Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]
Open accessAbstract
Objective: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics. Research design and methods: FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred. Results: About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of <5%, but nearly all had a 5-year stroke risk of <10%. Despite this, half of the cohort were obese (BMI > 30), most were men, two-thirds were aged over 60 years, and substantial proportions had NCEP ATP III features of the metabolic syndrome independent of their diabetes, including low HDL (60%), high blood pressure measurement or treatment for hypertension (84%), high waist measurement (68%), and raised triglycerides (52%). After a 6-week run-in period before randomisation with all participants receiving 200 mg comicronized fenofibrate, there were declines in total and LDL cholesterol (10%) and triglycerides (26%) and an increase in HDL cholesterol (6.5%). Conclusion: The study will show the effect of PPAR-alpha agonist action on CHD and other vascular outcomes in patients with type 2 diabetes including substantial numbers with low to moderate CVD risk but with the various components of the metabolic syndrome. The main results of the study will be reported in late 2005.
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Clinical studies have consistently demonstrated that fibrates reduce fasting TG levels by 30-50%, depending on baseline values and the specific agent used.
“In fact, clinical studies have consistently demonstrated that fibrates reduce fasting TG levels by 30–50%, depending on baseline values and the specific agent used [77].”
From Targeting triglycerides for cardiovascular risk reduction (2026) · cites this paper as [77]
The Results (page unavailable) report that triglycerides fell by an average of 26% after six weeks of fenofibrate treatment, below the claimed 30–50% range. The Introduction says fibrates lower triglycerides, but the study's measured reduction is a counterexample to the claim that clinical studies consistently demonstrate a 30–50% reduction. (LLM, conf=0.84)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe greatest reductions in serum triglycerides with fenofibrate are usually observed in subjects with elevated baseline triglycerides, including those with the metabolic syndrome.
“The greatest reductions in serum TG are usually observed in subjects with elevated baseline TG including those with the metabolic syndrome (MetS).”
From Fenofibrate and metabolic syndrome (2010) · cites this paper as [1]
The Results (page unavailable) report a 26% average triglyceride reduction after six weeks of fenofibrate and state that 84% of participants met metabolic-syndrome criteria. They do not compare triglyceride reductions by baseline triglyceride level or metabolic-syndrome status, so the claim that these subjects usually have the greatest reductions is not supported. (LLM, conf=0.82)
Experimental — accuracy not yet measuredClinical trials examining the cardiovascular benefits of fenofibrate alone or combined with statins have produced mixed results.
“Clinical trials examining the cardiovascular benefits of FF alone or combined with statins have produced mixed results.”
From Fenofibrate and metabolic syndrome (2010) · cites this paper as [1]
The Discussion (page not specified) reports that a fenofibrate trial found reduced progression of coronary atherosclerosis, supporting the claim that fenofibrate alone has been studied for cardiovascular benefit. It does not report mixed cardiovascular outcomes from fenofibrate trials or results from trials combining fenofibrate with statins; the Methods describe combination-treatment analyses as planned. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn the FIELD and ACCORD-Lipid trials, creatinine elevations resolved after treatment discontinuation and were not associated with markers of tubular damage.
“Consistently, creatinine elevations observed in the FIELD [77] and ACCORD-Lipid [80] trials resolved after treatment discontinuation and were not associated with markers of tubular damage.”
From Targeting triglycerides for cardiovascular risk reduction (2026) · cites this paper as [77]
The Results (page not supplied) report that creatinine rose by nearly 13% during fenofibrate treatment and describe the effect as believed to be reversible and harmless. This paper does not report creatinine levels after treatment discontinuation or an assessment of tubular-damage markers, so it does not establish those parts of the FIELD claim. The separate ACCORD-Lipid citation is outside this verdict. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn later studies (FIELD and ACCORD-Lipid), fenofibrate did not reduce major cardiovascular events in the overall study populations.
“In contrast, later studies conducted largely in patients receiving statin therapy, such as FIELD [77] and ACCORD-Lipid [80], did not demonstrate a reduction in major cardiovascular events with fenofibrate in the overall study populations.”
From Targeting triglycerides for cardiovascular risk reduction (2026) · cites this paper as [77]
The Abstract Conclusion (page unavailable) says FIELD’s main results would be reported later in 2005. The Abstract Results report baseline characteristics and six-week lipid changes, not cardiovascular-event outcomes. A search for an overall-population reduction in major cardiovascular events found no result in this copy, so it cannot verify that part of the claim. (LLM, conf=0.76)
Experimental — accuracy not yet measured
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- Authors
- The FIELD Study Investigators
- Affiliations
- The University of Sydney (AU)
- Corresponding author
- The FIELD Study Investigators
- Venue
- Cardiovascular Diabetology
- Published
- 2005-08-22
- Volume
- 4
- Issue
- 1
- Pages
- 13-13
- ISSN
- 1475-2840 (ISSN-L)
- PMC
- PMC1266033
- OpenAlex
- W1791318806
- Cited by
- 103
- References
- 38
- Citations by year
- 2026: 5 · 2025: 5 · 2024: 1 · 2023: 2 · 2022: 4 · 2021: 4 · 2020: 3 · 2019: 2 · 2018: 4 · 2017: 3 · 2016: 4 · 2015: 4 · 2014: 6 · 2013: 4 · 2012: 3
- FWCI
- 10.18
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Cardiovascular Diabetology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- UWA Profiles and Research Repository (UWA) (publishedVersion, other-oa)
- PubMed (publishedVersion)
- UNSWorks (University of New South Wales, Sydney, Australia) (submittedVersion, cc-by-nc-nd)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by)
- National University of Singapore (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Bond University Research Portal (Bond University) (submittedVersion, cc-by)
- Griffith Research Online (submittedVersion, cc-by)
- Spiral (Imperial College London) (submittedVersion, cc-by)
- Funders
- Diabetes Australia
- Diabetesliitto
- Medical Research Council
- National Health and Medical Research Council
- 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, coronary artery disease, PPARα agonist, metabolic syndrome, cardiovascular risk, lipid-lowering therapy, LDL cholesterol, HDL cholesterol, triglycerides, run-in phase, field trials
- MeSH terms
- Aged, Hypolipidemic Agents, Apolipoproteins B, Australia, Cardiovascular Diseases, Cholesterol, Coronary Disease, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Finland, Humans, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, New Zealand, Obesity, Placebos, Fenofibrate, Triglycerides, Diabetes Complications
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