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1 NHLBI/NEI National Institutes of Health NHLBI/NEI National Institutes of Health
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2 Diabetes & CVD Patients with type 2 diabetes 2 to 4 X increased risk of CVD Question: What is value of intensive control of CVD risk factors in reducing CVD rates? Glycemia Lipids (HDL-C/TG) Systolic Blood Pressure
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3 Overall Goal for ACCORD To test three complementary medical treatment strategies for type 2 diabetes to enhance options for reducing the very high rate of major CVD morbidity and mortality
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4 The Three Medical Strategies (Three Trials in One) Intensive glycemic control A1C < 6% versus 7.0%-7.9% Treatment to increase HDL-C and lower TG (in context of good LDL-C and glycemia control) Fenofibrate + Simvastatin versus Simvastatin Intensive blood pressure control (in context of good glycemia control) SBP < 120 mmHg versus SBP < 140 mmHg
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5 Double 2 x 2 Intensive Glycemic Control 5000 Standard Glycemic Control 5000 LipidBP FibratePlaceboIntensiveStd 2100 2900 1450 1050 10,000 42005800
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6 Primary Outcome Measure First occurrence of a major cardiovascular disease event: Nonfatal MI Nonfatal Stroke Cardiovascular Death MI’s, Strokes, and Deaths adjudicated by a committee masked to treatment assignment
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7 Other ACCORD Outcomes Other cardiovascular outcomes Total mortality Microvascular outcomes Health-related Quality of Life (subset) Cost-effectiveness (subset)
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8 ACCORD Eye Study National Eye Institute
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9 important primary endpoint common cause of vision loss medical management crucial standard of care: yearly dilated eye exams Diabetic Retinopathy ACCORD Eye Study Rationale
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10 important primary endpoint DCCT – Primary outcome UKPDS – Composite primary outcome Diabetic Retinopathy
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11 Diabetes Control and Complications Trial (DCCT) Randomized Clinical Trial Intensive Blood Glucose Control vs. Conventional Blood Glucose Control Type 1 Diabetes
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12 Primary Intervention - 3 Step Change Years Percent With Event DCCT Results Conventional Intensive
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13 Secondary Intervention - 3 Step Change Years Percent With Event DCCT Results Conventional Intensive
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14 Secondary Intervention - 3 Step Change Years Percent With Event DCCT Results P < 0.02 Conventional Intensive
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15 Results of Intensive Therapy: Clinically Important Retinopathy (34-76%) Photocoagulation (34%) First Appearance of Retinopathy (27%) DCCT Summary Reduction in Retinopathy
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16 Further Retinopathy Progression from the Level at DCCT Closeout Adjusted For DCCT Closeout Level Percentage Years of follow-up in EDIC Conventional Rx Tight Control Rx
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17 Randomized Clinical Trial Intensive Blood Glucose Control vs. Conventional Blood Glucose Control U K Prospective Diabetes Study Type 2 Diabetes
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18 U K Prospective Diabetes Study Microvascular Endpoints 10% 30% 20% 69301512 Years Conventional Intensive 0% Event Rate Photocoagulation/VH Renal Failure/Death Myocardial Infarction p=0.0099
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19 U K Prospective Diabetes Study Retinopathy - 2 Step Progression 10% 30% 40% 20% 693012 Years Conventional Intensive 50% 0% Event Rate p=0.78 p=0.02p=0.01
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20 Randomized Clinical Trial Intensive Blood Pressure Control vs. Conventional Blood Pressure Control U K Prospective Diabetes Study Type 2 Diabetes
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21 U K Prospective Diabetes Study Blood Pressure by Treatment Group mm Hg 100 80 120 140 160 3690 Years 124587 Less Tight - Systolic More Tight - Systolic Less Tight - Diastolic More Tight - Diastolic
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22 Retinopathy - 2 Step Progression 10% 30% 40% 20% 693012 Years Less Tight BP Control More Tight BP Control 50% 0% Event Rate UKPDS Blood Pressure Trial P=0.38P=0.02P=0.004
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23 Serum Cholesterol Diabetic Retinopathy and
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24 Early Treatment Diabetic Retinopathy Study (ETDRS) Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) Serum cholesterol Observational Data
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25 Doubled the risk of retinal hard 50% increased risk of moderate vision 50% increased risk of developing hard exudate at baseline Serum cholesterol-ETDRS Results Elevated levels: exudate during follow-up loss at 5 years
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26 to assess the rates of progression of medical treatment on diabetic retinopathy To evaluate the effects of these 3 diabetic retinopathy ACCORD Eye Study Objectives
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27 Baseline (within 4 months of enrollment) Sample size: n=4,065 4 years for all enrolled at baseline ACCORD Eye Study Eye Exam and Fundus Photos
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28 Clinical coordinator from the diabetes Coordinating Center (Wake Forest U.) and Eye exam form, fundus photographs sent to clinic will schedule patient ACCORD Eye Study Study flow Reading Center (U. of Wisconsin)
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29 Alexandria meeting Feb 18-20, 2004
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