Jaakko Tuomilehto. MD, MA, PhD, FRCP(Edin), FESC

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1 Políticas en diabetes para la prevención y manejo de la enfermedad cardiovascular. Nueva directiva Europea 2013 Jaakko Tuomilehto MD, MA, PhD, FRCP(Edin), FESC Department of Chronic Disease Prevention, National Institute for Health and Welfare, Helsinki, Finland; Centre for Vascular Prevention Danube-University Krems,Krems, Austria; Instituto de Investigacion Sanitaria del Hospital Universario LaPaz (IdiPAZ), Madrid, Spain.

2 What do the ESC Guidelines recommend as best management Do we need guidelines on diabetes, prediabetes and cardiovascular diseases

3 Incidence of Myocardial Infarction (MI) in Type 2 Diabetes (DM) in Middle-aged Finns 1373 patients without DM and prior MI 1059 patients with type 2 DM and without prior MI Followed for 7 years No DM DM No Prior MI Prior MI Haffner SM et al. N Engl J Med. 1998;339:229.

4 Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III ATP III)) JAMA, May 16, Vol 285, No. 19 Diabetes counts as a CHD risk equivalent because it confers a high risk of new CHD within 10 years, in part because of its frequent association with multiple risk factors. Furthermore, because persons with diabetes who experience a myocardial infarction have an unusually high death rate either immediately or in the long term, a more intensive prevention strategy is warranted.

5 Time trends in 1-year mortality after Myocardial Infarction, Sweden One-year mortality (%) Andel (%) Diabetes Yes No Diabetiker Ej diabetiker År Figur 27j. Utvecklingen av 1-årsmortalitet vid hjärtinfarkt i relation till diabetes hos patienter, <80 år, Norhammar et al Heart J 2007; 93:1577 & Swedeheart årsrapport 2013

6 Burden of diabetes in Europe 2011 and prediction for 2030 International Diabetes Federation: Diabetes Atlas 2013

7 What do the ESC Guidelines recommend as the best management Diabetes and IGT rapidly increasing across the globe Diabetes and CAD common & serious combination The negative impact of dysglycemia apparent before onset of diabetes The prognosis remains unfavorable The patients deserve increased attention Therapeutic success depends on collaboration across speciality borders

8 What do the ESC Guidelines recommend as best management Rydén et al Europ Heart J 2013; 34:

Principles for diagnosis and management Cardiovascular disease (CVD) and

ECG, Echocardiography Exercise test, Holter ECG CVD known ECG,

1c FPG, If needed OGTT Blood lipids If MI/ACS aim for reasonable glycaemic

diabetology consultation Normal Follow up Abnormal Cardiology consultation

10 Principles for diagnosis and management Cardiovascular disease (CVD) and Diabetes mellitus (DM) Main diagnosis DM±CVD Main diagnosis CVD±DM CVD unknown ECG, Echocardiography Exercise test, Holter ECG CVD known ECG, Echocardiography Holter ECG If positive cardiology consultation DM unknown HbA 1c FPG, If needed OGTT Blood lipids If MI/ACS aim for reasonable glycaemic control DM known Screen for microangiopathy If poor glycaemic control diabetology consultation Normal Follow up Abnormal Cardiology consultation Ischaemia treatment Non-invasive or invasive Normal Follow up Newly detected DM or IGT Diabetology consultation

11 Classes of recommendations Classes of recommendations Class I Definition Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, effective. Suggested wording to use Is recommmended/ is indicated. Class II Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of the given treatment or procedure. Class IIa Weight of evidence/opinion is in favour of usefulness/efficacy. Should be considered. Class IIb Usefulness/efficacy is less well established by evidence/opinion. May be considered. Class III Evidence or general agreement that the given treatment or procedure is not useful/effective, and in some cases may be harmful. Is not recommended.

12 Levels of evidence Level of Evidence A Data derived from multiple randomized clinical trials or meta-analyses. Level of Evidence B Data derived from a single randomized clinical trial or large non-randomized studies. Level of Evidence C Consensus of opinion of the experts and/ or small studies, retrospective studies, registries.

13 84 recommendations Class Level of evidence 24% 7% 8% 61% 24% 44% 32% I IIa IIb III Compared to 2007 expanding evidence A B C

14 Screening for glucose perturbations Questionnaires e.g FINDRISC Symptoms Random glucose Fasting glucose HbA1c Oral glucose tolerance test 75 g glucose in 200 ml H 2 O P-glucose after 0 and 120 minutes

HbA1c and/or fasting glucose OGTT only if in doubt High risk groups (CVD, gestational

15 Screening for glucose perturbations Fasting glucose, OGTT or HbA1c General population/assumed abnormality Risk score Low value no further investigation High value HbA1c and/or fasting glucose OGTT only if in doubt High risk groups (CVD, gestational diabetes ) HbA1c and/or fasting glucose If abnormal no further investigation needed If normal - OGTT

16 Dysglycemia and coronary artery disease Glucometabolic category by OGTT in patients without known perturbations 31% 34% 18% 45% 27% 36% 35% 37% 37% GAMI Sweden 1 n=164 Eur Heart Survey 2 n=1,920 China Heart Survey 3 n=2,263 Normoglycaemia Prediabetes Type 2 diabetes (1. Norhammar et al. Lancet. 2002;359:2140 4) (2. Bartnik et al. Eur Heart J. 2004;25: ) (3. Hu et al. Eur Heart J. 2006;27:2573 9)

antiplatelets and statins if not contraindicated Revascularization thrombolysis, PCI or

17 Euro Heart Survey diabetes and the heart Impact of Evidence Based Medicine on 1-year prognosis Evidence based medicine The combined use of β-blockade, RAA-inhibition, antiplatelets and statins if not contraindicated Revascularization thrombolysis, PCI or CABG during index hospitalisation (Anselmino et al Europ J Cardiovasc Prev Rehab 2008;15: ) 1 17

18 Euro Heart Survey diabetes and the heart mpact of Evidence Based Medicine (EBM) on 1-year mortality Cumulative survival 1,00 0,99 0,98 0,97 0,96 0,95 0,94 0,93 0,92 No DM EBM + No DM EBM - DM EBM + p<0.001 DM EBM - 0, Time of follow up (days) (Anselmino et al Europ J Cardiovasc Prev Rehab 2008;15: ) 1 18

19 Cumulative event free rate Euro Heart Survey diabetes and the heart Impact of Revascularisation on 1-year mortality 1,00 0,99 0,98 0,97 0,96 0,95 0,94 0,93 p<0.001 No DM RV + No DM RV - DM RV + 0,92 0, Time of follow up (days) (Anselmino et al Europ J Cardiovasc Prev Rehab 2008;15: ) DM RV -

20 HbA1c as a diagnostic tool Questions: Primary tool Supplementary tool Alternative tool (alternative to glucose?)..

21 Committee on Diagnosis of Diabetes Advantages of A1C over FPG or 2HPG The HbA1c assay (standardized and aligned to the DCCT/UKPDS assay) has the advantages compared with the currently used laboratory measurements of glucose: 1. Better index of overall glycemic exposure 2. At least as good at predicting risk for long-term complications (retinopathy) 3. Similar standardization 4. Substantially less pre-analytic instability 5. Substantially less biologic variability 6. No need for fasting or timed samples 7. Relatively unaffected by acute (e.g. stress or illness-related) perturbations in glucose levels 8. Used to guide management and adjust therapy

22 Screening for hyperglycaemia in patients with acute MI in Stockholm Hage et al. Eur J Prev Cardiol 2012

23 FPG: 2.5% A1c: 1.6% 2-hPG: 4.9%

24 Factors reported to alter HbA1c, grouped according to their likely mechanism

25 EUROASPIRE IV A cross-sectional study conducted at 79 centres (hospitals) in 24 European countries May 2012 to April Men and women aged 18 <80 years with first or recurrent clinical evidence of CHD at 6-36 months before recruitment were included: (i) coronary artery bypass grafting (CABG), (ii) percutaneous coronary intervention (PCI), (iii) acute myocardial infarction (AMI), and (iv) acute myocardial ischemia.

26 EUROASPIRE IV Diabetes and Glycaemia assessment

27 Assessment of Glycaemia EUROASPIRE IV An Oral Glucose Tolerance Test was performed with 75 g glucose in 200 ml of water in the morning after at least 10 hours of fasting. Blood for Fasting Plasma Glucose was drawn before intake of glucose with a dip safe from the EDTA-tube in which the HbA1c was collected. Samples for 2h Plasma Glucose was drawn from whole venous blood using an EDTA-tube. Plasma glucose was analysed locally with a photometric point-ofcare technique (Glucose 201, HemoCue, Ängelholm, Sweden). HbA1c was measured at the central laboratory (Disease Risk Unit, National Institute for Health and Welfare, Helsinki, Finland) with an immunoturbidimetric method (Abbot Architect analyzer) in fasting venous whole blood sampled in an EDTA-tube.

28 The Prevalence of Diabetes and Prediabetes based on the WHO and ADA Criteria A WHO: OGTT = FPG + 2hPG B ADA: FPG + HbA1c 10,5% 26,6% NGT 27,7% DM NGT 23,5% DM 45,7% 66,0% PRE-DM PRE-DM ADA = American Diabetes Association

29 Diagnostic criteria of diabetes and other disorders of glucose metabolism Diagnostic Criteria according to Tool WHO Am Diabetes Assoc. (ADA) High risk HbA1c Not recommended mmol/mol = %)

30 The DECODE Study: Diabetes Epidemiology: Collaborative analysis Of Diagnostic criteria in Europe

31 All-cause mortality in people without history of diabetes by plasma glucose compared to people treated for diabetes Hazards ratio (95% CI) h post-load glucose = a Linear relation DECODE study FPG < 7.0 mmol/l = No relation < hour glucose (mmol/l) Known DM <4.75 Fasting glucose (mmol/l)

32 Screening for glucometabolic disturbances FINnish Diabetes RIsk SCore (FINDRISC) to assess 10-year risk of type 2 diabetes in adults. Score 0-26 points. Available at (Modified after Lindstrom & Tuomilehto Diabetes Care. 2003;26:725)

33 Diabetes incidence during 10-year follow-up by baseline FINDRISC Score % Men Women FINDRISC Score

34 The risk increment per 1 score point increase in FINDRISC for the incidence of acute CHD and stroke event, and total mortality among year old Finnish men and women (n=17,725) CHD Stroke Mortality incidence incidence HR (95% CI) HR (95% CI) HR (95% CI) Men 1.18 ( ) 1.23 ( ) 1.16 ( ) Women 1.21 ( ) 1.16 ( ) 1.18 ( ) Silventoinen et al. Eur J Cardiovasc Prev Rehab 2005;12:

35 Screening for glucose perturbations Fasting glucose, OGTT or HbA1c Recommendations Class Level It is recommended that the diagnosis of diabetes is based on HbA 1c and FPG combined or on an OGTT if still in doubt. I B It is recommended that an OGTT is used for diagnosing IGT. I B It is recommended that screening for potential T2DM in people with CVD is initiated with HbA 1c and FPG and that an OGTT is added if HbA 1c and FPG are inconclusive. I A Bad practice not to perform an OGTT when needed in patients with CVD

36 Cardiovascular risk assessement in people with dysglycaemia Recommendations Class Level It should be considered to classify patients with DM as at very high or high risk for CVD depending on the presence of concomitant risk factor and target organ damage. IIa B Very high risk Diabetes + 1 cardiovascular risk factor or target organ damage (Low ABI, increased IMT, arterial stiffness, CAC score, CAN, SMI) High risk All other patients with diabetes

37 Cardiovascular risk assessement in people with dysglycaemia Recommendations Class Level Risk assessment based on risk engines or biomarkers It is not recommended to assess the risk for CVD in patients with DM based on risk scores developed for the general population. Generally applicable risk engines Difficult to develop due to confounders Metaanalyses of risk engines Little evidence of added benefit Biomarkers So far of limited value III B

38 Cardiovascular risk assessement in people with dysglycaemia Markers that may add to risk prediction Risk assessment based on risk engines or biomarkers Ankle brachial index (ABI) Carotid intima-media thickness (IMT) and carotid plaques Arterial stiffness disclosed by pulse wave velocity Cardiac autonomic neuropathy (CAN) Recommendations Class Level It is indicated to estimate the urinary albumin excretion rate when performing risk stratification in patients with DM. Screening for silent myocardial ischaemia may be considered in selected high risk patients with DM. I IIb A C

39 Multifactorial management for risk reduction Life style modification Glycaemic control Antiplatelet therapy Blood pressure control Lipid control

40 Multifactorial management For risk reduction Life style modification Glycaemic control Antiplatelet therapy Best practice Blood pressure control Lipid control

41 Multifactorial management For risk reduction Life style modification Glycaemic control Antiplatelet therapy Bad practice Blood pressure control Lipid control

43 Multifactorial management Treatment targets Life style modification Best practice

58% 20 10 0 0 1 2 3 4 5 6 YEAR Risk 58% Risk 58% EDIPS Newcastle - UK Da

44 Prevention of Type 2 DM by Lifestyle Management: The Evidence DPS - Finland DPP - USA SLIM - Netherlands Intervention group Control Group Risk 58% YEAR Risk 58% Risk 58% EDIPS Newcastle - UK Da Qing - China IDPP - India Control Risk 43% Risk 28,5% Metformin Risk 55% Lifestyle

45 Finnish Diabetes Prevention Study (DPS): Intervention group Weight reduction > 5% Fat intake < 30 % of energy Saturated fat intake < 10 % of energy Fibre intake 15 g/1000 kcal Physical activity > 30 min/day Individually tailored diet based on 3-day food diary 7 dietary counselling sessions during the first year, every 3 months thereafter Free-of-charge gym lifestyle goals Control group General advice about healthy diet and exercise habits No individualised counselling Tuomilehto et al. NEJM 2001 Lindström et al. Diabetes Care 2003

46 Development of diabetes is inversely related to the success in achieving multiple intervention targets during the 1 st year of the study - DPS % Intervention Control SUCCESS SCORE (number of lifestyle goals achieved)

47 Adjusted HR: Adjusted for sex, age, 2h glucose and BMI at baseline. Diabetes incidence in the DPS until 2009 was 41% reduced in the intervention group probability of remaining ree of diabetes Intervention period Adjusted HR=0.59 Intervention) Control Log-rank test: p< Follow-up time, years

48 Percentage Decreasing complications with life style modification The Da Qing experience Cumulative incidence (%) Da Qing study development of DM Long term impact on severe retinopathy Control Intervention Years of follow-up 6-years intervention hazard rate ratio 0.49 (95% CI ) 20-years follow-up hazard rate ratio 0.57 (95% CI ) HR 0.53 (95% CI ) Control Intervention Follow-up time (years) Number at risk: Control Intervention Gong et al Diabetologia 2011; 54: 300

49 Decreasing complications with life style modification The Da Qing experience Da Qing study impact on mortality Control Intervention Li et al. Lancet Diab & Endocrin 2014; 2: 474

Lifestyle modification recommendation Smoking Cessation obligatory; passive smoking none Physical activity Weight Dietary habits Fat intake (% of dietary energy) Total Saturated Monounsaturated fatty

50 Lifestyle modification recommendation Smoking Cessation obligatory; passive smoking none Physical activity Weight Dietary habits Fat intake (% of dietary energy) Total Saturated Monounsaturated fatty acids Dietary fibre intake Moderate to vigorous 150 min/week Aim for weight stabilization in the overweight or obese DM patients based on calorie balance, and weight reduction in subjects with IGT to prevent development of T2DM <35% <10% >10% >40 g/day (or 20 g/1000 Kcal/day)

51 Lifestyle modification recommendations Best practice - to follow these recommendations Recommendations Class Level Any diet with reduced energy intake can be recommended in lowering excessive body weight in DM. I B Moderate to vigorous physical activity of 150 min/week is recommended for the prevention and control of T2DM, and prevention of CVD in DM. I A Aerobic exercise and resistance training are recommended in the prevention of T2DM and control of DM, but best when combined. I A

52 Recommendations for life-style modification in diabetes

53 The strategic 5 A:s for smoking cessation

9% Antiplatelet therapy Patients with CVD ASA 75-160mg/d Best practice Blood pressure

54 Multifactorial management Treatment targets Lifestyle modification Glycaemic control (HbA1c) in general <7.0% on indivual basis < % Antiplatelet therapy Patients with CVD ASA mg/d Best practice Blood pressure control <140/85 mmhg Nephropathy: SBP <130mmHg Lipid control (LDL-C) very high risk <1.8 mmol/l high risk <2.5mmol/L or 50%

Individualised management Best practice is to follow these recommendations Recommendations Class Level Patient-centred care is recommended to facilitate shared control and decisionmaking within the

55 Individualised management Best practice is to follow these recommendations Recommendations Class Level Patient-centred care is recommended to facilitate shared control and decisionmaking within the context of patient priorities and goals. Multidisciplinary teams and nurse-led programmes should be considered to support lifestyle change and self-management. I IIa C B Truly bad practice to treat people like numbers and not as individuals with the right to be part of their care and to express their own needs and expectations

61 Diabetes and Cardiovascular Disease: What do the ESC Guidelines recommend as best management Thanks for the attention!!! Gracias por su atención!!!

Master class in preventive cardiology Focus on diabetes and cardiovascular disease Geneva April

Master class in preventive cardiology Focus on diabetes and cardiovascular disease Geneva April 14 2011 Introduction Course objectives A review of available guidelines Lars Rydén Cardiology Unit Department