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

Keech, Anthony; Simes, R. John; Barter, Philip J.; Best, James D.; Scott, Russell S.; Taskinen, Marja‐Riitta; Forder, Peter; Pillai, Anita; Davis, Timothy; Glasziou, Paul; Drury, Paul; Kesäniemi, Y. Antero; Sullivan, David; Hunt, David; Colman, Peter G; d’Emden, Michael C; Whiting, Malcolm J.; Ehnholm, Christian; Laakso, Markku

doi:10.1016/s0140-6736(05)67667-2

Cited by 2,800 publications

(592 citation statements)

References 29 publications

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“…The diabetic status of patients with both diabetes and dyslipidemia is crucial when assessing CV outcomes compared with non-diabetic patients with dyslipidemia. As shown in a clinical study [26], the manipulation of high TG and low HDL-C levels in diabetic patients by medical interventions does not reduce their risk of CV outcomes. Consequently, the utility of the TG/HDL-C ratio for predicting long-term CV outcomes in diabetic MHD patients needs to be carefully assessed in further large-scale investigations.…”

Section: Discussionmentioning

confidence: 90%

An Invitation of the Combination of the Geriatric Nutritional Risk Index and the Triglyceride to High-Density Lipoprotein Cholesterol Ratio as a Mortality Predictor in Maintenance Hemodialysis Patients

Hasegawa¹,

Hanafusa²,

Okazaki³

et al. 2017

IJCM

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Background: The geriatric nutritional risk index (GNRI) has been developed as a tool to assess the nutritional risk. The triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio has been shown to be a predictor of cardiovascular (CV) outcomes in the general population. Objectives: The aim of this study was to determine whether the combination of GNRI and TG/HDL-C ratio is a predictor of all-cause mortality and CV deaths in maintenance hemodialysis (MHD) patients. Methods: We performed a retrospective, observational cohort study in which we enrolled 341 MHD patients from a single center in Japan who had been followed up for a mean of 48.0 ± 12.7 months. The outcomes were defined as the occurrence of all-cause mortality and CV deaths during the follow-up period. Baseline GNRI and TG/HDL-C ratios were investigated for associations with outcomes by using Cox proportion hazards models adjusted for demographic parameters. Results: Overall, 101 of the subjects had died, of whom 52 died due to CV events during the mean follow-up period of 48.0 ± 12.7 months. The patients were grouped into four categories according to a median GNRI < 95.3 or ≥95.3 and a median TG/HDL-C ratio < 2.09 or ≥2.09. The group with a GNRI ≥ 95.3 and TG/ HDL-C ≥ 2.09 had significantly lower overall and CV mortality rate when compared with the other three groups. Conclusion: The combination of GNRI and TG/HDL-C ratio is an easily accessible marker for predicting allcause mortality and CV deaths in MHD patients.

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Section: Discussionmentioning

confidence: 90%

An Invitation of the Combination of the Geriatric Nutritional Risk Index and the Triglyceride to High-Density Lipoprotein Cholesterol Ratio as a Mortality Predictor in Maintenance Hemodialysis Patients

Hasegawa¹,

Hanafusa²,

Okazaki³

et al. 2017

IJCM

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“…However, surprisingly, the proportion of patients in whom fibrates were added to previous therapy during the index visit did not significantly decrease. It could be hypothesized that a similar proportion of patients who were prescribed fibrates during the index visit in the 2009 and the 2015 registry might be related to: 1) the fact that no clear benefit of fenofibrate therapy seen in the ACCORD trial (2010) was concordant with the results of the previous FIELD study (2005); 2) the fact that fibrates remain the most effective agents lowering triglyceride concentrations, (and in both registries approximately one quarter of patients had a triglyceride level of above 200 mg/dL despite hitherto hypolipidemic treatment) -although it needs to be emphasized that in patients at high cardiovascular risk with moderately elevated triglyceride levels, statins (especially more potent statins, such as atorvastatin or rosuvastatin) should be the first drugs of choice, as they reduce both triglyceride concentration and cardiovascular mortality [6,7,14,15].…”

Section: Discussionmentioning

confidence: 99%

How has the treatment of hypercholesterolemia in Poland changed over the last six years?

et al. 2017

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“…Examples from both the human and veterinary literature help illustrate this point. One study35 evaluated human patients with diabetes at risk for heart disease with a composite endpoint of nonfatal myocardial infarction or coronary‐related death, and found that treatment significantly lowered the risk of nonfatal infarction by 24%, but the rate of coronary‐related death tended to increase in patients receiving treatment. Another example from human medicine is a study36 that reported that treatment with an insulin sensitizer significantly decreased risk of a composite endpoint consisting of new onset of diabetes or death by 60%.…”

Section: Composite Endpointsmentioning

confidence: 99%

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges

Oyama

Ellenberg

Shaw

2017

Veterinary Internal Medicne

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Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even misleading unless the study design and reporting are carried out with care. Herein, we offer some perspective on several emerging challenges associated with RCTs, including use of composite endpoints, the reporting of different forms of risk, analysis in the presence of missing data, and issues of reporting and safety assessment. These topics are explored in the context of previously reported veterinary internal medicine studies as well as through illustrative examples with hypothetical data sets. Moreover, many insights germane to RCTs in veterinary internal medicine can be drawn from the wealth of experience with RCTs in the human medical field. A better understanding of the issues presented here can help improve the design, interpretation, and reporting of veterinary RCTs.

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

Cited by 2,800 publications

References 29 publications

An Invitation of the Combination of the Geriatric Nutritional Risk Index and the Triglyceride to High-Density Lipoprotein Cholesterol Ratio as a Mortality Predictor in Maintenance Hemodialysis Patients

An Invitation of the Combination of the Geriatric Nutritional Risk Index and the Triglyceride to High-Density Lipoprotein Cholesterol Ratio as a Mortality Predictor in Maintenance Hemodialysis Patients

How has the treatment of hypercholesterolemia in Poland changed over the last six years?

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges

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