Primary Prevention Project - PPP
The goal of this study was to assess the safety and efficacy of low-dose aspirin and vitamin E therapy in the primary prevention of cardiovascular events among patients with one or more cardiovascular risk factors.
Chronic vitamin E and low-dose aspirin therapy will be effective in the primary prevention of major fatal and nonfatal cardiovascular events among patients with one or more cardiovascular risk factors.
Patients Enrolled: 4,495
Mean Follow Up: Mean 3.6 ± 1 years
Mean Patient Age: Mean age 64.4 ± 7.6 years
One or more of the following major cardiovascular risk factors: old age (≥65 years), hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg on at least three separate occasions), hypercholesterolemia (total blood cholesterol ≥6.4 mmol/l on at least two separate occasions), diabetes mellitus (fasting venous plasma glucose concentration ≥7.8 mmol/l on at least two separate occasions [chronic drug treatment for any of the three latter conditions was also a criterion for inclusion]), obesity (body mass index ≥30 kg/m2), and family history of MI before 55 years of age in at least one parent or sibling
Treatment with antiplatelet drugs (history of vascular events or diseases), chronic use of anti-inflammatory agents or anticoagulants, contraindications to aspirin, diseases with predictable poor short-term prognosis, and predictable psychological or logistical difficulties affecting compliance with the trial requirements
The cumulative rate of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke
Cardiovascular deaths, total deaths, and total cardiovascular events (cardiovascular death, nonfatal MI, nonfatal stroke, angina pectoris, transient ischemic attacks, peripheral artery disease, and revascularization procedures)
Using a 2x2 factorial design, eligible patients were randomized to receive aspirin (100 mg enteric coated aspirin per day) or no aspirin and vitamin E (300 mg synthetic α-tocopherol per day) or no vitamin E.
Aspirin therapy significantly lowered the incidence of cardiovascular death (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.26–0.88) and total cardiovascular events (OR 0.72, 95% CI 0.57–0.91). Vitamin E had no significant beneficial effect on any of the combined or individual endpoints.
Among patients with major risk factors for cardiovascular disease, low-dose daily aspirin therapy significantly reduced the incidence of cardiovascular death and total cardiovascular events, whereas daily low-dose vitamin E therapy had no significant beneficial effect on any of the combined or individual endpoints. These findings suggest that low-dose aspirin therapy is effective in the primary prevention of major cardiovascular events in at-risk patients.
de Gaetano G, for the Collaborative Group of the Primary Prevention Project. Low-dose aspirin and vitamin E in people at cardiovascular risk: a randomised trial in general practice. Lancet 2001;357:89-95.
Keywords: Odds Ratio, Vitamin E, Platelet Aggregation Inhibitors, Blood Pressure, Risk Factors, Hypercholesterolemia, Primary Prevention, Glucose, Body Mass Index, alpha-Tocopherol, Cardiovascular Diseases, Obesity, Confidence Intervals, Hypertension, Diabetes Mellitus, Fasting
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