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KEY POINTS - Southern Medical Association

KEY POINTS - Southern Medical Association

Intensive Glycemic

Intensive Glycemic Control Standard Glycemic Control ACCORD: Study Design Lipid BP Placebo Fibrate Intensive Standard 1383 1374 1370 1391 2753 2765 5518 1178 1184 2362 4733 * 1193 1178 2371 5128 5123 10,251 *94% power for 20% reduction in event rate, assuming standard group rate of 4% / yr and 5.6 yrs follow-up The ACCORD Study Group. New Engl J Med. 2010;362:1575-85, ACCORD: Outcomes Primary Composite Outcome • First occurrence of a major cardiovascular event: nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes Secondary Outcomes • Nonfatal myocardial infarction • Fatal or nonfatal stroke • Death from any cause • Cardiovascular death • Hospitalization due to heart failure • Primary outcome + revascularization of hospitalization for heart failure: “expanded macrovascular outcome” • Fatal coronary event, nonfatal myocardial infarction, or unstable angina: “major coronary disease events” The ACCORD Study Group. New Engl J Med. 2010;362:1575-85, ACCORD: Baseline Characteristics Characteristi c Mean or % Age (yrs) 62 Women % 48 2° prevention % Race / Ethnicity Characteristic Blood Pressure (mmHg) On Antihypertensive % Mean or % 139/76 87 34 Creatinine (mg/dL) 0.9 eGFR (mL/min/1.73m 2 ) White % 61 DM Duration (yrs) * 10 Black % 24 A1C (%) 8.3 Hispanic % 7 BMI (kg/m 2 ) 32 The ACCORD Study Group. New Engl J Med. 2010;362:1575-85, 92 * Median value ACCORD: Achieved Systolic BP SBP (mm Hg) 140 130 120 110 0 0 1 2 Standard Average : 133.5 Standard vs. 119.3 Intensive, Delta = 14.2 at year 1 3 4 5 6 Years since randomization Intensive Mean no. of medications prescribed: Intensive 3.2 3.4 3.4 3.5 3.5 3.5 3.4 3.4 Standard 1.9 2.1 2.1 2.2 2.2 2.3 2.3 2.3 No. of patients: Intensive 2174 2071 1973 1792 1150 445 156 156 Standard 2208 2136 2077 1860 1241 504 203 201 The ACCORD Study Group. New Engl J Med. 2010;362:1575-85, 7 8 Patients with Events (%) 20 15 10 5 0 ACCORD Blood-Pressure Trial: Primary Outcome and Total Stroke Primary Outcome Nonfatal MI, Nonfatal Stroke or CVD Death HR = 0.88 95% CI (0.73–1.06) P= 0.20 0 1 2 3 4 5 6 7 8 Years Post-Randomization Intensive The ACCORD Study Group. New Engl J Med. 2010;362:1575-85, Patients with Events (%) 20 15 10 5 0 Total Stroke HR = 0.59 95% CI (0.39–0.89) P = 0.01 0 1 2 3 4 5 6 7 8 Standard Years Post-Randomization Primary & Secondary Outcomes Intensive Standard Events (%/yr) Events (%/yr) HR (95% CI) P Primary 208 (1.87) 237 (2.09) 0.88 (0.73-1.06) 0.20 Total Mortality 150 (1.28) 144 (1.19) 1.07 (0.85-1.35) 0.55 Cardiovascular Deaths 60 (0.52) 58 (0.49) 1.06 (0.74-1.52) 0.74 Nonfatal MI 126 (1.13) 146 (1.28) 0.87 (0.68-1.10) 0.25 Nonfatal Stroke 34 (0.30) 55 (0.47) 0.63 (0.41-0.96) 0.03 Total Stroke 36 (0.32) 62 (0.53) 0.59 (0.39-0.89) 0.01 Also examined Fatal/Nonfatal HF (HR=0.94, p=0.67), a composite of fatal coronary events, nonfatal MI and unstable angina (HR=0.94, p=0.50) and a composite of the primary outcome, revascularization and unstable angina (HR=0.95, p=0.40) The ACCORD Study Group. New Engl J Med. 2010;362:1575-85,

ACCORD: Adverse Events Intensive Standard N (%) N (%) P Serious Adverse Events 77 (3.3) 30 (1.3)

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