Aspirin effect on the incidence of major adverse cardiovascular events in patients with diabetes mellitus: a systematic review and meta-analysisReport as inadecuate

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Cardiovascular Diabetology

, 10:25

First Online: 01 April 2011Received: 08 March 2011Accepted: 01 April 2011


BackgroundAspirin has been recommended for the prevention of major adverse cardiovascular events MACE, composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death in diabetic patients without previous cardiovascular disease. However, recent meta-analyses have prompted re-evaluation of this practice. The study objective was to evaluate the relative and absolute benefits and harms of aspirin for the prevention of incident MACE in patients with diabetes.

MethodsWe performed a systematic review and meta-analysis on seven studies N = 11,618 reporting on the use of aspirin for the primary prevention of MACE in patients with diabetes. Two reviewers conducted a systematic search of electronic databases MEDLINE, EMBASE, the Cochrane Library, and BIOSIS and hand searched bibliographies and clinical trial registries. Reviewers extracted data in duplicate, evaluated the quality of the trials, and calculated pooled estimates.

ResultsA total of 11,618 participants were included in the analysis. The overall risk ratio RR for MACE was 0.91 95% confidence intervals, CI, 0.82-1.00 with little heterogeneity among trials I 0.0%. Secondary outcomes of interest included myocardial infarction RR, 0.85; 95% CI, 0.66-1.10, stroke RR, 0.84; 95% CI, 0.64-1.11, cardiovascular death RR, 0.95; 95% CI, 0.71-1.27, and all-cause mortality RR, 0.95; 95% CI, 0.85-1.06. There were higher rates of hemorrhagic and gastrointestinal events. In absolute terms, these relative risks indicate that for every 10,000 diabetic patients treated with aspirin, 109 MACE may be prevented at the expense of 19 major bleeding events with the caveat that the relative risk for the latter is not statistically significant.

ConclusionsThe studies reviewed suggest that aspirin reduces the risk of MACE in patients with diabetes without cardiovascular disease, while also causing a trend toward higher rates of bleeding and gastrointestinal complications. These findings and our absolute benefit and risk calculations suggest that those with diabetes but without cardiovascular disease lie somewhere between primary and secondary prevention patients on the spectrum of benefit and risk. This underscores the importance of considering individual risk in clinical decision making regarding aspirin in those with diabetes.

Electronic supplementary materialThe online version of this article doi:10.1186-1475-2840-10-25 contains supplementary material, which is available to authorized users.

Sonia Butalia, Alexander A Leung contributed equally to this work.

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Author: Sonia Butalia - Alexander A Leung - William A Ghali - Doreen M Rabi


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