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Collaborative Atorvastatin Diabetes Study (CARDS or CARD study)

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

The Collaborative Atorvastatin Diabetes Study (CARDS) randomised patients to either atorvastatin 10mg per day or to placebo.

  • patients were between 40 and 75 years of age and had type 2 diabetes but no history of vascular disease
    • in order to be included in the trial they needed one other risk factor for CVD which could include:
      • hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure > 90 mmHg)
      • retinopathy
      • micro or macroalbuminuria, or,
      • being a current smoker
    • it was also required that patients had an LDL cholesterol below 4.4. mmol/l and a triglyceride level below 6.78 mmol/l to be included in the study. There were 2,838 patients in the study - about half the patients were over 60 years of age, one-third were women and about one-fifth were smokers
  • median LDL cholesterol at entry was 3.1 mmol/l; median HDL-cholesterol at entry was 1.4mmol/l and median triglycerides was 1.7 mmol/l
  • during the course of the four-year study:
    • there was an absolute LDL reduction of 1.2 mmol/l (p=0.0001) in the atorvastatin arm. HDL levels were unchanged. Triglycerides were 21% (0.4 mmol/l) lower in the atorvastatin arm
    • 127 events occurred in the placebo arm and 83 in the atorvastatin 10mg arm
      • patients receiving atorvastatin had 36% fewer acute coronary events, 31% fewer revascularisation procedures and 48% fewer strokes
      • all-cause mortality was reduced by 27% in the atorvastatin group
      • the number needed to treat over four years to avoid one event is 27
    • no significant differences between treatments in safety, tolerability and non-CVD related deaths

Note that during the study about 9% of placebo patients started statin treatment in line with the trial protocol. Also, about 15% of patients in the atorvastatin arm stopped atorvastatin treatment. This may have led to an underestimation of benefit of atorvastatin treatment of about 25% (1).


  1. Br J Cardiol 2004;11(4):75.

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