Cardiovascular outcome trial · JAMA 1998
AFCAPS/TexCAPS trial
Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study.
The bottom line
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.
BenefitUS status: US-approved
At a glance
- Medicine
- Lovastatin (20-40 mg daily)
- Compared with
- Placebo
- People
- 6,605
- Who took part
- Men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C and below-average HDL-C levels
- Design
- A randomized, double-blind, placebo-controlled trial
- Follow-up
- average follow-up of 5.2 years
- Main question
- First acute major coronary event defined as fatal or nonfatal myocardial infarction, unstable angina, or sudden cardiac death
Main result
183 vs 116 first events; relative risk [RR], 0.63; 95% confidence interval [CI], 0.50-0.79; P<.001
Effect on LDL cholesterol
Lovastatin (20-40 mg daily) reduced LDL-C by 25% to 2.96 mmol/L (115 mg/dL) and increased HDL-C by 6% to 1.02 mmol/L (39 mg/dL).
Other results
Myocardial infarction (95 vs 57 myocardial infarctions; RR, 0.60; 95% CI, 0.43-0.83; P=.002), unstable angina (87 vs 60 first unstable angina events; RR, 0.68; 95% CI, 0.49-0.95; P=.02), coronary revascularization procedures (157 vs 106 procedures; RR, 0.67; 95% CI, 0.52-0.85; P=.001), coronary events (215 vs 163 coronary events; RR, 0.75; 95% CI, 0.61-0.92; P=.006), and cardiovascular events (255 vs 194 cardiovascular events; RR, 0.75; 95% CI, 0.62-0.91; P=.003)
Safety
There were no clinically relevant differences in safety parameters between treatment groups.
In the trial's own words
“After an average follow-up of 5.2 years, lovastatin reduced the incidence of first acute major coronary events (1 83 vs 116 first events; relative risk [RR], 0.63; 95% confidence interval [CI], 0.50-0.79; P<.001)”
Quoted from the abstract of JAMA 1998, checked word for word against PubMed. PubMed 9613910 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the AFCAPS/TexCAPS trial find?
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.
Who was in AFCAPS/TexCAPS?
6,605 people. Men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C and below-average HDL-C levels.
What was AFCAPS/TexCAPS's main result?
183 vs 116 first events; relative risk [RR], 0.63; 95% confidence interval [CI], 0.50-0.79; P<.001
How much did LDL cholesterol change in AFCAPS/TexCAPS?
Lovastatin (20-40 mg daily) reduced LDL-C by 25% to 2.96 mmol/L (115 mg/dL) and increased HDL-C by 6% to 1.02 mmol/L (39 mg/dL).
Related trials
- 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.
- 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.
- WOSCOPS (1995)In middle-aged men with moderate hypercholesterolemia and no prior MI, pravastatin significantly reduced coronary events and cardiovascular death without increasing noncardiovascular deaths.
- 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.
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