Clinical Investigation
Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Diabetes: A Meta-Analysis

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Abstract

Introduction

The use of low-dose aspirin for primary prevention of cardiovascular events in patients with diabetes is recommended by existing guidelines, but definitive evidence supporting its efficacy is lacking. The authors undertook a meta-analysis of published trials to determine the effect of low-dose aspirin for primary prevention of cardiovascular events in patients with diabetes.

Methods

Randomized controlled trials comparing low-dose aspirin versus placebo or no treatment in patients with diabetes (either exclusively or as a subgroup) with no previous history of cardiovascular disease were identified through MEDLINE and EMBASE databases.

Results

Seven randomized controlled trials met the inclusion criteria. Two studies included exclusively patients with diabetes, whereas the remaining 5 studies included patients with diabetes as a subgroup. Two studies were excluded because they did not provide diabetes-specific data. Overall, aspirin was associated with a nonsignificant reduction in the hazard rate of the composite endpoint of major cardiovascular events compared with control (hazard ratio = 0.89, 95% confidence interval: 0.70–1.13, P = 0.33). Similarly, there was a nonsignificant reduction in the hazard rate of the individual endpoints of myocardial infarction, stroke, cardiovascular and all-cause mortality. The risk of major bleeding increased nonsignificantly with aspirin compared with control (relative risk = 3.02, 95% confidence interval: 0.48–18.86, P = 0.24).

Discussion

The role of low-dose aspirin for primary prevention of cardiovascular events in patients with diabetes remains unproven, and its routine use cannot be justified at present. More trials are needed to definitively address this issue.

Section snippets

Data Sources and Searches

We searched MEDLINE and EMBASE databases for studies evaluating the effect of aspirin in the primary prevention of cardiovascular events in patients with DM through November 2009. Our MEDLINE search included both medical subject headings (MeSH) and keywords including: (1) aspirin OR acetylsalicylic acid AND (2) myocardial infarction OR stroke OR cerebrovascular accident OR cardiovascular diseases OR myocardial ischemia AND (3) primary prevention AND (4) random allocation OR randomized

RESULTS

The results of our search strategy are shown in Figure 1. Seven randomized controlled trials met the inclusion criteria.14., 15., 21., 22., 23., 24., 25. We also extracted data from a published subgroup analysis of the Primary Prevention Project (PPP) trial26 and from a book chapter summarizing subgroup analysis results from the Hypertension Optimal Treatment (HOT) trial.27 We excluded 2 large trials that examined the effect of aspirin in patients with stable angina because > 10% of the

DISCUSSION

Our analysis reveals that, in patients with a history of DM but without apparent cardiovascular disease, the use of low-dose aspirin did not confer protection against the composite endpoint of major cardiovascular events, including cardiovascular death, nonfatal MI and nonfatal stroke. There was also no significant reduction in the individual endpoints of MI, cardiovascular mortality, stroke and all-cause mortality with the use of aspirin. However, we cannot exclude a small beneficial effect of

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