Sydney, May 21: Researchers in Australia, Finland and New Zealand have found that the risk of limb amputation in patients with type 2 diabetes can be reduced by Fenofibrate. The drug, originally used to lower blood fat levels in diabetics, was found to cut the chances of minor amputation by 36 percent.
The study's authors, Professor Anthony Keech and Dr. Kushwin Rajamani of the National Health and Medical Research Council Clinical Trials Centre at University of Sydney, Australia, assessed the effectiveness of fenofibrate in lowering amputation risk through the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.
The main purpose of the FIELD study was to review if a long-term treatment with fenofibrate could reduce adverse macrovascular and microvascular outcomes in patients with type 2 diabetes, including amputations.
Researchers considered amputations as minor if they were below the ankle and major if they were above the ankle. They also classified them on whether or not large blood vessel disease or small blood vessel disease was found in the amputated limb.
Details of the study
The study included 9,795 people, aged 50 to 75 with type 2 diabetes. Half the patients were given 200 milligrams of fenofibrate and the rest a placebo daily for five years.
Over the course of the study, the researchers reported that 115 people had at least one lower-limb amputation related to their diabetes.
They also found that the risk of first amputation was 36 percent lower for all patients given fenofibrate as compared to those given placebo. Nearly 70 of those on placebo had an amputation while only 45 on the drug did.
The risk of minor amputation in patients who did not have large vessel disease and were on the drug was 47 percent lower than the placebo users.
Height played an important role. It was found that an additional 10 centimeters of height was associated with a 60 percent increase in risk (P<0.0001). Also, each additional three years in age increased the risk by 30 percent.
However the risk of major amputations didn't differ much between the two groups.
"(Fenofibrates) is the first therapy that has been shown to reduce these amputations," said Keech.
Other observations included that people with history of cardiovascular disease, microvascular disease, previous amputation, skin ulcer, smoking and chronic diabetes were more likely to have amputations as opposed to those who had neither cardiovascular issues nor amputations.
The researchers concluded: "Treatment with fenofibrate was associated with a lower risk of amputations, particularly minor amputations without known large-vessel disease ... These findings could lead to a change in standard treatment for the prevention of diabetes-related lower-limb amputations."
Amputation and Type 2 diabetes
According to the American Diabetes Association, people with diabetes are more likely to have a foot or leg amputated. This is mainly because diabetes reduces blood flow to the lower legs and feet leading to a disease called diabetic neuropathy, which increases the risk of ulcers and infections that can, in turn, result in amputation.
The results were published in the medical journal Lancet. It was sponsored by Laboratoires Fournier SA, now part of Solvay Pharmaceuticals, which makes fenofibrates, and the National Health and Medical Research Council of Australia.