Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes

N Engl J Med. 2003 Jan 30;348(5):383-93. doi: 10.1056/NEJMoa021778.

Abstract

Background: Cardiovascular morbidity is a major burden in patients with type 2 diabetes. In the Steno-2 Study, we compared the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment on modifiable risk factors for cardiovascular disease in patients with type 2 diabetes and microalbuminuria.

Methods: The primary end point of this open, parallel trial was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, revascularization, and amputation. Eighty patients were randomly assigned to receive conventional treatment in accordance with national guidelines and 80 to receive intensive treatment, with a stepwise implementation of behavior modification and pharmacologic therapy that targeted hyperglycemia, hypertension, dyslipidemia, and microalbuminuria, along with secondary prevention of cardiovascular disease with aspirin.

Results: The mean age of the patients was 55.1 years, and the mean follow-up was 7.8 years. The decline in glycosylated hemoglobin values, systolic and diastolic blood pressure, serum cholesterol and triglyceride levels measured after an overnight fast, and urinary albumin excretion rate were all significantly greater in the intensive-therapy group than in the conventional-therapy group. Patients receiving intensive therapy also had a significantly lower risk of cardiovascular disease (hazard ratio, 0.47; 95 percent confidence interval, 0.24 to 0.73), nephropathy (hazard ratio, 0.39; 95 percent confidence interval, 0.17 to 0.87), retinopathy (hazard ratio, 0.42; 95 percent confidence interval, 0.21 to 0.86), and autonomic neuropathy (hazard ratio, 0.37; 95 percent confidence interval, 0.18 to 0.79).

Conclusions: A target-driven, long-term, intensified intervention aimed at multiple risk factors in patients with type 2 diabetes and microalbuminuria reduces the risk of cardiovascular and microvascular events by about 50 percent.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amputation
  • Angiotensin II / antagonists & inhibitors
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Antihypertensive Agents / therapeutic use
  • Cardiovascular Diseases / mortality
  • Cardiovascular Diseases / prevention & control*
  • Combined Modality Therapy
  • Diabetes Mellitus / diet therapy
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / therapy*
  • Diet, Fat-Restricted
  • Exercise
  • Female
  • Humans
  • Hyperlipidemias / complications
  • Hyperlipidemias / therapy
  • Hypertension / complications
  • Hypertension / drug therapy
  • Hypoglycemic Agents / therapeutic use
  • Hypolipidemic Agents / therapeutic use
  • Male
  • Middle Aged
  • Myocardial Infarction / prevention & control
  • Obesity
  • Risk Factors
  • Smoking Cessation
  • Stroke / prevention & control
  • Vitamins / therapeutic use

Substances

  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Hypoglycemic Agents
  • Hypolipidemic Agents
  • Vitamins
  • Angiotensin II