Favourable effects of fenofibrate on lipids and cardiovascular disease in women with type 2 diabetes: results from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study
Open accessAbstract
Aims/hypothesis In the double-blind placebo-controlled Fenofibrate Intervention and Event Lowering in Diabetes trial (n = 9,795), fenofibrate reduced major cardiovascular events in type 2 diabetes. Sex-related differences in fenofibrate response could be clinically relevant and were pre-specified analyses.Methods Women (n = 3,657) and men (n = 6,138) with type 2 diabetes not using statins were assigned fenofibrate (200 mg/day) or placebo for 5 years. Effects on lipoproteins and total cardiovascular events were evaluated by sex.Results Baseline total, LDL-, HDL- and non-HDL cholesterol and apolipoproteins A-I and B differed between sexes, and these and triacylglycerol levels improved with fenofibrate in both sexes (all p < 0.001). Fenofibrate reduced total, LDL- and non-HDL cholesterol and apolipoprotein B more in women (all p < 0.001), independent of menopausal status and statin uptake. Adjusted for covariates, fenofibrate reduced total cardiovascular outcomes (cardiovascular death, fatal and non-fatal stroke and carotid and coronary revascularisation) by 30% in women (95% CI 8%, 46%; p = 0.008) and 13% in men (95% CI -1%, 24%; p = 0.07) with no treatment-by-sex interaction (p > 0.1). In patients with high triacylglycerol levels and low HDL-cholesterol, fenofibrate reduced total cardiovascular outcomes by 30% (95% CI -7%, 54%) in women and 24% (95% CI 2%, 42%) in men, with no treatment-by-sex interaction (p > 0.1).Conclusions/interpretation Fenofibrate improved the lipoprotein profile more in women than men. Cardiovascular event reductions with fenofibrate were consistently similar in women and men, both overall and among those with low HDL-cholesterol and high triacylglycerol levels. These data provide reassurance about fenofibrate efficacy in women and men. Both sexes with type 2 diabetes should be considered for fenofibrate therapy for cardioprotection.
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The ACCORD lipid study showed less primary event reduction with combination therapy in women, whereas the recent FIELD analysis showed consistent CV event reduction in women and men.
“The ACCORD lipid study showed less primary event reduction with combination therapy in women, but the recent FIELD study analysis showed consistent CV event reduction in women and men. 315”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [315]
A recent FIELD study analysis showed consistent cardiovascular event reduction in women and men.
“the recent FIELD study analysis showed consistent CV event reduction in women and men.315”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [315]
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- Authors
- on behalf of the FIELD Study Investigators, d’Emden, M. C., Jenkins, A. J., Li, L., Zannino, D., Mann, K. P., Best, J. D., Stuckey, B. G. A., Park, K., Saltevo, J., & Keech, A. C.
- Affiliations
- Royal Brisbane and Women's Hospital (AU)
- The University of Sydney (AU)
- The University of Melbourne (AU)
- Nepean Hospital (AU)
- Corresponding author
- Keech, Anthony C.
- ORCID
- Venue
- Diabetologia
- Published
- 2014-08-23
- Volume
- 57
- Issue
- 11
- Pages
- 2296-2303
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- OpenAlex
- W2081494120
- Cited by
- 49
- References
- 23
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 2 · 2023: 6 · 2022: 3 · 2021: 4 · 2020: 7 · 2019: 7 · 2018: 5 · 2017: 2 · 2016: 6 · 2015: 4 · 2013: 1
- FWCI
- 3.96
- Type
- journal article
- Language
- en
- Update notices
- correction (2015-07-18)
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Diabetologia (publishedVersion)
- PubMed (publishedVersion)
- The Sydney eScholarship Repository (The University of Sydney) (submittedVersion)
- Funders
- Medical Research Council
- National Health and Medical Research Council (1024105, 1037786, 457103)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Keywords
- fenofibrate, type 2 diabetes, sex differences, women, cardiovascular events, lipoprotein profile, cholesterol, apolipoprotein A-I, apolipoprotein B, triglycerides, HDL cholesterol, cardiovascular risk reduction, field trials, statin-naive patients, menopause, revascularization, stroke, cardiovascular mortality, cardioprotection, fibrates
- MeSH terms
- Aged, Hypolipidemic Agents, Apolipoproteins B, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Humans, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Fenofibrate, Triglycerides
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