Fenofibrate Reduces the Risk of Amputations in Patients With Type 2 Diabetes

    ROME, Sept. 9 /CNW/ -

    -   Exciting New Data From the FIELD Study Show Additional
        Microvascular-Associated Benefits of Fenofibrate
    -   The First Time in a Large-Scale Prospective Study That any
        Lipid-Modifying Therapy has Been Shown to Significantly Reduce the
        Risk of Lower-Limb Amputation in Patients With Type 2 Diabetes

    Fenofibrate treatment in people with type 2 diabetes mellitus reduces the
risk of amputations, including those associated with microvascular disease,
according to new data from the FIELD study presented for the first time at the
European Association for the Study of Diabetes, Rome, September 2008.(1) These
findings add to other microvascular benefits demonstrated with fenofibrate in
diabetic retinopathy, published in The Lancet 2007,(2) and diabetic
nephropathy, published in The Lancet 2005.(3)
    The FIELD study researchers showed that, over an average follow-up of 5
years, treatment with fenofibrate reduced the risk of non-traumatic amputation
by 38% (p=0.011), mainly due to a reduction in amputation considered related
to microvascular disease by 47% (p=0.025). Patients who had an amputation
associated with microvascular disease were slightly younger and heavier and
were more likely to have other microvascular disease, including diabetic eye
and kidney disease.
    According to Professor Keech, lead investigator of the FIELD study: "The
effects of fenofibrate in reducing the risk of amputations in patients with
established microvascular complications were particularly striking, and
further support the important clinical benefits of fenofibrate on
microvascular associated events in type 2 diabetes."

    The FIELD analysis on amputations

    All non-traumatic amputations that occurred during the FIELD study were
reviewed by 2 clinicians blinded to study treatment. Reasons for amputation
were recorded as presumed microvascular (amputations of toes or forefoot
(called "minor" amputations), without embolism or existing large artery
disease in the limb) or macrovascular (all other "minor" and all below-knee
and above-knee ("major") amputations).

    The profile of patients more likely to require amputation was:

    -   Male
    -   Longer duration of diabetes
    -   Higher systolic blood pressure
    -   Current smoker
    -   Previous vascular disease
    -   More microvascular complications
    -   More insulin use at baseline

     All these characteristics were considerably more common than in patients
who did not undergo amputation.

    Among all patients with an amputation, the profile of patients with a
microvascular-associated complication was:

    -   Slightly younger (p=0.03)
    -   Heavier (p(less than)0.001)
    -   Slightly higher HbA1c (p=0.07)
    -   More other microvascular complications (p=0.002)

    Significance for millions of type 2 diabetes patients

    Peripheral neuropathy (nerve damage) is a serious complication of
diabetes. Recent data indicate that one in 5 people with diabetes (20%) have
peripheral neuropathy, irrespective of whether diabetes has been clinically
diagnosed. The risk for peripheral neuropathy is about 2-fold higher than in
people without diabetes.(4) The combination of peripheral neuropathy with
problems associated with the blood supply to the feet can lead to foot ulcers
and slow-healing wounds. Infection of these wounds can result in amputation.
Every 30 seconds a limb is lost to diabetes and 40-70% of all lower extremity
amputations are related to diabetes.(5)
    Evidence indicates that improvements in management, specifically drug
therapy, have contributed to a decline in cardiovascular mortality in patients
with diabetes.(6) As people with diabetes live longer, they are more likely to
experience microvascular complications of diabetes. Together with the
increasing prevalence of type 2 diabetes among an ageing population,(7) the
burden of microvascular complications, including diabetic neuropathy and
amputation, is expected to increase substantially in the future.
    Even when treated in accordance with current standards for diabetes care,
patients remain at high residual risk of vascular complications. This is
highlighted by evidence from the STENO-2 trial in patients with type 2
diabetes. Despite optimal control of LDL-cholesterol and diastolic blood
pressure and fair glycaemic and systolic blood pressure control, microvascular
disease such as diabetic retinopathy, nephropathy or neuropathy developed or
progressed in up to 50% of these patients within 8 years.(8)
    Fenofibrate reduces the total cardiovascular risk in patients with type 2
diabetes and atherogenic dyslipidaemia (elevated triglycerides and low
    While current management strategies aimed at lowering LDL cholesterol
with statin therapy are effective in reducing cardiovascular risk in patients
with diabetes, supported by extensive evidence from a large number of
well-controlled studies,(9) there are also clear limitations to statin
treatment. Even at optimal statin doses, extensive evidence from large
clinical trials show that 65-90% of CVD events in diabetes patients are not
prevented with statin therapy.(9) This is largely because statins only partly
address the abnormalities of low HDL-cholesterol and elevated triglycerides
which are common in patients with type 2 diabetes. It is important to note
that triglyceride and HDL-cholesterol levels are strong predictors of
cardiovascular events, even in patients achieving LDL-cholesterol levels below
1.8mmol/L (70mg/dL)
    Additional FIELD data presented at this year's EASD highlight that
cardiovascular risk reduction with fenofibrate treatment is greatest in
patients with type 2 diabetes with atherogenic dyslipidaemia (the combination
of elevated triglycerides ((greater than)2.3mmmol/L) plus low high-density
lipoprotein (HDL) cholesterol ((less than)1.0mmol/L for men and (less
than)1.3mmol/L for women); fenofibrate treatment showed a 27% reduction in CVD
risk in these patients.(10) The FIELD study investigators showed that in
patients with marked diabetic dyslipidemia, 23 patients have to be treated
with fenofibrate for 5 years to avoid one CV event (NNT = 23), which is
comparable with the benefits of statin therapy already shown in landmark
    These new data highlight the benefits of fenofibrate on amputations,
including microvascular-associated amputations. Together, with previously
published data showing benefits for the eye and the kidney, these results
highlight the urgent need to address residual vascular risk in patients with
type 2 diabetes.

    Note to Editors

    A complete version of this release including all reference information
can be found at:

For further information:

For further information: Australia: James Best, Diabetologist, Russell
Scott, Diabetologist, Michael d'Emden, Diabetologist, Via: Beth Quinlivan,
University of Sydney, Ph: +61-2-9036-65-28, Mob: +61-0-419-229-134; At EASD,
Rome, Italy, Peter Colman, Diabetologist, Richard O'Brien, Diabetologist,
Anthony Keech, Study Chairman, Via: Wendy Gerber, MS&L, Ph: +44-20-7878-3259,
Mob: +44-7949-034-007

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