Cholesterol Lowering Drug Reduces Diabetic Amputation Risk

One in ten diabetics will require a lower extremity amputation as a result of diabetes complications during their lifetime. According to the Center for Disease Control (CDC), approximately 71,000 nontraumatic lower-limb amputations were performed in individuals with diabetes in 2004. Some common risk factors associated with lower extremity amputations include peripheral neuropathy, large and small blood vessel disease and foot ulceration.

An ulceration (ulcer) is a break in the skin. Ulcers can develop as a result of an injury or a blister, rubbing from shoes on a prominent bone, from dry cracking skin at the heel or foot fungus between the toes. A small area of irritation can go unnoticed and develop into an open sore in diabetics with peripheral neuropathy (loss of sensation).

Ulcers which go unnoticed can become infected and this increases the risk of amputation. Diabetics with poor circulation as a result of microvascular (small blood vessel) or macrovascular (large blood vessel) disease will have difficulty healing the ulcer and difficulty healing an infection.

University of Sydney researchers reported results from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study The Lancet's Diabetes Special Issue. The study, funded by Solvay Pharmaceuticals, evaluated fenofibrate and the risk of cardiovascular death and amputation in type 2 diabetics.

The study included 9,795 diabetics ages 50 to 75 who were given either 200 mg of fenofibrate daily or a placebo. The clinicians followed the patients for five years and were blinded to the treatment allocation (fenofibrate or placebo). After five years, they found no difference between the two groups in the rate of cardiovascular death, but they did find that diabetics taking fenofibrate had a 36% lower risk of minor amputations.

Minor amputation was defined as an amputation occurring below the ankle. Previous studies have found that fenofibrate reduces the risk of microvascular complications in type 2 diabetics. As a cholesterol lowering medication known to reduce low-density lipoprotein (LDL) and triglycerides and increase high-density lipoprotein (HDL), fenofibrate has been shown to reduce overall cardiovascular events.

Microvascular complications in diabetics include ulcerations, infections and possibly even peripheral neuropathy, all of which can lead to amputation. Macrovascular disease is more often associated with below knee amputations. Fenofibrate may be a treatment option for type 2 diabetics with the potential for microvascular disease and minor amputation risk.

Rajamani K et al. Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): a prespecified analysis of a randomized controlled trial. The Lancet, Volume 373, Issue 9677, Pages 1780 - 1788, 23 May 2009.