Steno-2: study design

1
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 199935361722
2
Steno-2 treatment conditions

• Intensive group
• Aim to modify CV risk factors to strict targets
• Systolic BP lt 140
• Diastolic BP lt 85
• HbA1c lt 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 lt 160
• Diastolic BP lt 95
• HbA1c lt 7.5
• Fasting serum total cholesterol 250 mg/dl
• Fasting serum triglycerides 195 mg/dl
• Aspirin for those with known ischaemia

Steno-2 N Engl J Med 200334838393
Steno-2 Lancet 199935361722
3
Steno-2 participant characteristics
Conventional Intensive
Age (years) 55.2 54.9
BMI (kg/m2) 29.88 29.68
HbA1c 8.8 8.4
Systolic BP (mm Hg) 149 146
Diastolic BP (mm Hg) 86 85
Total cholesterol (mmol/l) 5.8 5.4
Triglycerides 3.0 2.2
Current Smokers () 33.75 40
Steno-2 Lancet 199935361722
4
Steno-2 intensive treatment had a greater impact
on HbA1c and triglycerides
HbA1c ()
Years of follow-up
Adapted from N Engl J Med 200334838393
5
Steno-2 intensive treatment had a greater effect
on blood pressure
Blood pressure (mm Hg)
Adapted from N Engl J Med 200334838393
6
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 200334838393
7
Steno-2 relative risk reduction with intensive
treatment
Autonomic neuropathy
Nephropathy
Retinopathy
CVD
Relative risk reduction for intensive vs
conventional treatment ()
p lt 0.05 p lt 0.01




Adapted from N Engl J Med 200334838393