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Steno-2: study design. Patents with type 2 diabetes and microalbuminuria (n = 160). Stratification by urinary albumin excretion. Randomisation. Intensive therapy (n = 80). Conventional therapy (n = 80). Stepwise behaviour modification
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Steno-2: study design Patents with type 2 diabetes and microalbuminuria (n = 160) Stratification by urinary albumin excretion Randomisation Intensive therapy (n = 80) Conventional therapy (n = 80) Stepwise behaviour modification and pharmacotherapy according to strict treatment goals Treatment according to standard guidelines Steno-2: Lancet 1999;353:617–22
Intensive group Aim: to modify CV risk factors to strict targets: Systolic BP < 140 Diastolic BP < 85 HbA1c < 6.5 Fasting serum total cholesterol 190 mg/dl Fasting serum triglycerides 150 mg/dl Aspirin for those with known ischaemia or peripheral vascular disease Automatic treatment with ACE inhibitor Conventional group Aim: to modify CV risk factors to conventional targets: Systolic BP < 160 Diastolic BP < 95 HbA1c < 7.5 Fasting serum total cholesterol: 250 mg/dl Fasting serum triglycerides: 195 mg/dl Aspirin for those with known ischaemia Steno-2: treatment conditions Steno-2: N Engl J Med 2003;348:383–93 Steno-2: Lancet 1999;353:617–22
Steno-2: participant characteristics Steno-2: Lancet 1999;353:617–22
Intensive 11 Conventional 350 10 300 9 250 8 200 Triglycerides (mg/dl) 7 150 6 100 5 50 0 0 0 2 4 6 8 0 2 4 6 8 Steno-2: intensive treatment had a greater impact on HbA1c and triglycerides HbA1c (%) Years of follow-up Adapted from: N Engl J Med 2003;348:383–93
160 Systolic 150 Intensive Conventional 140 130 120 110 100 Diastolic 90 80 70 0 2 4 6 8 0 Years of follow-up Steno-2: intensive treatment had a greater effect on blood pressure Blood pressure (mm Hg) Adapted from: N Engl J Med 2003;348:383–93
LDL Total Intensive Conventional 350 175 300 150 250 125 200 100 150 75 100 50 50 0 0 2 4 6 8 0 2 4 6 8 0 Steno-2: intensive treatment reduced total and LDL-cholesterol Total cholesterol (mg/dl) LDL cholesterol (mg/dl) Years of follow-up Adapted from: N Engl J Med 2003;348:383–93
Steno-2: relative risk reduction with intensive treatment Autonomic neuropathy Nephropathy Retinopathy CVD Relative risk reduction for intensive vs conventional treatment (%) * p < 0.05 ** p < 0.01 * * ** ** Adapted from: N Engl J Med 2003;348:383–93