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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


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
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


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


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


Primary outcome measure
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


Other ACCORD Outcomes

  • Other cardiovascular outcomes

  • Total mortality

  • Microvascular outcomes

  • Health-related Quality of Life (subset)

  • Cost-effectiveness (subset)


ACCORD Eye Study

National Eye Institute


ACCORD Eye Study Rationale

Diabetic Retinopathy

•important primary endpoint

•common cause of vision loss

•medical management crucial

•standard of care: yearly dilated eye exams


Diabetic Retinopathy

• important primary endpoint

•DCCT – Primary outcome

•UKPDS – Composite primary outcome


Diabetes Control and Complications

Trial (DCCT)

Randomized Clinical Trial

Intensive Blood Glucose Control

vs.

Conventional Blood Glucose Control

Type 1 Diabetes


Conventional

Intensive

DCCT Results

Primary Intervention - 3 Step Change

Percent

With Event

Years


Conventional

Intensive

DCCT Results

Secondary Intervention - 3 Step Change

Percent

With Event

Years


Conventional

Intensive

DCCT Results

Secondary Intervention - 3 Step Change

Percent

With Event

P < 0.02

Years


DCCT Summary

Results of Intensive Therapy:

Reduction in Retinopathy

  • Clinically Important Retinopathy (34-76%)

  • Photocoagulation (34%)

  • First Appearance of Retinopathy (27%)


Further retinopathy progression from the level at dcct closeout adjusted for dcct closeout level
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


U K Prospective Diabetes Study Closeout

Randomized Clinical Trial

Intensive Blood Glucose Control

vs.

Conventional Blood Glucose Control

Type 2 Diabetes


U K Prospective Diabetes Study Closeout

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


U K Prospective Diabetes Study Closeout

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


U K Prospective Diabetes Study Closeout

Randomized Clinical Trial

Intensive Blood Pressure Control

vs.

Conventional Blood Pressure Control

Type 2 Diabetes


U K Prospective Diabetes Study Closeout

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


UKPDS Blood Pressure Trial Closeout

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


Serum Cholesterol Closeout

and

Diabetic Retinopathy


Serum cholesterol Closeout

Observational Data

 Early Treatment Diabetic

Retinopathy Study (ETDRS)

 Wisconsin Epidemiologic Study of

Diabetic Retinopathy (WESDR)


Serum cholesterol-ETDRS Results Closeout

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


ACCORD Eye Study Closeout

Objectives

 to assess the rates of progression of

diabetic retinopathy

 To evaluate the effects of these 3

medical treatment on diabetic retinopathy


ACCORD Eye Study Closeout

Eye Exam and Fundus Photos

 Baseline (within 4 months of enrollment)

 4 years for all enrolled at baseline

Sample size: n=4,065


ACCORD Eye Study Closeout

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)


Alexandria meeting Closeout Feb 18-20, 2004


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