Aspirin for primary prevention of cardiovascular events in people with diabetes

Meta-analysis of randomised controlled trials

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

Research output: Contribution to journalArticle

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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 (I2=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.

Original languageEnglish
Pages (from-to)1238
Number of pages1
JournalBritish Medical Journal
Volume339
Issue number7732
DOIs
Publication statusPublished - 2009

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Primary Prevention
Aspirin
Meta-Analysis
Randomized Controlled Trials
Myocardial Infarction
Mortality
Cardiovascular Diseases
Stroke
Placebos
Confidence Intervals
Preexisting Condition Coverage
Information Storage and Retrieval
Risk Reduction Behavior
Libraries
Cause of Death

ASJC Scopus subject areas

  • Medicine(all)

Cite this

De Berardis, G., Sacco, M., Strippoli, G. F. M., Pellegrini, F., Graziano, G., Tognoni, G., & Nicolucci, A. (2009). Aspirin for primary prevention of cardiovascular events in people with diabetes: Meta-analysis of randomised controlled trials. British Medical Journal, 339(7732), 1238. https://doi.org/10.1136/bmj.b4531

Aspirin for primary prevention of cardiovascular events in people with diabetes : Meta-analysis of randomised controlled trials. / De Berardis, Giorgia; Sacco, Michele; Strippoli, Giovanni F M; Pellegrini, Fabio; Graziano, Giusi; Tognoni, Gianni; Nicolucci, Antonio.

In: British Medical Journal, Vol. 339, No. 7732, 2009, p. 1238.

Research output: Contribution to journalArticle

De Berardis, G, Sacco, M, Strippoli, GFM, Pellegrini, F, Graziano, G, Tognoni, G & Nicolucci, A 2009, 'Aspirin for primary prevention of cardiovascular events in people with diabetes: Meta-analysis of randomised controlled trials', British Medical Journal, vol. 339, no. 7732, pp. 1238. https://doi.org/10.1136/bmj.b4531
De Berardis, Giorgia ; Sacco, Michele ; Strippoli, Giovanni F M ; Pellegrini, Fabio ; Graziano, Giusi ; Tognoni, Gianni ; Nicolucci, Antonio. / Aspirin for primary prevention of cardiovascular events in people with diabetes : Meta-analysis of randomised controlled trials. In: British Medical Journal. 2009 ; Vol. 339, No. 7732. pp. 1238.
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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 (I2=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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N2 - 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 (I2=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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