Cardiovascular outcome trial · Lancet 2002
PROSPER trial
Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial.
The bottom line
In elderly people at risk of vascular disease, pravastatin reduced coronary heart disease events and coronary death but did not reduce stroke risk.
BenefitUS status: US-approved
At a glance
- Medicine
- Pravastatin 40 mg per day (n=2891)
- Compared with
- Placebo (n=2913)
- People
- 5,804
- Who took part
- Men (n=2804) and women (n=3000) aged 70-82 years with a history of, or risk factors for, vascular disease; baseline cholesterol 4.0-9.0 mmol/L
- Design
- randomised controlled trial
- Follow-up
- 3.2 years on average
- Main question
- Composite of coronary death, non-fatal myocardial infarction, and fatal or non-fatal stroke
Main result
Reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo (hazard ratio 0.85, 95% CI 0.74-0.97, p=0.014)
Effect on LDL cholesterol
Pravastatin lowered LDL cholesterol concentrations by 34%
Other results
Coronary heart disease death and non-fatal myocardial infarction risk was also reduced (0.81, 0.69-0.94, p=0.006); Stroke risk was unaffected (1.03, 0.81-1.31, p=0.8); hazard ratio for transient ischaemic attack was 0.75 (0.55-1.00, p=0.051); Mortality from coronary disease fell by 24% (p=0.043) in the pravastatin group
Safety
New cancer diagnoses were more frequent on pravastatin than on placebo (1.25, 1.04-1.51, p=0.020); however, incorporation of this finding in a meta-analysis of all pravastatin and all statin trials showed no overall increase in risk; Pravastatin had no significant effect on cognitive function or disability
In the trial's own words
“Pravastatin lowered LDL cholesterol concentrations by 34% and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo (hazard ratio 0.85, 95% CI 0.74-0.97, p=0.014).”
Quoted from the abstract of Lancet 2002, checked word for word against PubMed. PubMed 12457784 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the PROSPER trial find?
In elderly people at risk of vascular disease, pravastatin reduced coronary heart disease events and coronary death but did not reduce stroke risk.
Who was in PROSPER?
5,804 people. Men (n=2804) and women (n=3000) aged 70-82 years with a history of, or risk factors for, vascular disease; baseline cholesterol 4.0-9.0 mmol/L.
What was PROSPER's main result?
Reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo (hazard ratio 0.85, 95% CI 0.74-0.97, p=0.014)
How much did LDL cholesterol change in PROSPER?
Pravastatin lowered LDL cholesterol concentrations by 34%
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.
- 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.
- 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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