Journal article
Sex disparities in cardiovascular outcome trials of diabetes populations: a systematic review and meta-analysis
- Abstract:
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Background: Sex differences have been described in cardiovascular outcome trials (CVOTs) of diabetes populations.
Purpose: We systematically reviewed for baseline sex differences in CV risk factors and CV protection therapy in diabetes CVOTs published since 2008.
Data Sources: 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.
Study Selection: 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.
Data Extraction: Two reviewers independently abstracted study data.
Data Synthesis: 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.
Limitations: 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.
Conclusions: 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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Accepted manuscript, pdf, 332.6KB, Terms of use)
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- Publisher copy:
- 10.2337/dc19-2257
Authors
- Publisher:
- American Diabetes Association
- Journal:
- Diabetes Care More from this journal
- Volume:
- 45
- Issue:
- 5
- Pages:
- 1157-1163
- Publication date:
- 2020-04-20
- Acceptance date:
- 2020-02-08
- DOI:
- EISSN:
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1935-5548
- ISSN:
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0149-5992
- Language:
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English
- Keywords:
- Pubs id:
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1087474
- Local pid:
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pubs:1087474
- Deposit date:
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2020-02-14
- ARK identifier:
Terms of use
- Copyright holder:
- American Diabetes Association
- Copyright date:
- 2020
- Rights statement:
- © 2020 by the American Diabetes Association https://www.diabetesjournals.org/content/license Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
- Notes:
- This is the accepted manuscript version of the article. The final version is available from the American Diabetes Association at: https://doi.org/10.2337/dc19-2257
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