substituted for a thiazide diuretic if control of ml/sec), a loop diuretic should be substituted for a thiazide diuretic if control of volume is desiredvolume is desired

Threshold equal or over 130/80 mmHg and Threshold equal or over 130/80 mmHg and TARGET below 130/80 mmHgTARGET below 130/80 mmHg

DiabetesDiabetes

withwithNephropathyNephropathy

Combination(Effective

2-drug combination)

ACE Inhibitoror ARB

withoutwithoutNephropathyNephropathy

1. ACE-Inhibitor or ARB

or

2. Thiazide diuretic or DHP-CCB

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Blood pressure response in the INSIGHT studyBlood pressure response in the INSIGHT studyDiabetic vs non-diabetic patientsDiabetic vs non-diabetic patients

Brown M J et al. Hypertension 2000; 35: 1038-1042Brown M J et al. Hypertension 2000; 35: 1038-1042

5669 5669 ptspts

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MI and microvascular endpointsMI and microvascular endpointsIncidenceIncidence by HbAby HbA1c1c concentration concentration

Stratton et al. Stratton et al. BMJ.BMJ. 2000, 321: 405-412 2000, 321: 405-412

Updated mean HbAUpdated mean HbA1c1c

concentration (%)concentration (%)

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1000

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-y (

%)

MIMIMicrovascular end pointsMicrovascular end points

8080

6060

4040

2020

0055 66 77 88 99 1010 1111

UKPDS 35UKPDS 35

MI

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Maîtrise glycémique pour la protection vasculaire :Maîtrise glycémique pour la protection vasculaire :Une fois tous les patients sous IECA, AAS et maîtrise des lipides (statine)Une fois tous les patients sous IECA, AAS et maîtrise des lipides (statine)

UKPDS 35. UKPDS 35. BMJBMJ 2000; 321: 405-12. 2000; 321: 405-12.

ACD 2003 :ACD 2003 :CIBLES GLYCÉMIQUESCIBLES GLYCÉMIQUES

AA1c1c 7 % chez la 7 % chez la plupart des patientsplupart des patients

AA1c1c 6 % quand cela 6 % quand cela est possible en toute est possible en toute sécuritésécurité

Infarctus du myocarde mortel ou non :Infarctus du myocarde mortel ou non :

Diminution de 14 % pour chaque Diminution de 14 % pour chaque % de réduction de% de réduction de l’ l’A1CA1C

pp < 0,0001 < 0,0001

0,50,5

11

55

00 55 66 77 88 99 1010 1111AA moyenne mise à jourmoyenne mise à jour1c1c

Rapport de risque

Rapport de risque

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CCS position statement 2006CCS position statement 2006Treatment of dyslipidemia and prevention of CVDTreatment of dyslipidemia and prevention of CVD

Adapté de: Can J Cardiol 2006; 22 (11): Adapté de: Can J Cardiol 2006; 22 (11): 913-927913-927

NiveauNiveau

de risquede risque

Risque Risque MCASMCAS

en 10 ansen 10 ansRecommendationsRecommendations

But duBut du

traitementtraitement

ObjectifObjectif

accessoireaccessoire

LDL-CLDL-C

mmol/Lmmol/LCT/HDLCT/HDL

BaisseBaisse

de LDL-Cde LDL-CApo BApo B

ÉlevéÉlevé≥ ≥ 20 %20 %ou ASOou ASO

ou Diabèteou Diabète

Cible Cible primaireprimaire

< 2.0< 2.0

Cible Cible secondairesecondaire

< 4.0< 4.0> 50%> 50% < 0.85< 0.85

ModéréModéré 10 - 19%10 - 19%Traiter siTraiter si

≥ ≥ 3.53.5Traiter siTraiter si

≥ ≥ 5.05.0> 40%> 40%

< 1.05< 1.05

BasBas < 10%< 10%Traiter siTraiter si

≥ ≥ 5.05.0Traiter siTraiter si

≥ ≥ 6.06.0 < 1.2< 1.2

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Étude HPSÉtude HPSNotion de patient à risque plutôt que de lipides anormauxNotion de patient à risque plutôt que de lipides anormaux

HypertensionHypertensionn=8,455 (41%)n=8,455 (41%)

HypertensionHypertensionn=8,455 (41%)n=8,455 (41%)

CVDCVDn=3,280 (16%)n=3,280 (16%)

CVDCVDn=3,280 (16%)n=3,280 (16%)

PVDPVDn=6,748 (33%)n=6,748 (33%)

PVDPVDn=6,748 (33%)n=6,748 (33%)

DiabetesDiabetesn=5,963 (29%)n=5,963 (29%)DiabetesDiabetes

n=5,963 (29%)n=5,963 (29%)

CHDCHDn=13,379 (65%)n=13,379 (65%)

CHDCHDn=13,379 (65%)n=13,379 (65%)

with CHDwith CHD1,458 (7%)1,458 (7%)with CHDwith CHD1,458 (7%)1,458 (7%)

no CHDno CHD1,822 (9%)1,822 (9%)no CHDno CHD

1,822 (9%)1,822 (9%)with CHDwith CHD

4,042 (20%)4,042 (20%)with CHDwith CHD

4,042 (20%)4,042 (20%)no CHDno CHD

2,706 (13%)2,706 (13%)no CHDno CHD

2,706 (13%)2,706 (13%)with CHDwith CHD

1,978 (10%)1,978 (10%)with CHDwith CHD

1,978 (10%)1,978 (10%)no CHDno CHD

3,985 (19%)3,985 (19%)no CHDno CHD

3,985 (19%)3,985 (19%)

no CHDno CHD2,860 (14%)2,860 (14%)

no CHDno CHD2,860 (14%)2,860 (14%)

with CHDwith CHD5,595 (27%)5,595 (27%)with CHDwith CHD

5,595 (27%)5,595 (27%)with MIwith MI

8,510 (41%)8,510 (41%)with MIwith MI

8,510 (41%)8,510 (41%)no MIno MI

4,869 (24%)4,869 (24%)no MIno MI

4,869 (24%)4,869 (24%)

20,53620,536patientspatients20,53620,536

patientspatients

Lancet 2002; 360: 7-22Lancet 2002; 360: 7-22

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BaselineBaseline feature featureBaselineBaseline feature feature

Previous MIPrevious MIPrevious MIPrevious MI 11,,00700711,,007007 11,,25525511,,255255

Other CHD (not MI)Other CHD (not MI)Other CHD (not MI)Other CHD (not MI) 452452452452 597597597597

No prior CHDNo prior CHDNo prior CHDNo prior CHD

CVDCVDCVDCVD 182182182182 215215215215

PVDPVDPVDPVD 332332332332 427427427427

DiabetesDiabetesDiabetesDiabetes 279279279279 369369369369

ALL PATIENTSALL PATIENTSALL PATIENTSALL PATIENTS 22,,04204222,,042042 22,,60660622,,606606(19.9%)(19.9%)(19.9%)(19.9%) (25.4%)(25.4%)(25.4%)(25.4%)

24%24% SE 2.6SE 2.6 reductionreduction24%24% SE 2.6SE 2.6 reductionreduction(2P<0.00001)(2P<0.00001)(2P<0.00001)(2P<0.00001)

0.40.40.40.4 0.60.60.60.6 0.80.80.80.8 1.01.01.01.0 1.21.21.21.2 1.41.41.41.4

Risk ratio and 95% CIRisk ratio and 95% CIRisk ratio and 95% CIRisk ratio and 95% CIStatinStatin(n=10,269)(n=10,269)

StatinStatin(n=10,269)(n=10,269)

PPlacebolacebo(n=10,267)(n=10,267)PPlacebolacebo

(n=10,267)(n=10,267)

StatinStatin better betterStatinStatin better better StatinStatin worse worseStatinStatin worse worseLancet 2002; 360: 7-22Lancet 2002; 360: 7-22

Étude HPSÉtude HPSÉvènements selon le critère d’entréeÉvènements selon le critère d’entrée

Étude HPSÉtude HPSÉvènements selon le critère d’entréeÉvènements selon le critère d’entrée

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6 week pre-randomisation placebo run in phase then 6 week pre-randomisation placebo run in phase then visits at month 1, 3, 6 and 6 monthlyvisits at month 1, 3, 6 and 6 monthly

Atorvastatin 10mg

Placebo

2838patients

CARDS CARDS Collaborative Atorvastatin Diabetes StudyCollaborative Atorvastatin Diabetes Study Objective andObjective and DesignDesign

Placebo

Test the effectiveness and safety of lipid Test the effectiveness and safety of lipid lowering for “primary” prevention in diabetic lowering for “primary” prevention in diabetic patients with low levels of LDL-Cpatients with low levels of LDL-C

Colhoun H M. Lancet 2004: 364: 685-Colhoun H M. Lancet 2004: 364: 685-696696

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CARDS Eligibility CriteriaCARDS Eligibility Criteria

Type 2 male or female diabetes 40-75 years of ageType 2 male or female diabetes 40-75 years of age

No clinical history of CAD, CVD or severe PADNo clinical history of CAD, CVD or severe PAD

LDL-C LDL-C 4.14 mmol/L4.14 mmol/L

TG TG 6.78 mmol/L6.78 mmol/L

One of :One of : Hypertension defined as receiving antihypertensive Hypertension defined as receiving antihypertensive

treatment or SBP treatment or SBP 140 mm Hg or DBP 140 mm Hg or DBP 90 mm Hg90 mm Hg

RetinopathyRetinopathy

Microalbuminuria or macroalbuminuriaMicroalbuminuria or macroalbuminuria

Current smokingCurrent smoking


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CARDS EndpointsCARDS Endpoints Primary Efficacy ParametersPrimary Efficacy Parameters

Acute CHD deathAcute CHD death Non-fatal MI including silent MINon-fatal MI including silent MI Hospitalised unstable anginaHospitalised unstable angina Resuscitated cardiac arrestResuscitated cardiac arrest Coronary revascularisationCoronary revascularisation StrokeStroke

Secondary Efficacy ParametersSecondary Efficacy Parameters Total mortalityTotal mortality

Any cardiovascular endpointAny cardiovascular endpoint

Lipid and lipoproteinsLipid and lipoproteins

Major coronary Major coronary eventsevents

Major coronary Major coronary eventsevents


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CARDSCARDSDiabetes Related CharacteristicsDiabetes Related Characteristics

214 (15.0%)214 (15.0%)228 (16.2%)228 (16.2%) Diet onlyDiet only

932 (65.3%)932 (65.3%)916 (65.0%)916 (65.0%) Oral hypoglycaemic onlyOral hypoglycaemic only

210 (14.7%)210 (14.7%)207 (14.7%)207 (14.7%) Insulin onlyInsulin only

72 (5.0%)72 (5.0%)59 (4.2%)59 (4.2%) Insulin+oral hypoglycaemicInsulin+oral hypoglycaemic

10.0 (3.3)10.0 (3.3)9.8 (3.2)9.8 (3.2)Plasma glucose mmol/LPlasma glucose mmol/L

7.9 (1.4)7.9 (1.4)7.8 (1.4)7.8 (1.4)HbAHbA1c 1c %%

Diabetes treatmentDiabetes treatment

7.9 (6.4)7.9 (6.4)7.8 (6.3)7.8 (6.3)Diabetes duration (years)Diabetes duration (years)

AtorvastatinAtorvastatinMean (SD) or N (%)Mean (SD) or N (%)

PlaceboPlaceboMean (SD) or N (%)Mean (SD) or N (%)


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CARDSCARDSLipid Levels by TreatmentLipid Levels by Treatment

Total cholesterol (mmol/L) LDL cholesterol (mmol/L)

0 2 3 41 4.5 2 3 41 4.5

Years of Study Years of Study

00

1

2

3

4

0

2

4

6

Placebo Atorvastatin

Average difference 26%

1.4 mmol/L (54mg/dL) p<0.0001

Average difference 40%

1.2 mmol/L (46mg/dL) p<0.0001


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CARDSCARDSCumulative Hazard for Primary EndpointCumulative Hazard for Primary Endpoint

Relative Risk Reduction 37% (95% CI: 17-52) p=0.001Relative Risk Reduction 37% (95% CI: 17-52) p=0.001

YearsYears

328328305305

694694651651

1074107410221022

1361136113061306

1392139213511351

AtorvaAtorvaPlaceboPlacebo

1428142814101410

PlaceboPlacebo127 events127 events

AtorvastatinAtorvastatin83 events83 events

Cu

mu

lati

ve H

azar

d (

%)

Cu

mu

lati

ve H

azar

d (

%)

00

55

1010

1515

00 11 22 33 44 4.754.75


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CARDSCARDSCumulative Hazard for All Cause MortalityCumulative Hazard for All Cause Mortality

Relative Risk Reduction 27% (95%CI: -1-48) p=0.059Relative Risk Reduction 27% (95%CI: -1-48) p=0.059

Cu

mu

lati

ve H

azar

d (

%)

Cu

mu

lati

ve H

azar

d (

%)

YearsYears

AtorvaAtorvaPlaceboPlacebo

PlaceboPlacebo82 deaths82 deaths

AtorvastatinAtorvastatin61 deaths61 deaths

351351332332

730730709709

1110111010941094

1401140113701370

1418141813951395

1428142814101410

11 22 33 44 4.754.7500

22

44

66

88

1010

00


Subgroup*Subgroup* Placebo**Placebo** Atorva**Atorva** Hazard Ratio Risk Reduction (CI)Hazard Ratio Risk Reduction (CI)

LDL-C LDL-C ≥ 3.06≥ 3.06 66 (9.5)66 (9.5) 44 (6.1)44 (6.1) 38% (9-58)38% (9-58)

LDL-C LDL-C < 3.06< 3.06 61 (8.5)61 (8.5) 39 (5.6)39 (5.6) 37% (6-58)37% (6-58)

p=0.96p=0.96

HDL-C HDL-C ≥ 1.35≥ 1.35 62 (8.4)62 (8.4) 36 (5.2)36 (5.2) 41% (11-61)41% (11-61)

HDL-C HDL-C < 1.35< 1.35 65 (9.6)65 (9.6) 47 (6.4)47 (6.4) 35% (5-55)35% (5-55)

p=0.71p=0.71

Trig. Trig. ≥ 1.7≥ 1.7 67 (9.6)67 (9.6) 40 (5.5)40 (5.5) 44% (18-62)44% (18-62)

Trig. Trig. < 1.7< 1.7 60 (8.4)60 (8.4) 43 (6.1)43 (6.1) 29% (-5-52)29% (-5-52)p=0.40p=0.40

* units in mmol/L (mg/dL) * units in mmol/L (mg/dL) ** N (% of randomised)** N (% of randomised)

CARDSCARDSTreatment Effect Treatment Effect on the Primary Endpoint by Subgroupon the Primary Endpoint by Subgroup

.2.2 .4.4 .6.6 .8.8 11 1.21.2

Favours Atorvastatin Favours PlaceboFavours Atorvastatin Favours Placebo


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ASPENASPENAAtorvastatin torvastatin SStudy for tudy for PPrevention of CAD revention of CAD EEndpointsndpoints

in in NNon-insulin-dependent DMon-insulin-dependent DM

Objective and DesignObjective and Design assess the effect of 10 mg of atorvastatin versus assess the effect of 10 mg of atorvastatin versus

placebo on CVD prevention in subjects with type 2 placebo on CVD prevention in subjects with type 2 diabetes and diabetes and LDL cholesterol levels below LDL cholesterol levels below contemporary guideline targetscontemporary guideline targets..

2410 pts double blind 4 year study2410 pts double blind 4 year study Composite primary endpoint:Composite primary endpoint:

CV death, MI, Stroke, PTCA, CABG, Resc. card. CV death, MI, Stroke, PTCA, CABG, Resc. card. Arrest , ACS requiring hosp.Arrest , ACS requiring hosp.

Knopp RH et al. Diabetes Care 2006; 29(7):1478-85Knopp RH et al. Diabetes Care 2006; 29(7):1478-85

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ASPENASPENResults for 2410 patients for 4 yearsResults for 2410 patients for 4 years

Knopp RH et al. Diabetes Care 2006; 29(7):1478-85Knopp RH et al. Diabetes Care 2006; 29(7):1478-85

LDL-Chol and End pointsLDL-Chol and End points Atorvastatine 10 mgAtorvastatine 10 mg PlaceboPlacebo

Reduction LDL-CholReduction LDL-Chol29% vs Placebo29% vs Placebo

P < 0.0001P < 0.0001--

Composite Primary end-point (CPEP)Composite Primary end-point (CPEP)

All patientsAll patients13.7% HR 0.9 ns13.7% HR 0.9 ns 15.0% 15.0%

CPEP without MI-PTCA-CABGCPEP without MI-PTCA-CABG

1905 pts1905 pts10.4% HR 0.97 ns10.4% HR 0.97 ns 10.8%10.8%

CPEP with MI-PTCA-CABGCPEP with MI-PTCA-CABG

505 pts505 pts26.2% HR 0.82 ns26.2% HR 0.82 ns 30.8%30.8%

MI, fatal or notMI, fatal or not

All patientsAll patients

27% RRR27% RRR

P = 0.10P = 0.10

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LDL cholesterol levelLDL cholesterol levelAtorvastatin Atorvastatin

10 mg 10 mg (n=753)(n=753)

Atorvastatin Atorvastatin 80 mg (n=748)80 mg (n=748)

Mean baseline LDL Mean baseline LDL cholesterol levels (mmol/L)cholesterol levels (mmol/L)

after 8-week open-label after 8-week open-label treatmenttreatment

2.52.5 2.52.5

Final LDL cholesterol levels Final LDL cholesterol levels (mmol/L) (mmol/L) after randomizationafter randomization

2.62.6 2.02.0

TNT diabetes analysisTNT diabetes analysisBaseline and final LDL cholesterol levelsBaseline and final LDL cholesterol levels

Shepherd J. Shepherd J. American Diabetes Association 2005 American Diabetes Association 2005 Scientific Sessions; June 10-14, 2005; San Diego, CA.Scientific Sessions; June 10-14, 2005; San Diego, CA.

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Shepherd J. Shepherd J. American Diabetes Association 2005 Scientific American Diabetes Association 2005 Scientific Sessions; June 10-14, 2005; San Diego, CA.Sessions; June 10-14, 2005; San Diego, CA.

OutcomeOutcomeAtorvastatin Atorvastatin

10 mg 10 mg (n=753)(n=753)

Atorvastatin Atorvastatin 80 mg 80 mg

(n=748)(n=748)

Hazard ratioHazard ratio(95% CI)(95% CI) pp

Total major Total major cardiovascular cardiovascular

events events 17.9 %17.9 % 13.8 %13.8 % 0.750.75

(0.58-0.97)(0.58-0.97) 0.0260.026

Total major Total major cerebrovascular cerebrovascular

eventsevents10.0 %10.0 % 7.0 %7.0 % 0.690.69

(0.48-0.98)(0.48-0.98) 0.0370.037

TNT diabetes analysisTNT diabetes analysisEfficacy outcomes Efficacy outcomes

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Effects of long-term fenofibrate therapy on CV eventsEffects of long-term fenofibrate therapy on CV events

Lancet 2005Lancet 2005

366: 1849-61366: 1849-61

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Effects of long-term fenofibrate therapy on CV eventsEffects of long-term fenofibrate therapy on CV events

Lancet 2005. 366: 1849-61Lancet 2005. 366: 1849-61

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Effects of long-term fenofibrate therapy on CV eventsEffects of long-term fenofibrate therapy on CV eventsDrop-outs and Drop-ins (mostly statins)Drop-outs and Drop-ins (mostly statins)

Lancet 2005. 366: 1849-61Lancet 2005. 366: 1849-61

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Lipid Tx: meta-analysis BMJ 2006Lipid Tx: meta-analysis BMJ 2006Major coronary events inMajor coronary events in Primary Primary prevention trials prevention trials

Costa J et al. BMJ 2006; 332: 1115-1124Costa J et al. BMJ 2006; 332: 1115-1124

Mean F-up Mean F-up

4.5 yrs4.5 yrs

21% RRR21% RRR

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Lipid Tx: meta-analysis BMJ 2006Lipid Tx: meta-analysis BMJ 2006 Major coronary events inMajor coronary events in Secondary Secondary prevention trials prevention trials

Costa J et al. BMJ 2006; 332: 1115-1124Costa J et al. BMJ 2006; 332: 1115-1124

21% RRR21% RRR

Mean F-up Mean F-up

4.5 yrs4.5 yrs

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Tabagisme: outils thérapeutiquesTabagisme: outils thérapeutiques

Le médecinLe médecin Cliniques anti-tabacCliniques anti-tabac Substituts tabagiques: timbres etcSubstituts tabagiques: timbres etc Bloqueurs “non-sélectifs”Bloqueurs “non-sélectifs”

BupropionBupropion Bloqueurs cannabinoides CB1Bloqueurs cannabinoides CB1

RimonabantRimonabant Bloqueurs nicotiniquesBloqueurs nicotiniques

Cytisine: Cytisine: Selective Selective αα44 β β2 Nicotinic Receptor Partial Agonist2 Nicotinic Receptor Partial Agonist

Varenicline: Varenicline: Selective Selective αα44 β β2 Nicotinic Receptor Partial Agonist2 Nicotinic Receptor Partial Agonist

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Varenicline vs Bupropion vs PlaceboVarenicline vs Bupropion vs Placebo

Nides M et al. Arch Intern Med. 2006;166:1561-1568Nides M et al. Arch Intern Med. 2006;166:1561-1568

Carbon monoxide confirmed continuous quit rates

10 minutes of standardized, individual smoking cessation counseling from trained staff

smoking cessation booklet at the baseline visit.

7 week Tx → 52 week follow-up

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Lifestyle ModificationLifestyle ModificationLow Cardiorespiratory Fitness and Physical Inactivity as Low Cardiorespiratory Fitness and Physical Inactivity as

Predictors of Mortality in Men with Type 2 DiabetesPredictors of Mortality in Men with Type 2 Diabetes

FIT

UNFIT

Wein M et al. Ann Intern Med 2000; 132: 605-611Wein M et al. Ann Intern Med 2000; 132: 605-611

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Lifestyle ModificationLifestyle ModificationLow Cardiorespiratory Fitness and Physical Inactivity as Low Cardiorespiratory Fitness and Physical Inactivity as

Predictors of Mortality in Men with Type 2 DiabetesPredictors of Mortality in Men with Type 2 Diabetes

Wein M et al. Ann Intern Med 2000; 132: 605-611Wein M et al. Ann Intern Med 2000; 132: 605-611

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Lifestyle modificationLifestyle modificationCDA 2003CDA 2003

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Lifestyle modification: Aerobic physical activityLifestyle modification: Aerobic physical activityADA 2006ADA 2006

To improve glycemic control, assist with weight To improve glycemic control, assist with weight

maintenance, and reduce risk of CVD,maintenance, and reduce risk of CVD,

at least 150 min/weekat least 150 min/week of moderate-intensityof moderate-intensity aerobic aerobic

physical activity (50–70% of maximum heart rate) is physical activity (50–70% of maximum heart rate) is

recommended recommended

and/or at least 90 min/week of vigorousand/or at least 90 min/week of vigorous aerobic aerobic

exercise (>70% of maximum heart rate)exercise (>70% of maximum heart rate)

The physical activity should be distributed over The physical activity should be distributed over at at

least 3 days/weekleast 3 days/week and with no more than 2 and with no more than 2

consecutive days without physical activityconsecutive days without physical activity

Level of evidence : ALevel of evidence : A

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Lifestyle modification: Resistance exerciseLifestyle modification: Resistance exerciseADA 2006ADA 2006

In the absence of contraindications, people with In the absence of contraindications, people with type 2 diabetes should be encouraged to:type 2 diabetes should be encouraged to:

perform resistance exercise perform resistance exercise three times a weekthree times a week targeting all major muscle groupstargeting all major muscle groups progressing to three sets of 8-10 repetitionsprogressing to three sets of 8-10 repetitions at a weight that cannot be lifted more than 8-10 at a weight that cannot be lifted more than 8-10

timestimes

Level of evidence : ALevel of evidence : A

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VASCULAR PROTECTION - DIABETES - 2006VASCULAR PROTECTION - DIABETES - 2006

For almost all: ACEI + ASA 80mgFor almost all: ACEI + ASA 80mg BP < 130/80BP < 130/80 A1C ≤ 7% for most patientsA1C ≤ 7% for most patients

A1C ≤ 6% if can be achieved securelyA1C ≤ 6% if can be achieved securely

Statins for most pts with high CV riskStatins for most pts with high CV risk Reduce LDL-Chol ≥ 50%Reduce LDL-Chol ≥ 50% Minimal target: LDL-Chol ≤ 2.0 mmol/L and TC/HDL ≤ 4Minimal target: LDL-Chol ≤ 2.0 mmol/L and TC/HDL ≤ 4

Smoking cessationSmoking cessation Lifestyle modificationLifestyle modification

Good eating habits and healthy weightGood eating habits and healthy weight Aerobic and resistance exercise 3 times per weekAerobic and resistance exercise 3 times per week

a roussin vascular protection - diabetes - 2006 è evidence è guidelines cda 2003 cda 2003 ada 2006...

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