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Review
. 2009 Nov 6:339:b4531.
doi: 10.1136/bmj.b4531.

Aspirin for primary prevention of cardiovascular events in people with diabetes: meta-analysis of randomised controlled trials

Giorgia De Berardis  1 , Michele Sacco, Giovanni F M Strippoli, Fabio Pellegrini, Giusi Graziano, Gianni Tognoni, Antonio Nicolucci
Affiliations
Review

Aspirin for primary prevention of cardiovascular events in people with diabetes: meta-analysis of randomised controlled trials

Giorgia De Berardis et al. BMJ. .

Erratum in

  • BMJ. 2010;340:c374

Abstract

Objective: To evaluate the benefits and harms of low dose aspirin in people with diabetes and no cardiovascular disease.

Design: Meta-analysis of randomised controlled trials.

Data sources: Medline (1966-November 2008), the Cochrane central register of controlled trials (Cochrane Library 2008;issue 4), and reference lists of retrieved articles. Review methods Randomised trials of aspirin compared with placebo or no aspirin in people with diabetes and no pre-existing cardiovascular disease were eligible for inclusion. Data on major cardiovascular events (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, and all cause mortality) were extracted and pooled with a random effect model. Results are reported as relative risks with 95% confidence intervals.

Results: Of 157 studies in the literature searches, six were eligible (10 117 participants). When aspirin was compared with placebo there was no statistically significant reduction in the risk of major cardiovascular events (five studies, 9584 participants; relative risk 0.90, 95% confidence interval 0.81 to 1.00), cardiovascular mortality (four studies, n=8557, 0.94; 0.72 to 1.23), or all cause mortality (four studies, n=8557; 0.93, 0.82 to 1.05). Significant heterogeneity was found in the analysis for myocardial infarction (I(2)=62.2%; P=0.02) and stroke (I(2)=52.5%; P=0.08). Aspirin significantly reduced the risk of myocardial infarction in men (0.57, 0.34 to 0.94) but not in women (1.08, 0.71 to 1.65; P for interaction=0.056). Evidence relating to harms was inconsistent.

Conclusions: A clear benefit of aspirin in the primary prevention of major cardiovascular events in people with diabetes remains unproved. Sex may be an important effect modifier. Toxicity is to be explored further.

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Conflict of interest statement

Competing interests: None declared.

Figures

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Fig 1 Flow of trial selection process
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Fig 2 Effect of aspirin therapy on primary prevention of major cardiovascular events, myocardial infarction, stroke, death from cardiovascular causes, and all cause mortality in participants with diabetes. JPAD=Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes; POPADAD=Prevention Of Progression of Arterial Disease And Diabetes; WHS=Women’s Health Study; PPP=Primary Prevention Project; ETDRS=Early Treatment Diabetic Retinopathy Study. Number in group have been reported as provided by trialists or estimated from any available data in the publications
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Fig 3 Effect of aspirin therapy on primary prevention of myocardial infarction and stroke among men and women with diabetes. PPP=Primary Prevention Project; ETDRS=Early Treatment Diabetic Retinopathy Study; PHS=Physicians’ Health Study; WHS=Women’s Health Study. Number in group have been reported as provided by trialists or estimated from any available data in the publications
See this image and copyright information in PMC

Comment in

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