Diabetes and cardiovascular risk: MIND.IT Study

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1 Diabetes and cardiovascular risk: MIND.IT Study The clinical reality of guidelines for primary prevention of cardiovascular disease in type 2 diabetes in Italy Prof. Ivana Zavaroni Dipartimento di Medicina Interna e Scienze Biomediche Università di Parma

2 BACKGROUND Studio MIND-IT Type 2 diabetes is charaterized by multiple coronary risk factors leading to a 2-4-fold increase of cardiovascualr morbidity and mortality in comparison to general population. Several clinical trials have clearly demonstrated that the correction of a single cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of myocardial infarction and other cardiovascular disease (CVD) events So far only the Steno II study has been performed to evaluate the effect of a multifactorial intervention strategy on macrovascular complicationsin in microalbuminuric diabetic patients. For this reason, the disease management approach currently endorsed by international guidelines (i.e correction of all major CVD risk factors to target levels usually lower than lower risk populations) has not been extensively investigated in terms of prevalence of application in current clinical practice and in terms of real efficacy.

3 Studio MIND-IT BARI LA SPEZIA MASSA CARRARA PAVIA PIACENZA PISA PERUGIA ROMA TORINO Parallel group, randomized intervention study comparing the usual-care for primary prevention with an intensive multi-factorial treat-to-target intervention program designed according to international guidelines (Intensive Care)

4 Studio MIND-IT Exclusion criteria Age <50 o > 65 anni Cardiovascolar events CKD (creatinin > 1.7 mg/dl) transaminases >2 fold higher Others severe diseases

5 MIND-IT Type 2 diabetes Age years Two risk factors : Smoke >10 sigarets/die Blood pressure >140/90* LDL > 130 mg /dl * Inclusion Criteria HDL <35 mg /dl (uomini), <45 mg /dl (donne)* Triglyceride >200 mg /dl* * In pharmacological treatement included

6 Methods " Clinical record form (web-based) - Coordinating center: IRCA, Ancona External Quality Assessment Service (EQAS) : HbA1c, glicemia, colesterolo, TG, HDL Coordinating center : Istituto Scientifico San Raffaele, Milano Educational training ( intensive):nutrition,exercise, smoke On-site monitoring Central data QC with query manegement Biological bank

7 Study design Cross sectional evaluation ad interim 2 years analysis Primary 5 years end-point Primary End-point : 5 years incidence of major events (MACE)

8 MIND-IT CROSS-SECTIONAL EVALUATION

9 Atherosclerosis 2008;198: ] Clinical characteristics of study participants Studio MIND-IT Variable Men (n=1297) Women (n=1168) All (n=2465) p * Age (years) 60±5 61±5 61±5 <0.007 Diabetes duration (years) 7(8) 7(8) 7(8) NS BMI (kg/m 2 ) 28.6± ± ±5.0 < Waist (cm) 101±10 100±13 101±12 NS Systolic BP (mmhg) 141±16 142±17 141±16 <0.004 Diastolic BP (mmhg) 85±9 84±8 84±9 <0.036 HbA1c (%) 7.5± ± ±1.4 < Total Cholesterol (mg/dl) 208±37 219±39 213±38 <0.001 HDL Cholesterol (mg/dl) 46±11 53±13 49±12 < LDL Cholesterol (mg/dl) 130±34 135±34 133±34 < Triglycerides (mg/dl) 164±97 158±89 161±93 NS Current smokers (%) <0.001

10 Studio MIND-IT Proportion (%) of diabetic men and women achieving goals for major cardiovascular risk factors correction set by current guidelines Men Women p<0.001 Percentuale p<0.001 p<0.001 p< IMC < 25 kg/m2 HbA1c < 7 % LDL < 100 mg/dl BP < 130/80 mmhg Non smokers

11 Studio MIND-IT Risk factors treatment stratified by age groups Age Variables anni (n=1021) anni (n=723) anni (n=721) p * BG-lowering drugs Diet 179 (17.5) 105 (14.5) 99 (13.7) Oral drugs 712 (69.7) 523 (72.4) 500 (69.3) Insulin 55 (5.4) 43 (6.0) 66 (9.2) Oral + Insulin 75 (7.3) 51 (7.1) 56 (7.8) BP-lowering drugs 565 (55.3) 428 (59.2) 480 (66.6) <0.001 Lipid-lowering drugs 275 (26.9) 193 (26.7) 193 (26.8) N.S. Aspirin 177 (17.4) 171 (23.7) 175 (24.3) <0.001 Data are reported as number (%) of non-missing values. *Chi-square test BG=Blood Glucose; BP=Blood Pressure

12 Studio MIND-IT Risk factors treatment stratified by duration of disease Years from diabetes diagnosis Variables 5 years (n=935) 6-10 years (n=735) > 10 years (n=777) p * BG-lowering drugs Diet 251 (26.4) 81 (11.0) 51 (6.6) Oral drugs 676 (71.0) 558 (75.9) 501 (64.5) Insulin 12 (1.3) 44 (6.0) 108 (13.9) Oral + Insulin 13 (1.4) 52 (7.1) 117 (15.1) < BP-lowering drugs 552 (57.9) 455 (61.9) 466 (60.0) N.S. Lipid-lowering drugs 240 (25.2) 225 (30.6) 196 (25.2) Aspirin 176 (18.5) 152 (20.7) 195 (25.1) Data are reported as number (%) of non-missing values. *Chi-square test BG=Blood Glucose; BP=Blood Pressure

13 Studio MIND-IT Use of lipid lowering and antihypertensive medication by attained LDL and blood pressure values % on lipid lowering medication p for linear trend: NS < >=160 LDL cholesterol mg/dl % on antihypertensive medication <130/ / >=160 / 95 Blood pressure mmhg p for linear trend < 0.001

14 Studio MIND-IT Number of patients stratified by CHD risk Number of patients >= 60 UKPDS risk engine (10 years % of CHD)

15 Studio MIND-IT Percent of treatment for risk factors stratified by CHD risk Treated patients (%) p = p < BP-lowering treatment Cholesterol-lowering treatment Anti-platelets treatment 20 p = N.S >= 60 UKPDS risk engine (10 years % of CHD)

16 Summary - The vast majority (66%) has unsatisfactory control of three or more of these factors. - Only a minority of patients (5%) meets the targets set for optimal LDL cholesterol, blood pressure, HbA1c and smoking cessation. - Lipid lowering and, to a lesser extent, antihypertensive medications are under-used and the treatment is independent of age, diabetes duration, BP and LDL levels and Global CVD risk - The titration is insufficiently target-driven. - Prophylactic use of aspirin is limited, particularly in women and in high risk patients. - An additional finding of this study is a gender gap in the achievement of desirable control of cardiovascular risk factors

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