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Applicability of Cholesterol-Lowering Primary Prevention Trials to a General Population
The Framingham Heart Study
Donald M. Lloyd-Jones, MD;
Christopher J. O'Donnell, MD, MPH;
Ralph B. D'Agostino, PhD;
Joseph Massaro, PhD;
Halit Silbershatz, PhD;
Peter W. F. Wilson, MD
Arch Intern Med. 2001;161:949-954.
Background Four large trials have shown cholesterol-reduction therapy to be effective
for primary prevention of coronary heart disease (CHD).
Methods To determine the generalizability of these trials to a community-based
sample, we compared the total cholesterol and high-density lipoprotein cholesterol
(HDL-C) distributions of patients in the 4 trials with those of Framingham
Heart Study subjects. Lipid profiles that have not been studied were identified.
Twelve-year rates of incident CHD were compared between subjects who met eligibility
criteria and those who did not.
Results The Framingham sample included 2498 men and 2870 women aged 30 to 74
years. Among Framingham men, 23.4% to 42.0% met eligibility criteria for each
of the 4 trials based on their lipid levels; 60.2% met eligibility criteria
for at least 1 trial. For the 1 trial that included women, 20.2% of Framingham
women met eligibility criteria. In general, subjects with desirable total
cholesterol levels and lower HDL-C levels and subjects with average total
cholesterol levels and average to higher HDL-C levels have not been included
in these trials. Among subjects who developed incident CHD during follow-up,
25.1% of men and 66.2% of women would not have been eligible for any trial.
Most ineligible subjects who developed CHD had isolated hypertriglyceridemia
(>2.25 mmol/L [>200 mg/dL]).
Conclusions In our sample, 40% of men and 80% of women had lipid profiles that have
not been studied in large trials to date. We observed a large number of CHD
events in "ineligible" subjects in whom hypertriglyceridemia was common. Further
studies are needed to define the role of lipid-lowering therapy vs other strategies
for primary prevention in the general population.
From the Framingham Heart Study, National Heart, Lung and Blood Institute,
the National Institutes of Health, Bethesda, Md (Drs Lloyd-Jones, O'Donnell,
and Wilson); the Cardiology Division, Department of Medicine, Massachusetts
General Hospital and Harvard Medical School (Drs Lloyd-Jones and O'Donnell),
the Departments of Mathematics and Statistics, Boston University (Drs D'Agostino
and Silbershatz), and Epidemiology and Biostatistics, Boston University School
of Public Health (Dr Massaro), Boston, Mass.
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