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NHLBI/NEI National Institutes of Health

NHLBI/NEI National Institutes of Health. 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. Overall Goal for ACCORD.

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NHLBI/NEI National Institutes of Health

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  1. NHLBI/NEI National Institutes of Health

  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

  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

  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

  5. Double 2 x 2 Lipid BP Fibrate Placebo Intensive Std Intensive Glycemic Control 1450 1450 1050 1050 5000 Standard Glycemic Control 1450 1450 1050 1050 5000 2900 2100 2100 10,000 2900 5800 4200

  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

  7. Other ACCORD Outcomes • Other cardiovascular outcomes • Total mortality • Microvascular outcomes • Health-related Quality of Life (subset) • Cost-effectiveness (subset)

  8. ACCORD Eye Study National Eye Institute

  9. ACCORD Eye Study Rationale Diabetic Retinopathy •important primary endpoint •common cause of vision loss •medical management crucial •standard of care: yearly dilated eye exams

  10. Diabetic Retinopathy • important primary endpoint •DCCT – Primary outcome •UKPDS – Composite primary outcome

  11. Diabetes Control and Complications Trial (DCCT) Randomized Clinical Trial Intensive Blood Glucose Control vs. Conventional Blood Glucose Control Type 1 Diabetes

  12. Conventional Intensive DCCT Results Primary Intervention - 3 Step Change Percent With Event Years

  13. Conventional Intensive DCCT Results Secondary Intervention - 3 Step Change Percent With Event Years

  14. Conventional Intensive DCCT Results Secondary Intervention - 3 Step Change Percent With Event P < 0.02 Years

  15. DCCT Summary Results of Intensive Therapy: Reduction in Retinopathy • Clinically Important Retinopathy (34-76%) • Photocoagulation (34%) • First Appearance of Retinopathy (27%)

  16. Further Retinopathy Progression from the Level at DCCT CloseoutAdjusted For DCCT Closeout Level Conventional Rx Tight Control Rx Percentage Years of follow-up in EDIC

  17. U K Prospective Diabetes Study Randomized Clinical Trial Intensive Blood Glucose Control vs. Conventional Blood Glucose Control Type 2 Diabetes

  18. U K Prospective Diabetes Study Microvascular Endpoints Event Rate 30% Photocoagulation/VH Renal Failure/Death Myocardial Infarction p=0.0099 20% Conventional 10% Intensive 0% 0 3 6 9 12 15 Years

  19. U K Prospective Diabetes Study Retinopathy - 2 Step Progression Event Rate 50% Conventional 40% 30% Intensive 20% 10% p=0.02 p=0.01 p=0.78 p=0.01 0% 0 3 6 9 12 Years

  20. U K Prospective Diabetes Study Randomized Clinical Trial Intensive Blood Pressure Control vs. Conventional Blood Pressure Control Type 2 Diabetes

  21. U K Prospective Diabetes Study Blood Pressure by Treatment Group mm Hg 160 Less Tight - Systolic More Tight - Systolic 140 120 100 Less Tight - Diastolic 80 More Tight - Diastolic 0 1 2 3 4 5 6 7 8 9 Years

  22. UKPDS Blood Pressure Trial Retinopathy - 2 Step Progression Event Rate 50% Less Tight BP Control 40% 30% More Tight BP Control 20% 10% P=0.38 P=0.02 P=0.004 0% 0 3 6 9 12 Years

  23. Serum Cholesterol and Diabetic Retinopathy

  24. Serum cholesterol Observational Data  Early Treatment Diabetic Retinopathy Study (ETDRS)  Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR)

  25. Serum cholesterol-ETDRS Results Elevated levels:  Doubledthe risk of retinal hard exudateat baseline  50%increased risk of developing hard exudate during follow-up  50%increased risk of moderate vision loss at 5 years

  26. ACCORD Eye Study Objectives  to assess the rates of progression of diabetic retinopathy  To evaluate the effects of these 3 medical treatment on diabetic retinopathy

  27. ACCORD Eye Study Eye Exam and Fundus Photos  Baseline (within 4 months of enrollment)  4 years for all enrolled at baseline Sample size: n=4,065

  28. ACCORD Eye Study Study flow  Clinical coordinator from the diabetes clinic will schedule patient  Eye exam form, fundus photographs sent to Coordinating Center (Wake Forest U.) and Reading Center (U. of Wisconsin)

  29. Alexandria meeting Feb 18-20, 2004

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