Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial

@article{Keech2005EffectsOL,
  title={Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial},
  author={Anthony C. Keech and R. John Simes and Philip John Barter and James D. Best and R Scott and Marja-Riitta Taskinen and Peta M Forder and A Pillai and Timothy M. E. Davis and Paul P. Glasziou and Paul L. Drury and Y. Antero Kes{\"a}niemi and David Sullivan and David M. Hunt and Peter G. Colman and M. D'emden and Malcolm J. Whiting and Christian Ehnholm and Markku Laakso},
  journal={The Lancet},
  year={2005},
  volume={366},
  pages={1849-1861}
}
BACKGROUND Patients with type 2 diabetes mellitus are at increased risk of cardiovascular disease, partly owing to dyslipidaemia, which can be amenable to fibrate therapy. [...] Key MethodWe did a multinational, randomised controlled trial with 9795 participants aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry.Expand
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
TLDR
Fenofibrate improved the lipoprotein profile more in women than men, independent of menopausal status and statin uptake and among those with low HDL-cholesterol and high triacylglycerol levels. Expand
Effects of combination lipid therapy in type 2 diabetes mellitus.
TLDR
The routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with type 2 diabetes does not support the routine use. Expand
Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study
TLDR
Fenofibrate reduced albuminuria and slowed estimated GFR loss over 5 years, despite initially and reversibly increasing plasma creatinine, and may delay album inuria and GFR impairment in type 2 diabetes patients. Expand
Association of Fenofibrate Therapy With Long-term Cardiovascular Risk in Statin-Treated Patients With Type 2 Diabetes
TLDR
Evidence is found that fenofibrate therapy effectively reduced CVD in study participants with dyslipidemia, defined as triglyceride levels greater than 204 mg/dL and high-density lipoprotein cholesterol levels less than 34 mg/LC, which was comparable with that originally observed in ACCORD. Expand
Effects of fenofibrate on cardiovascular events in patients with diabetes, with and without prior cardiovascular disease: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.
TLDR
The findings do not support treating patients with fenofibrate differently based on any history of CVD, in line with evidence from other trials. Expand
Fenofibrate effects on arterial endothelial function in adults with type 2 diabetes mellitus: A FIELD substudy.
TLDR
The long-term beneficial vascular effects of fenofibrate in type 2 diabetes are likely to be mediated via mechanisms other than improvement in endothelium-dependent dilatation of conduit arteries, and may differ for the microcirculation. Expand
After the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: implications for fenofibrate.
  • F. Sacks
  • Medicine
  • The American journal of cardiology
  • 2008
TLDR
Prevention of microvascular disease, specifically, reduction in the rate of laser treatment for retinopathy and progression of albuminuria, may well be the most innovative finding of the FIELD study, especially in view of the current lack of effective preventative treatments for diabetic ret inopathy and the need for additional treatments that slow the progression of diabetic nephropathy. Expand
Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus.
TLDR
Fenofibrate treatment was not associated with beneficial changes in IMT, augmentation index, or biomarkers of inflammation and endothelial function, in patients with type 2 diabetes. Expand
Benefits and Safety of Long-Term Fenofibrate Therapy in People With Type 2 Diabetes and Renal Impairment
TLDR
Patients with type 2 diabetes and moderate renal impairment benefit from long-term fenofibrate, without excess drug-related safety concerns compared with those with no or mild renal impairment, suggesting that current guidelines may be too restrictive. Expand
Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
TLDR
The current protocol is designed to provide an ethically justifiable test of combined statin plus fibrate treatment consistent with the highest level of safety and lipid treatment standards of care. Expand
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References

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The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]
TLDR
The current evidence about use of fibrates in type 2 diabetes, from around 2000 people treated, will increase with FIELD to evidence from around 12000, and the role of fenofibrate treatment in reducing cardiovascular risk in people with type 1 diabetes will be established. Expand
The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]
BackgroundFibrates correct the typical lipid abnormalities of type 2 diabetes mellitus, yet no study, to date, has specifically set out to evaluate the role of fibrate therapy in preventingExpand
Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial
TLDR
Atorvastatin 10 mg daily is safe and efficacious in reducing the risk of first cardiovascular disease events, including stroke, in patients with type 2 diabetes without high LDL-cholesterol. Expand
Effect of fenofibrate on progression of coronary-artery disease in type 2 diabetes: the Diabetes Atherosclerosis Intervention Study, a randomised study
TLDR
Treatment with fenofibrate reduces the angiographic progression of coronary-artery disease in type 2 diabetes, even those previously judged not to need treatment, according to a computer-assisted quantitative approach. Expand
Fenofibrate reduces progression to microalbuminuria over 3 years in a placebo-controlled study in type 2 diabetes: results from the Diabetes Atherosclerosis Intervention Study (DAIS).
BACKGROUND Microalbuminuria is an early marker of diabetic nephropathy and an independent risk factor for cardiovascular disease. In the Diabetes Atherosclerosis Intervention Study (DAIS), treatmentExpand
MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial
TLDR
Direct evidence is provided that cholesterol-lowering therapy is beneficial for people with diabetes even if they do not already have manifest coronary disease or high cholesterol concentrations and statin therapy should now be considered routinely for all diabetic patients at sufficiently high risk of major vascular events, irrespective of their initial cholesterol concentrations. Expand
Secondary prevention of cardiovascular events with long-term pravastatin in patients with diabetes or impaired fasting glucose: results from the LIPID trial.
TLDR
Cholesterol-lowering treatment with pravastatin therapy prevents cardiovascular events, including stroke, in patients with diabetes or IFG and established CHD and the absolute benefits of statin therapy in these patients were confirmed. Expand
Cardiovascular Outcomes in Type 2 Diabetes: A double-blind placebo-controlled study of bezafibrate: the St. Mary's, Ealing, Northwick Park Diabetes Cardiovascular Disease Prevention (SENDCAP) Study
TLDR
Improving dyslipidemia in type 2 diabetic subjects had no effect on the progress of ultrasonically measured arterial disease, although the lower rate of “definite CHD events” in the treated group suggests that this might result in a reduction in the incidence of coronary heart disease. Expand
Diabetes, plasma insulin, and cardiovascular disease: subgroup analysis from the Department of Veterans Affairs high-density lipoprotein intervention trial (VA-HIT).
TLDR
In men with CHD and a low high-density lipoprotein cholesterol level, gemfibrozil use was associated with a reduction in major cardiovascular events in persons with diabetes and in nondiabetic subjects with a high fasting plasma insulin level. Expand
Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins
TLDR
Statin therapy can safely reduce the 5-year incidence of major coronary events, coronary revascularisation, and stroke by about one fifth per mmol/L reduction in LDL cholesterol, largely irrespective of the initial lipid profile or other presenting characteristics. Expand
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