Fenofibrate - First Lipid Modifying Agent Shown to Protect Diabetic Eye

    -   First Lipid Modifying Agent Shown to Reduce Risk of Leading Causes of
        Blindness and Deteriorating Vision in Patients With Type 2 Diabetes

    -   Reduces Need for Laser Treatment in Patients With and Without Known
        Diabetic Retinopathy

    -   Significantly Decreases Progression of Diabetic Eye Disease

    SYDNEY, Nov. 6 /CNW/ - Fenofibrate is the first and only widely available
lipid modifying agent to demonstrate significant protection to the eye of
patients with type 2 diabetes, reducing the need for laser therapy in a wide
spectrum of patients which should decrease the risk of progressive loss of
    These effects appear independent from blood glucose as well as baseline
lipid levels, and are not explained by blood pressure values.
    These important, new results are published online in the Lancet today by
investigators from the Fenofibrate Intervention and Event Lowering in Diabetes
(FIELD) Study.
    Analyses of the results show that fenofibrate:

    -   Significantly reduces the requirement for a first laser treatment
        for diabetic eye disease:

        -  31 per cent overall (p=0.0002)

        -  31 per cent (p=0.002) for maculopathy, a major cause
           of blindness

        -  30 per cent for proliferative retinopathy (p=0.015).

        -  Significantly decreases the total number of laser therapies by
           37 per cent (p=0.0003).

    Additionally, fenofibrate almost halved (49 per cent,                   
p=0.0002) the need for laser therapies in patients who were not known to have
diabetic eye disease at study entry when considering all courses of laser
    These protective effects appear to begin after only eight months of
treatment and increase throughout the five-year treatment period.
    Fenofibrate also demonstrated, in a sub-study, a significant reduction in
the progression of eye disease with a:

    -   34 per cent reduction in a combined exploratory endpoint (progression
        of retinopathy grading by 2 steps, development of macular oedema and
        one or more laser treatments, 16.1% vs. 11.1% - HR 0.66,
        95% CI 0.47-0.94; p=0.022).

    -   Reduction by 79 per cent of the progression of existing retinopathy
        (14 cases with placebo, 14.6% vs. 3 cases with fenofibrate,
        3.1% p=0.004).

    -   Several other endpoints did not differ significantly between groups
        such as the occurrence of new retinopathy, of hard exudates or
        worsening in visual acuity.

    These new results from the FIELD trial conducted in Australia, New
Zealand and Finland, come from an analysis of the reasons for the reduction in
laser therapy reported in the initial FIELD publication and a pre-specified
ophthalmology sub-study of the effect of fenofibrate on the progression of
diabetic retinopathy in 1,012 patients who had repeated eye examinations.
    Lead investigator of FIELD, Professor Anthony Keech of the NHMRC Clinical
Trials Centre, University of Sydney, Australia, said: "For the first time we
have shown that a widely available lipid modifying agent, fenofibrate, reduces
the complications of diabetic eye disease - the major cause of impaired vision
in adults in the industrialised world."
    "Importantly, the study also demonstrates that patients without prior
known diabetic eye disease (but probably already at early stage of
retinopathy) gain significantly from fenofibrate.
    In this group the subsequent need for total laser therapy was almost
halved. Therefore, we can now hope that we can intervene to significantly
reduce the progression of retinopathy before it requires laser treatment."

    Importance for millions of diabetics

    Eye disease, including diabetic retinopathy and macular oedema, affects
up to 50 million of the 200 million people with diabetes worldwide, as after
about 10 years of diabetes most patients will experience clinically
significant changes in their vision.
    Even with intensive multifactorial therapy (antihypertensive agents, oral
antidiabetic agents, statins) retinopathy either developed or progressed in
about half of patients with type 2 diabetes within eight years (STENO 2
    Moreover, beyond control of blood pressure and blood glucose, no
effective treatment is widely available, according to another FIELD
investigator, Professor Paul Mitchell of Westmead Hospital, Sydney, Australia.
    He said: "We have to rely on laser treatment which is only partially
effective and can result in diminished visual field and other adverse effects.
Additionally, access to laser treatment is limited in many countries.
Therefore, these results offer an important new treatment option to protect
the eye of many patients with type 2 diabetes."

    Other clinical benefits

    Additional results from the FIELD Study reported this week at the
Scientific Sessions of the American Heart Association in Orlando, show that
fenofibrate significantly decreased the risk of non-traumatic amputations by
38 per cent (p=0.011). Meanwhile, earlier data demonstrated that fenofibrate
also significantly reduces microalbuminuria, a marker of the risk of
progressive renal disease.
    In addition to these microvascular benefits, new data presented at the
AHA 2007 demonstrate that fenofibrate reduced total CVD events by 26 per cent
in diabetic patients with elevated triglycerides ((greater than)2.26 mmol/L)
and low HDL-cholesterol ((less than)1 mmol/L for men and (less than)1.3 mmol/L
for women).
    Discussing the implications of these new results, Professor Keech said:
"The microvascular benefits of fenofibrate - in the eye, the limbs and the
kidney - combined with the reduction in overall cardiovascular events, means
that fenofibrate offers an important opportunity to protect patients from the
most serious consequences of type 2 diabetes.
    The FIELD study and the detailed examinations in the sub-study represent
the largest randomised trial database addressing the effects of a fibrate on
diabetic retinopathy and its treatment. The protective effects on the eye
alone are enough to support its consideration for many patients but the
determination of the stage of the disease as to when to intervene should be
considered exploratory."

    Notes to editors

    About the study

    The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study
was conducted in 9795 patients aged 50-75 from Australia, New Zealand and
Finland with type 2 diabetes. In addition a sub-study was conducted in 1,012
to evaluate the development of diabetic retinopathy and the symptoms of eye
disease. The study was supported by the manufacturer of fenofibrate,
Laboratoires Fournier SA, part of the Solvay Group: FIELD was designed,
conducted and analysed independently of the sponsor by the FIELD study
investigators, and coordinated by the NHMRC Clinical Trials Centre, University
of Sydney. Fenofibrate is marketed world-wide by Solvay Pharmaceuticals and
Abbott USA. Results of the latest study are published on-line in the Lancet
    The absolute risk reductions in first laser treatment were:

    -   Overall 1.5 per cent

    -   Maculopathy 1.0 per cent

    -   Proliferative retinopathy 0.7 per cent.

    About diabetic eye disease

    Diabetes-related eye disease is common and if untreated or poorly treated
leads to deterioration of vision and ultimately blindness. It occurs when the
small vessels (microvasculature) of the eye are damaged by the consequences of
diabetes such as increased glucose and raised blood pressure. Research also
suggests other critically important factors such as inflammation of the small
vessels of the eye which significantly increase the risk of damage to the

    What are diabetic retinopathy and macular oedema?

    Diabetic retinopathy arises from changes in the blood vessels of the
retina, a nerve layer behind the eye that senses light. When these blood
vessels become damaged, vision loss occurs by two processes known as
"proliferative retinopathy" and "macular oedema". Proliferative retinopathy
occurs when new vessels bleed into the centre of the eye often resulting in
blurred vision. Macular oedema occurs when fluid leaks from these blood
vessels into the centre of the retina or macula, making it difficult to focus.
Both of these conditions may eventually destroy the retina if left untreated.
While laser therapy is a successful treatment in preventing blindness, it may
result in the loss of vision when the macula is already involved.

For further information:

For further information: or to arrange an interview, please contact:
Australia: Justin O'Day, Ophthalmologist, Peter Colman, Diabetologist, Tim
Davis, Diabetologist, Via: Beth Quinlivan, University of Sydney, Ph:
+61-2-9036-6528, Mob: +61-0-419-229-134; At the AHA Conference, Orlando
Florida, Anthony Keech, Study Chairman, Paul Mitchell, Ophthalmologist, Via:
Olivia Rajabaly, Euro RSCG Life, Ph: +33-1-58-47-87-64, Mob:

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