People with diabetes have a 28 times greater risk of amputation than people without the disease, according to the Amputee Coalition of America (ACA), but new research from Australia shows that a drug may drastically improve the chances that people with diabetes can keep their feet.
In a five-year, randomized clinical trial reported this month in Lancet, the drug fenofibrate seemed to cut the risk of amputations in people with Type 2 diabetes by 36 percent. The reduction was due to a 47-percent reduction of risk of amputations below the ankle, absent known large-vessel disease. Rates of amputation above the ankle and amputations with large-vessel disease were seemingly unaffected by the drug.
The research team, headed by Kushwin Rajamani, MBBCh, wrote, “These findings could lead to a change in standard treatment for the prevention of diabetes-related lower-limb amputations.” Writing in an accompanying article, Sergio Fazio, MD, PhD, and MacRae Linton, MD, speculated that fenofibrate might work by improving wound healing. “This effect—more so than anti-inflammatory, antioxidant, or endothelium-mediated effects—would set fibrates apart from the many agents (statins, antihypertensives, aspirin, and vitamin E) that have so far been unable to reduce amputations in people with diabetes.”
The trial, dubbed the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, tested 9,795 participants ages 50 to 75 who had Type 2 diabetes. Half were randomly assigned to a placebo group, and the other half received 200mg of fenofibrate per day. All patients received “optimal medical treatment,” according to MedPage Today. The authors admit that the study was limited because prevalence of vascular disease in the participants was not routinely tested when the study began.
The study also identified certain risk factors among the entire set of participants. Greater height and age indicated greater risk—each additional 10cm of height meant an additional 60-percent increase in risk, and each additional three years of age added a 30 percent increase. The factors that most reliably predicted future amputation were a history of nontraumatic amputation or skin ulcer, neuropathy, and peripheral vascular disease.
The study was funded by the National Health and Medical Research Council (NHMRC) of Australia and by Laboratoires Fournier SA, Chenove, France.
