1. Results of the ACCORD Glycemia Trial on Mortality and the Primary Outcomes
Presented at the American Diabetes Association
68th Scientific Sessions on June 10, 2008.

2. Participant Followup Randomized N=10,251 Intensive Group (N=5128)
Refused Intensive Approach (N=11)
Lost to Follow-up (N=26)
Discontinued Intervention (N=336)
Analyzed (N=5128)
Excluded from analysis (N=0)
Standard Group (N=2123)
Refused Standard Approach (N=26)
Lost to Follow-up (N=24)
Discontinued Intervention (N=322)
Analyzed (N=5123)

3. Median A1C and Interquartile Ranges

4. Adverse Events Intensive N (%) Standard P CHF 152 (3.0) 124 (2.4) 0.10
MVA*
9 (0.2)
14 (0.3)
0.31
Non-hypo SAE
113 (2.2)
82 (1.6)
0.03
Fluid Retention
3541 (70.1)
3378 (66.8)
<0.001
ALT > 3 X Normal
51 (1.0)
77 (1.5)
0.02
*Motor Vehicle Accident

5. Stopping the Glycemia Comparison
10 member DSMB reviewed interim results every 6 mo.
Monitored primary outcome, mortality rates and other variables to assure safety of participants
Recommended discontinuing the intensive glycemia intervention on January 8, 2008 after reviewing mortality trends for several months; this was accepted by NHLBI
ACCORD participants were informed on February 5 and switched to standard glycemia group goals
Results presented here are based on data available to the DSMB at their meeting in January

6. All Cause Mortality
1.41%/yr
1.14%/yr
HR = 1.22 ( )
P = 0.04

7. Primary & Secondary Outcomes
Intensive
N (%)
Standard
HR (95% CI) P
Primary
352 (6.86)
371 (7.23)
0.90 ( )
0.16
Secondary
Mortality
257 (5.01)
203 (3.96)
1.22 ( )
0.04
Nonfatal MI
186 (3.63)
235 (4.59)
0.76 ( )
0.004
Nonfatal Stroke
67 (1.31)
61 (1.19)
1.06 ( )
0.74
CVD Death
135 (2.63)
94 (1.83)
1.35 ( )
0.02
CHF
152 (2.96)
124 (2.42)
1.18 ( )
0.17

8. Cause of Death Intensive N (%) Standard Unexpected/Presumed CVD
86 (1.7)
67 (1.3) MI
19 (0.4)
13 (0.3)
CHF
23 (0.5)
16 (0.3)
CV Procedure
10 (0.2)
3 (0.1)
Arrhythmia
4 (0.1)
Non-CV Procedure
1 (0.02)
Stroke
9 (0.2)
11 (0.2)
Other CVD
8 (0.2)

9. Cause of Death, continued
Intensive
N (%)
Standard
Cancer
65 (1.3)
63 (1.2)
Not Cancer or CVD
50 (1.0)
35 (0.7)
Respiratory (not pneumonia) 12 1
Infectious 19 17
Accident/Trauma 8 9
Renal Failure 2
Liver Disease 5
Neurologic 3
Other 4
Indeterminate
7 (0.1)
11 (0.2)

10. All Cause Mortality
1.41%/yr
1.14%/yr
HR = 1.22 ( )
P = 0.04

11. Hazard Ratios for Total Mortality by Subgroup

12. Primary & Secondary Outcomes
Intensive
N (%)
Standard
HR (95% CI) P
Primary
352 (6.86)
371 (7.23)
0.90 ( )
0.16
Secondary
Mortality
257 (5.01)
203 (3.96)
1.22 ( )
0.04
Nonfatal MI
186 (3.63)
235 (4.59)
0.76 ( )
0.004
Nonfatal Stroke
67 (1.31)
61 (1.19)
1.06 ( )
0.74
CVD Death
135 (2.63)
94 (1.83)
1.35 ( )
0.02
CHF
152 (2.96)
124 (2.42)
1.18 ( )
0.17

13. Primary Outcome
2.29%/yr
2.11%/yr
HR = 0.90( )
P = 0.16

14. Hazard Ratios for Primary Outcome by Subgroup

15. Conclusions
In people with type 2 diabetes at high risk for CVD, with an A1C of 7.5% or more, a therapeutic strategy that targets an A1C <6% vs % increases mortality over 3.5 years
There is no significant effect of the glycemic intervention on the primary outcome at this time
Ongoing follow-up and ongoing analyses (both epidemiologic & within baseline subgroups) will add further insight and generate more hypotheses