Cardiovascular outcome trial · Lancet 2004
CARDS trial
Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial.
The bottom line
In people with type 2 diabetes but no prior cardiovascular disease and no high LDL-cholesterol, taking atorvastatin 10 mg daily substantially lowered the risk of heart attacks, revascularization, and stroke, with no increase in adverse events.
BenefitUS status: US-approved
At a glance
- Medicine
- Atorvastatin 10 mg daily
- Compared with
- Placebo
- People
- 2,838
- Who took part
- 2838 patients aged 40-75 years with type 2 diabetes, no documented previous history of cardiovascular disease, LDL-cholesterol concentration of 4.14 mmol/L or lower, fasting triglyceride amount of 6.78 mmol/L or less, and at least one of: retinopathy, albuminuria, current smoking, or hypertension
- Design
- Multicentre randomised placebo-controlled trial
- Follow-up
- Median duration of follow-up was 3.9 years (IQR 3.0-4.7)
- Main question
- Time to first occurrence of acute coronary heart disease events, coronary revascularisation, or stroke
Main result
127 patients allocated placebo (2.46 per 100 person-years at risk) and 83 allocated atorvastatin (1.54 per 100 person-years at risk) had at least one major cardiovascular event (rate reduction 37% [95% CI -52 to -17], p=0.001).
Effect on LDL cholesterol
''
Other results
Atorvastatin reduced the death rate by 27% (-48 to 1, p=0.059).
Safety
No excess of adverse events was noted in the atorvastatin group.
In the trial's own words
“127 patients allocated placebo (2.46 per 100 person-years at risk) and 83 allocated atorvastatin (1.54 per 100 person-years at risk) had at least one major cardiovascular event (rate reduction 37% [95% CI -52 to -17], p=0.001).”
Quoted from the abstract of Lancet 2004, checked word for word against PubMed. PubMed 15325833 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the CARDS trial find?
In people with type 2 diabetes but no prior cardiovascular disease and no high LDL-cholesterol, taking atorvastatin 10 mg daily substantially lowered the risk of heart attacks, revascularization, and stroke, with no increase in adverse events.
Who was in CARDS?
2,838 people. 2838 patients aged 40-75 years with type 2 diabetes, no documented previous history of cardiovascular disease, LDL-cholesterol concentration of 4.14 mmol/L or lower, fasting triglyceride amount of 6.78 mmol/L or less, and at least one of: retinopathy, albuminuria, current smoking, or hypertension.
What was CARDS's main result?
127 patients allocated placebo (2.46 per 100 person-years at risk) and 83 allocated atorvastatin (1.54 per 100 person-years at risk) had at least one major cardiovascular event (rate reduction 37% [95% CI -52 to -17], p=0.001).
How much did LDL cholesterol change in CARDS?
''
Related trials
- PROVE IT-TIMI 22 (2004)In patients recently hospitalized for acute coronary syndrome, intensive lipid lowering with high-dose atorvastatin (80 mg) reduced death and major cardiovascular events more than standard-dose pravastatin (40 mg).
- ASCOT-LLA (2003)In hypertensive patients with average or below-average cholesterol, adding atorvastatin 10 mg to antihypertensive therapy substantially reduced coronary events, stroke, and total cardiovascular events, though it did not significantly reduce all-cause mortality.
- IDEAL (2005)High-dose atorvastatin lowered LDL-C more than usual-dose simvastatin and reduced some secondary cardiovascular endpoints and nonfatal MI, but did not significantly reduce the primary composite of major coronary events or all-cause mortality after prior MI.
- TNT (2005)In patients with stable coronary disease, treating to a much lower LDL target with high-dose atorvastatin (80 mg) further reduced major cardiovascular events compared with the standard 10 mg dose, though with more liver enzyme elevations and no difference in overall mortality.
Get your LDL treated to a goal
Preval Health's protocols follow trials like this one. Licensed clinicians set your goal, prescribe and recheck until you reach it.
Get startedEducation only, not medical advice. Results describe the people in this trial and can differ for you. Talk with your clinician before starting or stopping any medicine. Back to all 106 trials.