Primary Prevention Project - PPP

Mar 01, 2004
Font Size
A
A
A
Date Published:
01/01/2001
Date Updated:
03/01/2004
Original Posted Date:
03/01/2004
References

Description:

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.

Hypothesis:

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.

Study Design

Study Design:

Patients Enrolled: 4,495
Mean Follow Up: Mean 3.6 ± 1 years
Mean Patient Age: Mean age 64.4 ± 7.6 years
Female: 58

Patient Populations:

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

Exclusions:

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

Primary Endpoints:

The cumulative rate of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke

Secondary Endpoints:

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)

Drug/Procedures Used:

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.

Principal Findings:

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.

Interpretation:

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.

References:

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


< Back to Listings