Cardiovascular outcome trial · Lancet 2002
HPS trial
MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial.
The bottom line
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.
BenefitUS status: US-approved
At a glance
- Medicine
- 40 mg simvastatin daily (average compliance: 85%)
- Compared with
- matching placebo (average non-study statin use: 17%)
- People
- 20,536
- Who took part
- 20,536 UK adults (aged 40-80 years) with coronary disease, other occlusive arterial disease, or diabetes
- Design
- randomized, placebo-controlled
- Follow-up
- scheduled 5-year treatment period
- Main question
- Mortality (for overall analyses) and fatal or non-fatal vascular events (for subcategory analyses)
Main result
All-cause mortality was significantly reduced (1328 [12.9%] deaths among 10,269 allocated simvastatin versus 1507 [14.7%] among 10,267 allocated placebo; p=0.0003)
Effect on LDL cholesterol
average difference in LDL cholesterol of 1.0 mmol/L
Other results
Highly significant 18% (SE 5) proportional reduction in the coronary death rate (587 [5.7%] vs 707 [6.9%]; p=0.0005); for the first occurrence of any major vascular event, a definite 24% (SE 3; 95% CI 19-28) reduction in the event rate (2033 [19.8%] vs 2585 [25.2%] affected individuals; p<0.0001)
Safety
The annual excess risk of myopathy with this regimen was about 0.01%. There were no significant adverse effects on cancer incidence or on hospitalisation for any other non-vascular cause.
In the trial's own words
“All-cause mortality was significantly reduced (1328 [12.9%] deaths among 10,269 allocated simvastatin versus 1507 [14.7%] among 10,267 allocated placebo; p=0.0003), due to a highly significant 18% (SE 5) proportional reduction in the coronary death rate (587 [5.7%] vs 707 [6.9%]; p=0.0005)”
Quoted from the abstract of Lancet 2002, checked word for word against PubMed. PubMed 12114036 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the HPS trial find?
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.
Who was in HPS?
20,536 people. 20,536 UK adults (aged 40-80 years) with coronary disease, other occlusive arterial disease, or diabetes.
What was HPS's main result?
All-cause mortality was significantly reduced (1328 [12.9%] deaths among 10,269 allocated simvastatin versus 1507 [14.7%] among 10,267 allocated placebo; p=0.0003)
How much did LDL cholesterol change in HPS?
average difference in LDL cholesterol of 1.0 mmol/L
Related trials
- 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.
- 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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