Benefits and safety of long-term fenofibrate therapy in people with Type 2 diabetes and renal impairment: The FIELD Study

Ting, Ru-Dee, Keech, Anthony C., Drury, Paul L., Donoghoe, Mark W., Hedley, John, Jenkins, Alicia J., Davis, Timothy M. E., Lehto, Seppo, Celermajer, David, Simes, R. John, Rajamani, Kushwin, Stanton, Kim, on behalf of the FIELD Study Investigators and Morton, A. (2012) Benefits and safety of long-term fenofibrate therapy in people with Type 2 diabetes and renal impairment: The FIELD Study. Diabetes Care, 35 2: 218-225. doi:10.2337/dc11-1109

Author Ting, Ru-Dee
Keech, Anthony C.
Drury, Paul L.
Donoghoe, Mark W.
Hedley, John
Jenkins, Alicia J.
Davis, Timothy M. E.
Lehto, Seppo
Celermajer, David
Simes, R. John
Rajamani, Kushwin
Stanton, Kim
on behalf of the FIELD Study Investigators
Morton, A.
Title Benefits and safety of long-term fenofibrate therapy in people with Type 2 diabetes and renal impairment: The FIELD Study
Journal name Diabetes Care   Check publisher's open access policy
ISSN 0149-5992
Publication date 2012-02
Sub-type Article (original research)
DOI 10.2337/dc11-1109
Volume 35
Issue 2
Start page 218
End page 225
Total pages 8
Place of publication Alexandria, VA, USA
Publisher American Diabetes Association
Language eng
Formatted abstract
OBJECTIVE Diabetic patients with moderate renal impairment (estimated glomerular filtration rate [eGFR] 30–59 mL/min/1.73 m2) are at particular cardiovascular risk. Fenofibrate’s safety in these patients is an issue because it may elevate plasma creatinine. Furthermore, guidelines regarding fenofibrate dosing in renal impairment vary internationally. We investigated fenofibrate’s effects on cardiovascular and end-stage renal disease (ESRD) events, according to eGFR, in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study.

Type 2 diabetic patients (aged 50–75 years) with eGFR ≥30 mL/min/1.73 m2 were randomly allocated to a fixed dose of fenofibrate (200 mg daily) (n = 4,895) or placebo (n = 4,900) for 5 years. Baseline renal function (Modification of Diet in Renal Disease equation) was grouped by eGFR (30–59, 60–89, and ≥90 mL/min/1.73 m2). The prespecified outcome was total cardiovascular events (composite of cardiovascular death, myocardial infarction, stroke, and coronary/carotid revascularization). Serious adverse events and instances of ESRD (plasma creatinine >400 μmol/L, dialysis, renal transplant, or renal death) were recorded. Analysis was by intention to treat.

Overall, fenofibrate reduced total cardiovascular events, compared with placebo (hazard ratio 0.89 [95% CI 0.80–0.99]; P = 0.035). This benefit was not statistically different across eGFR groupings (P = 0.2 for interaction) (eGFR 30–59 mL/min/1.73 m2: 0.68 [0.47–0.97], P = 0.035; eGFR ≥90 mL/min/1.73 m2: 0.85 [0.70–1.02], P = 0.08). ESRD rates were similar between treatment arms, without adverse safety signals of fenofibrate use in renal impairment.

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. Fenofibrate treatment should not be contraindicated in moderate renal impairment, suggesting that current guidelines may be too restrictive.

Keyword Randomized controlled-trial
Blood-glucose control
Multifactorial intervention
Microvascular outcomes
Cardiovascular events
Position statement
Q-Index Code CX
Q-Index Status Confirmed Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
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