Collaborative Atorvastatin Diabetes Study (CARDS or CARD study)

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).

Reference:

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