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

Andrew Tonkin, David Hunt, Merryn Voysey, Antero Kesäniemi, Andrew Hamer, Jonathon Waites, Leo Mahar, Stewart Mann, Paul Glasziou, Peta Forder, John Simes, Anthony C. Keech

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Abstract

Background: In the FIELD study, comparison of the effect of fenofibrate on cardiovascular disease (CVD) between those with prior CVD and without was a prespecified subgroup analysis. Methods: The effects of fenofibrate on total CVD events and its components in patients who did (n = 2,131) and did not (n = 7,664) have a history of CVD were computed by Cox proportional hazards modeling and compared by testing for treatment-by-subgroup interaction. The analyses were adjusted for commencement of statins, use of other CVD medications, and baseline covariates. Effects on other CVD end points were explored. Results: Patients with prior CVD were more likely than those without to be male, to be older (by 3.3 years), to have had a history of diabetes for 2 years longer at baseline, and to have diabetic complications, hypertension, and higher rates of use of insulin and CVD medications. Discontinuation of fenofibrate was similar between the subgroups, but more patients with prior CVD than without, and also more placebo than fenofibrate-assigned patients, commenced statin therapy. The borderline difference in the effects of fenofibrate between those who did (hazard ratio [HR] 1.02, 95% CI 0.86-1.20) and did not have prior CVD (HR 0.81, 95% CI 0.70-0.94; heterogeneity P =.045) became nonsignificant after adjustment for baseline covariates and other CVD medications (HR 0.96, 95% CI 0.81-1.14 vs HR 0.78, 95% CI 0.67-0.90) (heterogeneity P =.06). Conclusions: Our findings do not support treating patients with fenofibrate differently based on any history of CVD, in line with evidence from other trials.

Original languageEnglish
Pages (from-to)508-514
Number of pages7
JournalAmerican Heart Journal
Volume163
Issue number3
DOIs
Publication statusPublished - Mar 2012

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Fenofibrate
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Diabetes Complications
Type 2 Diabetes Mellitus

Cite this

Tonkin, Andrew ; Hunt, David ; Voysey, Merryn ; Kesäniemi, Antero ; Hamer, Andrew ; Waites, Jonathon ; Mahar, Leo ; Mann, Stewart ; Glasziou, Paul ; Forder, Peta ; Simes, John ; Keech, Anthony C. / 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. In: American Heart Journal. 2012 ; Vol. 163, No. 3. pp. 508-514.
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title = "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",
abstract = "Background: In the FIELD study, comparison of the effect of fenofibrate on cardiovascular disease (CVD) between those with prior CVD and without was a prespecified subgroup analysis. Methods: The effects of fenofibrate on total CVD events and its components in patients who did (n = 2,131) and did not (n = 7,664) have a history of CVD were computed by Cox proportional hazards modeling and compared by testing for treatment-by-subgroup interaction. The analyses were adjusted for commencement of statins, use of other CVD medications, and baseline covariates. Effects on other CVD end points were explored. Results: Patients with prior CVD were more likely than those without to be male, to be older (by 3.3 years), to have had a history of diabetes for 2 years longer at baseline, and to have diabetic complications, hypertension, and higher rates of use of insulin and CVD medications. Discontinuation of fenofibrate was similar between the subgroups, but more patients with prior CVD than without, and also more placebo than fenofibrate-assigned patients, commenced statin therapy. The borderline difference in the effects of fenofibrate between those who did (hazard ratio [HR] 1.02, 95{\%} CI 0.86-1.20) and did not have prior CVD (HR 0.81, 95{\%} CI 0.70-0.94; heterogeneity P =.045) became nonsignificant after adjustment for baseline covariates and other CVD medications (HR 0.96, 95{\%} CI 0.81-1.14 vs HR 0.78, 95{\%} CI 0.67-0.90) (heterogeneity P =.06). Conclusions: Our findings do not support treating patients with fenofibrate differently based on any history of CVD, in line with evidence from other trials.",
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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. / Tonkin, Andrew; Hunt, David; Voysey, Merryn; Kesäniemi, Antero; Hamer, Andrew; Waites, Jonathon; Mahar, Leo; Mann, Stewart; Glasziou, Paul; Forder, Peta; Simes, John; Keech, Anthony C.

In: American Heart Journal, Vol. 163, No. 3, 03.2012, p. 508-514.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Effects of fenofibrate on cardiovascular events in patients with diabetes, with and without prior cardiovascular disease

T2 - The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

AU - Tonkin, Andrew

AU - Hunt, David

AU - Voysey, Merryn

AU - Kesäniemi, Antero

AU - Hamer, Andrew

AU - Waites, Jonathon

AU - Mahar, Leo

AU - Mann, Stewart

AU - Glasziou, Paul

AU - Forder, Peta

AU - Simes, John

AU - Keech, Anthony C.

PY - 2012/3

Y1 - 2012/3

N2 - Background: In the FIELD study, comparison of the effect of fenofibrate on cardiovascular disease (CVD) between those with prior CVD and without was a prespecified subgroup analysis. Methods: The effects of fenofibrate on total CVD events and its components in patients who did (n = 2,131) and did not (n = 7,664) have a history of CVD were computed by Cox proportional hazards modeling and compared by testing for treatment-by-subgroup interaction. The analyses were adjusted for commencement of statins, use of other CVD medications, and baseline covariates. Effects on other CVD end points were explored. Results: Patients with prior CVD were more likely than those without to be male, to be older (by 3.3 years), to have had a history of diabetes for 2 years longer at baseline, and to have diabetic complications, hypertension, and higher rates of use of insulin and CVD medications. Discontinuation of fenofibrate was similar between the subgroups, but more patients with prior CVD than without, and also more placebo than fenofibrate-assigned patients, commenced statin therapy. The borderline difference in the effects of fenofibrate between those who did (hazard ratio [HR] 1.02, 95% CI 0.86-1.20) and did not have prior CVD (HR 0.81, 95% CI 0.70-0.94; heterogeneity P =.045) became nonsignificant after adjustment for baseline covariates and other CVD medications (HR 0.96, 95% CI 0.81-1.14 vs HR 0.78, 95% CI 0.67-0.90) (heterogeneity P =.06). Conclusions: Our findings do not support treating patients with fenofibrate differently based on any history of CVD, in line with evidence from other trials.

AB - Background: In the FIELD study, comparison of the effect of fenofibrate on cardiovascular disease (CVD) between those with prior CVD and without was a prespecified subgroup analysis. Methods: The effects of fenofibrate on total CVD events and its components in patients who did (n = 2,131) and did not (n = 7,664) have a history of CVD were computed by Cox proportional hazards modeling and compared by testing for treatment-by-subgroup interaction. The analyses were adjusted for commencement of statins, use of other CVD medications, and baseline covariates. Effects on other CVD end points were explored. Results: Patients with prior CVD were more likely than those without to be male, to be older (by 3.3 years), to have had a history of diabetes for 2 years longer at baseline, and to have diabetic complications, hypertension, and higher rates of use of insulin and CVD medications. Discontinuation of fenofibrate was similar between the subgroups, but more patients with prior CVD than without, and also more placebo than fenofibrate-assigned patients, commenced statin therapy. The borderline difference in the effects of fenofibrate between those who did (hazard ratio [HR] 1.02, 95% CI 0.86-1.20) and did not have prior CVD (HR 0.81, 95% CI 0.70-0.94; heterogeneity P =.045) became nonsignificant after adjustment for baseline covariates and other CVD medications (HR 0.96, 95% CI 0.81-1.14 vs HR 0.78, 95% CI 0.67-0.90) (heterogeneity P =.06). Conclusions: Our findings do not support treating patients with fenofibrate differently based on any history of CVD, in line with evidence from other trials.

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U2 - 10.1016/j.ahj.2011.12.004

DO - 10.1016/j.ahj.2011.12.004

M3 - Article

VL - 163

SP - 508

EP - 514

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 3

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