Cardiovascular outcome trial · Lancet 2003
ASCOT-LLA trial
Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial.
The bottom line
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.
BenefitUS status: US-approved
At a glance
- Medicine
- Atorvastatin 10 mg
- Compared with
- Placebo
- People
- 10,305
- Who took part
- Hypertensive patients aged 40-79 years with at least three other cardiovascular risk factors and non-fasting total cholesterol concentrations 6.5 mmol/L or less (lipid-lowering arm of ASCOT)
- Design
- randomised controlled trial
- Follow-up
- median follow-up of 3.3 years (planned average 5 years)
- Main question
- Non-fatal myocardial infarction and fatal CHD
Main result
100 primary events in the atorvastatin group compared with 154 events in the placebo group (hazard ratio 0.64 [95% CI 0.50-0.83], p=0.0005)
Effect on LDL cholesterol
Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months, and by 1.1 mmol/L after 3 years of follow-up.
Other results
There were 185 deaths in the atorvastatin group and 212 in the placebo group (0.87 [0.71-1.06], p=0.16). Fatal and non-fatal stroke (89 atorvastatin vs 121 placebo, 0.73 [0.56-0.96], p=0.024), total cardiovascular events (389 vs 486, 0.79 [0.69-0.90], p=0.0005), and total coronary events (178 vs 247, 0.71 [0.59-0.86], p=0.0005) were also significantly lowered.
In the trial's own words
“By that time, 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group (hazard ratio 0.64 [95% CI 0.50-0.83], p=0.0005).”
Quoted from the abstract of Lancet 2003, checked word for word against PubMed. PubMed 12686036 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the ASCOT-LLA trial find?
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.
Who was in ASCOT-LLA?
10,305 people. Hypertensive patients aged 40-79 years with at least three other cardiovascular risk factors and non-fasting total cholesterol concentrations 6.5 mmol/L or less (lipid-lowering arm of ASCOT).
What was ASCOT-LLA's main result?
100 primary events in the atorvastatin group compared with 154 events in the placebo group (hazard ratio 0.64 [95% CI 0.50-0.83], p=0.0005)
How much did LDL cholesterol change in ASCOT-LLA?
Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months, and by 1.1 mmol/L after 3 years of follow-up.
Related trials
- HPS (2002)Adding simvastatin 40 mg daily to existing treatment in high-risk patients safely reduced all-cause mortality and major vascular events, regardless of baseline cholesterol level.
- PROSPER (2002)In elderly people at risk of vascular disease, pravastatin reduced coronary heart disease events and coronary death but did not reduce stroke risk.
- CARDS (2004)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.
- 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).
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