1. Vanguard Phase Results for the Blood Pressure Component
Presented at the American Diabetes Association
68th Scientific Sessions on June 10, 2008.

2. Vanguard BP Participants (N=491) Baseline Characteristics
Mean or %
Age (yrs) 63
BMI (kg/m2) 32
Race / Ethnicity
Creatinine (mg/dL)
1.0
White % 52
eGFR (mL/min/1.73m2) 99
Black % 30
2° prevention, %
Hispanic % 11
Current smoking % 12
Minority % 51
On Antihypertensive % 83
Women %
On Thiazides % 19
DM Duration (yrs) 10
On ACE Inhibitor % 55
A1C (%)
8.7
On ß-Blocker % 15 3

3. Blood Pressure Protocol
Various drugs/combinations provided to achieve goal BP according to randomized assignment.
2-drug therapy initiated in Intensive BP group: thiazide-type diuretic + ACEI, ARB, or ß-blocker.
Drugs added and/or titrated at each visit to achieve BP goals.
In Intensive group, at periodic “Milepost” visits addition of another drug “required” if not at goal.
Down-titration in Standard group if SBP:
<135 mm Hg on 2 consecutive visits or
<130 mm Hg at one visit

4. Milepost Visit Approach for Intensive BP Participants
Start 1 2 3
4 mos 5 6 7
Entry
Milepost
Visit
SBP: 134
On meds: 2
Add: CCB
Total: 3
SBP: 152
On meds: 0
Start: Diuretic/ACE
Total: 2
8 mos
12 mos 9 10 11
Milepost
Visit
Milepost
Visit
SBP: 122
On meds: 3
Add: Reserpine
Total: 4
SBP: 114
On meds: 4
Add: 0
Total: 4

5. Vanguard SBP Distribution for Intensive Group
12+16 mo mean =
121 mm Hg
BL mean =
142 mm Hg
Restricted to 211 participants with measurements at all 3 visits

6. Achieved Systolic Pressures in VG Means +/- 95% Confidence Intervals
Mean # Meds:
Mean # Meds:
Points of Emphasis / Key Messages
The risk of cardiovascular death is substantially increased in patients with type 2 diabetes and comorbid elevated SBP. For an SBP of 120 to 139 mm Hg, concurrent diabetes is equivalent to adding 40 mm Hg to the systolic pressure.
In addition, MRFIT demonstrated that SBP (as well as elevated serum cholesterol levels and cigarette smoking) is a significant predictor of mortality in men with and without diabetes.
The Multiple Risk Factor Intervention Trial (MRFIT) enrolled 361,662 men 35 to 37 years of age. A total of 5625 were receiving treatment for diabetes; the remaining 356,037 did not have diabetes.
The study did not classify diabetes as insulin-dependent or non-insulin-dependent (NIDDM), but because of the participants’ age, more than 90% were assumed to have NIDDM. 
Men whose SBP was ³180 mm Hg had nearly twice the risk of CV mortality if they had diabetes. If SBP was 140 to 179 mm Hg, the risk was more than twice that of men with diabetes. 
Reference
Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr
cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial.
Diabetes Care. 1993;16: 7

7. SBP Delta between Treatment Arms in Vanguard Means & 95% Confidence Intervals8

8. Vanguard Medication Use by Class 16 Month Visit
* thiazide diuretics: intensive: 74%, standard:41%

9. Vanguard DBP Distribution for Intensive Group
BL mean =
76 mm Hg
12+16 mo mean =
66 mm Hg
Restricted to 211 participants with measurements at all 3 visits

10. UKPDS, ADVANCE, and ACCORD BP reduction in context: UK Prospective Diabetes Study Epidemiologic Data
SBP
UK Prospective Diabetes Study 11

11. Vanguard BP Conclusions
Achieved SBPs and delta SBP between randomized groups supported continuation of the ACCORD BP trial into the full-scale trial.
With this treatment algorithm SBP was lowered to an average of 120 mm Hg in patients with type 2 DM over 16 months, using an average of about 3 medications.
The data suggest ACCORD will provide definitive clinical trial data on possible benefits and risks of treating to lower BP goals in patients with type 2 DM.