Cardiovascular outcome trial · N Engl J Med 1995
WOSCOPS trial
Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group.
The bottom line
In middle-aged men with moderate hypercholesterolemia and no prior MI, pravastatin significantly reduced coronary events and cardiovascular death without increasing noncardiovascular deaths.
BenefitUS status: US-approved
At a glance
- Medicine
- Pravastatin 40 mg each evening
- Compared with
- Placebo
- People
- 6,595
- Who took part
- Men, 45 to 64 years of age, with hypercholesterolemia (mean plasma cholesterol 272 +/- 23 mg/dl) and no history of myocardial infarction
- Design
- double-blind, randomized, placebo-controlled (primary prevention)
- Follow-up
- 4.9 years (average)
- Main question
- Combined incidence of nonfatal myocardial infarction and death from coronary heart disease (definite coronary events)
Main result
There were 248 definite coronary events in the placebo group, and 174 in the pravastatin group (relative reduction in risk with pravastatin, 31 percent; 95 percent confidence interval, 17 to 43 percent; P < 0.001).
Effect on LDL cholesterol
Pravastatin lowered plasma cholesterol levels by 20 percent and low-density-lipoprotein cholesterol levels by 26 percent, whereas there was no change with placebo.
Other results
22 percent reduction in the risk of death from any cause in the pravastatin group (95 percent confidence interval, 0 to 40 percent; P = 0.051); 32 percent reduction in death from all cardiovascular causes (P = 0.033)
Safety
There was no excess of deaths from noncardiovascular causes in the pravastatin group.
In the trial's own words
“There were 248 definite coronary events (specified as nonfatal myocardial infarction or death from coronary heart disease) in the placebo group, and 174 in the pravastatin group (relative reduction in risk with pravastatin, 31 percent; 95 percent confidence interval, 17 to 43 percent; P < 0.001).”
Quoted from the abstract of N Engl J Med 1995, checked word for word against PubMed. PubMed 7566020 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the WOSCOPS trial find?
In middle-aged men with moderate hypercholesterolemia and no prior MI, pravastatin significantly reduced coronary events and cardiovascular death without increasing noncardiovascular deaths.
Who was in WOSCOPS?
6,595 people. Men, 45 to 64 years of age, with hypercholesterolemia (mean plasma cholesterol 272 +/- 23 mg/dl) and no history of myocardial infarction.
What was WOSCOPS's main result?
There were 248 definite coronary events in the placebo group, and 174 in the pravastatin group (relative reduction in risk with pravastatin, 31 percent; 95 percent confidence interval, 17 to 43 percent; P < 0.001).
How much did LDL cholesterol change in WOSCOPS?
Pravastatin lowered plasma cholesterol levels by 20 percent and low-density-lipoprotein cholesterol levels by 26 percent, whereas there was no change with placebo.
Related trials
- 4S (1994)In patients with coronary heart disease and elevated cholesterol, simvastatin reduced the risk of death and major coronary events compared with placebo over about 5.4 years.
- CARE (1996)In patients with average cholesterol levels after myocardial infarction, pravastatin significantly reduced the risk of fatal coronary events and nonfatal MI, as well as the need for revascularization and stroke, without a significant effect on overall mortality.
- AFCAPS/TexCAPS (1998)In men and women with average cholesterol but low HDL-C and no known heart disease, lovastatin substantially lowered the risk of a first major coronary event.
- LIPID (1998)In patients with coronary heart disease and a broad range of cholesterol levels, pravastatin reduced death from coronary heart disease, overall mortality, and other cardiovascular events compared with placebo.
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