Fenofibrate Might Reduce Amputations Caused by Microvascular Disease in Patients with Diabetes

In the manufacturer-supported FIELD trial (JW Gen Med Jan 17 2006), nearly 10,000 patients with type 2 diabetes who were not receiving lipid-lowering therapy (total cholesterol level, 116–250 mg/dL, plus plasma triglyceride level, 90–440 mg/dL or total–to–HDL-cholesterol ratio ≥4.0) were randomized to daily fenofibrate (200 mg; Tricor, Antara, and others) or placebo for 5 years. The groups did not differ in the primary outcome of first myocardial infarction or cardiovascular-related death, but fenofibrate recipients had significantly less progression of albuminuria and fewer retinal laser procedures than placebo recipients.

Now, investigators report the effects of fenofibrate on FIELD’s tertiary endpoint of nontraumatic lower-limb amputations. Amputations occurred significantly less often in the group that received fenofibrate than in the placebo group (0.9% vs. 1.4%), as did below-ankle amputations (0.6% vs. 1.1%) and below-ankle amputations without concomitant large-vessel disease (0.4% vs. 0.7%). No between-group differences were noted in above-ankle amputations or in amputations with concomitant large-vessel disease. The effect of fenofibrate on amputation risk was independent of dyslipidemia and glycemic control. The overall number needed to treat (NNT) to prevent one amputation in this trial was 197, but the NNT was only 25 for patients with previous foot ulcers and albuminuria.