1/28/2014. The Metabolic Syndrome: Early History. Insulin Resistance: Early Diagnosis and Treatment to Prevent Cardiovascular Disease

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1 : Early Diagnosis and Treatment to Prevent Cardiovascular Disease Henry N. Ginsberg, M.D. Irving Professor of Medicine Columbia University College of Physicans and Surgeons The Metabolic Syndrome: Early History First described in the 1920s by Kylin, a Swedish physician (Innere Medizin 44:105-27, 1923) hypertension hyperglycemia gout In 1947, Vague (Presse Med. 30: ) drew attention to upper body adiposity as the obesity phenotype that commonly occurred with metabolic abnormalities associated with type 2 diabetes and CVD Harmonizing the metabolic syndrome: a joint interim statement of the Circulation Oct 20;120(16): Risk Factor ( 3) Abdominal obesity Triglycerides HDL-C Blood glucose Blood pressure Defining Level Geographic waist circumference 150 mg/dl and/or <34/8 (0.9) mg/dl in men; <38.7 (1.0) mg/dl in women >100 mg/dl >130/>85 mm Hg.European, African, Middel Eastern men >94 cm; Chinese, South Asian, Central and South American natives men >90 cm; Japanese men >85cm. All women (except Japanese) >80 cm. 1

2 Interrelationships Between and Obesity Increased CVD and All-cause Mortality 1209 Finnish men HBP Inflammation Insulin Diabetes TG Dense LDL-C Low HDL-C Coag. Endothelial dysfunction Lakka H, et al. JAMA 2002;288; Association Between The Number of Metabolic Syndrome Components and Incident CVD Prediction of CHD Prevalence using Multivariate Logistic Regression: NHANES Variable Odds Ratio Lower 95% Limit Upper 95% Limit Waist Circumference Triglycerides HDL Cholesterol Blood Pressure Impaired Fasting Glucose Diabetes Metabolic Syndrome Significant predictors of prevalent CHD in yellow. Klein BEK, et al. (Beaver Dam Study). Diabetes Care 2002;25: Alexander C, et al. Diabetes 52: ,

3 Increased insulin resistance is associated with increased CVD risk: San Antonio Heart Study HOMA IR Quintiles Association between HOMA-IR and 8-year risk of CV outcomes (CV death, MI, CABG, CVA, angina) in 2600 subjects free of DM and CVD at baseline Quintile 5 Quintile 4 Quintile 3 Quintile Odds ratio for risk of CVD (95% CI) The Metabolic Syndrome and Type 2 Diabetes Incidence 3-fold Kokalainen P et al Diab Care, fold Park PJ et al Diab Care, ,3-fold Hanson RL et al Diabetes, fold Lorenzo C et al Diabetes Care, fold Nakanishi N et al Diab Res Clin Pract, ,4-fold Wang JJ et al Horm Metab Res, 2004 Quintile of HOMA-IR adjusted for age, sex, ethnicity, LDL, triglyceride, HDL, systolic blood pressure, smoking, alcohol consumption, leisure time exercise and waist circumference (median split) P (trend) = Adapted from Hanley AJ, et al. Diabetes Care 2002; 25: Nesto Slide #9 How can you diagnosis? Many way Waist; waist hip; waist/tg; waist/hdl Fasting insulin, HOMA, Quickie GTT, ITT, Minimal Model Clamp HighTG with low HDL Race/ethnicity/geographical origin What can we do about it? Many things But can we reduce cardiovascular disease by treating insulin resistance? And, what exactly do we treat? 3

4 Resistance and Obesity Resistance and HBP Inflammation Insulin Diabetes TG Dense LDL-C Low HDL-C Coag. Glucose Endothelial dysfunction hr Post 50g Blood G vs. CHD Death Resistance and Excluded New DM from Analysis; Threshold = 4.6 mm Age-adjusted HR: 1.22 ( )/1 mm 2 hr G rise >4.6 Multiple adjusted HR: 1.12 ( )/1 mm 2 hr G rise >4.6 Glucose before you have diabetes BG (mmol/l) Brunner et al. Diabetes Care 2006:

5 Finnish Diabetes Prevention Study: Effect of Lifestyle Intervention Cumulative probability of remaining free of diabetes Control (23%) Intensive Lifestyle (11%) Years on trial 58% Relative Risk Reduction Toumilehto J et al. N Engl J Med. 2001;344: Cumulative incidence (%) Incidence Percent developing of Diabetes diabetes Placebo (n=1082) All participants Metformin (n=1073, p<0.001 vs. Placebo) Lifestyle (n=1079, p<0.001 vs. Met, p<0.001 vs. Plac ) 40 Lifestyle Metformin (n=1079, (n=1073, p<0.001 vs. Metformin, Plac) Placebo (n=1082) p<0.001 vs. Placebo) Risk reduction 30 31% by metformin 58% by lifestyle Years from randomization Diabetes Prevention Program Research Group. N Engl J Med. 2002;346: year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study Figure 3 Cumulative frequency of diabetes Development of diabetes since Diabetes Prevention Program (DPP) randomisation for (A) all participants, (B) those aged years at randomisation, (C) years, (D) and 60 years and older; and since enrolment... The Lancet Volume 374, Issue Figure 2 Mean weight changes Weight changes for originally assigned treatment group since Diabetes Prevention Program (DPP) randomisation for (A) all participants, (B) those aged years at randomisation, (C) years, and (D) 60 years and older; a... The Lancet Volume 374, Issue

6 Long term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: a report from the DPP Outcomes Study Long term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: a report from the DPP Outcomes Study Diabetic Medicine Volume 30, Issue 1, pages 46-55, 13 DEC 2012 DOI: /j x Diabetic Medicine Volume 30 Issue 1 pages 46-55, 13 DEC 2012 So lowering glucose in prediabetics can prevent diabetes - but what about CVD No data from Finnish or DPP studies Other data? % Free of CVD Events Time to Any Cardiovascular Event In STOP NIDDM Mean treatment duration Acarbose Placebo p = Days after Randomization Chiasson et al. JAMA Jul 23;290(4):

7 Kaplan Meier Curves for the Coprimary and Two Exploratory Outcomes in the Nateglinide and Placebo Groups. ORIGIN: Outcome Reduction with Initial Insulin Glargine INtervention 12,537 IFG, IGT, Type 2 DM (mean 5.5 yrs) 60% prior CV event insulin glargine vs usual care to FBG<95 mg/dl 6.2 years follow-up RESULTS No effect on all CV events No increased risk for cancer Severe hypoglycemia 1.0 %/yr insulin 0.31%/yr usual care Any hypoglycemic episode 16.7% insulin 5.2% usual care The NAVIGATOR Study Group. N Engl J Med 2010;362: So lowering glucose in prediabetics probably doesn t prevent CVD Resistance and Glucose when you have diabetes for a long time 28 7

8 Kaplan-Meier Curves for Four Prespecified Aggregate Clinical Outcomes Holman RR et al. N Engl J Med 2008;359: DCCT-EDIC: Long-term Risk of CV Events is Reduced by Intensive Glycemic Control in Type 1 DM 12% Conventional Intensive Any CV Outcome A1C 10% 8% 6% P<0.001 P<0.001 DCCT EDIC End of Year 1 randomized treatment P=0.61 EDIC Year 7 Cumulative Incidence % risk reduction P=0.02 Conventional Years Since Entry* Intensive *DCCT ended and EDIC began in year 10 (1993). Mean follow-up: 17 years. DCCT/EDIC Research Group. JAMA. 2002;287: Nathan DM, et al. N Engl J Med. 2005;353: Strokes Non fatal MI and CV Mortality 8

9 1.41%/yr 1.14%/yr All Cause Mortality HR = 1.22 ( ) P = 0.04 So lowering glucose in diabetics probably does prevent CVD a little: but at what cost? Resistance and Coagulation Inflammation 36 9

10 Forest plots for mortality, myocardial infarction, and ischemic stroke. Selected outcomes in secondary prevention trials of aspirin by sex.33 Reprinted with permission from Elsevier. Fuster V, and Sweeny J M Circulation. 2011;123: Calvin A D et al. Dia Care 2009;32: So treating with ASA reduced CVD in secondary prevention and possibly in primary prevention as well Resistance and HBP 40 10

11 Trial N Mean SBP < intense Mean SBP > intense CVD Risk Reduction SHEP % Syst-EUR % HOT 1, % Mean # Meds Intensive: Standard: Average after 1 st year: Standard vs Intensive, Delta = 14.2 UKPDS 1, % ABCD No CVD ADVANCE 11, % mortality 20 Primary Outcome Nonfatal MI, Nonfatal Stroke or CVD Death 20 Nonfatal Stroke 20 Total Stroke Patients with Events (%) HR = % CI ( ) P=0.20 Patients with Events (%) HR = % CI ( ) P= Years Post-Randomization Patients with Events (%) HR = % CI ( ) P= Years Post-Randomization Years Post-Randomization 11

12 So lowering blood pressure in diabetics prevent CVD, but there are limits Do ACEI or ARBs Prevent Diabetes Mellitus? DREAM No. at Risk Placebo Ramipril Cumulative Hazard Primary Outcome Ramipril Primary Outcome: Ramipril HR 0.91 (CI ); P=0.15 Placebo Ramipril Year 3 4 Placebo Ramipril Do ACEI or ARBs Prevent Diabetes Mellitus? NO 12

13 Resistance and Resistance and TG LDL HDL-C TG LDL HDL-C Statins and Diabetes? Lowering LDL is good for diabetics Prediabetics are at higher risk to develop diabetes on statins but benefit almost certainly outweighs potential harm Sattar et al Lancet % increase heterogeneity modest 13

14 Resistance and 53 DREAM Cumulative Hazard Primary Primary Outcome: Rosiglitazone Year 3 4 Placebo No. at Risk Placebo Rosiglitazone HR = 0.40 ( ); P< Placebo Rosiglitazone Rosiglita DREAM Cardiovascular Outcomes: Rosiglitazone Kaplan Meier Plot of Hazard Ratios for Time to Development of Diabetes. Composite HR 1.37 ( ): P=0.08 MI Stroke CV Death CHF New Angina Revascularized 14 (0.5%) vs. 2 (0.1%); P= LOG HR (95% CI) DeFronzo RA et al. N Engl J Med 2011;364:

15 Annual carotid intima media thickness (CIMT) progression rates, mm/year 103 by intention to treat groups. DREAM Saremi A et al. Arterioscler Thromb Vasc Biol. 2013;33: Copyright American Heart Association, Inc. All rights reserved. PROactive: Difference in Number of First Events Comprising the Primary Composite Endpoint: Pioglitazone vs Placebo Difference in Number of First Events Death *Excluding silent MI Pioglitazone: n = 2605 Placebo: n = Nonfatal MI* -3 Silent MI Stroke MLA ACS Revascularization Coronary Leg ACS = acute coronary syndrome; MLA = major leg amputation Adapted from Dormandy JA, et al. Lancet. 2005;366(9493):

16 PERISCOPE: Primary Efficacy Parameter Change in Percent Atheroma Volume (%) 10 TRIPOD Study: Carotid IMT Results P < P = Carotid IMT (% Change from Basal) Placebo (n=99) Troglitazone (n=93) p=0.05 Glimepiride P = 0.44 Pioglitazone Nicholls SJ, et al. J Am Coll Cardiol 2011; 57: Years on Trial Xiang et al: JCEM, ALECARDIO: Does a dual PPAR reduce CVD? Treating insulin resistance probably does prevent CVD Double-blind, placebo-controlled, randomized, international study 1 CV Event-driven outcome study Screened patients Study population Known or recently diagnosed T2DM Hospitalized for ACS Treatment period 2.5 years and 950 events Aleglitazar 150 µg, once daily Placebo CV Death, MI, stroke Standard care 1 (diabetes and other CV risk factors) Week Hospital admission Randomization up to 8 weeks post-discharge 2 Randomization up to 12 weeks post-cabg or PCI years 2.5 years 1. Available at: (accessed ). 16

17 Resistance and Look AHEAD: Study design Look Action for Health in Diabetes N = years with T2DM, BMI 25 kg/m 2 ( 27 kg/m 2 if taking insulin) Obesity Usual medical care + diabetes support and education for 4 years Total follow-up 11.5 years Usual medical care + lifestyle intervention* for 4 years, with maintenance counseling thereafter Primary endpoint: CV death, nonfatal MI, nonfatal stroke 65 * 7% mean weight loss with hypocaloric diet ± pharmacologic therapy min/week moderate physical activity Diet = kcal/day (<250 lbs) or kcal/day ( 250 lbs) Look AHEAD Research Group. Control Clin Trials. 2003;24:610-28; Obesity. 2006;14: Effects of intensive lifestyle intervention on CVD risk factors Median percent change in hepatic steatosis by percent weight change. Lazo M et al. Dia Care 2010;33:

18 Changes in Weight, Physical Fitness, Waist Circumference, and Glycated Hemoglobin Levels during 10 Years of Follow-up. Cumulative Hazard Curves for the Primary Composite End Point. The Look AHEAD Research Group. N Engl J Med 2013;369: The Look AHEAD Research Group. N Engl J Med 2013;369: Will identifying insulin resistance early lead to better outcomes for patients and if so, why? At the present time the answer to the first half is yes For the second half, probably because you treat the associated risk factors: obesity, hypertension, dyslipidemia, hypercoagulation (?). There is no basis for treating glucose in nondiabetics with insulin resistance. 18

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