Diabetes-related amputations can be reduced

May 27 2009

Using fenofibrate to lower blood fats in people with diabetes reduces the risk of a first diabetes-related amputation by 36 per cent. This is among the conclusions of the FIELD study, reported in an article in this week's diabetes special issue of The Lancet.

Professor Anthony Keech and Dr Kushwin Rajamani, from the NHMRC Clinical Trials Centre, University of Sydney, and colleagues, analysed data from 9795 diabetic patients aged 50-75 who took part in the FIELD study - a randomised controlled trial. Patients received either fenofibrate 200mg day (4895) or placebo (4900) for five years.

Information on amputation - a prespecified tertiary endpoint of the trial - was routinely gathered. Amputations were deemed minor if below the ankle and major if above the ankle. They were also classified on whether or not large-vessel disease was present in the limb, to distinguish amputations related to large-artery atherosclerosis from those related to diabetic microvascular disease.

One hundred and fifteenpatients had lower-limb amputations due to diabetes. Previous cardiovascular disease, microvascular disease, previous nontraumatic amputation or skin ulcer, smoking, and longer duration of diabetes were more frequent in patients who had amputations during the trial than in those who had other cardiovascular events, or in those who had neither cardiovascular events nor amputations. The risk of a first amputation was 36 per cent lower for patients given fenofibrate compared with placebo; the risk of minor amputations without known large-vessel disease was 47 per cent lower for the fenofibrate group. The risk of major amputations did not differ significantly between the two groups. Furthermore, the authors identified height as a major predictor of amputations, with a 1.6-fold increase in amputation risk for every increase of 10 cm in height.

Over a million Australians have diabetes. The costs of diabetes were estimated by the Diabcost survey in 2002 at $3 billion a year, and diabetes is implicated in 8 per cent of deaths in Australia. Nearly 6 per cent of the disease burden in Australia was attributed to diabetes in 2003, the latest year for which national statistics are available. Type 2 diabetes was responsible for most of this burden. Diabetes is increasing and is projected to be the leading specific cause of disease burden for men and second for women by 2023.

Professor Keech says: "The risk of having an amputation is a real threat for diabetes patients, even when their blood glucose and blood pressure are kept under control, and the risk is dramatically greater for those who have already had skin ulcer or amputation. Fenofibrate treatment appears to substantially reduce this risk."

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