Low-Dose Aspirin and Vitamin E in People at Cardiovascular Risk: A Randomised Trial in General Practice - Low-Dose Aspirin and Vitamin E in People at Cardiovascular Risk: A Randomised Trial

Description:

Low-Dose Aspirin and Vitamin E in People at Cardiovascular Risk: A Randomised Trial in General Practice.

Hypothesis:

To determine the benefit of ASA and vitamin E for primary prevention of cardiovascular events (CVD) in a clinical practice setting.

Study Design

Study Design:

Patients Enrolled: 4495

Patient Populations:

Eligible patients had one or more cardiac risk factors (CRF) including: hypertension, hypercholesterolemia, diabetes, obesity, family history of premature myocardial infarction or advanced age defined as < 65 years.

Exclusions:

Patients with a history of CVE or CV diseases and the need for aspirin or NSAIDs.

Drug/Procedures Used:

A randomized open labeled 2 x 2 factorial trial of low dose ASA (100 mg/d) and vitamin E (300 mg/d), either or neither agent in 4495 men and women at least 50 years of age visiting a primary care physician.

Principal Findings:

57% were women, mean age was 64.4 years, 15% were smokers, mean blood pressure was 145/85 mm Hg, BMI 27.5 k/m2. About 70% had two or more CRFs. The study was terminated prematurely at a mean follow-up of 3.6 years because the benefit of ASA was demonstrated in similar trials. ASA lowered the frequency of all CVE end points including CV death from 1.4 to 0.8% (relative risk [RR] 0.56), and total CVE from 8.2 to 6.3% (RR 0.77). Bleeding was considerably more frequent in the ASA group, 1.1% vs. 0.3%. Vitamin E showed no effect on any end points.

In women and men over 50 years at risk for CVEs with at least one risk factor including age 65 years and obesity, low-dose aspirin (100 mg) given in addition to standard treatment of risk factors contributes additional benefit with an acceptable safety profile. The negative results with vitamin E are not conclusive but are consistent with the results of other large secondary prevention trials.

Interpretation:

The evidence in support of ASA for primary prevention of cardiovascular events has mounted and appears to be independent of dose (100-325 mg), age, gender and CV risk status. While this study lends support in a practice setting of patients at high risk and includes a reduction in CV mortality, it should be noted the Physicians Health Study benefits of ASA were demonstrated in low-risk men over 50 years. The lack of support for vitamin E continues to wane.

References:

1. Collaborative Group of the Primary Prevention Project. Lancet 2001;357:89-95.

Clinical Topics: Dyslipidemia, Prevention, Homozygous Familial Hypercholesterolemia, Hypertension

Keywords: Myocardial Infarction, Vitamin E, Follow-Up Studies, Platelet Aggregation Inhibitors, Physicians, Primary Care, Risk Factors, Hypercholesterolemia, Primary Prevention, Body Mass Index, General Practice, Secondary Prevention, alpha-Tocopherol, Obesity, Hypertension, Diabetes Mellitus


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