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Vanguard Phase Results for the Blood Pressure Component

Vanguard Phase Results for the Blood Pressure Component. Presented at the American Diabetes Association 68 th Scientific Sessions on June 10, 2008. Vanguard BP Participants (N=49 1 ) Baseline Characteristics. Blood Pressure Protocol.

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Vanguard Phase Results for the Blood Pressure Component

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  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

  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 Approachfor Intensive BP Participants Start 1 4 mos 6 7 2 3 5 Entry Milepost Visit SBP: 134 On meds: 2 Add: CCB Total: 3 SBP: 152 On meds: 0 Start: Diuretic/ACE Total: 2 12 mos 8 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: 1.5 1.7 1.8 1.9 1.8 Mean # Meds: 1.9 2.4 2.8 3.0 3.1

  7. SBP Delta between Treatment Arms in VanguardMeans & 95% Confidence Intervals

  8. Vanguard Medication Use by Class16 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 ADV UKPDS, ADVANCE, and ACCORD BP reduction in context:UK Prospective Diabetes Study Epidemiologic Data ACCORD SBP UK Prospective Diabetes Study

  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.

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