| Summary: | <p><strong>Background:</strong> Sex differences have been described in cardiovascular outcome trials (CVOTs) of diabetes populations.</p>
<p><strong>Purpose:</strong> We systematically reviewed for baseline sex differences in CV risk factors and CV protection therapy in diabetes CVOTs published since 2008.</p>
<p><strong>Data Sources:</strong> Randomized placebo-controlled trials that evaluated the effect of diabetes medications (oral or injectable) on 3 or 4-point MACE in individuals ≥18 years with type 2 diabetes.</p>
<p><strong>Study Selection:</strong> Included trials reported baseline sex-specific characteristics including standard medications for the reduction of CV risk. Our primary interest was to examine for sex differences in CV risk factors and CV protection therapy.</p>
<p><strong>Data Extraction:</strong> Two reviewers independently abstracted study data.</p>
<p><strong>Data Synthesis:</strong> We included 5 CVOTs of 46 606 participants. We summarized sex-specific data using mean differences (MDs) and relative risks (RR), and pooled estimates using random effects meta-analysis. There were fewer women than men (28.5-35.8% women) across trials. Women were older (MD 1.03 years, 95% CI 0.18 to 1.89), and more often had stroke (RR 1.28, 1.09 to 1.50), heart failure (RR 1.30, 1.21 to 1.40), peripheral arterial disease (RR X, X to X) and chronic kidney disease (RR X, X to X). Women less often used statins (RR 0.90, 0.86 to 0.93) and beta-blockers (RR 0.93, 0.88 to 0.97), and had higher systolic blood pressure (MD 1.66 mmHg, 0.90 to 2.41), low-density lipoprotein cholesterol (MD 0.34 mmol/L, 0.29 to 0.39) and hemoglobin A1c (MD 0.11%, 0.09 to 0.14 or 1.2 mmol/mol, 1.0 to 1.5) than men.</p>
<p><strong>Limitations:</strong> We could not carry out meaningful subgroup analyses due to a small number of studies. Our study is not generalizable to low CV risk groups or high-risk CV patients in routine care.</p>
<p><strong>Conclusions:</strong> There were baseline sex disparities in diabetes CVOTs. We suggest ongoing efforts to recruit women in clinical trials, and the promotion of equitable CV management across the sexes.</p>
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