cardiovasculair risicomanagement bij dm2 · questionnaire questionnaire questionnaire 2007 # with...
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Cardiovasculair Risicomanagement bij
DM2
Guy RuttenJulius Centrum
voor Gezondheidswetenschappen en
Eerstelijns Geneeskunde
DiHAG Sterrencursus 2009
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Van de mensen met DM 2 sterft50 - 70%aan een cardiovasculaire aandoening
Mensen met DM 2 hebben
2 – 4 x zoveel kansop een cardiovasculaire aandoening
Relevantie
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DM 2 en CV-risico (2)
• MI-groep: 3x zo hoog overlijdensrisico aan CV-dood dan mensen met DM2
• MI-groep: ook hoger risico op heropname voor MI
• Risico steeg met de leeftijd• Geen verschil man / vrouw
Evans J. BMJ 2002;324:939-42
Dus niet….
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Does an intensive glucose Does an intensive glucose control policy reduce the control policy reduce the risk of complications of risk of complications of
diabetes?diabetes?
UK Prospective Diabetes Study
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HbA1c
cross-sectional, median values
06
7
8
9
0 3 6 9 12 15
HbA
1c (
%)
Years from randomisation
Conventional
Intensive
6.2% upper limit of normal range
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Any Diabetes Related Endpoint (cumulative )
0%
20%
40%
60%
0 3 6 9 12 15
% o
f pat
ient
s w
ith a
n ev
ent
Years from randomisation
Intensive (2729)
Conventional (1138)
Risk reduction 12%(95% CI: 1% to 21%)
p=0.029 1401 of 3867
patients (36%)
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Hyperglycaemie en complicaties
% In
cide
nce/
1000
pat
ient
-yea
rs
0000
10101010
20202020
30303030
40404040
50505050
60606060
<6<6<6<6 6666----<7<7<7<7 7777----<8<8<8<8 8888----<9<9<9<9 9999----<10<10<10<10 10+10+10+10+
Updated HbA 1C (%)
MacrovasculardiseaseMicrovasculardisease
UKPDS 35. BMJ 2000;321:405-12
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Aggregate Clinical Endpoints
Favoursconventional
0.5 1 2
0.88
0.90
0.94
0.84
1.11
0.75
0.029
0.34
0.44
0.052
0.52
0.0099
Any diabetes related endpoint
Diabetes related deaths
All cause mortality
Myocardial infarction
Stroke
Microvascular
RR p
Favoursintensive
Relative Risk& 95% CI
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Does metformin in overweight diabetic patients
have any advantages or disadvantages?
UK Prospective Diabetes Study
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0.0
0.2
0.4
0.6
0 3 6 9 12 15
Pro
port
ion
of p
atie
nts
with
eve
nts
Years from randomisation
Conventional (411)
Intensive (951)
Metformin (342)
Any diabetes related endpoint, overweight patients
M v Ip=0.0034
M v C p=0.0023
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Metformine bij patiënten met BMI > 27
• Vergeleken met ' conventional policy'
32% risicoreductie in 'any diabetes-related endpoint' 42% risicoreductie in met diabetes samenhangende dood36% risicoreductie in 'all cause mortality'39% risicoreductie in myocardinfarct
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Post-Trial Monitoring: Patients
880Conventional
2,118Sulfonylurea/Insulin
279Metformin
1997# in survivor cohort
2002
Clinic
Clinic
Clinic
Questionnaire
Questionnaire
Questionnaire
2007# with final year data
379Conventional
1,010Sulfonylurea/Insulin
136Metformin
P
P
Mortality 44% (1,852)Lost-to-follow-up 3.5% (146)
Mean age62±8 years
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Post-Trial Changes in HbA 1c
UKPDS resultspresented
Mean (95%CI)
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Microvascular Disease Hazard Ratio
Intensive (SU/Ins) vs. Conventional glucose control
(photocoagulation, vitreous haemorrhage, renal failure)
HR (95%CI)
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Myocardial Infarction Hazard Ratio
(fatal or non-fatal myocardial infarction or sudden death)
Intensive (SU/Ins) vs. Conventional glucose control
HR (95%CI)
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All-cause Mortality Hazard Ratio
Intensive (SU/Ins) vs. Conventional glucose control
HR (95%CI)
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After median 8.5 years post-trial follow-up
Aggregate Endpoint 1997 2007
Any diabetes related endpoint RRR: 12% 9%P: 0.029 0.040
Microvascular disease RRR: 25% 24%P: 0.0099 0.001
Myocardial infarction RRR: 16% 15%P: 0.052 0.014
All-cause mortality RRR: 6% 13%P: 0.44 0.007
RRR = Relative Risk Reduction, P = Log Rank
'Legacy Effect' van eerdereGlucoseverlaging
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ACCORD Studie
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HbA1c verschil tussen groepen
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ACCORD Resultaten
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ACCORD vervolganalyses, ADA 2009
• Hypothes es m.b.t. verhoogde mortaliteit: hypo's, gewichtstoename, combinatie medicamenten, te snelle daling HbA1c
• Ieder % HbA1c stijging leidde tot 20% meer risico op dood(UKPDS 14%, HOPE 12%), maar verschillend verband in intensieve en controlegroep, oversterfte in groep HbA1c> 7%
• Snelle daling leidde in intensieve groep juist tot minder doden
• Hypo's inderdaad geassocieerd met mortaliteit, maar risico op sterfte na hypo grootst in zeer slecht ingestelde groep
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Veteran’s Affairs Diabetes Trial
• 1791 patiënten• 97% mannen van ± 60 jaar bij start van studie• 40% cardiovasculaire voorgeschiedenis• Bij start: HbA1c 9.4%
• Gemiddelde follow-up 6.25 jaar• Intensief : Streven naar HbA1c < 7%• Standaard: streven naar HbA1c 8-9%
• Eerst alle ander risicofactoren optimaal……!
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HbA1c% en therapie
Intensieve groep• Gemiddeld HbA1c 6.9%
• Op einde 90% insuline• Rosiglitazon: 85% eerste jaar, 72% jaar 3• Metformine: 75% eerste jaar, 60% jaar 5
Standaard groep• Gemiddeld HbA1c 8.4%• Op einde 74% insuline• Rosiglitazon: 78% eerste jaar, 62% jaar 3• Metformine: 71% eerste jaar, 55% jaar
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VADT Primair eindpunt
Combinatie van• MI• CVA• Cardiovasculaire dood• Ernstig hartfalen• Coronaire / perifere Bypass-chirurgie• Amputaties
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Resultaat VADT
NEJM 2009;129-39
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Conclusies
1. Hyperglykemie behandelen heeft niet alleen effect op microvasculaire complicaties, maar ook op sterfte en op macrovasculaire complicaties
2. Het effect van het behandelen van hyperglykemietreedt pas na meerdere jaren op
3. Meteen na de diagnose moet in zo kort mogelijke tijd naar een HbA1c < 7% worden gestreefd
4. Het effect van een goede behandeling in het begin ijlt 10 jaar na.
5. Individualisering is vereist
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Stappenplan Medicatie
Factoren om rekening mee te houden
1. Potentie om HbA1c te verlagen2. Veiligheid3. Bijwerkingen4. Gebruiksgemak5. Kosten6. Effect op lange termijn7. Niet-glykemische effecten
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Deel 2Deel 2HypertensieHypertensie
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Hypertensie en sterfte aan CVA
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Meta-analyse
• Verschil van 20 mm Hg bij SBD komt overeen met risico van 10 mm Hg bij DBD
• Verschil van 2 mm SBD geeft 10% minder fatale CVA’s op middelbare leeftijd
• Vasculaire mortaliteit door CVA 50% lager bij bloeddruk van 120 mm Hg dan bij 140 mm Hg
Lancet 2002;360:1903-13
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Blood Pressure Control Study
UK Prospective Diabetes Study
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baseline mean over 9 years
Less tight control 160 / 94 154 / 87
Tight control 161 / 94 144 / 82
difference 1 / 0 10 / 5
p n.s. <0.0001
ACE inhibitor 159 / 94 144 / 83
Beta blocker 159 / 93 143 / 81
difference 0 / 0 1 / 1
p n.s. n.s. / p=0.02
Mean Blood Pressure
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Any diabetesAny diabetesAny diabetesAny diabetes----related endpointsrelated endpointsrelated endpointsrelated endpoints
0%
10%
20%
30%
40%
50%
0 3 6 9
% o
f pat
ient
s w
ith e
vent
s
Years from randomisation
Tight blood pressure control (758)
Less tight blood pressure control (390)
risk reductionrisk reductionrisk reductionrisk reduction24% p=0.004624% p=0.004624% p=0.004624% p=0.0046
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No Legacy Effect of Earlier BP Control
After median 8.0 years post-trial follow-up
Aggregate Endpoint 1997 2007
Any diabetes related endpoint RRR: 24% 7%P: 0.0046 0.31
Microvascular disease RRR: 37% 16%P: 0.0092 0.17
Myocardial infarction RRR: 21% 10%P: 0.13 0.35
All-cause mortality RRR: 18% 11%P: 0.17 0.18
RRR = Relative Risk Reduction, P = Log Rank
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No Legacy Effect of Earlier BP Control
After median 8.0 years post-trial follow-up
Aggregate Endpoint 1997 2007
Any diabetes related endpoint RRR: 24% 7%P: 0.0046 0.31
Microvascular disease RRR: 37% 16%P: 0.0092 0.17
Myocardial infarction RRR: 21% 10%P: 0.13 0.35
All-cause mortality RRR: 18% 11%P: 0.17 0.18
RRR = Relative Risk Reduction, P = Log Rank
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Enkele andere hypertensie-trials
1.HOT
2.HOPE
3.ALLHAT
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HOT Studie - 1501 mensen met DM 2
• ≤≤≤≤ 80mm Hg versus ≤≤≤≤ 90 mm Hg
• 78% felodipine, 41% ACE, 28% ß-blokker, 23 % diureticum
• Gecombineerd eindpunt: MI, CVA en cardiovasculaire dood –50%
• Conclusie: hoe lager, hoe beter
Lancet 1998;351:1755-62
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HOPE - 3577 mensen met DM 2
• Placebo versus ramipril 5–10 mg; • Follow-up 4,5 jr
• Gecombineerd eindpunt: MI, CVA, cardiovasculaire dood: - 25%
• Nefropathie: - 24%
• Effect onafhankelijk van bloeddrukdaling
Lancet 2000;355:253-9
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AntihypertensiveTrial Design
• Randomized, double-blind, multi-center clinical trial
• Determine whether occurrence of fatal CHD or nonfatal MI is lower for high-risk hypertensive patients treated with newer agents (CCB, ACEI, alpha-blocker) compared with a diuretic
• 42,418 high-risk hypertensive patients ≥≥≥≥ 55 years
• About 36% people with DM2 in all groups
ALLHAT
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Years to CHD Event0 1 2 3 4 5 6 7
Cum
ulat
ive
CH
D E
vent
Rat
e
0
.04
.08
.12
.16
.2
Number at Risk:Chlorthalidone 15,255 14,477 13,820 13,102 11,362 6,340 2,956 209Amlodipine 9,048 8,576 8,218 7,843 6,824 3,870 1,878 215Lisinopril 9,054 8,535 8,123 7,711 6,662 3,832 1,770 195
Cumulative Event Rates for the Primary Outcome (Fatal CHD or Nonfatal MI) by ALLHAT Treatment Group
ChlorthalidoneAmlodipineLisinopril
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Overall ConclusionsALLHAT
Because of the superiority of thiazide-type diuretics in preventing one or more major forms of CVD and their lower cost, they should be the drugs of choice for first-step antihypertensive drug therapy.
JAMA 2002;288:2981-2997
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Deel 3Deel 3DislipidemieDislipidemie
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Cholesterolverlaging
Relatieve risicodaling op cardiovasculaire pathologie per mmol LDL-daling (14 RCTs, 18.686 mensen)
Lancet 2008;371:117-25
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Relatieve risicodaling per mmol LDL-dalingbij mensen met DM2
• 13% op vasculaire mortaliteit
• 21% op combinatie MI, coronaire dood, CVA, CABG
• 22% op MI
• 22% op coronaire dood
• 25% op CABG
• 21% op CVA
• Na 5 jaar 1000 mensen behandelen met statine: 42 minder
'major vascular events'
• Interpretation: 'Statin therapy should be considered for all
diabetic individuals who are at sufficiently high risk of vascular
events'
Lancet 2008;371:117-25
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Deel 4Deel 4MultifactorieelMultifactorieel
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Steno 2 Studie
• 160 patienten met DM2 en persisterende microalbuminurie
• Intensief of conventioneel behandelen
• Gemiddelde behandelduur 7.8 jaar.
• Patienten vervolgens 'observationeel' gevolgd , gemiddeld 5.5 jaar.
• Primaire eindpunt na 13.3 jaar follow-up: tijd tot dood door elke oorzaak.
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Patiënten die streefdoel halen
NEJM 2008;358:580-91
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Cardiovasculaire morbiditeit
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Tijd tot dood door welke oorzaak ook
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ADDITION Studie
Screening• Niet DM patiënten • 50-70 jaar• 79 huisartspraktijken• SHL-regio, ZW
Nederland• 56.978 mensen
uitgenodigd
• Intensieve behandeling
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Streefwaarden
• HbA1c 6.5 - 7.0 %
• Bloeddruk < 135/85 mm Hg
• ACE remmer bij bloeddruk > 120/80 mm Hg
• Totaal cholesterol < 3.5 mmol/l
• Iedereen aspirine
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0.000- 1.1 ± 1.0- 0.4 ± 1.0LDL-cholesterol (mmol/l)
0.000- 1.2 ± 1.2- 0.6 ± 1.2Cholesterol (mmol/l)
0.000- 1.1 ± 1.5- 0.7 ± 1.4HbA1c (%)
0.000- 1.2 ± 2.2- 0.8 ± 2.6FBG (mmol/l)
0.000- 11 ± 11- 7 ± 10Diastolische Bloeddruk
0.000- 33 ± 23- 19 ± 21
Systolische Bloeddruk
(mmHg)
0.000- 1.3 ± 2.0- 0.4 ± 2.9BMI (kg/m2)
250237n
Verschil
P waarde
Intensieve
behandelingGewone zorg
ADDITION-NL, Verschil na 1 jaarJanssen P et al, Br J Gen Pract 2009;43-8
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Samengevat
Intensieve behandeling vancardiovasculaire risicofactoren bijmensen met DM2
• Spaart levens• Spaart veel ellende• Moet meteen na de diagnose starten