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Design of the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with type 2 diabetes

H M Colhoun1, M J Thomason, M I Mackness

  • 1EURODIAB, Department of Epidemiology and Public Health, Royal Free and University College Medical School, London, UK. h.colhoun@public-health.ucl.ac.uk

Diabetic Medicine : a Journal of the British Diabetic Association
|March 29, 2002
PubMed

Insights

This study investigated atorvastatin for primary prevention of cardiovascular disease in Type 2 diabetes patients. Results will clarify lipid-lowering therapy benefits and risks in this population.

Area of Science:

  • Cardiology
  • Endocrinology
  • Pharmacology

Background:

  • Limited data exists on lipid-lowering therapy for primary prevention of coronary heart disease (CHD) in diabetic patients.
  • This study addresses this gap by designing a collaborative clinical trial.

Purpose of the Study:

  • To investigate the efficacy of atorvastatin in reducing major cardiovascular events in patients with Type 2 diabetes.
  • To evaluate the role of lipid-lowering therapy in the primary prevention of cardiovascular disease in diabetic individuals.

Main Methods:

  • The Collaborative AtoRvastatin Diabetes Study (CARDS) is a multicenter, randomized, placebo-controlled, double-blind trial.
  • Participants (n=2838) with Type 2 diabetes and at least one additional CHD risk factor were included.
  • Patients had baseline low-density lipoprotein (LDL) cholesterol ≤ 4.14 mmol/l and triglycerides ≤ 6.78 mmol/l.

Main Results:

  • The primary objective is to determine if atorvastatin reduces the incidence of major cardiovascular events.
  • Patient follow-up is ongoing until 304 primary endpoints are accrued, with expected completion in early 2005.

Conclusions:

  • The evidence supporting lipid-lowering therapy for primary CHD prevention in diabetes is currently insufficient.
  • The CARDS trial will provide crucial data on the benefits and adverse effects of atorvastatin in diabetic patients without prior CHD.
Abstract

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